Methods: Between July 1, 2010 and March 31, 2012, in Tokai University Hospital, 173 patients who are scheduled moderately and highly emetogenic chemotherapy were enrolled. We underwent the additional administration of aprepitant to standard antiemetic therapy for patients
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had CINV Grade 2 or more in CTCAE ver. 4.0. The primary endpoint was complete response (CR) during the acute and delayed phase. Results: By the combination of standard antiemetic therapy and aprepitant, reducing effect of CINV comparable to those patients who do not require the additional administration of aprepitant were observed. In Cisplatin (CDDP) regimen with aprepitant, a significant improvement was observed in acute and delayed period. In Carboplatin (CBDCA) regimen, CR on the acute phase with standard therapy had been obtained, a significant improvement with aprepitant was observed in the delayed period. By looking at the changes in CINV, CDDP regimen showed improvement around the fourth day from the first day. On the other hand, with CBDCA regimen showed improvement after the second day, in the third and fourth day in particular. The improvement of CINV by administering aprepitant positive correlation was observed. Conclusions: Addition of aprepitant to standard antiemetic therapy was effective for gynecologic cancer chemotherapy.
MASCC-0369 Cisplatin intraperitoneal administration for treatment of symptomatic malignant ascites in patients with advanced gastric cancer S. Hamauchi1, H. Yasui1, Y. Onozawa1, A. Fukutomi1, K. Yamazaki1, N. Machida1, T. Yokota1, A. Todaka1, T. Tsushima1 1 Gastrointestinal Oncology, Shizuoka Cancer Center, Sunto-gun, Japan Introduction: Symptomatic ascites is a most common complication of advanced gastric cancer (AGC), and impair a patient’s quality of life. The treatment for these patients is limited. Objectives: The objective of this study was to review the safety and efficacy of cisplatin intraperitoneal administration (CDDP i.p.) in Japanese patients with AGC. Methods: The subjects were 59 patients with AGC who received CDDP i.p. for symptomatic malignant ascites between September 2002 and October 2012 at the Shizuoka Cancer Center. Intraperitoneal CDDP was administered once a week at 200 mg/body with thiosulfate 10 g/body bolus and continuous infusion after drainage almost ascites. Drainage free survival (DFS) was counted from the date of treatment initiation to the date of re-drainage or death. Results: Of the 59 patients, 40 (68 %) were male, 36 (61 %) were ECOG PS of 3 and the median age was 58 years. Fifty five patients (93 %) have received prior chemotherapy with a median number of regimens of 2 (range: 0–5). The median DFS was 30 days, and the median survival time was 90 days. The median length of hospitalization was 16 days. Ascites response was 47 % and the rate of PS improvement was 27 %. Twenty seven patients (46 %) could increase dietary intake and eight patients (14 %) became to be able to withdraw intravenous infusion. The most commonly CDDP i.p. related adverse events were fever (Grade1/2 34 %) and abdominal pain (Grade1/2 27 %). Conclusions: The CDDP i.p. for symptomatic malignant ascites of AGC patients is well tolerated and may be one optional treatment.
MASCC-0370 Transcriptome profiling of peripheral leukocytes to identify potential biomarkers for oxaliplatin induced neuropathy M. Morales1, L. Boronat1, M.L. Soriano1, R. Gonzalez-Fernandez2, J. Avila2, P. Martin-Vasallo2 1 Medical Oncology, Hospital Universitario Ns Candelaria, SANTA CRUZ DE TENERIFE, Spain, 2Biochemistry & Molecular Biology, University of La Laguna, LA LAGUNA, Spain Introduction: Peripheral neuropathy is an important side effect of oxaliplatin, greatly affecting function and quality of life.
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Objectives: The aim of the study is the differential gene expression induced by FOLFOX chemotherapy (CT) in leucocytes. Methods: Peripheral leukocytes from patients before and after three FOLFOX cycles were isolated with Ficoll-Hypaque gradient. We isolated mRNA from leukocytes from ten patients with 2–4 grade neuropathy and differential transcriptome were analysed. Results: Differential transcriptomics showed a series of genes expressed at variable number of mRNA copies. Comparison between both series (post- and pre-CT) gave a list of about 1,200 genes, from those, we selected all expressed, at least, twice as much as their correspondent. 270 genes were selected. This list includes genes coding for metabolic proteins (mitochondrial and cytosolic), transcription factors, cellular dynamics and enzymes involved in drug resistance mechanisms. Conclusions: These results show that FOLFOX chemotherapy varies the expression of some genes that, ultimately, drives the cell to two opposite fates: apoptosis or survival and mitosis. Along with this effects on cancer cells, cytotoxicity produces non-desirable effects on normal healthy tissues, some of these variations could be causative CT unwanted effects. Is our propose to get the trascriptome of patients suffering from peripheral neural toxicity induced by FOLFOX in order to know what genes are involved in such non-desirable effect and through what specific signal transduction ways. References: 1. Eur J Cancer 2008: 44; 1507–1515. 2. J. Peripher. Nerv. Syst. 2008: 13; 27–46. 3. Eur. J. Cancer 2007: 43; 2658–2663.
MASCC-0371 Interregional guideline of the role of complementary therapies in supportive care in oncology S. Trager1, M. Rodrigues2, F. Farsi3, D. Alimi4, I. Krakowski5 1 Oncology, Groupe Hospitalier Public du sud de l’Oise, Senlis, France, 2 Oncology, Institut Curie, Paris, France, 3Oncology, Réseau Espace Santé Cancer Rhône-Alpes, Lyon, France, 4Centre de Traitement de la Douleur, Institut Gustave Roussy, Villejuif, France, 5Oncology, Centre Alexis Vautrin, Vandoeuvre les Nancy, France Introduction: Complementary and alternative medicines are used worldwide by cancer patients. Those practices are now taking a significant place in the health services though they still represent a divisive issue in France. The French public authorities have recently launched a global reflection on this subject. The French association for supportive care in cancer (AFSOS) has organized a survey in partnership with the French National Academy of Medicine and a guideline to offer to caregivers information on complementary therapies. Objectives: To elaborate a guideline for professionals to better inform cancer patients about the use of complementary therapies. Methods: In accordance with the AFSOS1 procedure, an interregional working group including physicians, oncologists, nurses, supportive care specialists, and other professionals involved in complementary therapies has been created. This group achieved the following tasks: - An analysis of the literature published on this topic. - Several phone meetings allowing circumscribing the question, defining the methodology and elaborating a work plan. - This work has been presented and discussed during the “national supportive care guidelines sharing days”, which were organized by AFSOS in December 2012. As a result of the working session, the modifications were integrated and a complete validation was obtained by consensus in plenary session Results: cf
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Conclusions: This French interregional and multidisciplinary guideline is a very useful tool to help teams informing patients on risks and benefits of these therapies, aiming at getting rid of prejudices and reminding the regulatory framework. The final goal is to enhance the relationship and the dialog between patients, complementary medicine practitioners and caregivers.
MASCC-0372 Factors contributing to a good cancer death—findings from a study of hospital and home deaths in Cape town C. Manicom1 1 Social Work, GVI Oncology, Cape Town, South Africa Introduction: A study of hospital and home deaths from patients of a private oncology practice in Cape Town provided insight into the survey respondent’s observations about the dying process. Objectives: The objectives were to establish whether or not a Good Death was possible in a hospital context, and what other factors contributed to the respondent’s perception of a Good Death. To quantify these objectives, the study listed components that family members believed contributed to a Good Death, and assessed how many family members thought the death they experienced was a Good Death. Methods: The postal survey yielded 24 respondents from the Hospital Death (HospD) category and 34 from the Home Death (HD) category who were requested to provide their own wording to describe a Good Death and were additionally asked whether they believed the death to have been a Good Death. Results: Basic demographic details of the deceased are provided as a backdrop to survey results. The ten most commonly mentioned themes formed the list of components of a Good Death which will be presented. 50 % of the HospD and 56.7 % of the HD group believed this was a Good Death, with 25 % and 40 % respectively being unsure. 25 % of the HospD group and 3.3 % of the HD group responded that this had not been a Good Death. Conclusions: Good Death is possible in an acute care hospital setting, and dying at home does not always guarantee a Good Death. Suggestions for assisting the dying patient to a better death are provided.
MASCC-0374 The brief cope in cancer research M. Hankins1, C. Foster1, N. Hulbert Williams2, M. Breckons1 1 Faculty of Health Sciences, Macmillan Survivorship Research Group, Southampton, United Kingdom, 2Department of Psychology, University of Chester, Chester, United Kingdom Introduction: The need to understand the problems faced following treatment and how they are resolved is becoming increasingly important for cancer survivors and service planners. The Brief COPE is used in research to assess coping strategies used by cancer patients at various stages; it comprises 28 items covering 14 domains of coping and is reported to have acceptable reliability and validity. Objectives: To explore the reliability and factor structure of the Brief COPE for cancer research using data from three separate studies Methods: Brief COPE data were collected in three separate studies (N=182; N=160; N=130). Reliability of subscales was assessed cross-sectionally within each sample using Cronbach’s Alpha. Factor structure was examined using exploratory and confirmatory factor analysis on pooled data (N=472). Results: Scale reliability varied widely across scales and samples (0.40 to 0.96), equating to measurement error of between 4 % (good) and 60 % (unacceptable). Scales with low reliability were Acceptance, Self-distraction, Behavioural Disengagement, Venting and Denial.
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Scales with high reliability (Alpha>0.80) were Emotional Support, Substance use, Religion and Humour. The proposed structure of 14 subscales was not supported by the pooled data Conclusions: The Brief COPE measures coping strategies with varying reliability, with some scales falling far below acceptable thresholds. The proposed structure of 14 subscales was not supported by analysis of the pooled data, The kinds of coping strategies used by people with cancer should be clarified with more detailed qualitative research and new, more reliable measures developed with greater patient involvement if the concept is to retain any utility in cancer research.
MASCC-0375 Vaginal dryness in haemato-oncological patients prevention and treatment decision tree C. Eeltink1, O. Visser1 1 Haematology, VU University Medical Center, Amsterdam, Netherlands
Conclusions: With help of the decision tree, healthcare providers are able to distinguish between the various options to treat and prevent vaginal dryness. Women should be educated about the need of the various strategies, such as vaginal lubricants, moisturizers and estrogen therapy.
MASCC-0376 Early evaluation predicts pain relief of irradiated bone metastases: a single-center prospective study P. Truntzer1, D. Atlani2, M. Pop1, J.B. Clavier1, S. Guihard1, C. Schumacher1, G. Noel1 1 Radiotherapy, Centre Paul Strauss, STRASBOURG Cedex, France, 2 Radiotherapy, Centre Hospitalier Pasteur, Colmar, France Introduction: Radiation therapy is an effective modality used for palliative care. Most studies completed to date have endpoints of 1 month or greater after treatment completion. Objectives: This study analyzed the response rates at different time points during the first month after treatment
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Introduction: Haemato-oncological patients can suffer from vaginal dryness causing itching, burning, irritation, and pain, and as a result sexual activity can be compromised. Despite the various safe and effective options only a minority of the patients will seek help. Objectives: To present a decision tree in which basic information on the differential diagnosis can decide which treatment should be used. Methods: Relevant published literature was used to identify the etiology and the available strategies for vaginal dryness in haematooncological female patients. Results: In haemato-oncological patients vaginal dryness can be caused by different reasons, e.g. sexual problems, or by vaginal atrophy as a result of (premature) menopause, or by pain due to (chronic) graft versus host disease. The decision tree differentiates between prevention and treatment. Each risk factor needs a particular intervention: topical or systemic estrogen therapy for vaginal atrophy, non-hormonal moisturizer to hydrate the vaginal mucosa, or a vaginal lubricant to minimize dryness and pain during sexual activity.
Methods: From May 2010 to November 2011, 61 patients treated for 74 metastases were included in the study. The end points were defined as the completion of treatment (CT) and d8, d15 and d30 after the completion of treatment. The response rate was measured by the worst pain in the last 24 h and the administered opioid dose. Patient assessment was performed during consultations and phone appointments. Results: The overall response rate significantly improved from the CT (38 %) to d8 (53.8 %), d15 (53.8 %) and d30 (57.1 %) (respectively p< 0.001; p < 0.001 and p = 0.001). The improvement peaked at d8. Patients responding to the treatment at d8 had a significative longer pain relapse free survival (PRFS) compared to patients not responding (3.38 weeks vs 0.3 weeks; p<0.001). However, the pain decrease did not result in a performance status improvement, which declined over time (p<0.001). Conclusions: Radiation therapy is an efficient treatment method for providing pain relief. This relief continues until d8 after treatment, and the response at d8 is predictive of the response at 4 weeks. Pain management alone is not enough to improve performance status, further studies are need to evaluate a more global supportive care approach.
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MASCC-0377 Content validation of the brain symptom and impact questionnaire (BASIQ) in patients and health-care professionals to assess quality of life in patients with brain metastases G. Bedard1, S. Ray2, L. Zhang1, L. Zeng1, D. Cella3, E. Wong1, C. Danjoux1, M. Tsao1, E. Barnes1, A. Sahgal1, L. Holden1, N. Lauzon1, E. Chow1 1 Radiation Oncology, Sunnybrook Health Sciences Centre, Toronto, Canada, 2Health Economics & Outcomes Research (HEOR), Abbvie, North Chicago, USA, 3Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, USA Introduction: Brain metastases specific questionnaires are lacking. Objectives: To validate the content items of the Brain Symptom and Impact Questionnaire (BASIQ) for brain metastases. Methods: Patients with brain metastases and their health care professionals (HCPs) assessed the relevance of each item of the BASIQ on a 0–10 scale with 10 as extremely relevant. Results: Fifty two patients and 20 HCPs participated in this study. 95 % of HCPs and 85 % of patients found all items on the BASIQ to be relevant. Balance and walking ability were rated relevant by 100 % of patients and HCPs. Headache, nausea, energy, memory, and ability to do housework were also rated relevant by 100 % of HCPs. Over 95 % of patients determined the items of ability to do housework, tiredness, energy, vision, memory, and putting ideas into words as relevant. There were no items rated below 7 by patients or below 5 by HCPs. Balance (8.4) and walking ability (8.3) were rated the most relevant items by patients, while headache (8.4) and nausea (8.3) were rated the most relevant by HCPs. No new issues were consistently identified, and no item was consistently rated as being inappropriate, upsetting or irrelevant. When comparing patients with HCPs, there was no significant difference in the determination of whether or not an item was relevant. Conclusions: The BASIQ encompassing symptom and impact designed specifically for use in the brain metastases population has undergone successful content validation. Its psychometric validation is ongoing. References Acknowledgement: We thank the sponsor of Abbvie and the survey participants
MASCC-0378 Efficacy and cost-evaluation of web-based guided self-help targeting psychological distress in cancer survivors I. Verdonck-de Leeuw1, A.M. Krebber1, H.F.E. Smit2, B.I. Witte3, R. de Bree4, P. Cuijpers2, A. van Straten2, G.M. Eeckhout5, A.T.F. Beekman5, C.R. Leemans4 1 Otolaryngoloy/Head and Neck Surgery, VU University Medical Center, Amsterdam, Netherlands, 2Clinical Psychology, VU University, Amsterdam, Netherlands, 3 Epidemiology and Biostatistics, VU University, Amsterdam, Netherlands, 4Otolaryngology/Head and Neck Surgery, VU University, Amsterdam, Netherlands, 5Psychiatry, VU University, Amsterdam, Netherlands Introduction: Cancer survivors often suffer from psychological distress. Information on cost-effectiveness of psychosocial intervention among cancer survivors with distress is scarce. Objectives: To develop and evaluate efficacy and costs of a web-based guided self-help intervention targeting psychological distress in head and neck cancer survivors Methods: In a randomized clinical trial, patients with distress in the intervention group followed a stepped care model: 1. Watchful waiting 2. Guided self-help. In the control group, patients received care as usual. Outcome measures were the HADS, EORTC QLQ-C30, QLQ-HN35,
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and QLQ-PATSAT and were evaluated before and direct and at 3 months after intervention. Effect sizes were calculated and linear mixed models and t-tests were used to assess differences between the groups regarding the course of the outcomes from baseline to follow-up. A cost utility analysis was performed using data on EQ-5D and health care utilization and work loss (TIC-P and PRODISQ). Results: Forty-five patients were randomized into the intervention group (24 % preferred to use the Internet format) and 36 in the control group. Intervention was beneficial with effect sizes ranging from 0.80 (HADS-total), 0.73 (HADS-A), and 0.75 (HADS-D) post-treatment to 0.72, 0.64, and 0.67 at follow-up. At follow-up, mean HADS differences were no longer statistical significant. Several QOL domains improved significantly, especially at follow-up. The incremental costs were €438 (SE=372) and the incremental effect utility was 0.06 (SE=0.045) Conclusions: This pilot RCT reveals that among distressed cancer survivors, guided self-help speeds up recovery of distress with beneficial effects on quality of life in the longer term, but to additional costs.
MASCC-0379 Development and validation of a new tool for functional evaluation in cancer patients: the cancer functional assessment set (CFAS) C. Miyata1, T. Tsuji1, K. Honaga1, A. Ishikawa1, A. Tanuma2, M. Liu1 1 Rehabilitation, Keio University School of Medicine, Tokyo, Japan, 2 Rehabilitation, Shizuoka Cancer Center, Shizuoka, Japan Introduction: Over the past several years, the demand for cancer rehabilitation services has increased. Rehabilitation specialists must properly evaluate the neuromuscular, musculoskeletal, and functional status of patients in order to deliver more effective rehabilitation. Such a measurement tool should be a single assessment that is both usable in daily clinical practice and suitable for various stages of cancer. Objectives: The purpose of this study was to develop and evaluate psychometric properties of a new measurement tool, the Cancer Functional Assessment Set (cFAS). Methods: This study took place in four phases: 1) item generation, literature search, and a round table discussion with three rehabilitation specialists; 2) item reduction and selecting appropriate items from the first item pool; 3) validity testing involving 69 cancer inpatients at the Shizuoka Cancer Center to assess construct validity and concurrent validity; and 4) responsiveness, in which standardized response mean values were calculated. Results: The cFAS consists of 24 items. Factor analysis identified six factors: maximal ability for daily living activity (factor 1); muscle strength (factor 2); balance (factor 3); ankle ROM (factor 4); sensory function (factor 5); and shoulder ROM (factor 6). Significant correlations were found between the total cFAS score and existing scales (ECOG-PS, KPS, and FIM). The cFAS was more responsive to changes than the other tools, regardless of the treatment regimen. Conclusions: The cFAS was developed and found to have good validity and responsiveness. It can be a useful tool in clinical trials and contribute to development of cancer rehabilitation.
MASCC-0380 Reliability of the newly developed cancer functional assessment set (CFAS) C. Miyata1, T. Tsuji1, K. Honaga1, A. Ishikawa1, A. Tanuma2, M. Liu1 1 Rehabilitation, Keio University School of Medicine, Tokyo, Japan, 2 Rehabilitation, Shizuoka Cancer Center, Shizuoka, Japan Introduction: A new tool for functional evaluation in cancer patients, the Cancer Functional Assessment Set (cFAS), was developed. It is
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based on the World Health Organization model of ICIDH and ICF and is useful for planning a more effective rehabilitation program and modifying goals in accordance with patients’ conditions. Objectives: The purpose of this study was to evaluate the reliability of the cFAS. Methods: Cronbach’s alpha was calculated for a sample of 69 cancer inpatients to determine the degree of internal reliability of the 24 items of the cFAS. Inter-rater reliability testing was conducted in 20 inpatients. Two raters evaluated each patient with cFAS independently within a 24-hour period. To estimate inter-rater reliability, weighted kappa statistics were used for the 24 items, and the intra-class correlation coefficient, the ICC (2,1), was used for the total cFAS score. Results: Cronbach’s alpha coefficient for the cFAS exceeded Nunnally’s criterion of 0.7. The ICC (2,1) for the total cFAS score was 0.97. Using the weighted kappa for scale items, agreement between investigators ranged from substantial (0.74) to almost perfect (1.00). Conclusions: Cronbach’s alpha coefficient for the cFAS demonstrates acceptable internal consistency. The weighted kappa statistics for the 24 items of the cFAS and the ICC for the total cFAS score demonstrated sufficient inter-rater reliability. These results indicate that the cFAS is a reliable instrument.
MASCC-0381 Development of a self-management portal for patients after total laryngectomy I. Verdonck-de Leeuw1, I.C. Cnossen1, C.F. van Uden-Kraan1, S.E. Eerenstein1, R. de Bree1, C.R. Leemans1 1 Otolaryngology/Head and Neck Surgery, VU University Medical Center, Amsterdam, Netherlands Introduction: After total laryngectomy patients have to deal with altered speech, swallowing and smell function. Objectives: We aim to develop a self-management portal to support patients in their rehabilitation process. To ensure sufficient adoption, a participatory process design is followed. Methods: A patient’s needs assessment (N=9) was conducted through a focus group interview. Care professionals (N=11) discussed the intervention content and structure. A plan of requirements was formulated. Usability of the intervention prototype was tested by patients (N=6). Speech therapists (N=10) participated in cognitive walkthroughs. Results: A self-management portal was build including information about 1) flexibility exercises for neck and shoulders, 2) nutrition, 3) olfactory rehabilitation, 4) tracheostomy care, 5) voice prosthesis care, 6) speech rehabilitation. Based on the usability tests the user interface was adjusted. Speech therapists appreciated the completeness of information and the way the information was offered (multimedia). All expressed the intention to implement the intervention in regular care when available Conclusions: Study results give insight into the characteristics needed to design a useful e-health portal, with a guided web-based intervention to provide information and support patients after a laryngectomy during the rehabilitation process. A booklet with DVD will be made available for patients without internet access. References: www.verderzonderstembanden.nl
MASCC-0382 The utilization of telephone follow-up in the advanced cancer population: a review of the literature R. Chow1, M. Zhou1, E. Chow1, G. Bedard1, L. Zeng1, H. Lam1, D. Chu1, N. Lao1, N. Lauzon1, L. Holden1 1 Radiation Oncology, Odette Cancer Centre, Toronto, Canada
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Introduction: Telephone follow-up is becoming more frequently used as an adjunct to clinical follow-up Objectives: To review the literature, examine the utility and effectiveness of telephone follow-up in the advanced cancer population Methods: A literature search was conducted on Medline (1980—April week 4 2012), Embase (1980—2012 week 17), Cochrane Central Register of Controlled Trials (April 2012) and CINAHL (1981—July 31 2012) Results: A total of 11 studies were identified that were published between 2001 and 2011. Follow-up at week 4 (month 1) was the most common interval for patient contact. Information collected during the contact varied with the study, however the most commonly used tool was the ESAS. Other information included analgesic diary, patient feedback, satisfaction with the care, post treatment side effects, along with a variety of quality of life questionnaires. Some studies provided information to the patient about protocols for care, advice and coping strategies. Attrition was common even with the use of telephone contact in place of clinical follow-up. Conclusions: Telephone follow-up is a feasible alternative to traditional hospital follow-ups for assessment of symptom palliation. There are fewer burdens on the patient allowing for a better maintenance of quality of life and lower rates of attrition in clinical trials. Patients had an overall positive opinion of the use of this alternate approach with no common disadvantages. A combination of follow-up strategies, such as clinic follow-up and telephone contact for those not attending, may result in a more comprehensive assessment.
MASCC-0383 Palliative radiotherapy in the treatment of lung metastases or advanced lung cancer J. Nguyen1, D. Chu1, G. Bedard1, E. Wong1, F. Jon1, C. Danjoux1, E. Barnes1, M. Tsao1, L. Holden1, E. Chow1, E. Lauzon1 1 Department of Radiation Oncology, Odette Cancer Centre Sunnybrook Health Sciences Centre University of Toronto, Toronto, Canada Introduction: In patients with advanced lung cancers or lung metastases, an improvement or maintenance of quality of life (QOL) is a primary endpoint for treatment. External beam radiotherapy (EBRT) is effective in palliating numerous debilitating symptoms in this population; however, the side-effects of the treatment itself have yet to be adequately examined. Objectives: This case series aims to assess whether the palliative benefits of EBRT outweigh its acute toxicities in patients with advanced primary lung cancers or lung metastases. Methods: Five cases in which patients were diagnosed with advanced lung cancers or lung metastases and treated with palliative EBRT were appraised. Every day from baseline until 10 days post-treatment, the patients filled out diaries, which noted their medications and evaluated their perceived severity of the following symptoms: coughing, hemoptysis, dysphagia, chest pain and dyspnea. In conjunction with the diaries, two QOL questionnaires, the EORTC QLQ-C15 PAL and the EORTC QLQ-LC13, were completed. Results: The patients’ QOL assessments revealed that two patients had an improved QOL, another two experienced no change in QOL and one had a worsened QOL. Analysis of the patients’ diaries showed that three patients noticed symptom palliation, one perceived no change in symptoms, and another patient recognized multiple acute side-effects post-treatment. Conclusions: Due to the limited number of cases and time of assessment, it remains unclear whether EBRT provides benefits that
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supersede its acute side-effects. Further research is recommended in order to guide future modifications in EBRT treatment for patients with advanced primary lung cancers and lung metastases.
MASCC-0384 An update of the quality of life measurements in advanced lung cancer patients receiving palliative radiotherapy: a literature review
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an uncommon endpoint for this patient population. Thus, physicians should focus more on QOL assessment as symptom palliation tools can potentially show inconsistencies between the physician and the patient. It is also encouraged that lung-specific QOL questionnaires be used in tandem with general questionnaires within this cohort.
MASCC-0385 Elderly survivors reflect on coping with their cancer journey
D. Chu1, J. Nguyen1, K. Koo1, L. Zeng1, G. Bedard1, H. Lam1, E. Wong1, M. Popovic1, E. Chow1 1 Department of Radiation Oncology, Odette Cancer Centre Sunnybrook Health Sciences Centre University of Toronto, Toronto, Canada
E. Kahana1, B. Kahana2, B. Kahana3 Sociology, Case Western Reserve University, Cleveland OH, USA, 2 Psychology, Cleveland State University, Cleveland OH, USA, 3 Radiation Oncology, Marshfield Clinic, Marshfield WI, USA
Introduction: Lung cancer is the leading cancer-related cause of death in both men and women. As lung cancers tend to be diagnosed in its advanced stages, their treatments are mainly palliative in intent; therefore, quality of life (QOL) should be used to assess overall well-being, rather than traditional endpoints, such as survival rate Objectives: To conduct a systematic review of validated instruments used to assess QOL in patients with advanced primary or metastatic lung neoplasms. Methods: A literature search was conducted in the EMBASE (1950–2012 week 30) and MEDLINE (1946–2012 week 3 July) databases. All compiled studies utilized QOL or symptom palliation as a primary or secondary outcome for patients with advanced lung cancer. Results: A total of 17 studies met the criteria required for inclusion. Four questionnaires were most commonly used: the EORTC QLQ-C-30, the EORTC QLQ-C-13, the Rotterdam Symptom Check-list (RSCL), and the Hospital Anxiety and Depression Scale (HADS). Eleven of seventeen (65 %) studies evaluated symptom palliation. Nine of the seventeen (53 %) studies evaluated QOL in their cohorts; of those nine, seven (77 %) utilized a lung-specific tool Conclusions: The limited number of studies assessing QOL in patients with advanced lung cancers suggests that QOL is still
Introduction: This paper focuses on perspectives of elderly cancer survivors on their experiences of coping with cancer during various phases of their illness career (Charmaz, 1991) Objectives: Anchored in the sociology of the life course this study explores the meaning of living with cancer as reflected in narratives of elderly cancer survivors. Methods: A nonclinical sample of 174 older adults who reported a cancer diagnosis were selected from a panel study of successful aging (Kahana et al., 2009). In depth interviews with respondents focused on perceived stressors and coping strategies at different phases of their cancer experience. Themes were derived from narratives based on consensus by three raters Results: Elderly patients accepted the diagnosis without dismay. Most respondents (62 %) expressed determination to fight the disease. Less than 10 % expressed fear after diagnosis. Resolve and determination during the diagnosis phase was followed by assuming a more passive ‘sick role’ during the treatment phase, relying on expert medical care (Parsons, 1951). Elderly patients reported confidence and trust in their doctors and satisfaction with communications. During the longer term survivorship phase older adults looked back at the adaptations they found most useful. The majority reported valuing active coping styles. These include seeking social support and instrumental orientations to dealing with the illness followed by religious or spiritual approaches.
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Table 2 Coping Strategies in the Post Survivorship Phase 1. The number one ranking coping strategy referred to marshaling social support. This included turning to others for emotional or instrumental support (35 responses). We refer to respondents using this type of coping asa “The Neworkers”. Response examples include: “My wife was supportive and I am still trying to get help from my doctors” and “I moved in with my daughter, she knows what to do”. 2. The second highest ranking focused on instrumental coping strategies whereby patients took active steps to manage their illness (25 responses). We refer to this group as the “Take Charge Patients”. Examples include: “I choose self-reliance, if you have a problem, take care of it” and “I consistently kept doctor appointments, I tried an organic diet, read pertinent articles and shared my experiences with others.” 3. The next highest ranking included religious coping (24 responses). This included turning to religion, praying, or spirituality. We refer to this group as the “Pious Copers”. Examples include: “I used my spiritual self to cope” and “I had a belief God was looking after me and he did. Religion and spirituality, prayer has been a big help.” 4. The next group of responses relate to intra-psychic coping strategies including reappraisal of the situation and making positive comparisons (23 responses). We referred to this group as “Stay Positive Patients” examples include: “Acceptance helped me by seeking the inspiration and consolation. I kept a positive attitude” and “Forgetting about it and live your life every day, just be positive”. 5. Number five included coping strategies that reflected “keeping busy” and keeping one’s mind off the challenges of the cancer experience (14 responses). We referred to this group as the “Busy Bees”. Examples include: “Keeping up routines as much as possible and continuing to focus on other areas of my life as well, giving is a therapeutic environment for me” and “It wasn’t a challenge for me I didn’t have time… I had teenagers at home”. 6. The next group felt there was no need to enact coping strategies as the treatment they received cured them of their cancer (12 responses). We referred to this group as the “Get Treated and Forget It” patients. Examples include: “I didn’t have to cope, he cut it out and that was it” and “the cancer was eliminated and I led my life as it should”. 7. This group included people who went on their lives and chose not to dwell on their cancer experience. This group realized that they were living with cancer, but made a conscious decision to not focus on their illness. We referred to this group as the “The Passers By” (11 responses). Examples include: “There was no coping, I did what had to be done and that’s it” and “I have inner strength, I am a fatalist, what will be, will be”. 8. This group was characterized as dependent copers, in the sense that they left the coping to someone else. We referred to this group as “Dependent Copers”. This orientation is reflected in the following statement, “My spouse dealt with my cancer for me” (5 responses) 9. This group consisted of the emotional copers, or people who referred to crying or becoming very sad in response to their cancer. We referred to this pattern as the “Emotionally Afflicted” It is notable that there were only 3 people who reported engaging in this coping strategy. 10. This group referred to post-traumatic growth or transformation. We referred to them as the “Benefit Fiders” (3 responses). Examples include, “Some priorities have changed—you know what is important”.
Conclusions: The ‘on time’ interpretation of having a cancer diagnosis in old age may diminish the stressfulness of the diagnosis and may enhance the patients’ ability to proactively deal with the reality of their illness.
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MASCC-0386 Screening for distress in community-based cancer support organizations M. Fitch1, A. McAndrew2, K. Pang2 1 Oncology Nursing/Patient & Family Support Program, Odette Cancer Centre Sunnybrook Health Sciences Centre, Toronto, Canada, 2Oncology Nursing, Odette Cancer Centre Sunnybrook Health Sciences Centre, Toronto, Canada Introduction: Distress is recognized as the 6th vital sign. Distress screening is used in clinical settings to identify what patients are most concerned about and guide discussion about interventions that would be helpful. Recently questions have been raised from community–based cancer support volunteer organizations about the relevancy of screening for distress for them. Objectives: The purpose of this project was to develop and field-test an approach to distress screening in community settings. Methods: A literature review was conducted to identify relevant screening tools for a community-based volunteer setting. Focus groups with patients/survivors, volunteers, and staff members of communitybased agencies were held to review tools and explore ideas for distress screening in their setting. Based on the focus group results, a new standardized approach to distress screening was designed and pilottested at three community organizations. Results: The literature contains many tools to identify distress. During focus group discussions, participants emphasized the need to tailor the approach to distress screening to be suitable for use in the communitybased setting, especially given their philosophy of creating an inviting, supportive and home-like environment. The new distress screening approach is embedded in a conversation rather than a paper-based or computer generated survey. A standardized tool is used by a trained individual during a discussion with the patient/survivor. Conclusions: The new approach allows for the identification of relevant patient issues and quantification of distress. This presentation will highlight the literature and focus group findings, describe the new approach to screening, and outline the experience with the new distress screening approach.
MASCC-0387 Implementing programmatic screening for distress: rapid identification of physical symptoms and emotional psychosocial concerns M. Fitch1, J. Myers2, S. Burlein-Hall3 1 Oncology Nursing/Patient & Family Support Program, Odette Cancer Centre Sunnybrook Health Sciences Centre, Toronto, Canada, 2 Palliative Care Consult Team, Sunnybrook Health Sciences Centre, Toronto, Canada, 3Oncology Nursing, Odette Cancer Centre Sunnybrook Health Sciences Centre, Toronto, Canada Introduction: Distress is commonly experienced as patients cope with the consequences of cancer. Identifying those individuals who would benefit from supportive care intervention remains a challenge in busy ambulatory settings. Objectives: We designed a concrete approach for early identification of patient distress related to both physical and psychosocial issues. Methods: We implemented a programmatic approach that includes a standardized tool to screening for distress, a brief assessment conversation with the patients, a subsequent dialogue for deeper assessment as required, and intervention or referral based on the assessment. Education, quality improvement cycles, evidenced-based practice guidelines and inter-professional team algorithms were introduced. Evaluation included pre- and post-measures. Results: Staff report that conversations with patients unfold differently than before the implementation and more psychosocial issues are being
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identified. The assessments provide a basis for tailoring the care plan with the patient. Referrals have increased as most of the issues are handled by the primary oncology team. Referrals are considered to be appropriate and require the intervention by professionals with additional psychosocial expertise. Staff members report it took time to gain confidence and comfort in using the standardized screening tool in routine practice. Conclusions: Successful implementation of distress screening requires a programmatic approach. Screening must be followed by appropriate assessment and intervention at the primary team level and referral if additional expertise is required. Staff members require education to perform successfully and relevant clinical tools and supports must be available to assist the members of the inter-professional team.
MASCC-0388 Identification of emotional distress: reflections on using the Edmonton symptom assessment system (ESAS) and the Canadian problem checklist (CPC) as screening tools M. Fitch1, A. McAndrew2, S. Burlein-Hall2, T. Lilien3 1 Oncology Nursing/Patient & Family Support Program, Odette Cancer Centre Sunnybrook Health Sciences Centre, Toronto, Canada, 2Oncology Nursing, Odette Cancer Centre Sunnybrook Health Sciences Centre, Toronto, Canada, 3Palliative Care Consult Team, Sunnybrook Health Sciences Centre, Toronto, Canada Introduction: In busy ambulatory cancer clinics, concrete strategies are needed for documenting symptom-related distress and supportive care needs, and identifying the individuals who would benefit from intervention. Objectives: The purpose of this study was to identify the types of concerns reported by patients attending a comprehensive ambulatory cancer clinic. Methods: The Edmonton Symptom Assessment System and the Canadian Problem Checklist were implemented in a standardized approach to screening for distress in our ambulatory cancer clinic. Collation of data allows identification of patient concerns at an individual patient level as well as at a population level. Descriptive statistical analysis facilitates targeted intervention and program planning. Results: 2,627 patient screenings with ESAS and 1,431 screenings with the CPC were completed in 1 month. The most frequently identified issues at the severe level on the ESAS were tiredness (13.2 %), anxiety (10 %) and well-being (10 %). The most frequently identified issues at the moderate level were tiredness (24.4 %), well-being (23.6 %), appetite (18.2 %) and anxiety (13.7 %). On the CPC, the most frequently identified issues included sleep (31.4 %), fears/worries (30.7 %), worry about family and friends (23.6 %), weight (23.5 %) and understanding illness/treatment (20.8 %). Conclusions: Patient distress can be related to physical, psychosocial or practical issues. Rapid identification of issues in these domains is facilitated in a busy clinic using standardized instruments. Using both ESAS and CPC is helpful in capturing relevant patient issues in the three domains and setting the stage for meaningful dialogue with patients. Collation of data at a population level facilitates the identification program gaps and areas for improvement.
MASCC-0389 Patient experience with percutaneous endoscopic gastrostomy tubes M. Fitch1, A. McAndrew2, E. Poslins3, E. Stokes3, J. Kwong4, K. Vandenbussche4 1 Oncology Nursing/Patient & Family Support Program, Odette Cancer Centre Sunnybrook Health Sciences Centre, Toronto, Canada, 2Oncology Nursing, Odette Cancer Centre Sunnybrook Health Sciences Centre, Toronto, Canada, 3Clinical Nutrition, Odette Cancer Centre Sunnybrook Health Sciences Centre, Toronto, Canada, 4 Clinical Nutrition, Sunnybrook Health Sciences Centre, Toronto, Canada
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Introduction: Percutaneous endoscopic gastrostomy (PEG) tubes are an established part of the management for head and neck cancer patients with impaired nutritional and functional status. Limited research has explored the impact of this potentially distressing intervention from a patient perspective. Objectives: The purpose of this study was to document the experiences of advanced head and neck cancer patients living with a PEG tube. Methods: The study was conducted using a descriptive qualitative design. A convenient sample of 16 participated in an in-depth interview about living with the PEG tube. Interviews were audio-recorded, transcribed verbatim, and subjected to a content and theme analysis. Results: Difficulty swallowing and weight loss emerged as the primary factors in influencing the PEG tube insertion. Fear and uncertainty characterized the initial reaction to the tube insertion. Although participants became accustomed to living with the tube, there were challenges to overcome in managing it on a daily basis. Resuming an oral diet required a gradual approach and engendered its own set of challenges. All participants recognized the value of the tube and considered it necessary for their survival—‘it was a life raft’. Conclusions: Living with a PEG tube was not seen as negative by these participants as has been described in the literature. How the discussion occurs at the onset of the decision-making about the insertion of the tube, the education patients received about the tube and its management, and the on-going support provided by health care professionals contributed to the positive experience.
MASCC-0390 Qualitative exploration of families’ experience caring for loved ones with advanced ovarian cancer M. Fitch1, T. DasGupta2, A. McAndrew3, M. Sapsford4, S. Moura5, K. Stilos6, K. Barrow6, L. Faltl3 1 Oncology Nursing/Patient & Family Support Program, Odette Cancer Centre Sunnybrook Health Sciences Centre, Toronto, Canada, 2 Professional Nursing, Sunnybrook Health Sciences Centre, Toronto, Canada, 3Oncology Nursing, Odette Cancer Centre Sunnybrook Health Sciences Centre, Toronto, Canada, 4Ontario Region, Ovarian Cancer Canada, Toronto, Canada, 5PMH Nursing Administration, University Health Network/Princess Margaret Hospital, Toronto, Canada, 6Palliative Care, Odette Cancer Centre Sunnybrook Health Sciences Centre, Toronto, Canada Introduction: Ovarian cancer is physically and psychologically challenging because of the advanced nature of the disease at diagnosis, side effects of the treatment, and impact on roles and responsibilities. The family plays an integral role in providing physical and emotional support. Research exploring the family experience is essential to inform practice and develop processes that foster family centered care. Objectives: The purpose of the study is to explore family members’ experiences of caring for a loved one with advanced ovarian cancer. Methods: The research question for this qualitative study was, ‘What are the experiences and challenges of individuals while caring for a family member with advanced ovarian cancer?’. Eligible patients were invited to participate until data saturation was reached. In-depth interviews were audio recorded, transcribed verbatim and subjected to standardized qualitative descriptive content and theme analysis. Thirteen interviews were conducted with family members. Results: Participants described an intensely emotional experience from diagnosis to end of life. Family members experienced on-going challenges with access to information, management of advanced symptoms, and the transition from active medical management to end of life care. All described a point when they recognized their family member was ‘truly dying’ and felt the need to be present on a 24-hour basis. Lack of information about what was happening and what would happen created distress for family members.
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Conclusions: Insight regarding families’ experiences has implications for nurses and physicians caring for women and their families at end of life in terms of providing relevant information, supportive communication, and anticipatory preparation.
MASCC-0391 Low bacterial diet versus control diet to prevent infection in cancer patients treated with chemotherapy causing episodes of neutropenia M. van de Wetering1, E. van Dalen2, A. Mank3, E. Leclercq2, R. Mulder2, M. Davies4, M.J. Kersten5 1 Paediatric Oncology, Academic Medical Center, Amsterdam, Netherlands, 2Cochrane Childhood Cancer Centre, Academic Medical Center, Amsterdam, Netherlands, 3Internal Medicine, Academic Medical Center, Amsterdam, Netherlands, 4Haematology and Transplant unit, NHS Manchester, Manchester, United Kingdom, 5Internal Medicine, Academic Medical Center, Amsterdam, Netherlands
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Conclusions: There is no evidence from individual RCTs in patients with cancer that underscores the use of an LBD for the prevention of infection. Based on the currently available evidence, we are not able to give recommendations for clinical practice. More high-quality research is needed. References: Gardner 2008, Journal of Clinical Oncology; 26(35); 5684–8 Moody 2006, Journal of Paediatric Hematology and Oncology;28(3): 126–33. van Tiel 2007; Annals of Oncology 2007;18:1080–4
MASCC-0392 Assessing client satisfaction among patients receiving hematopoietic stem cell transplantation at a designated transplant facility within the United States department of veterans affairs J. Toro1, R. Alonzo1, F. Gushiken1, D. Haile1, C. Freytes1 1 Medicine, South Texas Veterans Health Care System, San Antonio, USA
Introduction: It is thought that a low bacterial diet (LBD) can prevent the occurrence of infections in cancer patients receiving chemotherapy causing episodes of neutropenia, but much remains unclear. Objectives: To determine the efficacy of an LBD versus a control diet in preventing the occurrence of infection and to decrease (infectionrelated) mortality in cancer patients receiving chemotherapy. Methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (DARE)) PubMed EMBASE (and CINAHL (from 1981 to 20 October 2011) selection criteria; Randomised controlled trials (RCTs) comparing the use of an LBD with a control diet with regard to infection rate, (infection-related) mortality in cancer patients receiving chemotherapy. Two review authors independently performed the study selection, ‘Risk of bias’ assessment and data extraction. Analyses were performed according to the guidelines of the Cochrane Handbook for Systematic Reviews of Interventions. Results: Three RCTs were identified assessing different intervention and control diets in 192 patients (97 intervention diet; 95 control diet). Pooling of results of included studies was not possible. All 3 studies did not show a significant difference in infection rate between the intervention and control diet; None of the studies mentioned infection-related mortality.
Introduction: Hematopoietic stem cell transplantation (HSCT) is a complex and labor intensive procedure that requires specialized personnel and facilities. The United States Department of Veterans Affairs (VA) has developed regional, specialized centers where transplant candidates are referred. Objectives: The purpose of this project was to assess the satisfaction of patients who underwent HSCT at a designated VA transplant facility. Methods: The CSQ-8 was sent to 442 patients and 277 (63 %) completed and returned the questionnaire. Ninety-nine percent of respondents rated the quality of service received as ‘good’ or ‘excellent.’ The same proportion reported receiving the kind of ‘service they wanted’ and would ‘recommend the services’ to a friend. Only 4 % of respondents were dissatisfied with the ‘amount of help they received.’ Results: The CSQ-8 was sent to 442 patients and 277 (63 %) completed and returned the questionnaire. Ninety-nine percent of respondents rated the quality of service received as ‘good’ or ‘excellent.’ The same proportion reported receiving the kind of ‘service they wanted’ and would ‘recommend the services’ to a friend. Only 4 % of respondents were dissatisfied with the ‘amount of help they received.’
Conclusions: An overwhelming majority of patients were satisfied with the quality of service they received, felt that their needs were met and indicated that they would recommend or return if
needed. Studies utilizing other instruments should be performed as there is limited information regarding client satisfaction after HSCT.
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References: Nguyen TD, Attkisson CC, Stegner BL. Eval Program Plann. 1983;6(3–4):299–313.
MASCC-0393 A randomized trial of oral cryotherapy, saline solution and Caphosol for the prevention of high-dose melphalan-induced oral mucositis followed by autologous hematopoietic stem cell transplantation 1
1
1
1
1
1
J. Toro , D. Schneider , R. Alonzo , A. Hasan , S. Lee , F. Gushiken , D. Haile1, C.O. Freytes1 1 Medicine, South Texas Veterans Health Care System, San Antonio, USA Introduction: Oral mucositis (OM) is a frequent complication of highdose melphalan (HDM) followed by autologous hematopoietic stem cell transplantation (AHSCT). Objectives: To compare the efficacy of 3 interventions to prevent HDM-induced OM in patients with multiple myeloma (MM). Methods: One hundred seventeen MM patients who received HDM were randomized to 3 groups: oral cryotherapy (CT), saline solution rinses (SS) or Caphosol® (calcium phosphate). Patients were assessed daily for OM until resolution or hospital discharge using the World Health Organization (WHO) mucositis scale. We also evaluated pain level, use of narcotics and OM duration. Results
Gender, n (%) Male
110 (94)
36 (92)
38 (95)
36 (95)
Female
7 (6)
3 (8)
2 (5)
2 (5)
Caucasian
56 (75)
23 (59)
16 (40)
17 (45)
African Americans
40 (34)
11(28)
15 (37)
14 (37)
Hispanic
21 (18)
5 (13)
9 (23)
7 (18)
90 (70–90)
90 (80–90)
90 (70–90)
90 (80–90)
0.64 (0.22)
0.65 (0.21)
0.61 (0.19)
0.66 (0.25)
Race/Ethnicity, n (%)
Karnofsky score, median (range) Total Bilirrubin, mean (SD) Body Mass Index, mean (SD) Serum Creatinine, mean (SD) Diabetes, n (%)
30.87 (5.73) 29.48 (4.52) 31.72 (6.63) 31.40 (5.70) 1.12 (0.67)
1.28 (0.93)
1.00 (0.29)
1.09 (0.63)
Yes
32 (27)
9 (23)
13 (32)
10 (26)
No
85 (73)
30 (77)
27 (68)
28 (74)
Yes
32 (27)
9 (23)
13 (32)
10 (26)
No
85 (73)
30 (77)
27 (68)
28 (74)
Dentures, n %
Caphosol
Cyrotherapy Saline Solution
39
40
38
62 (45–68)
62 (39–75)
61.5 (43–70)
Only 10 % of patients in the CT group experienced OM ≥ grade 1, compared to 64 % and 66 % in the Caphosol® and SS groups, respectively (P<0.0001). None of the CT patients experienced grade 3–4 OM. There was a significant decrement in duration of OM in the CT group compared to the Caphosol® group (mean duration [MD] in days 0.8 vs. 4.77; p<0.001) and the SS group (MD 5.55 days; p< 0.001). Duration of OM was shorter in the CT group compared to the SS group (MD .9 days vs. 3.38 days; p=0.004) and the Caphosol® group (MD 2.97 days; p=0.020). Patients in the CT group required less use of analgesics when compared with the SS group (p=0.007).
Conclusions: CT significantly reduced OM frequency, duration and severity in MM patients who received HDM when compared to
Caphosol® or SS rinses. Patients who received CT had lower analgesic requirements than patients who received SS.
Table 1. Baseline Patient characteristics Total Patients, n
117
Age, median (range) 62 (39–75)
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MASCC-0394 Influence of oral mucositis on the quality of life of patients treated with high-dose melphalan and autologous hematopoietic stem cell transplantation J.J. Toro1, D. Schneider 1, R. Alonzo1, A. Hasan1, S. Lee 1, F. Gushiken1, D. Haile1, C.O. Freytes1 1 Medicine, South Texas Veterans Health Care System, San Antonio, USA Introduction: The influence of oral mucositis (OM) on the quality of life (QoL) of patients with multiple myeloma (MM) treated with highdose melphalan (HDM) and autologous hematopoietic stem cell transplantation has not been rigorously studied. Objectives: To assess the influence of mucositis on the QoL of MM patients treated with HDM. Methods: We analyzed parameters associated with QoL as part of a randomized study evaluating 3 interventions to prevent OM: cryotherapy (CT), saline solution rinses (SS) or Caphosol®. (calcium phosphate) The ‘Patient-Reported Oral Mucositis Symptom’ (PROMS) scale, a validated instrument to assess QoL, was utilized daily from HDM administration to OM resolution. Results: Patients in the CT cohort experienced less mucositis than the other cohorts based on established clinical criteria. Sixty-eight percent of study patients reported changes in taste. There was a significant difference in parameters associated with patient well-being among the 3 groups in favor of the CT cohort (see table). Patients who received CT had significantly less mouth pain than the other cohorts. Difficulty and restriction of speech, eating and drinking was significantly higher for the SS and Caphosol® cohorts. Table. PROMS variables reported at any point during the study Variables
Mouth pain Difficulty speaking because of mouth sores Restriction of speech because of mouth sores Difficulty eating hard foods because of mouth sores Difficulty eating soft foods because of mouth sores Restriction of eating because of mouth sores Difficulty drinking because of mouth sores Restriction of drinking because of mouth sores Difficulty swallowing because of mouth sores Change in taste a
Chi-Square b Fisher’s Exact Test
Caphosol n=39
Cryotherapy Saline P value n=40 solution n=38 Yes Yes Yes 21 (54 %) 6 (15 %) 23 (61 %) <.0001a 8 (21 %) 2 (5 %) 15 (39 %) 0.0009b 2 (5 %)
15 (39 %) 0.0008b
16 (41 %) 8(20 %)
21 (55 %) 0.0055a
12 (31 %) 2 (5 %)
14 (37 %) 0.0007b
15 (38 %) 2 (5 %)
19 (50 %) <.0001b
15 (38 %) 3 (8 %)
15 (39 %) 0.0007b
8 (21 %)
b
13 (33 %) 4 (10 %)
18 (47 %) 0.0008
20 (51 %) 6 (15 %)
20 (53 %) 0.0005a
29 (74 %) 21 (53 %)
29 (76 %) 0.0431a
Conclusions: Patients in the CT cohort experienced better QoL after HDM based on the PROMS scale. Since the CT cohort experienced less OM, this study suggests an important influence of mucositis on the QoL of patients treated with HDM. References: Krusher JA et al. J Can Dent Assoc. 2008; 74(1):59
MASCC-0395 High dose Asian Ginseng, (Panax Ginseng) for cancer related fatigue (CRF): a preliminary report S. Yennu1, A. Reddy1, N. Tannir2, R. Lee3, G. Lopez3, C. Escalante4, E. Manzullo4, S. Frisbee-Hume1, J. Williams1, S. Palla5, L. Cohen6, B. Eduardo1 1 Palliative Care and Rehab Medicine, University of Texas MD Anderson Cancer Center, Houston, USA, 2GU Oncology, University of Texas MD Anderson Cancer Center, Houston, USA, 3General Oncology, University of Texas MD Anderson Cancer Center, Houston, USA, 4Internal Medicine, University of Texas MD Anderson Cancer Center, Houston, USA, 5Biostatistics, University of Texas MD Anderson Cancer Center, Houston, USA, 6Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, USA Introduction: CRF is a common and severe symptom in patients with cancer. There are limited useful treatments available. Objectives: The objective of this preliminary study was to assess the safety of high dose Panax Ginseng (PG) on CRF. Methods: In this prospective open labeled study, 30 patients with cancer and fatigue ≥4/10 (0 = no fatigue, 10 = worst possible fatigue) received high dose PG 800 mg orally daily for 29 days. Functional Assessment of Cancer Therapy- fatigue (FACIT-F), Edmonton Symptom Assessment System (ESAS) (0 = best, 10 = worst), and Hospital Anxiety Depression Scale (HADS) were assessed at baseline and day 29. Results: Results in 24/30 (80 %) evaluable patients were as follows (Table 1). The median age was 58 year, 50 % were females, 84 % were white. The most common cancer type was genitourinary cancer (31 %). ESAS well-being improved from 4.67 (2.04) to 3.50 (2.34) (p=0.01374), appetite improved from 4.29 (2.79) to 2.96 (2.46) (p=0.0097). 21/24(87 %) patients had an improved FACIT-F fatigue score by day 15. Global Symptom Evaluation score of PG for fatigue was better in 15/24 patients (63 %) with median improvement of 5 (1 = hardly any better, 7 = very great deal better). No ≥ grade 3 adverse events related to the study drug were reported. Conclusions: 1) PG is safe and rapidly improved ESAS fatigue and FACIT-F fatigue scores; 2) overall quality of life (FACT-General), appetite, and sleep at night also improved. Randomized controlled trials of PG are justified in CRF. Table 1. Change in Symptoms after treatment with High Dose Ginseng Symptom Fatigue (ESAS) Drowsiness (ESAS) Sleep at night (ESAS) Depression (ESAS) Depression (HADS) FACIT-F Fatigue Subscale (primary outcome) FACIT-G FACIT-F physical
Baseline, mean (SD) 6.2 (1.82) 3.21 (2.21) 5.38 (2.37) 1.29 (2.22) 6.50 (3.34) 24.58 (8.9)
Day 29, mean (SD) 3.75 (1.62) 2.42 (2.28) 3.54 (2.02) 1.29 (2.03) 6.09 (3.86) 32.90 (11.01)
p value
71.42 (17.54) 17 (5.82)
77.29 (17.79) 19 (4.79)
0.0104 0.002
<0.0001 0.0948 0.0012 0.999 0.6088 <0.0001
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MASCC-0396 The mIAS scale: a scale to measure mTOR inhibitor-associated stomatitis C. Boers-Doets1, R.V. Lalla2 1 Clinical Oncology, Leiden University Medical Center, Leiden, Netherlands, 2Department of Oral Health and Diagnostic Sciences MC1605, University of Connecticut Health Center, Farmington CT, USA Introduction: mTOR inhibitor-associated stomatitis (mIAS) is a doselimiting toxicity of mTOR inhibitors. Even small ulcerations can cause significant pain and affect quality of life. Scales developed for conventional oral mucositis are currently used to assess mIAS. These scales are mainly driven by ulceration size and the resulting impact on diet. Since the morbidity of mIAS results from persistence of lesions and associated pain, these scales may not be appropriate to measure mIAS Objectives: To develop a scale specifically designed for mIAS, so that decisions on dose-modification can be made based on an accurate assessment of the toxicity Methods: A comprehensive literature review was performed in PubMed, to determine important features of mIAS that influence its morbidity. Keywords were assessment, questionnaire, tool, stomatitis, mucositis, and mTOR inhibitor. Commonly used oral mucositis scales were examined to identify suitable components for mIAS measurement Results: A new scale was generated with a subjective component measuring pain and an objective component measuring duration of lesions. The subjective grading criteria range from 0 for no pain to 3 for a pain score of 6 or higher on a 0–10 scale. The objective grading criteria range from 0 for no visible lesion to 3 for lesion(s) persisting for more than 7 days. It is suggested that dose-modification be considered only when both subjective and objective grades are 3, representing persistent lesions with significant pain, despite analgesic use Conclusions: Measurement of mIAS using this scale should facilitate the optimal management of the underlying malignancy, resulting in improved outcomes.
MASCC-0397 Toxicity profile of rituximab in Indian patients C. Basu1, B. Basu2 1 Gyn Oncology & Clinical Trial, Netaji Subhas Chandra Bose Cancer Research Institute, Kolkata, India, 2Screening, Cancer NOCK, Kolkata, India Introduction: The chimeric anti-CD20 monoclonal antibody rituximab (R) is increasingly being used for treating lymphoproliferative disorders. While life threatening toxicities like infusional, tumour lysis syndrome, Severe Mucocutaneous Reactions, Progressive Multifocal Leuko encephalopathies are very rare there is paucity of such toxicity study in Indian literature Objectives: In our tertiary cancer care centre in last 4 years (Jan 2009 to Jan 2013) we have experience of 125 lymphoma cases and 500 doses of Rituximab either alone or in combination with CHOP Methods: Hence, we are presenting this observational study on Indian patients Results: Outcomes were reported for only rituximab and addition of R with CHOP (cyclophosphamide, doxorubicin [hydroxydaunorubicin], vincristine [Oncovin], and prednisolone). In common this included 87 males and 38 females. The median age was 46 years (range 17 to 78 years). One-fourth of patients were above 60 years. The histology
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was aggressive NHL in 86, indolent NHL in 39. 32 were in early stage (I/II) and the remaining 93 were in advanced stage (III/IV) of disease. Total toxicity profile in our series was as follows: Infusional reaction 10 cases, Hypotension 12 cases. They are mostly in first infusion. Leucopenia in 30 occasions. Febrile neutropenia in four cases Secondary prophylaxis was not necessary in them. Peculiar thing was hyperglycemia which was constantly present in about forty percent cases (n=48). Bleeding piles developed for the first time in two cases. There were reactivation of hepatitis and development of pneumonitis in two cases each Conclusions: We did not find any other toxicity and found R is reasonably safe.
MASCC-0398 Current status and issues with psychosocial support for patients with recurrent colorectal cancer E. Shindo1, N. Yamagishi1, M. Chaen1, H. Komatsu1 1 Faculty of Nursing and Medical Care, Keio University, Tokyo, Japan Introduction: Recently, colorectal cancer has been increasing in Japan. Rapid advances have improved the survival of patients with recurrent colorectal cancer, but treatment creates physical, psychological, and social burdens. We previously demonstrated that patients with recurrent colorectal cancer live with a fear of self-dissolution. However, such programs for patients are not yet sufficient in Japan. We should investigate a customized support program. Objectives: To review the literature on current status and issues with psychosocial support programs for patients with recurrent colorectal cancer undergoing the treatment. Methods: Between 2009 and 2011, we searched Pubmed and CINAHL for studies on support programs for colorectal cancer patients using the keywords “colorectal cancer”, “patient”, and “support (supporting) program”, as well as studies on psychosocial support for cancer patients using the keywords “cancer survivor” and “psychosocial support”. Thirty articles were selected for analysis. Results: Few intervention studies on support for colorectal cancer patients were available, and we found no intervention study on support for patients receiving treatment after recurrence. The intervention Methods included group therapy, nurse-initiated customized support packages, and lifestyle education. Most interventions were tested as support for breast cancer survivors, and no study investigated patients with recurrent colorectal cancer. Conclusions: There have been few studies on support for patients with recurrent colorectal cancer. Unlike breast cancer patients, those with recurrent colorectal cancer are less likely to receive support. In the future, we will determine the needs of patients and investigate a customized support program.
MASCC-0399 Single fraction palliative radiotherapy in the treatment of bone metastases with soft tissue mass N. Lao1, M. Poon1, L. Probyn1, M. Popovic1, R. Chow1, N. Lauzon1, E. Chow1 1 Rapid Response Radiotherapy Program Department of Radiation Oncology, Sunnybrook Health Sciences Odette Cancer Centre, Toronto, Canada Introduction: Pain associated with bone metastases can substantially decrease quality of life (QOL) in cancer patients. Single or multiple fraction radiotherapy is commonly used to treat uncomplicated bone metastases; however, debate exists concerning the optimal fractionation scheme for palliative cancer patients.
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Objectives: The purpose of this present case report is to discuss the efficacy of single and multiple fraction radiotherapy in the treatment of bone metastases with soft tissue mass. Methods: A 56-year old female breast cancer patient was referred to Odette Cancer Centre, Sunnybrook Hospital. She presented with a right femur bone metastasis with soft tissue mass. She received a single 8Gy fraction of radiotherapy. Results: The patient responded well to treatment with good pain relief. A post-radiation CT scan was performed on the right femur. The soft tissue mass had substantially decreased in size, and new endosteal and periosteal bone had formed in the femur. Conclusions: The response of this patient to single fraction radiotherapy indicates the efficacy of this treatment for the palliation of bone metastases. Further evaluation for the benefits of using single fraction radiotherapy for soft tissue masses in patients with poor performance status should be considered.
MASCC-0400 Supportive care needs and quality of life among Chinese breast cancer survivors K.C. Choi1, W.K.W. So1, S.S.M. Ho1, C.W.H. Chan1, S.S.S. Mak2, R.W.M. Wan2, S.Y. Chair1 1 The Nethersole School of Nursing, The Chinese University of Hong Kong, Hong Kong, China, 2Department of Clinical Oncology, Prince of Wales Hospital, Hong Kong, China Introduction: Despite advanced cancer treatments prolong survivors’ lives, studies have been reported that cancer survivors experience poorer quality of life (QoL) than general populations. Identifying their needs is crucial to develop relevant follow-up health services for them. Objectives: To examine supportive care needs of Chinese breast cancer survivors and investigate its relationships with participants characteristics and their quality of life (QoL) Methods: One hundred and sixty-three participants were recruited from an out-patient oncology department of a local public hospital. They completed a self-report questionnaire: the 34-item Supportive Care Needs Survey, the supplementary module of access to healthcare and ancillary support services, and the Functional Assessment of Cancer Therapy. Results: The five most commonly reported unmet needs were all in the health system information domain (range: 55–63 %). In fact, most of the participants (84 %) reported at least one unmet need in relation to health care information. Stepwise multivariable regression analyses revealed that time traveling from home to hospital, physical and psychological unmet needs were independently associated with QoL among the breast cancer survivors. Conclusions: Breast cancer survivors perceived various unmet needs, and the health system information is the most common one. Those who have more unmet needs in the physical and psychological domain were more likely to perceive a poorer QoL.
MASCC-0401 Inpatient palliative care consultation for patients with glioblastoma in a tertiary hospital E. Lin1, M.A. Rosenthal2, B.H. Le1, P. Eastman1 1 Palliative Care, The Royal Melbourne Hospital, Parkville, Australia, 2 Medical Oncology, The Royal Melbourne Hospital, Parkville, Australia Introduction: Glioblastoma (GBM) is an uncommon disease with significant mortality and morbidity, but there is a lack of published evidence on palliative care involvement in this population.
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Objectives: To describe characteristics and outcomes of inpatients with GBM who are referred to the palliative care consultation service. Methods: This retrospective audit used data from The Royal Melbourne Hospital (RMH); a tertiary hospital and a major provider of neuro-oncology services in Victoria, Australia. Data were available for all GBM inpatients discharged between 1 July 2009 and 29 February 2012. From this group, the medical records of those who had their first palliative care involvement during the admission were extracted. Information collected included patient demographics, symptoms, reasons for referral to the palliative care consult service, use of allied health, length of stay and patient outcome. Results: A high symptom burden is experienced by GBM patients, with almost 75 % experiencing three or more symptoms. There were high levels of involvement from physiotherapy, occupational therapy and social work, but surprisingly little from pastoral care. The median time from diagnosis of GBM to palliative care consultation service referral was 111 days. Conclusions: This audit highlights the heavy symptom burden, extensive allied health involvement and discharge outcomes of GBM inpatients referred to the palliative care service. These data provide an important framework upon which further research can be built, and also support the vital role multidisciplinary palliative care services can and should play in the care of patients with GBM.
MASCC-0402 A systematic review on quality of life among patients at 1 year after treatment for head and neck cancer W.K.W. So1, R.J. Chan2,3, D.N.S. Chan1, B.G.M. Hughes2,4, S.Y. Chair1, K.C. Choi1, C.W.H. Chan1 1 The Nethersole School of Nursing, The Chinese University of Hong Kong, Hong Kong, China, 2Cancer Care Services, Royal Brisbane and Women’s Hospital, Brisbane, Australia, 3School of Nursing and Midwifery, University of Queensland, Australia, 4School of Medicine, University of Queensland, Australia Introduction: Although advances in treatment modalities have improved the survival of head and neck (H&N) cancer patients over recent years, survivors’ quality of life (QoL) could be impaired for a number of reasons. The investigation of QoL determinants can inform the design of supportive interventions for this population. Objectives: To examine the QoL of H&N cancer survivors at 1 year after treatment and to identify potential determinants affecting their QoL Methods: A systematic search of literature was done in December 2011 in five databases: Pubmed, Medline, Scopus, Sciencedirect and CINAHL, using combined search terms ‘head and neck cancer’, ‘quality of life’, ‘health-related quality of life’ and ‘systematic review’. The methodological qualities of selected studies were assessed by two reviewers using predefined criteria. The study characteristics and results were abstracted and summarized. Results: Thirty-seven studies met all inclusion criteria with methodological quality from moderate to high. The global QoL of H&N cancer survivors returned to baseline at 1 year after treatment. Significant improvement showed in emotional functioning while physical functioning, xerostomia, sticky/insufficient saliva, and fatigue were consistently worse at 12 months compared with baseline. Age, cancer sites and stages, social support, smoking, presence of feeding tube are significant QoL determinants at 12 months. Conclusions: Although the global QoL of H&N cancer survivors recover by 12 months after treatment, problems with physical functioning, fatigue, xerostomia and sticky saliva persist. Regular assessment should be carried out to monitor these problems. Further research is required to develop appropriate and effective interventions for this population.
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MASCC-0403 Medical expenditure and customer satisfaction degrees in independent hospice ward B. Kim1, S. Nam1, T. Lim1, M.S. Kim2, K.S. Yoon2, D.J. Lee2 1 Internal Medicine, VHS Medical Center, Seoul, Korea, 2Hospice Care Unit, VHS Medical Center, Seoul, Korea Introduction: Ward type in palliative hospice therapy may contribute to reduce economic medical costs as well as to more specific total care for terminal cancer patients (Am J Hosp Palliat Care. 2013;30:50–2). We expanded hospice care program and established the independent Hospice Ward (HW) in 2011. Objectives: This study compared medical expenditures between HW and other hospice care types in VHS Medical Center. In addition, we investigated customer satisfaction degrees every years. Methods: We set up the independent HW and intergated candidates into this hospice care facility. Medical expenditures in terms of daily general medical costs, analgesic costs, antibiotic costs, nutritional costs, laboratory test costs and transfusion costs were compared between the independent HW (2012) and other two types of hospice care (2011). The third party conducted the customer satisfaction survey to family members. Results: A total of 93 patients were enrolled into WT (n=29) and ST (n=64) in 2011. Seventy-seven patients were enrolled into HW in 2012. There is no significant factors except for laboratory test cost between WT and ST in 2011. But average daily medical cost and daily costs of antibiotics, parenteral nutrition, laboratory blood tests and blood products were significantly lower in HW than ST as well as WT. There were no cases for ICU in HW and WT, but fourteen (22 %) in ST had yet been experienced to admit in ICU. Customer satisfaction scores in were improved in 2012 than in 2011(from 4.74 to 5.00) Conclusions: For hospice care in terminal cancer patients, we can reduce medical expenditures in independent HW without loss of customer satisfaction.
MASCC-0404 Ultrasonographic evaluation of therapeutic effects after complex decongestive therapy in lymphedema S.I. Park1, Y.J. Sim1, G.C. Kim1, H.J. Jeong1 1 Department of Physical Medicine and Rehabilitation, Kosin University College of Medicine, Busan, Korea Introduction: Breast cancer related lymphedema (BCRL) is a chronic, progressive and multifactorial process. Ultrasonography is one of the diagnostic tools in BCRL. We investigated the usefulness of ultrasonography in complex decongestive therapy (CDT) in BCRL as a follow up tool. Objectives: To evaluate the usefulness of ultrasonography as a follow up tool for investigating of CDT in BCRL. Methods: Twenty patients with BCRL were enrolled in this study. All patients were taken therapies with CDT program for 2 weeks. Soft tissue thickness of both affected and unaffected upper limbs were measured before and after CDT. It was measured by 3 points (midpoint between the medial and lateral epicondyles at the elbow level, 10 cm proximal and distal to elbow) with or without pressure. And we calculate the compliance of soft tissue before and after CDT. The circumference of both affected and unaffected upper limb were measured before and after CDT. Results: Twenty patients examed by 1 sonographer. We compared 3 values (Soft tissue thickness, Compliance and circumference). After 2 weeks of CDT program, the soft tissue thickness and circumference of unaffected upper limb did not show significant changes between before and after CDT. But on affected upper limb, there was significantly reduced compared measurements taken prior to treatment.
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Conclusions: Our results suggest that circumference measurement and the soft tissue thickness measured by ultrasonography was useful for follow up tools for investigating therapeutic effects of CDT. References: Waren A, Borson H, Borud LJ, Slavian SA. Strength of materials. lymphedema: a comprehension review. Ann Plastic Surgery 2007; 59: 464–472
MASCC-0405 Community interventions for reducing breast health myths and promoting breast cancer screening: from Korean experience W. Hong1, K. Park2 Nursing, Kyungnam University, Changwon-si, Korea, 2Cancer Information and Education Branch, National Cancer Center, Goyang, Korea 1
Introduction: The Korean government provides biennial mammograms for Korean women over 40 years of age through the National Cancer Screening Program (NCSP). However, only 49.5 % of women undertakes in accordance with these guidelines. There are mythical health beliefs and different community participations related to breast cancer screening for women in Korea. Objectives: This study was to identify mythical health beliefs related to breast cancer and promote to take a breast cancer screening test free provided by the Korean NCSP. The researchers conducted a multicomponent community intervention trail to correct breast cancer myths and promote a breast cancer screening test for early detection for Korean women Methods: A 6-month, 2-city community intervention trial was conducted. In the intervention city, 480 women were surveyed at baseline and 7 months later to evaluate the effects of the intervention program. Strategies implemented in the intervention city included community outreach and clinic and pharmacy-based in-reach strategies. Results: This study showed a 20.4 % decrease in myths about the link between cancer and breast size, a 19.2 % decrease in myths concerning mammography costs, and a 14.1 % increase in intention to take screening mammography. The study also revealed a 23.4 % increase in the proportion of women at the action stage of the trans-theoretical model in the intervention city Conclusions: This study showed the value of the strategies aimed at reducing mythical beliefs in breast cancer for Korean women. The invention also stimulated women more likely to undertake breast cancer screening through mammography in the future.
MASCC-0406 First report on the contribution of metaphorical music therapy in supportive care of cancer patients C. JOURT PINEAU1, C. Chargari1, B. Ceccaldi1, S. Le Moulec1, L. Védrine1 1 Oncology, H.I.A. du Val-de-Grâce, Paris, France Introduction: Recent studies have validated the physiological and psychological benefits of both music therapy and art therapy as supportive cares in the management of patients with cancer. Objectives: Metaphorical music therapy is an emerging individual method that combines the benefits of music with those of artistic and narrative creation. Methods: This original method was applied to a 32 year old female patient with metastatic esophageal carcinoma. She was suffering from acute chest pain related to an extended tumor and was receiving chest radiation therapy. The pain was resistant to high doses of morphine and generated psychological withdrawal.
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From two words “magic” and “spell” given by the therapist at the beginning of the session, the patient, following a musical induction, achieved a metaphorical tale in the form of a collage and a short story. According to her musical tastes, she chose a sequence of music therapy known as “U-based”. As she was wearing headphones and listening to the music, she was asked to select cut/tear fragments of images in magazines. At the end of the musical sequence, she performed a narrative and composite collage using selected elements.
Results
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Objectives: 1,080 urogenital samples, HPV-16,18, 31, 45 DNAs. Methods: PCR, sequencing. Results: As the results showed in the territory of Belarus circulate, generally the European and East Asian HPV-16 type. Average pdistances between samples from Brest, Mogilyov and Vitebsk equaled 0.000 that points to a uniform source of an origin of these viruses and their long circulation in population of the people infected with HPV-16. In the analysis of HPV-16 DNA fragments received from the Gomel region, it was shown that the majority of samples also treat the European and Asian HPV-16 options, average p-distances between samples equaled 0.000, and with African 0.013–0.017. In the Grodno region all samples clastered round the “European” and “Asian” reference samples. Average p-distances between samples were 0.000–0.003, and with samples from Africa p-distances varied from 0.010 to 0.013. The exception was made by one sample, which on a phylogenetic tree clastered together with samples from Africa. Average p-distances of a sample No.8 with the African reference sequences were 0.000, and with the European and Asian varied from 0.010 to 0.013. Conclusions: Thus, use of molecular epidemiology Methods allows to give the qualitative characteristic to epidemiological process, to define the directions and time of virus drift to the country, to supervise virus circulation in population, at last to make recommendations about vaccines application. References: 1. Prevalence of high- and low-risk oncogenic human papillomaviruses in patients with external genital pathology. Vergeichik GI, Stribuk ZhA, Eremin VF. Vopr Virusol. 2011 Mar–Apr;56(2):26–8.
MASCC-0408 Assessing the use of wiki based clinical practice guidelines for lung cancer I. Olver1, J. von Dincklage2, A. Garrett2, L. Holliday2, C. Vuletich2 1 CEO, Cancer Council Australia, Sydney, Australia, 2Guidelines Group, Cancer Council Australia, Sydney, Australia
The patient produced a collage and a narrative story externalizing her clinical situation, emotions, fears and hopes, as she had never done before. At the same time, morphine doses could be partially reduced Conclusions: This single case suggests that metaphorical music therapy could be beneficial in selected patients suffering physically and psychologically, when verbal communication is not efficient. This clinical relevance will be prospectively assessed.
MASCC-0407 HPV high/risk molecular epidemiology in Belarus V. Eremin1, G.I. Vergeichik2, E.L. Gasich1, E.A. Shishkin1 1 Clinical Virology, Republican Research & Practical Center for Epidemiology & Microbiology, Minsk, Belarus, 2Oncology, Gomel State Medical University, Gomel, Belarus Introduction: 897 cases of a neck uterus cancer and 358 women death are registered in Belarus for 2008.
Introduction: The challenge for clinical practice guidelines is regularly updating with new evidence. Objectives: To develop and trial an internet based wiki platform for guidelines. Methods: Using lung cancer, the key steps in guideline development of identifying questions, literature searching, appraisal of papers, experts writing evidence-based recommendations and wide public consultation and dissemination were integrated in an access-protected wiki. Google web analytics were used to monitor usage. Authors updated the guidelines as new papers became available. Results: Sixty-seven clinical questions resulted in 2076 articles being critically appraised. Public acceptance of the wiki was demonstrated by 1,055 visits in the consultation month and 2,955 visits in the following 5 months. Access was from a mobile in up to 11 % visits. Wiki guidelines were internationally accessed, 80 % from Australia, 6 % New Zealand, 4 % USA and 2 % UK. In the consultation period the site was found by organic searches in 56 %, 31 % directly accessed it and 13 % were referred. Subsequently 72 % came from searches, 19 % direct and 11 % referrals. Australian government and Cancer Council websites were the major referral sources. Highlighting a role for social media in accessing guidelines, Facebook was responsible for 6–8 % of referrals. The average highest visit duration by a country was 9.06 min in the consultation month (Australia) and 7.24 for Canada. Bounce rates vary widely from 20 % (Germany) to above 70 % (USA, UK, India). Conclusions: Both clinicians and the public will engage with wiki guidelines and they reach a wide international audience.
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MASCC-0409 The need to enhance quality of life in palliative care hepatocellular cancer patients. Review of differences based on etiology and available therapeutic options C. Teresa1, J.S. Vilallonga1, A. Chandía1 1 Hepatologia, Hospital Universitari Bellvitge-IDIBELL, Hospitalet de Llobregat, Spain Introduction: Hepatocellular Carcinoma (HCC) is increasingly diagnosed worldwide, with significant differences related to etiology, culture and therapeutical options. Nowadays, there are more therapeutical options available. Nevertheless, curative therapies are restricted to a select group of patients (approximately 20 %). Objectives: To review the literature to study the management of patients with chronic liver disease and HCC in different countries and quality of life (QOL) assessment. Methods: We searched for ‘Hepatocellular carcinoma and QOL’ on Pubmed database, finding 19 studies that matched our purpose (Group A). We then reviewed our personal database consisting of 11 studies on QOL in patients with chronic liver disease and/or liver transplantation with or without HCC (Group B). We assessed the different characteristics within these 30 studies. Results: Group A: 8 out of 19 (42 %) HCC studies were carried out in Asia; 5 (26 %) in Europe and 6 (32 %) in America. The most used instruments for the assessment of QOL were FACT (in 8 studies: 42 %) and EORTC (in 6 studies: 31 %). Group B: None of the studies on other chronic liver diseases and liver transplantation were made in Asia; 6 (54 %) were made in Europe and 5 (46 %) in America. 8 of them used SF-36 (73 %), and 2 (18 %) used Karnofsky. Conclusions: The etiology and available therapies of liver disease in each country highlight the differences in therapeutic strategies and the assessment of quality of life. More patient oriented studies are needed in order to better understand QOL burden in HCC patients, clinicians and researchers.
MASCC-0410 Phase III clinical trials with anamorelin HCL, a novel ghrelin receptor agonist for the treatment of NSCLC cachexia A. Abernethy1, J.S. Temel2, D. Currow3, L. Gleich4, J. Friend5 1 Medicine/Medicine - Oncology, Duke University School of Medicine, Durham, USA, 2Hematology/Oncology Department of Medicine, Massachusetts General Hospital, Boston, USA, 3 Palliative and Supportive Services, Flinders University, Adelaide, Australia, 4Oncology, Medpace, Cincinnati, USA, 5R&D, Helsinn Therapeutics Inc., Bridgewater, USA Introduction: Cancer anorexia/cachexia, a multifactorial condition involving loss of appetite and lean body mass (LBM), is associated with increased morbidity and mortality and may occur in up to 80 % of advanced cancer patients. Anamorelin HCl (ANA) is a ghrelin receptor agonist that demonstrated significant increases in LBM, physical strength and body weight in Phase II trials. Through its ghrelin and growth hormone secretagogue activity, it displays anabolic and appetite stimulating properties—two aspects vital to treating cancer anorexia/cachexia. Objectives Methods: HT-ANAM-301 (NCT01387269) and HT-ANAM-302 (NCT01387282), also known as ROMANA1 and ROMANA2, are double-blind, placebo-controlled, randomized (2:1 ANA vs. placebo) Phase III trials in patients with non-small cell lung cancer (NSCLC) cachexia. Eligible patients must have unresectable Stage III or IV NSCLC and cachexia (≥5 % weight loss within prior 6 months or BMI<20 kg/m2). Patients receive once daily oral doses of ANA
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(100 mg) or placebo for 12 weeks. Co-primary endpoints are the change from baseline in LBM and in muscle strength (measured by DXA and handgrip strength, respectively). Secondary endpoints include change in body weight, overall survival, and quality of life (FACIT-F and FAACT). For HT-ANAM-301 only, population pharmacokinetics are tested at Week 6. After 12 weeks of treatment, patients may continue in a 12-week safety extension study (HTANAM-303 [ROMANA3] NCT01395914). At their last meeting (August 2012), the Independent Data Monitoring Committee suggested no safety issue and allowed the trials to continue as planned. Results Conclusions
MASCC-0412 Salivary flow rate in chemotherapy receiving cancer patients T. Davidowitz1, S. Stemmer2, I. Kaplan3 Oral Medicine, SHEBA medical center, Ramat Gan, Israel, 2Institute of Oncology, Rabin medical center, Petach Tikva, Israel, 3Institute of Pathology, Rabin medical center, Petach Tikva, Israel 1
Introduction Objectives: To Investigate early and delayed chemotherapy- induced effects on salivary flow in patients with breast and colon cancer. Methods: Thirty-nine patients completed the study. Patient were evaluated before chemotherapy treatment, and again at 1, 3 and 6 months. Resting and stimulated salivary flow rates were measured (spit method). Questionnaires evaluated subjective symptoms and function (Fox and UKU adapted questionnaires). Results: The study population included 34 F, 5 M, 28–70 years old (median 52 years). 14 (32.5 %) patients with colon cancer, 35 (67.5 %) with breast cancer. In comparison with pre-chemotherapy flow rates, unstimulated salivary flow decreased at 1 and 3 months and stayed low at 6 months (mean 3.28, 2.87, 2.86, 2.85 ml/10 min. respectively). The stimulated flow rate showed a similar trend (mean 4.32, 3.58, 3.08, 3.34 ml/10 min. respectively). In the questionnaires, the proportion of complaint- free patients decreased with time (67.5 %, 45 %, 32.5 %, and 30 % respectively in the Fox and 70 %, 40 %, 22.5 % and 42.5 % UKU questionnaire, p<0.05). Conclusions: Chemotherapy for breast and colon cancer caused significant decrease in stimulated and unstimulated salivary flow rates. This effect lasted for at least 6 months after treatment, and correlated with an increased level of patient discomfort. Patients receiving chemotherapy should get counseling and supportive treatment to deal with the decrease in salivary flow. In view of limited number of patients completing this study, larger numbers of patient are needed to further validate these findings.
MASCC-0413 Monitoring instruments for nutritional status in head and neck cancer patients J. Büntzel1, H. Buentzel2, C. Donner3, K. Meyer4 1 Otolaryngology, Südharz Klinikum, Nordhausen, Germany, 2Palliative Medicine, Südharz Klinikum, Nordhausen, Germany, 3Palliative Medicine, Palliative Care Network, Nordhausen, Germany, 4Home Care, Südharz Klinikum, Nordhausen, Germany Introduction: Weight, body mass index, screening and assessment tools are well established in the diagnosis of malnutrition. We need more detailed information about the value and practicability of such instruments in the follow up of our cancer patients. Objectives: What are the best diagnostic instruments for nutritional monitoring of advanced head neck cancer patients?
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Methods: We have included 30 patients (23 men, 7 women) to this observational study. We have registered body weight, body mass index, nutritional risk screening tool, bioimpedance vector analysis (BIVA), bioimpedance phase angle (BIA) and RTOG dysphagia classification about 12 month. At the end of observation the nutrition team had to categorize the used instruments regarding their information value, practicability, and therapeutic impact. Results: Regarding the information value we observed following categorization: BIA > body weight > NRS-2002 > BMI > RTOG dysphagia scale > BIVA. Following therapeutic impact was seen: BIA > RTOG dysphagie scale > body weight > BIVA > NRS-2002 > BMI. The practicability was categorized: body weight > BIA > RTOG dysphagia scale > BMI/BIVA > NRS-2002. Conclusions: Body weight and bioimpedance analysis should be used to monitor the nutritional status of head neck cancer patients. RTOG dysphagia scale should registered as additional information of daily nutritional problems.
MASCC-0414 Randomized, double-blind, phase iii trial of palonosetron versus granisetron in the triplet regimen for preventing chemotherapyinduced nausea and vomiting (CINV) after highly emetogenic chemotherapy (HEC) T. Yamanaka1, T. Yanai2, Y. Honma3, K. Arata4, R. Matsui5, K. Goto6, N. Yasumori7, W. Okamoto8, M. Takase9, K. Shibata10, M. Sano11, N. Haga12, N. Seki13, K. Suzuki4, N. Yamamoto14 1 Research Center for Innovative Oncology, National Cancer Center Hospital East, Chiba, Japan, 2Division of Pharmacy, National Cancer Center Hospital, Tokyo, Japan, 3Division of Gastrointestinal Oncology, National Cancer Center Hospital, Tokyo, Japan, 4Department of Pharmacy, Shizuoka Cancer Center, Shizuoka, Japan, 5Department of Pharmacy, National Cancer Center Hospital East, Chiba, Japan, 6 Division of Thoracic Oncology, National Cancer Center Hospital East, Chiba, Japan, 7Department of Pharmacy, National Kyushu Cancer Center, Fukuoka, Japan, 8Department of Medical Oncology, Kinki University Hospital, Osaka, Japan, 9Department of Pharmacy, Kouseiren Takaoka Hospital, Toyama, Japan, 10Department of Medical Oncology, Kouseiren Takaoka Hospital, Toyama, Japan, 11 Department of Pharmacy Services, Saitama Medical University, Saitama, Japan, 12Department of Digestive Tract and General Surgery, Saitama Medical University, Saitama, Japan, 13Division of Medical Oncology, Teikyo University School of Medicine, Tokyo, Japan, 14Division of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka, Japan Introduction: Standard antiemetic care for preventing CINV due to HEC is a combination of 5-HT3 receptor antagonist (RA), dexamethasone, and NK1 RA. Objectives: To compare the efficacy of two 5-HT 3 drugs, palonosetron and granisetron, within the triplet regimen for preventing HEC. Methods: Patients with a malignant solid tumor who were receiving HEC containing 50 mg/m2 or more cisplatin were eligible. They were randomly assigned to either Arm A (palonosetron 0.75 mg, i.v.) or Arm B (granisetron 1 mg, i.v.), before chemotherapy on day 1, both arms with dexamethasone (9.9 mg on day 1 and 6.6 mg on day 2–4, i.v.) and aprepitant (125 mg on day 1 and 80 mg on day 2– 3, p.o.). The primary endpoint was complete response (CR) at the overall (0–120 h) phase. Secondary endpoints included CR at the acute (0–24 h) and delayed (24–120 h) phases, and complete control (CC) and total control (TC). Planned sample size was 840. The exact Cochran-Mantel-Haenszel (CMH) test was performed at a significance level of 0.05.
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Results: Between July 2011 and June 2012, 842 patients were registered from 20 centers and 827 patients were evaluable. The median CDDP dose was 76.1 mg/m2 in Arm A and 75.7 mg/m2 in Arm B. Baseline characteristics were well-balanced. Efficacy results are summarized in the Table. Table
CR %
CC %
TC %
Overall Acute Delayed Overall Acute Delayed Overall Acute Delayed
Arm A, N=414 66 % 92 % 67 % 64 % 90 % 65 % 48 % 81 % 49 %
Arm B, N=431 59 % 92 % 59 % 56 % 90 % 56 % 41 % 81 % 41 %
Odds Ratio (95 % CI) 1.35 (0.99, 1.82) 1.00 (0.58, 1.71) 1.45 (1.07, 1.96) 1.41 (1.05, 1.90) 1.01 (0.61, 1.65) 1.51 (1.12, 2.04) 1.36 (1.01, 1.82) 1.00 (0.69, 1.45) 1.36 (1.02, 1.83)
P-value 0.0539 1.00 0.0142 0.0234 1.00 0.0053 0.0369 1.00 0.0369
Conclusions: The primary endpoint was not met (P=0.0539). However, the overall study results have shown the clinical utility of palonosetron in the triplet regimen. Palonosetron is a more preferable 5-HT3 RA than granisetron for preventing CINV due to HEC References: Registered with UMIN-CTR (http://www.umin.ac.jp/ctr/). Study ID: UMIN000004863
MASCC-0415 Changes of care and nursing after DNR decision making in oncology units L.E.E. SOON HAENG1, Y.A.N.G. yunjung2, P.A.R.K. jungyun3 1 ICU Care Nursing, Asan Medical Center, Seoul, Korea, 2Asan Cancer Center, Asan Medical Center, Seoul, Korea, 3Clinical Nursing, University of Ulsan, Seoul, Korea Introduction: Do-not resuscitate (DNR) in the event of cardiac arrest is the most common and important discussion between a patients’ family and physicians among the end-of-life decision-making process. To observe the performance of a DNR order in critically ill patients, we analyzed the incidence of DNR orders, the change in therapeutic level after DNR orders, and the cases of violated DNR codes in patient who had died in Korean Medical oncology unit between July 2011 and December 2012. Objectives: To evaluate treatments at the end of life care for terminal cancer patients during their last admission. Methods: Medical records of terminal cancer patients during their last admission at a district academic hospital were evaluated. Results: Total 585 patients were included. The median patients age was 58.5 years. The median length of admission was 17.3 days (rang: 1~367). Patients characteristics, 360 males and 225 females in total were enrolled. Lung cancer (30.4 %) accounted for the most common premorbid diagnosis during their last admission and on patients’ day of death. Ninety percent of the patients (92.3 %) had formal DNR orders. Fifty-four percent of the patients with a DNR order had received the order within 3 days death. Decrease in their tests (ABGA, culture, x-ray, fluid analysis, blood sample, CT, MRI, sono) number after implementing the DNR decision about thirty-two percent, but on patients’ day of death the average of four tests were conducted. Conclusions: DNR orders are initiated when patient death is imminent. However, on patients’ day of death tests were conducted.
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MASCC-0416 Unemployment correlates and association with quality of life in cervical cancer survivors S. Yoo1, Y. Yun1, S. Park2, Y. Kim3, S. Park3, D. Bae4, J. Nam5, C. Park6, C. Cho7, J. Lee8 1 Department of Medicine, Seoul National University College of Medicine, Seoul, Korea, 2Department of Family Medicine, Seoul National University College of Medicine, Seoul, Korea, 3Research Institute and Hospital, National Cancer Center, Goyang, Korea, 4Department of Obstetrics and Gynecology, Samsung Medical Center Sungkyunkwan University School of Medicine, Seoul, Korea, 5 Department of Obstetrics and Gynecology, Asan Medical Center University of Ulsan College of Medicine, Seoul, Korea, 6Department of Obstetrics and Gynecology, Kangnam Cha Hospital College of Medicine Pochon CHA University, Seoul, Korea, 7Department of Obstetrics and Gynecology, School of Medicine Keimyung University, Daegu, Korea, 8 Department of Obstetrics and Gynecology, East–west Neo Medical Center Kyung Hee University, Seoul, Korea Introduction: Little is known regarding cervical cancer survivors’ employment status, which represents social integration of cancer survivors as a pivotal domain of long-term quality of life. Objectives: We enrolled 858 cervical cancer survivors from the gynecological oncology departments in South Korea. Methods: Factors associated with unemployment were identified using multivariate logistic regression analyses. We assessed different HRQoL domains with multivariate-adjusted least-square means between cervical cancer survivors who currently work and those who do not. Results: After diagnosis and treatment, the percentage of unemployed survivors increased from 50.6 % to 72.8 %. Lower income (adjusted odds ratio [aOR] 1.97, 95 % confidence interval [CI] 1.38–2.81), medical aid (aOR 1.58, 95 % CI 1.05–2.38), two or more comorbidities (aOR 1.80, 95 % CI 1.12–2.90), current alcohol drinkers (aOR 2.33, 95 % CI 1.54– 3.52), and employed at the time of diagnosis (aOR 10.72, 95 % CI 7.10– 16.16) were significantly associated with unemployment. Non-working groups showed significant differences with respect to physical functioning, role functioning, depression, and existential well-being Conclusions: The proportion of unemployed cervical cancer survivors seems to increase, with low-income status and the presence of medical aid negatively associated with employment, in addition to other comorbidities and previous working status. Effort should be made to secure the financial status of cancer survivors. MASCC-0417 Intravenous methadone for severe cancer pain. Presentation of 10 cases D. Lossignol1, I. Libert1, B. Michel1, C. Rousseau1, M. Obiols-Portis1 1 Supportive care, Institut Jules Bordet, Brussels, Belgium Introduction: We present our preliminary experience with intravenous (IV) methadone in 10 cancer patients with advanced disease and severe cancer pain already treated with high doses of opioids. Objectives: To study the effectiveness of IV methadon in refractory cancer pain Methods: We followed 10 consecutives cancer patients with severe pain, treated with IV methadone. All had advanced disease and were already received strong opioids, some in association with ketamine. Pain was assessed at T0, T24 h, and at the end of treatment. Results: All patients benefited from the switch to IV methadone with a reduction of pain on VAS after 24 h (median: 4/10-range, 0–5) until the end of treatment (all cases<3/10). The median starting dose was 100 mg/day (range, 20–400) and the final dose remained stable with a median of 100 mg/day (range, 27–700). The median duration of IV methadone was 11 days (range, 2–59). No cardiac toxicity had been observed.
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Conclusions: IV methadone is an effective pain relieving alternative for the treatment of severe cancer pain, especially in refractory pain syndrome. No toxicity (neurological or cardiac) or any other major side effects were observed and the treatment were overall well tolerated. More extensive comparative studies should be planned. References: Lawlor PG, Turner KS, Hanson J et al (1998) Dose ratio between morphine and methadone in patients with cancer pain: a retrospective study. Cancer, 82:1167–1173 Shaiova L, Berger A, Blinderman CD et al. (2008) Consensus guideline on parenteral methadone use in pain and palliative care. Palliat Support Care 6:165–176 MASCC-0418 Comparison of different methods for measuring the nutritional status and the identification of malnutrition in patients with cancer C. Diemar1, J. Rüssel1, F. Güntsch1, T. Behlendorf1, M. Wass1, H.J. Schmoll1, K. Jordan1 1 Klinik für Innere Medizin IV Hämatologie/Onkologie, Universitätsklinikum Halle (Saale), Halle (Saale), Germany Introduction: Cancer patients are under risk to develop malnutrition due to disease and side effects of the therapy. However, there is neither an uniform definition of malnutrition nor a gold standard for the assessment of malnutrition which complicates the diagnosis and a timely intervention to counteract the loss of body mass. Objectives: We conducted a prospective study to analyze the feasibility and comparability of 3 different Methods for measuring the nutritional status and the identification of malnutrition in patients with cancer. Methods: The nutritional status of 50 cancer patients was assessed by the Nutritional Risk Screening (NRS-2002), a bioimpedance-analysis (BIA) and the measurement of albumin, prealbumin and retinol-binding protein (RBP) which are indicators of visceral proteins in serum. For statistical analysis the ANOVA-method was used to make a statement about the variance between well- and malnourished patients. Results: According to NRS-2002, 14 patients were at high risk of malnutrition, 7 patients were classified to be at moderate risk and 29 patients were not at risk of malnutrition. Albumin classified 28 patients as not well-nourished, prealbumin 7 patients and RBP 5 patients. Results of BIA measurements are still under investigation. Patients identified as malnourished by prealbumin and RBP showed significant lower values of albumin and prealbumin or respectively RBP and were at risk to develop malnutrition by NRS-2002. Conclusions: For diagnosis of malnutrition in patients with malignancies we preliminary suggest a well-defined screening according to NRS-2002 in each hospital patient and the determination of prealbumin or RBP as short-lived proteins. MASCC-0419 Changes in nutritional status and body composition in childhood cancer patients: a prospective cohort study A. Brinksma1, E. Sulkers1, P.F. Roodbol2, W.A. Kamps3, A.M. Boot4, J.G.M. Burgerhof5, R.Y.J. Tamminga3, W.J.E. Tissing3 1 Department of Pediatric Oncology and Hematology/School of Nursing and Health, University Medical Center Groningen University of Groningen, Groningen, Netherlands, 2School of Nursing and Health, University Medical Center Groningen University of Groningen, Groningen, Netherlands, 3Department of Pediatric Oncology and Hematology, University Medical Center Groningen University of Groningen, Groningen, Netherlands, 4Department of Pediatric Endocrinologie, University Medical Center Groningen University of Groningen, Groningen, Netherlands, 5 Department of Epidemiology, University Medical Center Groningen University of Groningen, Groningen, Netherlands
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Introduction: Since malnutrition and obesity have adverse outcomes during and after childhood cancer treatment, it is essential to gain insight in timing of weight loss and weight gain and in contributing factors. Objectives: To determine (1) in which period of treatment changes in nutritional status and body composition occurred, and (2) which factors contributed to those changes. Methods: We performed a prospective cohort study of 133 newly diagnosed cancer patients with hematological, solid, and brain malignancies. Anthropometric data and related factors were assessed at 0, 3, 6 and 12 months after diagnosis. Results: Despite initial weight loss in the first weeks after diagnosis in patients with hematological and solid malignancies, body mass index (BMI) and fat mass (FM) increased within 3 months with 0.13 SDS (P <0.001) and 0.05 SDS (P=0.021) respectively. Increase continued during the next 9 months, and resulted in doubling of the number obese patients. Fat free mass (FFM), already low at diagnosis, remained low. During the whole study period about 17 % of the patients were malnourished according to low FFM. Tube feeding and diminished activity level were related to increase in respectively BMI and %FM. No relationship was found between energy intake or corticosteroids and increase in BMI or %FM. Conclusions: Alarming increase of BMI and FM already started within the period of intensive treatment and continued thereafter, while FFM remained low. Improvement of nutritional status and body composition might be accomplished by prevention of overfeeding and improvement of physical activity in children on treatment.
MASCC-0420 Impact of high-level laser therapy on the weight of oncological patients affected by oral mucositis after radiotherapy of the head and neck region M. Gobbo1, G. Ottaviani1, F. Ciriello2, S. Zacchigna3, R. Di Lenarda1, A. Beorchia2, M. Biasotto1 1 Dental Science - Oral Medicine and Pathology, University of Trieste, Trieste, Italy, 2Radiotherapy, Ospedale Maggiore, Trieste, Italy, 3 Molecular Medicine, International Centre for Genetic Engineering and Biotechnology (ICGEB), Trieste, Italy Introduction: Weight loss is frequently noted among head and neck cancer patients during and after radiotherapy Objectives: To evaluate the capacity of High-level laser therapy to improve the nutritional status of patients affected by oral mucositis due to radiotherapy of the head and neck region during oncological treatment. Methods: Sixty-three oncological patients were retrospectively included in this study. All patients were affected by solid tumors of the head and neck and had developed oral mucositis following radiotherapy. 42 patients had been treated by High-level laser therapy in addition to traditional medications, whereas 21 patients had received traditional medications only. Weight (Kg) and BMI (mass(kg)/(height)(m)2) at the first and last day of radiotherapy, site and stage of tumor, and kind of oncological treatment, were considered for this study. Results: Laser-treated patients experienced a lower decline in BMI during radiotherapy. Patients treated by combined oncological treatment underwent a higher weight loss during radiotherapy. Multivariate regression analysis indicated that the only variable, which significantly influenced BMI decrease, was the execution of High-level laser therapy Conclusions: Laser therapy is actually considered one of the recommended therapies to improve the healing of oral mucositis in oncological patients, by reducing pain and increasing chewing and swallowing capacities. It significantly improve the feeding capacity of patients, prevent excessive weight loss and reduce the costs for hospitalization and supportive care. Laser therapy should become part of nutritional interventions in oncological patients affected by oral mucositis References: Ehrsson YTet al. Nutritional surveillance and weight loss in head and neck cancer patients; Support Care Cancer. 2012 Apr;20(4):757–65.
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MASCC-0421 Adequacy of energy intake in childhood cancer patients A. Brinksma1, E. Sulkers1, P.F. Roodbol2, W.A. Kamps3, W.J.E. Tissing3 1 Department of Pediatric Oncology and Hematology/School of Nursing and Health, University Medical Center Groningen University of Groningen, Groningen, Netherlands, 2School of Nursing and Health, University Medical Center Groningen University of Groningen, Groningen, Netherlands, 3Department of Pediatric Oncology and Hematology, University Medical Center Groningen University of Groningen, Groningen, Netherlands Introduction: Despite a widespread belief that adequate energy intake is needed to maintain weight during childhood cancer treatment, consensus on how to define adequate energy intake is lacking, and the impact of energy intake on weight has never been tested. Objectives: To evaluate which criterion is the best to determine the adequacy of energy intake during treatment for childhood cancer. Methods: Prospective cohort study of 115 newly diagnosed cancer patients assessing energy intake at diagnosis, 3, 6, and 12 months. Intake was compared to recommended daily allowances (RDA), healthy controls, individual energy requirements (IR) based on Schofield formula, and weight changes. Results: Energy intake was lower than RDA and lower than in healthy Dutch children (according to a food consumption survey 2008/2011) (FCS) at all measurement points. About 41–56 % of the patients had insufficient intake (<80 %) according to RDA or FCS. Energy intake matched IR at diagnosis and 6 months. However, energy intake was higher than IR at 3 months (P=0.020) and lower at 12 months after diagnosis (P=0.044). According to IR, intake was insufficient in 13–30 % of the patients. During the study period, weight-for-age (WFA) increased from .01 SDS to .34 SDS (P=0.001). Energy intake was not associated with increase of weight. Conclusions: Despite energy intake being lower than RDA and FCS, weight increased. Obviously, childhood cancer patients need less energy than RDA or than healthy children. Instead of using RDA or FCS, adequacy of energy intake can better be evaluated with IR.
MASCC-0422 Inadequate treatment of pain: time for the courts/legislature to redress these human rights violations? R. Jansen1 1 Private Law, University of the Free Sate, Bloemfontein, South Africa Introduction: “Of patients with advanced cancer, 70 % have pain and 70–90 % of those with advanced AIDS have uncontrolled pain … suffering on this scale is … unnecessary … Every individual has the right to pain relief.”[1]. In 90 % of patients pain can adequately be relieved, but in 80 % of cases this is not done, despite the fact that effective pain medication is available. Morphine, one of the most effective painkillers, has been known to mankind for approximately 3 000 years. Objectives: Over the last few decades the spotlight has fallen on the under-treatment of pain. Although attempts have been made to address this unnecessary human suffering, there are a number of reasons why too little progress has been made. In some countries, like the USA, fear of the regulatory authority has been mentioned. In South Africa this is not the case, but still people suffer needlessly. A lack of knowledge and archaic views have resulted in a so called “opiophobia” and a standard practice of giving no pain medication or as little medication as possible. Methods: Diverging views on whether the health care system’s failure to treat patient pain adequately needs corrective action by the judiciary, will be discussed. Other possible solutions such as recent legislative developments will also be considered.
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Results: Ideally the fear of lawsuits should not guide medical care. Conclusions: The basic ethical principle is that human dignity requires and demands that treatable pain be relieved. Simultaneous initiatives in medicine, law and ethics are required. References: [1] Korea Declaration 2005
MASCC-0423 Off label use of laser therapy for the treatment of radiodermatitis in breast cancer patients S. Zacchigna1, F. Ciriello2, M. Gobbo3, G. Ottaviani3, M. Biasotto3, R. Di Lenarda3, A. Beorchia2 1 Molecular Medicine, International Centre for Genetic Engineering and Biotechnology (ICGEB), Trieste, Italy, 2Radiotherapy, Ospedale Maggiore, Trieste, Italy, 3Dental Science - Oral Medicine and Pathology, University of Trieste, Trieste, Italy
A general improvement in pain sensation and hitching was seen both during laser session and follow up. Bleeding was stopped immediately after treatment. All patients referred to be highly satisfied, immediately after treatment as well as during follow up. Objective examination showed in all cases a noteworthy improvement of inflammation, oedema, erythema and swollenness. All patients underwent complete regression of all lesions in the treated areas. Conclusions: Our results suggest that HLLT might significantly contribute to the healing of radiodermatitis, thereby improving quality of life of cancer patients. References: Kumar S et al. Management of skin toxicity during radiation therapy: a review of the evidence. J Med Imaging Radiat Oncol. 2010 Jun;54(3):264–79.
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Introduction: Dermatitis is a common and distressing side effect of radiotherapy in patients with cancer. Swelling, redness, and ulceration of the skin are often associated to itching, pain and burning sensation. There is no convincing evidence supporting any single practice in the prevention or management of radiodermatitis. Objectives: To evaluate the effectiveness of High-level laser therapy (HLLT) in reducing the severity of radiodermatitis in breast cancer patients. Methods: Ten patients affected by severe radiodermatitis at the grade 3 or 4, according to Common Terminology Criteria for Adverse Events scale, were treated by 2 consecutive HLLT sessions, 3 times a week for 2 weeks. HLLT was applied to the intramammary fold and underarm. Follow up recalls were performed at 7, 14 and 30 days after the last laser session, by evaluating general discomfort, hitching, bleeding and subjective satisfaction. Before enrollment, all patients were asked to interrupt any medication. Results
MASCC-0424 The effect of modafinil on fatigue, cognitive functioning and mood in primary brain tumor patients: a multi-center RCT F. Boele1, L. Douw2, M. Groot de2, H. Thuijl van2, W. Cleijne1, J. Reijneveld2, J. Heimans2, M. Taphoorn3, M. Klein1 1 Medical Psychology, VU University Medical Center, Amsterdam, Netherlands, 2Neurology, VU University Medical Center, Amsterdam, Netherlands, 3Neurology, Medical Center Haaglanden, the Hague, Netherlands Introduction: Fatigue, cognitive deficits, and depression are frequently reported, but often undertreated symptoms that can profoundly affect daily life in patients with primary brain tumors (PBTs).
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Objectives: To evaluate the effects of the psychostimulant modafinil on fatigue, depression, health-related quality of life (HRQOL) and cognitive functioning in PBT patients, we performed a multi-center, double-blind placebo-controlled crossover trial. Methods: Patients randomly received either 6 weeks of treatment with modafinil (up to 400 mg/day) or 6 weeks with placebo. After a 1 week washout period, the opposite treatment was provided (6 weeks of placebo or 6 weeks of modafinil). Assessments took place at baseline, and immediately after the first and second condition. Patients completed self-reported questionnaires on fatigue (CIS), depression (CES-D), HRQOL (SF-36), and self-perceived cognitive functioning (MOS). They also underwent comprehensive neurocognitive testing. Results: Thirty-seven PBT patients participated. Relative to baseline, patients reported lower fatigue severity (CIS) and better motivation (CIS) both in the modafinil (p=0.010 and p=0.021, respectively) and placebo condition (p<0.001 and p=0.027, respectively). The same held for physical health (SF-36 PCS score; p=0.001 and p=0.008, respectively), working memory (p=0.040 and p=0.043, respectively) and information processing capacity (p=0.036 and p=0.040, respectively). No improvement in depressive symptoms was found in either condition. Conclusions: Modafinil did not exceed the effects of placebo with respect to symptom management. Patient accrual was slow and relatively many patients dropped out during the trial, mostly due to experienced side-effects. Other, preferably non-pharmacological intervention studies should be considered to improve symptom management of PBT patients.
MASCC-0425 Incidence and management of aspiration pneumonia in patients treated with radiotherapy for head and neck cancer S. Cousin1, M. Reich2, M. Degardin1, A. Mailliez1, V. Leclercq2, G. Lefebvre1 1 Head and Neck Cancerology, Centre Oscar Lambret, Lille, France, 2 supportive Care Department, Centre Oscar Lambret, Lille, France Introduction: Aspiration pneumonia (AP) has been reported as a frequent complication in patients treated with radiotherapy for head and neck cancer. Objectives: The aim of this study was to investigate the incidence, the mortality and the management of AP in unselected head and neck cancer patients consecutively treated by radiotherapy, independently of the other associated anti cancer treatments. Methods: We have carried out a retrospective analysis in our institution. Data about patients, tumors and treatment characteristics were recorded. Results: A total of 273 consecutive patients treated from December 2011 to December 2012 were included. AP occurred in 9 (3,2 %) patients, corresponding to an incidence rate of 33 [95 % CI 11–54] per 1,000 person-years. Seven episodes were hypoxemic pneumonia which required oxygenotherapy. At the time of the AP, 8 patients had a performance status ≥3, 5 had a gastrostomy and none had a feeding tube. They all received a probabilistic antibiotherapy: 8 penicillin-based, 1 by levofloxacin. Seven had a respiratory kinesitherapy but only 2 were treated by nebulization. The median time of hospitalization was 9 days [3–14]. One patient with AP died from this complication. Conclusions: In our population, the incidence of AP was lower than expected. The majority of our patients had a supportive care management with nutritional assessment before the
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beginning of the anti cancer treatment and an intensitymodulated radiation therapy, which can in part explain the low rate of AP. References: Eisbruch A, Lyden T, et al. Objective assessment of swallowing dysfunction and aspiration after radiation concurrent with chemotherapy for head-and-neck cancer. Int J Radiat Oncol Biol Phys 2002;53:23–8
MASCC-0426 Telephone versus face to face palliative care consults K.J. Weru1 1 Medicine, Aga Khan University Hospital, Nairobi, Kenya Introduction: Palliative care aims at ameliorating patients and families suffering when faced with life-limiting illnesses. It involves symptom management and psychosocial, spiritual support. Proper communication between clinicians is important for this. Studies show that errors in communication are common. Objectives: The aim was to assess the adequacy of information given in telephone versus face to face consults. Methods: Twenty-five consults received in 2 months; 16 telephone 8 face to face. Team did not ask any questions but recorded information given during the consultation. This was assessed for following details: I) name II) age, III) gender, IV) longevity of illness, V) location, VI) diagnosis, VII) reasons for referral, VIII) current treatments, IX) knowledge of diagnosis, X) family involvement XI) knowledge of referral. Results: Ninety percent of the telephone consults missed at least 5 parameters. These were, I, XI, IX, II, VI in that order. No face to face missed 5 or more parameters but 20 % missed 2–3 of the parameters which were: I, X and IX. Of note is 88 % of the cases had the patient’s name not mentioned. This is a case of...... was the commonest starting statement. Conclusions: Telephone consult is less informative than face to face. It is important to have a discussion after telephone consultation. Doctors are poor in the aspects of communicating with patients, families, colleagues. References: ISABEL, D; ET AL; 2012. Errors in Palliative Care: Kinds, Causes and Consequences PEREIRA, J; and BRUYERE, E; 2011. The Pallium Palliative Pocketbook
MASCC-0427 Associations between men’s experiences of prostate cancer care and health-related quality-of-life and psychological wellbeing: findings from a national study M. Hennessy1, H. Comber1, F.J. Drummond1, L. Sharp1 1 Research, National Cancer Registry Ireland, Cork, Ireland Introduction: Prostate cancer is the most commonly diagnosed cancer in men in developed countries. The care experience of cancer patients has been investigated in various countries. These studies show significant variations between patients in experiences of care, with prostate cancer patients reporting significant problems and dissatisfaction. The extent to which these experiences impact on health-related quality-of-life and psychological wellbeing is not well understood Objectives: The PiCTure 2 study aims to assess the care experiences of men recently diagnosed with prostate cancer and investigate associations between experiences and health-related quality-of-life and psychological wellbeing.
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Methods: Men diagnosed with invasive prostate cancer (ICD10 C61) 5–20 months prior to study commencement were identified through the National Cancer Registry. The study questionnaire was based on the Prostate Care Questionnaire (Baker et al. 2007), modified for Ireland and pre-tested using cognitive interviewing. Health-related quality-of-life and psychological well-being were assessed using the ED5D-5 L and DASS. The questionnaire was administered by post to >2,200 men during January-February 2013. Results: More than 950 completed questionnaires have so far been received. Men’s experiences will be compared by time since diagnosis, age at diagnosis, treatments received and socio-demographic factors. Factors which contribute to positive/negative experiences will be highlighted and the extent to which these are associated with healthrelated quality-of-life (utility) and psychological wellbeing (depression, anxiety and distress) described. Conclusions: If care experiences are associated with health-related quality-of-life and psychological wellbeing, this provides further rationale for initiatives to improve quality of care.
MASCC-0428 Men’s experiences of prostate cancer care: qualitative findings from cognitive interviews M. Hennessy1, H. Comber1, F.J. Drummond1, L. Sharp1 1 Research, National Cancer Registry Ireland, Cork, Ireland Introduction: Prostate cancer is the most common cancer in men in developed countries. Incidence in Ireland is the highest in Europe. Patients’ experiences of care are an important indicator of quality of care, but remain poorly understood Objectives: The PiCTure 2 study aims to assess the care experiences of men recently diagnosed with prostate cancer in Ireland Methods: A questionnaire was developed from the Prostate Care Questionnaire (PCQ; Baker et al., 2007). To modify as appropriate for Ireland, it was pre-tested using cognitive interviewing. Seventeen interviews were conducted with prostate cancer patients (managed by all major treatment modalities) recruited by Urologists and/or Clinical Nurse Specialists at three hospitals during September 2012–January 2013. Men were invited to ‘think-aloud’ whilst completing the survey; the interviewer used prompts to understand how respondents interpreted survey questions. Interviews lasted 20–90 min. Interview recordings were transcribed and analysed thematically Results: Emergent themes included: breaking the bad news; support (both informational and emotional) from doctors, nurses and spouses/partners; growth in knowledge throughout the diagnosistreatment trajectory but a reliance on ‘experts’ at the outset and how this impacted on their ability to participate in care and decision-making; and altruism. Key revisions were made to the survey so that it will accurately capture experiences of patients in Ireland. Conclusions: As well as informing survey development, cognitive interviews provided rich qualitative data which will add to the interpretation of the survey findings. The PiCTure 2 results will be of value to policy-makers, service providers, health professionals and patient support organisations.
MASCC-0429 Increase of life quality and toxicity decrease in patients with the ovarian cancer who’s taking adjuvant chemical therapy A.I. Rybin1, V.G. Dubinina1, O.V. Kuznetsova1, O.V. Lukyanchuk1 1 Oncology, Odessa National Medical University, Odessa, Ukraine
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Introduction: In Ukraine 75 % cases of ovarian cancer are diagnosed in late stages and need adjuvant chemotherapy. But in 30– 40 % of cases there are platinum resistant forms of ovarian cancer or the treatment should be stopped owing to toxicity of this drug. Objectives: The aim of this work is to study the clinical effectiveness of L-arginine in treatment of patients with ovarian cancer at later stages by assessing quality of life and toxicity of chemotherapy. Methods: Fifty patients with ovarian cancer at stage IIIA-IIIC were divided into 2 groups: in the first group on the background of traditional postoperative chemotherapy (cisplatin + paclitaxel) patients carried L-arginine: 500 mg per os twice a day during 10 days. In the second (control) group the patients received traditional adjuvant chemotherapy. Results: The results of L-arginine use clinical efficacy in complex treatment of patients with the ovarian carcinoma investigation are presented in the article. It was established that L-arginine use in parallel with postoperative chemical therapy improves indices of patient’s life quality and also decreases chemical drugs toxicity. The cause of such results is that L-arginine is donator of the nitric oxide. And one of the of nitric oxide effects is stimulation of tissue sanogenesis. Conclusions: Use of L-arginine in complex treatment of ovarian cancer increases patients’ life quality and reduces platinum drugs toxicity. References: Philip J. DiSaia, William T. Creasman. Clinical Gynecologic Oncology. Seventh edition. - Elsevier, 2011.
MASCC-0430 Prevalence of advanced directives and information needs of cancer patients during radiotherapy B. van Oorschot1 1 Department of Radiation Oncology, Interdisciplinary Center Palliative Care, Würzburg, Germany Introduction: Advanced directives (living wills, AD) are becoming increasingly widespread. Objectives: We examined prevalence and information needs concerning ADs during radiotherapy. Methods: A standardized questionnaire was handed out to all cancer patients on 4 random days between June 2009 and July 2010. Results: Of 470 questionnaires, 276 returned completed (58.7 %). 69 respondents had already an AD (25.6 %) and 143 thought they were likely to sign an AD (53.0 %). The concept of AD was unknown for 10 respondents (3.7 %). 28 respondents did not want to sign an AD (10.4 %). Patients with an AD were significantly older than 65 years. 82.0 % of all respondents, agreed with the statement that patients should be asked about an AD in context of every admission. Among them 93.1 % of all patients had an AD and 83.6 % of all respondents were likely to sign an AD. 94.4 % agreed with the statement that counselling concerning ADs is useful; among them, there were significantly more patients likely to sign an AD than patients with ADs (p=.000). 60.4 % wanted for themselves expert advice on Ads. Among them significantly more patients were likely to sign an AD than patients who already had ADs (66.0 % vs 57.3 %, p=.000). Among the patients who wanted expert advice 59.9 % wanted a consultation with their general practitioner, 25.7 % with a physician in charge in hospital and 6.7 % with another medical specialist. Conclusions: ADs are relevant and especially patients likely to sign an AD want expert advice. To optimize patients support communication about ADs in the context of oncological treatment should be improved.
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MASCC-0431 Development of a multidisciplinary, evidence based symptom management tool for oral care in cancer therapy I. Harle1, D. Saunders2, K. Bak3, V. Jarvis4, P. Argier5, A. Cheung6, A. Knight7, T. Murphy-Kane8, C. Root9, S. Wales Arnold10, S. Tierney11 1 Dental Oncology, Health Sciences North North East Cancer Center, Sudbury, Canada, 2 Palliative Care Medicine Program, Queen’s University, Kingston, Canada, 3Oncology Nursing Psychosocial and Palliative Care, Cancer Care Ontario, Toronto, Canada, 4Palliative Care Medicine Program, University of Ottawa the Ottawa Hospital Cancer Center, Ottawa, Canada, 5Supportive Care, R.S McLaughlin Durham Regional Cancer Center, Oshawa, Canada, 6Pharmacy, Cancer Care Ontario, Toronto, Canada, 7Palliative Care Medicine Program, Health Sciences North North East Cancer Center, Sudbury, Canada, 8Palliative Care Medicine Program, Princess Margaret Hospital, Toronto, Canada 9 NSMPCN Palliative Resource Team, North Simcoe Muskoka Palliative Care Network, Orillia, Canada, 10Supportive Care, Peel Regional Cancer Center, Mississauga, Canada, 11Palliative Care, Elisabeth Bruyere Hospital SCOHS, Ottawa, Canada Introduction: Cancer Care Ontario developed Symptom Management a series of evidence-based tools for oral care to assist healthcare professionals in the assessment and appropriate management of a patient’s cancer-related symptoms. The tools consist of a comprehensive Guideto-Practice, quick reference Pocket Guides and two-page Algorithms. Objectives: The overall goal of the oral care symptom management tools is to promote an interdisciplinary model of care, enabling earlier identification, assessment, communication and documentation of symptom, and optimal non-pharmacological and pharmacological management of symptoms, ranging from basic to palliative oral care. In order to reach a wide audience, the oral care tools were intended to be user-friendly and available in print, web and smart phone applications. Methods: The tools were developed by an interdisciplinary panel, using the ADAPTE guideline adaptation approach that includes identifying existing guidelines using a systematic search strategy, appraising guideline quality using the AGREE tool, selecting recommendations for inclusion and obtaining expert feedback. Results: The tools offer recommendations, based on the best available evidence and expert consensus, for the assessment, etiology and diagnosis of oral care. As well interventions for the following: general oral care (from basic to intensified to palliative oral care), oral mucositis, xerostomia and salivary gland dysfunction, dysgeusia, and intraoral infections, with specific reference to pharmacological and non-pharmacological interventions. Conclusions: Following the trends in user-friendly guideline development (eg using algorithms or smart phone applications), the primary goal was to develop a evidence based tools for oral care in cancer that were accessible to practitioners in a manner that suits their clinical needs.
MASCC-0432 Novel all-oral combination of netupitant plus palonosetron (NEPA) for preventing CINV with highly emetic chemotherapy: a randomized study exploring maximally convenient and effective regimens R. Gralla 1 , G. Rossi 2 , G. Rizzi 3 , M. Palmas 4 , A. Alyasova 5 , I. Drobner6, P. Hesketh7 1 Oncology, Albert Einstein College of Medicine, Bronx NY, USA, 2 Clinical Operations, Helsinn Healthcare S.A., Lugano, Switzerland, 3 Statistics & Data Management, Helsinn Healthcare S.A., Lugano, Switzerland, 4Corporate Clinical Development, Helsinn Healthcare S.A., Lugano, Switzerland, 5Oncology, Federal State Institution Privolzhsky District Medical Center under the Federal MedicalBiological Agency of Russia, Nizhny Novgorod, Russia, 6Oncology, Regional Oncology Center, Khmelnytsky, Ukraine, 7Thoracic Oncology, Lahey Hospital & Medical Center, Burlington MA, USA
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Introduction: Antiemetic goals are to provide maximally convenient approaches with safe and effective treatment. Objectives: This study was conducted to explore NEPA, an all-oral combination of netupitant (long-acting NK1 receptor antagonist) plus palonosetron to determine proper netupitant doses with palonosetron so that single-dosing formulations could be further investigated. Methods: This randomized, double-blind study included 694 chemotherapy-naïve patients receiving cisplatin. It compared 3 netupitant doses plus oral palonosetron 0.50 mg with oral palonosetron (PALO) 0.50 mg, all given on day 1. A fifth exploratory group received IV ondansetron (O) 32 mg plus aprepitant [days 1–3]. All patients received oral dexamethasone (D) on days 1–4. The primary endpoint was complete response (CR: no emesis, no rescue) during the overall (0–120 h) phase. Results: Treatment groups were similar: male (57 %), median age 55. Most frequent cancers: lung (27 %); head & neck (21 %). Median cisplatin dose: 75 mg/m2. While results were similar in all NK1-arms, the highest NEPA dose studied (netupitant 300 mg/palonosetron 0.50 mg) demonstrated the best overall CR, acute CR, and no significant nausea rates. All NK1 regimens had superior overall CR rates compared with palonosetron + dexamethasone; side effects were similar in all groups. CR Rates PALO + D NEPA100 + D NEPA200 + D NEPA300 + D APREP + O+D Patients
136
135
137
135
134
Overall
76.5 %
87.4 %*
87.6 %*
89.6 %*
86.6 %*
Acute
89.7 %
93.3 %
92.7 %
98.5 %*
94.8 %
Delayed
80.1 %
90.4 %*
91.2 %*
90.4 %*
88.8 %*
*p≤0.05 vs PALO + D Conclusions: The NEPA all-oral combination is convenient and highly effective in patients receiving cisplatin. NEPA300 was associated with the best results and is particularly suited for further trials using maximally convenient single-dosing strategies.
MASCC-0433 Phase 3 study of NEPA, a fixed-dose combination of netupitant (NETU) and palonosetron (PALO), versus PALO for prevention of CINV following moderately emetogenic chemotherapy (MEC) M. Aapro1, G. Rizzi2, M.E. Borroni3, M. Palmas3, S. Grunberg4 1 Oncology, Clinique de Genolier, Genolier, Switzerland, 2Statistics & Data Management, Helsinn Healthcare S.A., Lugano, Switzerland, 3 Corporate Clinical Development, Helsinn Healthcare S.A., Lugano, Switzerland, 4Division of Hematology/Oncology, Fletcher Allen Health Care, Burlington VA, USA Introduction: Targeting multiple molecular pathways is important for control of CINV. Novel agents are necessary for optimization of CINV control, particularly with regard to delayed nausea. NEPA is a fixeddose combination of NETU, a highly-selective NK1 receptor antagonist (RA) and PALO, a pharmacologically distinct 5-HT3 RA. Objectives: This was a multinational, randomized, double-blind, parallel-group study assessing the efficacy and safety of a single oral dose of NEPA (NETU 300 mg + PALO 0.50 mg) versus a single oral 0.50 mg dose of PALO in 1,455 chemotherapy-naïve patients receiving anthracycline-based chemotherapy. Methods: Patients in the NEPA and PALO arms received 12 mg and 20 mg dexamethasone on Day 1, respectively. After completion of the first cycle, eligible patients were allowed to continue into an unlimited multicycle extension. The primary efficacy endpoint was complete response (CR: no emesis, no rescue medication) during the delayed
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(25–120 h) phase. The primary analysis is a two-sided CochranMaentel-Haenszel test including treatment, age, and region as strata. NEPA will be declared superior to PALO if the p-value is less than or equal to 0.050 and favoring NEPA. Secondary efficacy endpoints include CR rates during the acute (0–24 h) and overall (0–120 h) phases, and proportion of patients with no emesis, no significant nausea and complete protection (no emesis, no rescue medication, and no significant nausea) during all phases. Key safety assessments include adverse events, ECGs, left ventricular ejection fraction, and cardiac troponin level. Results: The primary analyses are expected to be complete by March 15, 2013 and fully available as a late-breaking submission in May. Conclusions
MASCC-0434 Phase 3 study of NEPA (fixed-dose combination of netupitant and palonosetron) for prevention of CINV following repeated moderately (MEC) and highly (HEC) emetogenic chemotherapy cycles K. Jordan1, G. Rizzi2, M.E. Borroni3, M. Palmas3, R. Gralla4 1 Oncology/Hematology, University of Halle, Halle, Germany, 2Statistics & Data Management, Helsinn Healthcare S.A., Lugano, Switzerland, 3 Corporate Clinical Development, Helsinn Healthcare S.A., Lugano, Switzerland, 4Oncology, Albert Einstein College of Medicine, Bronx NY, USA Introduction: NEPA is a fixed-dose combination of netupitant (NETU), a highly selective NK1 receptor antagonist (RA) and palonosetron (PALO), a pharmacologically distinct 5-HT3 RA. Recent trials were conducted to establish the superiority of NEPA over PALO in preventing CINV following a single cycle of HEC and MEC. Objectives: This study was designed to examine the tolerability and efficacy of NEPA over multiple cycles of HEC and MEC. Methods: This was a multinational, randomized, double-blind, phase 3 study evaluating a single oral dose of NEPA (NETU 300 mg + PALO 0.50 mg) administered on day 1 of each cycle, and given with oral dexamethasone (day 1: MEC; days 1–4: HEC) prior to repeated cycles. A standard 3-day oral aprepitant + PALO + dexamethasone arm was included as a control with an unbalanced 3:1 (NEPA:aprepitant) randomization ratio. The number of cycles was not limited. Safety was the primary objective as assessed by adverse events; secondary variables included ECGs, left ventricular ejection fraction, and cardiac troponin levels. Efficacy was assessed as proportion of patients with complete response (no emesis, no rescue medication). No formal statistical comparisons are planned; data will be summarized descriptively. Results: Four hundred thirteen patients were randomized. Analyses will be completed by March and submitted as late-breaking. Conclusions: Few large randomized trials have documented safety and antiemetic control over multiple cycles of chemotherapy, especially HEC. The safety profile will provide new information over multiple cycles. NEPA is designed to provide maximal convenience with high degrees of antiemetic control throughout the patient’s full course of chemotherapy.
MASCC-0435 Mandibular osteoradionecrosis in squamous cell carcinoma (SCC) of the oral cavity and oropharynx : incidence and risk factors at the Lausanne University Hospital, Switzerland K. bouferrache1, C. Madrid1, M. Abarca1, Y. Monnier2 1 Oral surgery Oral medicine and Hospital Dentistry, Department of Ambulatory Care and Community medicine, Lausanne, Switzerland, 2 Otolaryngology Head and Neck surgery, Lausanne University Hospital (CHUV), Lausanne, Switzerland
Support Care Cancer (2013) 21 (Suppl 1):S1–S301
Introduction: Osteoradionecrosis (ORN) is defined as an area of exposed devitalized irradiated bone that fails to heal over a period of 3–6 months in the absence of local neoplastic disease. Its reported incidence in the literature is variable, from 0.4 % to 56 %. Objectives: To analyse the incidence and risk factors for mandibular ORN in SCC of the oral cavity and oropharynx. Methods: A monocentric retrospective study of 73 patients was conducted at the Lausanne University Hospital, between January 2000 and December 2007, with a minimum follow-up of 2 years. Different variables (age, sex, dental extraction before and after radiotherapy (RT), alcohol/tobacco consumption…) were taken into consideration to evaluate patient-related risk factors for mandibular ORN. Results: The incidence of mandibular ORN in the reported patient group was 40 % at 5 years. Two peaks of incidence were founded. All patients developing ORN had received radiation doses above 66 Gy, most of them (92 %) had undergone mandibular surgery. No patientrelated risk factor was statistically significant in the present study. Mandibular surgery prior to radiotherapy was the only independant risk factor associated ORN. Conclusions: Mandibular ORN is a frequent long-term complication of RT of oral cavity and oropharynx cancer. The reported incidence rate is high compared with most published data. The reason for this difference is most likely multifactorial. Interestingly, pre-irradiation dental extraction and poor oral and/or dental hygiene (before RT) were not statistically significant risk factors. Mandibular surgery proved to be the most important risk factor. References: Monnier, 2011
MASCC-0436 Vascular endothelial growth factor inhibitors (VEGFIS) and cognitive impairment: evidence and controversies T. Ng1, Y.T. Cheung1, Q.S. Ng2, A. Chan1 Department of Pharmacy, National University of Singapore, Singapore, Singapore, 2Department of Medical Oncology, National Cancer Centre Singapore, Singapore, Singapore 1
Introduction: It is suggested that vascular endothelial growth factor (VEGF) induces neurogenesis in the brain and provides neuroprotective effects; hence there are concerns that the use of VEGF inhibitors (VEGFIs) may induce cognitive disturbances in cancer patients. However, current evidence on VEGFI-induced cognitive impairment is limited. Objectives: The aim of this review is to summarize and critically evaluate the evidence and controversies surrounding the cognitive issues associated with the use of VEGFIs. Methods: A literature search was performed; articles and meeting abstracts evaluating the association between VEGFIs and cognitive disturbances were included from January 1995 to December 2012. Both preclinical and clinical studies were assessed. Studies that have evaluated the effects of VEGFIs on brain tumors were excluded. Results: A total of 4 articles and meeting abstracts were included in this review (2 clinical studies, 1 case-series and 1 preclinical study). Drugs being evaluated were bevacizumab, sunitinib, sorafenib and a non-commercially available VEGFI (PTK787/ZK222584). With the exception of a clinical study that reported a lack of association between VEGFIs and cognitive functioning, other studies have demonstrated that VEGFIs have a negative impact on cognitive functioning commonly in the memory domain Conclusions: This review has brought attention to the potential cognitive issues associated with the use of VEGFIs and has added a new, unexplored dimension to the problem of cancer treatment-related cognitive changes. However, due to conflicting results and a lack of substantial data, more well-designed longitudinal studies are required to ascertain this association.
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MASCC-0437 Natural history of insomnia in breast cancer patients L. Fleming1, E. Stewart1, C.A. Espie2, D. Morrison1, J. Paul3 1 Institute of Health and Wellbeing, University of Glasgow, Glasgow, United Kingdom, 2Nuffield Department of Clinical Neuroscience, University of Oxford, Oxford, United Kingdom, 3Cancer Research UK Trials Unit, Beatson Institute for Cancer Research, Glasgow, United Kingdom Introduction: Sleep disturbance is highly prevalent in breast cancer patients. The onset of sleep disruption commonly occurs at diagnosis and often becomes persistent. Despite its prevalence, and considerable evidence that Cognitive Behaviour Therapy (CBT) is an effective treatment, insomnia remains a neglected problem, due partly to the uncertainty around when CBT should be implemented. Objectives: To track the natural history of insomnia in breast cancer patients and report on the optimal time to provide CBT within cancer settings. Methods: This on-going study tracks 250 newly diagnosed breast cancer patients, gathering data on sleep, cancer-related and stress-response symptoms. This interim analysis reports data from the first 92 participants. Median age of the sample is 60 years. 52 % have a stage 1 tumour (X1), 37 % have X2, 9 % have X3 and 2 % have X0. 95 % of the sample has undergone radiotherapy and 48 % have had chemotherapy. Results: Preliminary analyses reveal pre-diagnosis median ISI score of 1.5, increasing to 9.0 at diagnosis. Scores remained in sub-clinical ranges at months 3 (9.0) and 6 (8.0), improving at month 9 (7.0). Baseline, ISI scores were significantly correlated with fatigue and depression but not with anxiety. Post-diagnosis ISI scores were associated with worsening fatigue, depression and anxiety. Conclusions: Early results suggest significant deterioration in sleep pattern/quality occurring around diagnosis. This pattern remains consistent throughout active treatment and sleep does not return to prediagnosis status after treatment completion. This study will provide important information about the natural history of sleep disturbance in this population, with implications for treatment and prevention.
MASCC-0438 Effectiveness of pegfilgrastim prophylaxis for reducing the risk of febrile neutropenia in patients with advanced stage solid tumors J. Crawford1, M. Reiner2, D. Dale3, P.K. Morrow4, E. Abella4, G.H. Lyman5 1 Department of Medicine, Duke University Medical Center, Durham, USA, 2Global Biostatistical Science, Amgen Inc., Thousand Oaks, USA, 3Department of Medicine, University of Washington, Seattle, USA, 4Hematology/Oncology, Amgen Inc., Thousand Oaks, USA, 5 Comparative Effectiveness and Outcomes Research – Oncology, Duke University School of Medicine and the Duke Cancer Institute, Durham, USA Introduction: Patients with advanced cancer receiving chemotherapy are at risk for developing febrile neutropenia (FN), which is associated with substantial morbidity. Objectives: To determine the impact of pegfilgrastim prophylaxis on grade 3/4 FN in patients with advanced stage solid tumors. Methods: Patients were pooled from three Amgen-sponsored placebocontrolled trials (placebo versus pegfilgrastim prophylaxis): a phase 3 trial in breast cancer patients (Vogel 2005) and a phase 2 and a phase 3 trial in CRC patients (Hecht 2012, Pinter 2013). Patients with advanced disease (stage III, IIIA, IIIB, IV) at baseline were included (N=1823). Grade 3/4 FN definition: ANC <1.0×109/L and either a temperature of ≥38.2 °C or sepsis, infection, or neutropenia-related hospitalization. The Chi-square test was used to evaluate the association between pegfilgrastim and grade 3/4 FN; the OR for treatment
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effect on the incidence of grade 3/4 FN was estimated from a multivariate logistic regression model with the inclusion of type of cancer and age at baseline. Results: Patient characteristics in the placebo (n=915) and pegfilgrastim (n=908) groups: median age, 57 and 57 years; ≥ 65 years, 252 (28 %) and 260 (29 %); breast cancer, 390 (43 %) and 375 (41 %); CRC, 525 (57 %) and 533 (59 %). Pegfilgrastim significantly reduced the incidence of grade 3/4 FN versus placebo four-fold (p<0.001; OR for pegfilgrastim versus placebo=0.18 [95 % CI:0.11, 0.28]). Conclusions: Pegfilgrastim prophylaxis reduced the risk of FN in patients with advanced stage cancer. Assessment of FN risk is essential in the advanced/metastatic treatment setting.
MASCC-0439 Using the internet to assess lymphedema in breast cancer survivors: agreement between face-to-face and telerehabilitation system N. Galiano Castillo 1 , A. Ariza García 2 , C. Fernández Lao 2 , I. Cantarero Villanueva2, M. Legeren Alvarez3, M. Arroyo Morales2 1 Physiotherapy. Fellow FPU AP2010-6075, Faculty of Health Sciences, Granada, Spain, 2Physiotherapy, Faculty of Health Sciences, Granada, Spain, 3Oncology, University Hospital San Cecilio, Granada, Spain Introduction: Lymphedema is a lifetime complication of breast cancer survivors that can limit their participation in recreational or sports activities. Follow-up of lymphedema using an Internet application could help patients to determine the influence on their condition of these activities and adapt them accordingly. We aimed to determine the level of agreement between lymphedema assessment by telerehabilitation and by the traditional face-to-face method. Objectives: The main objective of this study was to determine the level of agreement between lymphedema assessment by telerehabilitation and by the traditional face-to-face method in breast cancer survivors. Methods: Thirty breast cancer survivors participated in a descriptive study of repeated measures using a cross-over design. Patients attended a session for a clinical face-to-face and real-time online telerehabilitation assessment of lymphedema. There was a 120-min interval between these two sessions. The order of sessions was randomly selected for each patient. A caregiver (husband, sister or friend) conducted the telerehabilitation assessment using a system that includes a specific tool based on an arm diagram for measuring the participant’s arm circumferences via a telehealh application. Results: All outcome measures showed reliability estimates (α) ≥0.90; the lowest reliability was obtained for the total volume non-affected side (α=0.90). The diagnosis of lymphedema by the two Methods also showed a good inter-rater reliability (Rho=0.89). Conclusions: These preliminary findings support the use of an Internet-based system to assess lymphedema in breast cancer survivors, offering carers a useful role in helping patients to follow up this lifetime health problem.
MASCC-0440 Delivering better supportive care to people with lung cancer: an exploration of the use of a patient-reported outcome measure in clinical nursing practice R. Maguire1, G. Kotronoulas1, C. Papadopolou1, M.F. Simpson2, J. McPhelim2, I. Lynn2 1 School of Nursing and Midwifery, University of Dundee, Dundee, United Kingdom, 2Cancer Directorate, NHS Lanarkshire, Lanarkshire, United Kingdom Introduction: Supportive care needs (SCNs) of people with lung cancer (LC) are highly prevalent, yet, are often unrecognised and
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unmet. Patient Reported Outcome Measures (PROMs) are a way of identifying the SCNs of people with lung cancer in clinical practice. Objectives: To explore the use of PROM’s by lung cancer nurse specialists (LCNS) in the delivery of supportive care to people with LC. Methods: A mixed-Methods study design was used. Patients (N=20) were recruited from 3 sites in Scotland and took part in the study over 3 time-points: baseline (T1), 1 month (T2), 2 months (T3). At each time point, patients completed the Sheffield Profile for Assessment and Referral to Care (SPARC) and used the PROM to direct consultations with their LCNS (N=3). End of study interviews explored patients’/clinicians’ experiences of using the SPARC in the delivery of supportive care. Results: SCNs were highly prevalent at baseline. A significant reduction in overall psychological and spiritual needs from T1–T2, and family/social and treatment concerns from T1–T3 was recorded. The use of the SPARC resulted in patients disclosing needs that they would not have previously raised and promoted them to ask questions about their condition/care. LCNSs perceived that using the SPARC to guide consultations resulted in patients discussing a wider array of SCNs particularly sensitive issues such as death/dying, concerns regarding family/carers, and sexuality. Conclusions: Our findings demonstrate the feasibility and acceptability of the use of PROMs in the delivery of supportive care to people with LC in clinical practice.
MASCC-0441 Rolapitant and its major metabolite do not affect the pharmacokinetics of midazolam, a sensitive cytochrome P450 3A4 substrate A. Poma1, J.C. Christensen2, H.P. Pentikis3, S.A. Arora4, M.L.H. Hedley5 1 Medical Department, Tesaro, Waltham, USA, 2Program Management, Tesaro, Waltham, USA, 3Clinical Pharmacology, SAJE Consulting, Baltimore, USA, 4Statistics, Arora Consulting, North Oaks, USA, 5 President & CSO, Tesaro, Waltham, USA Introduction: Rolapitant is a highly selective and potent (Ki = 0.66 nM) neurokinin-1 receptor antagonist (NK-1RA). Other NK1RA are known inducer/inhibitors of cytochrome P450 3A4 and may require dose-adjustment of concomitantly administered drugs. Objectives: Evaluate potential effects of rolapitant on the PK of midazolam. Methods: Phase1 study in healthy subjects (16 M, 10 F) who received midazolam 3 mg on D1. D3, all subjects administered rolapitant 200 mg followed by midazolam. D8 and D11, subjects received midazolam. Comparisons in PK of midazolam and 1-OH-midazolam on D3, D8, and D11 versus D1 were made to evaluate the potential time-dependent effects of rolapitant on the PK of midazolam. Results: No significant PK interactions observed upon coadministration of rolapitant and midazolam. On D3, the geometric mean (90%CI) for Cmax and AUC were 0.86 (0.78, 0.94) and 0.98 (0.93, 1.03), respectively. Similarly, no significant PK interactions between SCH 720881 and midazolam observed as the Cmax and AUC of midazolam were 0.96 (0.88, 1.05) and 1.07 (1.01, 1.13), respectively on D8. Prolonged exposure to rolapitant did not demonstrate induction of the metabolism of midazolam as the Cmax and AUC were 1.04 (0.95, 1.14) and 1.18 (1.12, 1.24), respectively on D11. Additionally, no changes in the PK of 1-OH-midazolam in the presence of rolapitant or SCH 720881 were seen. Conclusions: These results demonstrate that neither rolapitant nor its major metabolite inhibits or induces the metabolism of midazolam. This suggests the administration of rolapitant, unlike other NK-1RA, does not require dose adjustment of concomitantly administered drugs, which are metabolized by CYP3A4. Rolapitant was safe and well tolerated in this study.
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MASCC-0442 Depressed mood in breast cancer survivors: associations with physical activity, cancer-related fatigue, quality of life and fitness level N. Galiano Castillo1, I. Cantarero Villanueva2, C. Fernández Lao2, L. Díaz Rodriguez3, C. Sánchez Salado4, M. Arroyo Morales2 1 Physiotherapy. Fellow FPU AP2010-6075, Faculty of Health Sciences, Granada, Spain, 2Physiotherapy, Faculty of Health Sciences, Granada, Spain, 3Nursing, Faculty of Health Sciences, Granada, Spain, 4Breast Oncology Unit, University Hospital Virgen de las Nieves, Granada, Spain Introduction: Close to 20 % of cancer survivors suffer depression after oncology treatment. Objectives: The aim of this study was to examine the relationship between quality of life, cancer-related fatigue, physical activity level, health-related fitness and salivary flow rate with depression in breast cancer survivors. Methods: One hundred and eight breast cancer survivors in the year after treatment is finished were included in this cross-sectional study. Demographic and clinical relevant information, cancer-related fatigue (Piper Fatigue Scale), quality of life (QLQ-Br23 module), pain intensity VAS scale, salivary flow rate, physical activity level (Minnesota Leisure Time Physical Activity Questionnaire) and health-related fitness (force handgrip, multiple sit-to-stand test and vertical jump performance) were assessed. Depressed mood was measured with the Profile of Mood state Depression subscale. Correlation and regression analyses were performed to determine the association among variables and to determine the proportions of explained variance in depressed mood. Results: Significant positive correlations between depression and fatigue, systemic side effects, perceived shoulder pain, breast and arm symptoms (r ranged between 0.57 and 0.28; p<0.001). Furthermore, significant negative correlations between depression and body image, future perspective, force handgrip and physical activity level (r ranged between −0.41/−0.19; p<0.05). Regression analyses revealed that cancer-related fatigue, physical activity level, systemic side effects and body image were significant predictors of depression and when they are combined, they explained 39.6 % of the variance in depression scores (F=14.43; p<0.001). Conclusions: In conclusion, cancer-related fatigue, physical activity level and quality of life correlates explain partially the variability of depression in breast cancer survivors.
MASCC-0443 Operable lung cancer patients experiences of rehabilitation and supportive needs at diagnosis. A qualitative study M. Missel1, J.H. Pedersen2, C. Hendriksen3, M. Tewes4, L. Adamsen5 1 Dept. of thoracic surgery, Copenhagen University Hospital, Copenhagen, Denmark, 2Dept. of thoracic surgery, University Hospital of Copenhagen, Copenhagen, Denmark, 3Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark, 4The Heart Centre, University Hospital of Copenhagen, Copenhagen, Denmark, 5University Centre for Nursing and Care research, University of Copenhagen, Copenhagen, Denmark Introduction: Lung cancer is one of the most frequently occurring cancers, and the cancer site with the highest mortality rate. Lung cancer patients have complex problems through the disease trajectory and they are considered as disadvantaged when compared with other cancer patients. There are limited intervention studies. These studies have demonstrated promising results, but lung cancer patients’ needs during treatment trajectory still remains to be identified systematically. Present study is part of a PhD study’ Four critical moments in everyday life during disease and treatment trajectory in operable lung cancer patients and relatives, and the significance of participation in an intervention consisting of physical exercise’.
Support Care Cancer (2013) 21 (Suppl 1):S1–S301
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Objectives: The objective is to explore lung cancer patients’ challenges, needs and problems at diagnosis in order to expose diagnosis interference in everyday life. Methods: A sample of 19 patients has been included. Inclusion criteria are diagnosis of non small cell lung cancer referred for surgery at department of thoracic surgery, Rigshospitalet and age above 18. Individual in-depths interviews combined with validated questionnaires with a phenomenological approach are conducted 5 days following diagnosis. Focus is the present and deals with themes of patients’ experiences with the diagnosis and everyday life. Follow-up interviews and questionnaires has been collected 14 weeks post surgery focusing on the patients return to everyday life. Results: Data are being analyzed and results are expected to be published spring 2013. Conclusions: Findings are expected to contribute to the development and initiation of further interventions for lung cancer patients early in the treatment trajectory.
Objectives: The objective of this study was to assess the efficacy of GCSF in treatment of established FN by evaluating clinical outcomes. Methods: This was a single-center, retrospective cohort study at the largest cancer center in Singapore. Adult patients who had received chemotherapy and manifested FN between January 2009 to January 2012 were included in this analysis. Results: Forty-hundred and thirty patients were included in this study, with majority being Chinese (72.6 %) and a mean age of 52.0 (14–81) years. Majority manifested lymphoma (31.6 %), breast cancer (25.3 %) and genitourinary cancers (11.6 %). Almost half (45.4 %) received primary prophylaxis with G-CSF. Mean MASCC risk score was 22.6 (11–26) and infections were documented in 57.4 % patients. Therapeutic G-CSF was given to majority of the patients (77.9 %). Patients receiving therapeutic G-CSF manifested a shorter duration of hospitalization and fever resolution than those who did not receive therapeutic G-CSF. However, patients receiving G-CSF experienced a longer duration of grade 4 neutropenia and antibiotics use.
MASCC-0445 Designing and testing of a new radiation therapy patient supportive care screening tool
Treatment Outcomes
J. Maamoun1, M.I. Fitch2 1 Radiation Therapy, Odette Cancer Centre Sunnybrook Health Sciences Centre, Toronto, Canada, 2Oncology Nursing, Odette Cancer Centre Sunnybrook Health Sciences Centre University of Toronto, Toronto, Canada Introduction: To enable Radiation Therapists to quickly identify their patients’ unmet supportive care needs and allow for early intervention and/or timely referral, the need for a new screening tool was anecdotally identified. Objectives: A screening tool was designed and tested for psychometric properties to facilitate the provision of in-depth quality patient centred supportive care by Radiation Therapists. Methods: A comprehensive/itemized screening tool was designed to identify the patient distress level and concerns, and to capture the patient desire for assistance. The tool was administered to 115 patients simultaneously with the EORTC QLQ-30 instrument; days 5, 7 and 16 of their radiation therapy treatments, and then tested for reliability, sensitivity and validity by analyzing the patient responses on both tools. Results: Comparing days 5 and 7, McNemar’s test and the Simple Kappa Coefficient both showed high agreement between item scores. Comparing days 5 and 16 the former test showed a shift from high agreement to lesser agreement across the item scores. The latter showed a shift in over 97.7 % of the items from a higher agreement to a lesser agreement. Data from the EORTC QLQ-C30 showed a similar change over time; the Pearson Product Moment Correlation Coefficient fell on average from 0.75 to 0.58 for the first and the second comparisons respectively with all p-values<0.0001. Concurrent validity was acceptable. Conclusions: The new tool was found to be reliable and sensitive with acceptable validity. It is anticipated that it will enable Radiation Therapists to standardize and formalize their approach to patient supportive care. MASCC-0446 Clinical impact of febrile neutropenia treatment with G-CSF: a retrospective analysis A. Chan1, Q.X. Wong1, M. Wong2, L.Y. Hsu3 1 Pharmacy, National University of Singapore, Singapore, Singapore, 2Medical Oncology, National Cancer Centre Singapore, Singapore, Singapore, 3 Medicine, National University of Singapore, Singapore, Singapore Introduction: The use of Granulocyte-Colony Stimulating Factor (G-CSF) for febrile neutropenia (FN) prophylaxis is well-documented in the literature, however, the use of G-CSF in established FN remains controversial.
With Therapeutic Without p-value G-CSF (n=335) Therapeutic G-CSF (n=95) 3.5 3.7 0.41
Duration of hospitalization (days) Duration to fever 3.5 resolution (days) Duration of grade 4 2.5 neutropenia (days) Duration of antibiotics 16.2 use (days)
4.2
0.066
2.0
0.011
14.0
0.11
Conclusions: In this cohort, there was a lack of clinical benefit with the use of therapeutic G-CSF in established FN. MASCC-0447 The effect of ginger (zingiber officinale roscoe) in patients with the anorexia cachexia syndrome (ACS) R. Bhargava1, A. Burns1, P. Enright1, M. Chasen1 1 Palliative Care, Elisabeth Bruyere Research Institute, Ottawa, Canada Introduction: ACS can present with a wide range of dyspeptic symptoms including nausea and vomiting. Ginger root has been used to treat a number of medical conditions, including those affecting the digestive tract such as dyspepsia, flatulence and nausea. This study is primarily exploratory as there is no data on pattern of Gastric Myoelectrical activity (GMA) in response to Ginger in patients with ACS. Objectives: (1) To determine the effect of oral Ginger administration on GMA (2) To evaluate the symptoms as measured by the Dyspepsia symptom severity index (DSSI), Edmonton symptom assessment scale (ESAS), the patient generated subjective global assessment form (PGSGA) (3) To correlate the level of inflammatory markers and Ghrelin in patients with ACS and impaired GMA. Methods: Fifteen Patients with ACS will be recruited to document a baseline and post water load Electrogastrography (EGG) after oral ingestion of Ginger capsule (1,650 mg) once daily, for 14 days. DSSI, ESAS, PG-SGA and Blood test to assess the level of Ghrelin, albumin and CRP will be done pre and post intervention. Descriptive statistics of EGG findings will be presented reflecting the categories of dysfunction. Correlations between types of GMA, gastrointestinal symptoms, Gherlin and inflammatory markers will be performed. Results: This study is active and the results will be analyzed in late spring 2013. Conclusions: Ginger enhances gastric motility as correlated by GMA measured by EGG. By increasing gastric emptying, ginger may improve a range of GI symptoms that can affect oral intake and quality of life.
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MASCC-0448 Spiritual care rating scale, translation and cultural adaptation to Portuguese nurses A. Martins1, S. Caldeira2, F.L. Pimentel3 1 Clinic., Cliria., Aveiro, Portugal, 2Health Sciences Institute, Catholic University, Lisboa, Portugal, 3Health Sciences Department, Lenitudes SA. Universidade de Aveiro, Aveiro, Portugal Introduction: Spirituality in nursing in Portugal isn’t a significant reality. Nurses consider this field as subjective and difficult to interpret. The Spirituality and Spiritual Care Rating Scale (SSCRS) allows us to evaluate the perception nurses have of spirituality and spiritual care and has been used in international studies. Objectives: Analyze the psychometric properties of the SSCRS, in Portugal Methods: Linguistic and conceptual equivalence was established for the SSCRS. Portuguese version was applied to a sample of 94 nurses working at Palliative Care. In the validation process the same methodology of the author of the original scale was followed. The nurses who participated in this study were asked for their written consent Results: Ninety-four nurses participated, (15—male; 79—female); age was between 21 and 39 years, had a full-time schedule, worked in shifts, and had 2 to 6 years of experience. 2 items were suppressed, resulting in an instrument with l5 items. Cronbach alpha was 0.76, which indicates that this instrument as adequate psychometric characteristics for this sample. Nurses recognized the importance of the spiritual needs, although 60.8 % of them mentioned the fact that they have not identified any diagnosis related to the spiritual sphere and 46.7 % of the nurses classify their formation regarding spirituality and/or spiritual care as insufficient. Conclusions: SSCRS Portuguese version is reliable and valid scale. The nurses acknowledge their role in spirituality and spiritual care, although the clear need to include these dimensions in nurses syllabus remains. References: McSherry W, et al: The construct of a rating scale… IntJNursing Studies 41;2003:151–161.
MASCC-0449 Identifying and addressing the unmet supportive care needs of radiation therapy patients in radiation therapy treatment settings: a role for radiation therapists J. Maamoun1, M.I. Fitch2 1 Radiation Therapy, Odette Cancer Center Sunnybrook Health Sciences Centre, Toronto, Canada, 2Oncology Nursing, Odette Cancer Center Sunnybrook Health Sciences Centre University of Toronto, Toronto, Canada Introduction: To date, little attention has been paid to implementing an approach that enables radiation therapists (RTs) to identify and address the unmet supportive care needs of their patients in radiation therapy treatment settings. Objectives: To explore the ease of use of a new radiation therapy patient supportive care needs screening tool in routine clinical practice following its previous psychometric evaluation. Also, to determine the level of unmet supportive care needs within the patient population, and to quantify the requirement for assistance and/or referral of patients to other services for unmet supportive care needs identified by the new tool. Methods: Sixteen RTs used the new tool over 6 weeks with 70 patients in their fourth week of their radiation treatments. Descriptive statistics for the patient responses on the screening tool and content analysis for the information on feedback forms completed by the RTs were compiled. Results: The 70 patients identified 407 concerns or unmet needs with an average score of 2.8 on the ten point Distress Thermometers. Patients wanted help with 32.2 % of their identified concerns. RTs found the new screening tool easy to use as did their patients. RTs were able to address 90.8 % of patient identified concerns when help was wanted.
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Conclusions: Given the right tools, RTs are able to identify the unmet supportive care needs of their patients and to address the vast majority of those needs. Screening for such needs should be part of RTs routine clinical practice and repeated throughout radiation therapy treatment delivery.
MASCC-0450 The role of human factors engineering in the development of self-administration drug delivery systems for patients requiring therapeutic and supportive care R. Ahmed1, R. Whelton1 Medical Affairs, BD Medical - Pharmaceutical Systems, Franklin Lakes NJ, USA 1
Introduction: Self-injection drug delivery systems offer the potential to reduce the burden of care in patients requiring supportive care. However, when selecting a drug delivery system, it is imperative that the patient can successfully use the device, with different degrees of physical limitations and co-morbidities impacting treatment adherence and compliance. To attain the highest levels of therapeutic benefit, a patient-centric design with a strong focus on human factors should be utilized to ensure the creation of successful self-injection devices. Objectives: To identify specific human factors that influence the usability, adherence, and compliance of self-injection pharmaceutical preparations in patients requiring supportive care, including antiemetic, anti-inflammatory, and pain-relief options. Methods: Multiple human factors studies were conducted to assess all aspects of performance safety, efficiency, pain perception, ease-of-use, and patient acceptance of disposable autoinjectors vs. prefilled syringes. Participants simulated use of each device following individual instructions for use, with observation of how patients reacted, capturing their initial response on a variety of human factor parameters, including tactical, visual, quality, and durability. Results: The studies provided essential insights regarding the patientproduct interface and demonstrated that patients had strong and positive input into product features and design. Specific human factor issues raised included dialing click sound, height/color of dosing fonts, visibility of drug reserve, needle size/attachment/positioning, capping/storage instructions, and tactical feel. Conclusions: To maintain high standards in human factors, drug delivery system manufacturers must work in close partnership with patients to identify the widest possible range of issues to improve user experience, therapeutic compliance, and overall patient care.
MASCC-0451 Assessment of psycho-social and communication needs in Romanian oncology patients (APSCO) C.L. Dégi1 1 Sociology and Social Work, Babes Bolyai University, CLUJ-NAPOCA, Romania Introduction: Romania has one of the fastest growing aging populations of all countries in Eastern Europe. This trend will continue to increase agespecific cancer rates. Cancer is an unmet psychosocial challenge to patients and to the specialized services, regardless of care type (Dégi, 2012). Objectives: This is the first extensive interdisciplinary research in Romania focusing on psychosocial aspects of adult cancer patients in oncology hospitals, in supportive cancer care groups and in palliative care services, including data from multi-centre questionnaire screening, survey and multivariate data analysis. Methods: According to the tumour location, a heterogenic, mixed sample of oncology patients will be screened; a sample of 300 patients suffering from cancer diseases. Data collection will be performed in the largest
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oncologic institutions, chosen based on recommendations from Ministry of Health, and in the best-practice cancer-care services. Also we intend to obtain direct information from the persons involved in the investigated phenomenon with 60 semi-structured interviews. Measurement of psychosocial factors includes: Functional Assessment of Cancer Therapy–General (FACT–G 4.0), Beck Depression Inventory (BDI), Social and Emotional Loneliness Scale (SELSA), and llness Intrusiveness Rating Scale (IIRS). Results: First results will be presented and the urgency of psychosocial screening in the Romanian cancer care system will be highlighted. Conclusions: APSCO will encourage implementation of new perspectives, practical and policy ideas in this very important field of psychooncology in Romania. References: Dégi, Csaba L. (2012). In search of the sixth vital sign: cancer care in Romania. Supportive Care in Cancer, 1–8. doi:10.1007/ s00520-012-1657-7. MASCC-0452 Evaluation of an education program for patients with cancer suffering from chemotherapy-induced peripheral neuropathy C. Cranston1, R. Bhargava2, M. Chasen1 Palliative Care, Bruyere Research Institute, Ottawa, Canada, 2 Pallliative Care, Bruyere Research Institute, Ottawa, Canada 1
Introduction: The incidence of chemotherapy-induced peripheral neuropathy (CIPN) for patients with cancer is increasing and many patients report that it disrupts their functioning and their quality of life. (Kautio et al. 2011) CIPN can lead to falls and other accidents and can disrupt any activity which involves handling objects. (Driessen et al. 2012; Tofthagen 2010). Objectives: The objective of this study is to evaluate the effectiveness of a brief education program for patients suffering from CIPN. Methods: This one-hour education session addresses three topics: preventing harmful secondary effects, compensating for CIPN in order to improve functioning, and non-pharmacological Methods of reducing the distress caused by CIPN. Questionnaires will be used to evaluate the effectiveness of the education in reducing the interference of CIPN for these patients. Results: The results will be analyzed and presented. Conclusions: An education program will help patients to address the effects of CIPN. References: Driessen, C. M., de Kleine-Bolt, K. M., Vingerhoets, A. J., Mols, F., & Vreugdenhil, G. 2012, ‘Assessing the impact of chemotherapy-induced peripheral neurotoxicity on the quality of life of cancer patients: the introduction of a new measure’, Support. Care Cancer, vol. 20, no. 4, pp. 877–881. Kautio, A. L., Haanpaa, M., Kautiainen, H., Kalso, E., & Saarto, T. 2011, ‘Burden of chemotherapy-induced neuropathy—a cross-sectional study’, Support. Care Cancer, vol. 19, no. 12, pp. 1991–1996. Tofthagen, C. 2010, ‘Patient perceptions associated with chemotherapyinduced peripheral neuropathy’, Clin.J. Oncol. Nurs., vol. 14, no. 3, p. E22–E28. MASCC-0453 Symptom clusters and demographic characteristics in advanced cancer A. Aktas1, D. Walsh1, L. Rybicki2, A. Fitz1 1 Department of Solid Tumor Oncology Harry R. Horvitz Center for Palliative Medicine and Supportive Oncology, Cleveland Clinic Taussig Cancer Institute, Cleveland, USA, 2Department of Quantitative Health Sciences, Cleveland Clinic Lerner Research Institute, Cleveland, USA Introduction: Little is known about demographic variations in cancer symptom clusters. Objectives: To determine whether clusters are associated with age, gender, race, primary cancer site group (PSG), or performance status (PS).
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Methods: Symptoms from 922 advanced cancer patients were analyzed with hierarchical cluster analysis. Comparisons were made between patients with and without each cluster using the chi-square test (<65 vs. ≥65 years; female (F) vs. male (M); Caucasian vs. African American; 10 PSG, or Wilcoxon rank sum test (ECOG PS 0–4); p< 0.05 indicated statistical significance. Results: 83 % Caucasian, 52 % ≥65 years, 56 % male, 55 % PS 3–4. Most common PSG: lung (25 %), genitourinary (18 %), gastrointestinal (GI) (11 %). 7 clusters identified. ‘Fatigue/anorexia-cachexia’ associated with Caucasian race (p=0.032) and PSG (pancreas) (p=0.012). ‘Neuropsychological’ associated with older age (p<0.001) and Caucasian race (p=0.001). ‘Upper GI’ associated with female gender (p=0.035) and PSG (pancreas) (p=0.035). ‘Nausea/Vomiting’ associated with younger age (p=0.01) and female gender (p<0.001). ‘Aerodigestive’ associated with male gender (p=0.01) and PSG (pancreas) (p<0.001). ‘Debility’ associated with Caucasian race (p=0.016) and poor PS (p<0.001). ‘Pain’ associated with younger age (p=0.028). Conclusions: 1. We identified 7 clusters whose prevalence were influenced by age (nausea/vomiting, neuropsychological, pain), gender (aerodigestive, upper GI, nausea/vomiting), race (fatigue/anorexia-cachexia, neuropsychological, debility), PSG (fatigue/anorexia-cachexia, upper GI, aerodigestive) or PS (debility). 2. Our findings support the clinical relevance of the symptom cluster concept in palliative and supportive care. 3. Demographic characteristics may warrant different clinical approaches to patient care. Identification of these differences may help develop more effective symptom management strategies. MASCC-0454 Using a patient navigation program to overcome health care disparities in cancer treatment in a multicultural setting T. Elrafei1, K. Alexis1, M. Strakhan1, L.J. Reed1, B. Shaker1, B. Stanise1, M. Marquez1, M. Castaldi1, R.J. Gralla1 1 Medical Oncology, Albert Einstein College of Medicine Jacobi Medical Center, New York, USA Introduction: Treating patients of differing cultures reveals barriers to good cancer care. Additional health disparities affect lower-income patients and are well documented. Causes of poor outcomes include treatment delays coupled with social and financial barriers. Navigation interventions have been more commonly applied in cancer screening and early diagnosis programs than in promoting adherence to treatment. Objectives: This report examines the early impact of patient navigation (PN) on adherence to prescribed cancer treatment. Methods: We initiated a PN program as a pilot project (supported by an Avon Foundation grant). Health care coverage: 58 % Medicaid—public assistance, 15 % uninsured or undocumented. Navigator duties included care coordination, appointment reminders, patient education, translations, and transportation arrangement. During a 4 month period new medical oncology patients at high risk received PN. Data collected prospectively included patient characteristics, cancer type, and compliance with visits; this was compared with usual care case controls in the same period Results: PN program patient characteristics: N=52 patients (22 breast cancer, 6 prostate cancer, 5 lung cancer and 19 patients other cancers). Mean age=55; 48 % Black, 38 % Hispanic, 8 % Asian, 6 % White. Adherence to visit results are in the table:
Physician Visits (n=2021) Infusion Visits (n=1656)
Navigated Care Adherence 86 % 79 %
Usual Care Adherence 97 % 90 %
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Conclusions: In its first 4 months, this PN program has been associated with observed improvements in adherence to chemotherapy appointments and follow up physician visits. These results document that a PN program can help overcome barriers to good cancer care while identifying areas for further improvement.
MASCC-0455 Caphosol, a therapeutic option in case of cancer therapy-induced oral mucositis in children? Results from a prospective multicenter double blind randomized controlled trial M.F. Raphael1, A.M. den Boer1, F.C.H. Abbink2, G.J.L. Kaspers2, W.J.W. Kollen3, H. Mekelenkamp3, K. Zomer-Kooijker4, B.H.W. Molmans5, W.J.E. Tissing6 1 Pediatric Hematology and Oncology, Wilhelmina Children’s Hospital University Medical Center Utrecht, Utrecht, Netherlands, 2Pediatric Hematology and Oncology, VU University Medical Center, Amsterdam, Netherlands, 3Pediatric Hematology and Oncology, Leiden University Medical Center, Leiden, Netherlands, 4Pediatrics, Wilhelmina Children’s Hospital University Medical Center Utrecht, Utrecht, Netherlands, 5 Hospital and Clinical Pharmacy, Beatrix Children’s Hospital University Medical Center Groningen, Groningen, Netherlands, 6Pediatric Hematology and Oncology, Beatrix Children’s Hospital University Medical Center Groningen, Groningen, Netherlands
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Introduction: Oral mucositis (OM) is a common side effect associated with severe morbidity in pediatric patients during cancer therapy. Caphosol, a calcium phosphate mouth rinse, is proven effective in reducing incidence, degree and duration of OM in adult patients undergoing hematopoietic stem cell transplantation. Objectives: To study the effect of Caphosol when used therapeutically in cancer therapy-induced mucositis in pediatric oncology patients. Methods: Hospitalized children who received chemotherapy and/or radiotherapy with a considerable risk to develop mucositis were enrolled. When first signs of mucositis appeared, patients rinsed daily with study rinse (Caphosol) or placebo rinse (sodium chloride 0.9 % (NaCl)), allocated according to randomization. Patients and observers were blinded. Trained nurses determined mucositis degree and pain scores daily. Results: Fifteen patients received Caphosol rinse, 14 patients received placebo rinse. The number of days with mucositis > grade 1 was not significantly different in the intervention group compared to the control group (9.93 vs.6.36 days; p=0.154). Caphosol rinse did not affect peak level of mucositis or pain compared to placebo rinse (2.20 vs. 2.43; p=0.317 and 6.33 vs. 6.29; p=0.964 respectively). A longer period of pain (11.33 vs. 7.29 days; p=0.043) and use of analgesics (15.53 vs. 9.14 days; p=0.035) was observed after using Caphosol rinse. Caphosol was well tolerated. No adverse effects were reported.
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Table 1. Characteristics of the patients
Variable Male gender Mean age (SD) Disease Hematologic malignancies Solid tumors Benign hematologic diseases Other Treatment regimen Chemotherapy HSCT (conditioning: chemo) HSCT (conditioning chemo + TBI) Neutropenia at starta Severe No Unknown Grade of mucositis >1 at start
Caphosol (n=15) 10 (66.7 %) 11.3±3.9
Placebo (n=14) 9 (64.3 %) 9.9±4.7
6 (40.0 %) 3 (20.0 %)
9 (64.3 %) 0 (0.0 %)
5 (33.3 %) 1 (6.7 %)
4 (28.6 %) 1 (7.1 %)
5 (33.3 %) 9 (60.0 %) 1 (6.7 %)
5 (35.7 %) 7 (50.0 %) 2 (14.3 %)
12 (80.0 %) 2 (13.3 %) 1 (6.7 %) 5 (33.3 %)
14 (100.0 %) 0 (0.0 %) 0 (0.0 %) 9 (64.3 %)
a Severe neutropenia defined as neutrophil count<0.5×109/L or leukocyte count<0.5×109/L (severe), determined on day 0, day −1 or day 1 of study. No neutropenia defined as neutrophil count>1.0×109/L. on day 0, day −1 or day 1 of study.
Table 2. Comparisons of outcomes between Caphosol and placebo Variable* Days of mucositis Days of mucositis > grade 1 Peak level of mucositis Peak level of mucositits (functional) Days of pain Peak level of pain Days of analgesic use Morphine use Morphine required Peak dose (mg/kg) Days of use Tube feeding Tube feeding required Nr of days during study period Parenteral feeding Parenteral feeding required Nr of days during study period Blood cultures Taken Positive if taken *
Caphosol (n=15) 15.8 (10.0) 9.9 (8.1) 2.2 (0.7) 2.7 (0.5)
Placebo (n=14) 10.2 (4.7) 6.4 (4.3) 2.4 (0.5) 2.4 (0.8)
0.069 0.154 0.317 0.418
11.3 (5.2) 6.3 (2.5) 15.5 (9.5)
7.3 (5.1) 6.3 (3.1) 9.1 (5.3)
0.043 0.964 0.035
10 (66.7 %) 0.89 (0.53) 10.9 (8.6)
9 (64.3 %) 0.77 (0.39) 9.0 (2.7)
0.893 0.583 0.534
14 (93.3 %) 13.2 (6.8)
9 (64.3 %) 12.1 (41.4)
0.080 0.670
6 (40 %) 14.7 (14.9)
4 (28.6 %) 10.5 (5.8)
0.700 0.601
11 (73.3 %) 6 (54.5 %)
13 (92.9 %) 2 (15.4 %)
Mean values (±SD) or numbers (%) of subjects are given
P-value
0.330 0.082
Conclusions: Caphosol therapy neither reduces duration or severity of mucositis nor its associated pain in pediatric patients with cancer therapy-induced OM compared to placebo, although it is difficult to reach valid Conclusions with this small sample size.
MASCC-0456 Relationship of race to cancer symptom profiles in advanced cancer A. Aktas1, D. Walsh1, L. Rybicki2, A. Fitz1 Department of Solid Tumor Oncology Harry R. Horvitz Center for Palliative Medicine and Supportive Oncology, Cleveland Clinic Taussig Cancer Institute, Cleveland, USA, 2Department of Quantitative Health Sciences, Cleveland Clinic Lerner Research Institute, Cleveland, USA 1
Introduction: Racial influences in advanced cancer symptoms are unknown. Objectives: To determine whether symptom prevalence, severity, and survival differed between African Americans (AA) and Caucasians. Methods: Thirty-eight symptoms assessed in 1,000 consecutive advanced cancer patients. Age compared between 167 AA and 803 Caucasians with t-test. Gender and primary site groups (PSG) compared with chi-square test. Performance status (PS) and symptom severity compared with Wilcoxon rank sum test. Kaplan–Meier method estimated post referral survival; p ≤0.05 indicated statistical significance. Results: Age, gender, PS, and PSG did not differ between AA and Caucasians (p≥0.36). AA had less edema (21 % vs. 30 %, p=0.02), depression (27 % vs. 44 %, p<0.001), anxiety (14 % vs. 26 %, p= 0.001), tremors (1 % vs. 6 %, p=0.018), anorexia (57 % vs. 67 %, p= 0.022), dry mouth (48 % vs. 59 %, p=0.01), but more headache (17 % vs. 11 %, p=0.035). Severity of 5 symptoms lower in AA: edema (p= 0.038), depression (p<0.001), anxiety (p<0.001), tremors (p=0.048), dry mouth (p=0.021). AA had more moderate/severe weight loss (24 % vs. 16 %, p=0.024), but less depression (12 % vs. 23 %, p= 0.002), anxiety (3 % vs. 13 %, p=0.001). AA had longer post referral survival (median 2.4 vs. 1.6 months, p=0.006). Conclusions: 1. We identified 7 symptoms whose prevalence and/or severity associated with race. 2. AA had higher prevalence of headache and more moderate/severe weight loss. 3. AA had less prevalent (edema, depression, anxiety, tremors, anorexia) and less severe (edema, depression, anxiety, tremors, dry mouth) of some important cancer symptoms. 4. Our findings may stimulate research to evaluate racial variability in the provision of supportive and palliative care services.
MASCC-0457 The value of serial blood cultures during the same febrile neutropenic episode in pediatric oncology patients M.F. Raphael1, L. Spanjaard2, M.D. van de Wetering3 1 Pediatric Hematology and Oncology, Wilhelmina Children’s Hospital University Medical Center Utrecht, Utrecht, Netherlands, 2Medical Microbiology, Academic Medical Center, Amsterdam, Netherlands, 3 Pediatric Oncology, Emma Children’s Hospital Academic Medical Center, Amsterdam, Netherlands Introduction: Infection remains an important cause of morbidity and mortality in neutropenic oncology patients. During febrile neutropenia most pediatric oncology centers obtain serial blood cultures. Objectives: To study the necessity to obtain repeatedly blood cultures during one febrile neutropenic episode while empiric antibiotic therapy is already initiated.
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Methods: An 8 year retrospective chart review was performed for pediatric oncology patients with fever during neutropenia for whom a blood culture was obtained at admission. Results: In 323 patients, 420 febrile neutropenic episodes revealed follow up blood cultures taken after the initial blood culture. The initial blood culture was positive in 72 (17 %) of the 420 episodes. In 33 (46 %) of the 72 febrile neutropenic episodes growth during follow-up was found. Of the positive febrile episodes in follow up 55 % showed a change of isolated pathogen. Positive follow-up cultures were associated with longer duration of neutropenia episode. Two patients in this group died of infection related disease. Of 420 febrile neutropenic episodes, 348 showed negative blood cultures before the start of antibiotics of which 42 (12 %) showed a positive blood culture in follow-up. In this group the neutropenic episodes had a tendency to have a longer mean duration of neutropenia and 6 patients deceased. Table 1. Characteristics of the patients with febrile neutropenia
Patients total Sex Male Female Deceased Type of Malignancy Haematological (lymphoma/leukaemia) Solid Other* Total blood cultures Total episodes of neutropenia Blood cultures during episode Episodes per patient 1 2 3 4 5 6 7
No. (%) 244 138 (57) 106 (43) 76 (31) 111 (45.5) 127 (52,0) 7 (2,9) 1494 420 2–26 148 (60,6) 51 (20,9) 24 (9,8) 12 (4,9) 5 (4,3) 3 (2,0) 1 (0,4)
*
e.g. MDS, Aplastic anaemia, Langerhanscell histiocystosis
Table 2. Results blood cultures per febrile episode Primary blood culture Positive 72 (17 %) Negative
348 (83 %)
Total
420
Follow-up blood culture Positive 33 (46 %) Negative 39 (54 %) Positive 42 (12 %) Negative 306 (88 %)
Legend Table 2. Every first blood culture in a febrile episode is defined as ‘primary blood culture’. Follow up samples of this primary blood culture are referred to as ‘follow-up blood culture’. The follow-up blood culture is not always the second drawn blood culture. Because some patients suffer more than one neutropenic fever episode, patients can be found more than once in this overview.
Conclusions: After reviewing the results in this study we recommend follow up blood cultures after an initially positive culture during febrile neutropenic episodes when neutropenia remains. And also in the primarily negative blood culture group with a prolonged neutropenic episode, follow-up blood cultures are of importance.
MASCC-0458 Concerns about opioids among young physicians at the University of Belgrade Medical School J. Dimitrijevic1, S. Bosnjak1, S. Susnjar1, A. Vujovic1 Oncology intensive care/Supportive care unit, Institute of Oncology and Radiology of Serbia, Belgrade, Serbia 1
Introduction: Curriculum for undergraduate education at the University of Belgrade Medical School does not include education about cancer pain assessment and management Objectives: The purpose of this research was to investigate concerns about opioids among young physicians at the University of Belgrade Medical School Methods: We introduced a questionnaire addressing concerns about: addiction, tolerance, respiratory depression, opioid-induced adverse effects and restrictive regulations for prescribing opioids to a group of 93 young (25–40 years) physicians with less than 5 years (group A) and 5–10 years of work experience (group B) Results: Majority of young physicians (82/93, 88.17 %) expressed concerns about opioids. Statistically higher proportion of physicians in the group A (61/82, 74.39 %) expressed concerns about opioids than physicians in the group B (21/82, 25.81 %) (chi-square, p= 0.00478). Physicians in the group A did not express any concern about tolerance, while those in the group B did not express any concern about respiratory depression. Among physicians in the group A the most frequent concerns were about respiratory depression (45/61, 73.77 %) and adverse effects of opioids (31/61, 50.82 %), while among physicians in the group B the most frequent were concerns about restrictive regulations for prescribing opioids (18/21, 85.71 %) and adverse effects of opioids (10/21, 47.62 %). Statistically lower proportion of physicians in the group A expressed concern about restrictive regulations than physicians in the group B (chi-square, p=0.000004) Conclusions: These results demonstrated inadequate knowledge about opioids among young physicians and the need to include education about opioid analgesics in curriculum for medical students.
MASCC-0459 Complex nursing interventions aimed at reducing chemotherapyrelated symptom burden: a systematic review of their characteristics and effectiveness A. Coolbrandt1, E. Van der Elst1, H. Wildiers2, B. Aertgeerts3, B. Dierckx de Casterlé1, T. van Achterberg4, A. Laenen5, K. Milisen1 1 Centre for Health Services and Nursing Research, KU Leuven, Leuven, Belgium, 2General Medical Oncology, University Hospitals Leuven, Leuven, Belgium, 3Academic Centre for General Practice, KU Leuven, Leuven, Belgium, 4 Scientific Institute for Quality of Healthcare, Radboud University Nijmegen Medical Centre, Nijmegen, Netherlands, 5Interuniversity Centre for Biostatistics and Statistical Bioinformatics, KU Leuven, Leuven, Belgium Introduction: Ambulatory organization of chemotherapy care leaves patients to deal with symptom burden at home and has challenged the role of nurses in supporting patients treated with chemotherapy to deal with and reduce their therapy-related symptom burden.
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Objectives: The aim of this systematic review was to describe the characteristics and to evaluate the effectiveness of complex nursing interventions that target multiple symptoms in patients receiving chemotherapy. Methods: Medline, Embase, Cinahl and the Cochrane Central Register of Controlled Trials were searched for randomized controlled trials that compared complex nursing interventions to usual care and that provided data on symptom prevalence, severity, distress or limitations. A narrative description of the interventions provided insight in the interventions’ content. Ratios of means were calculated to estimate and compare the effectiveness of the interventions. Results: Eleven studies were included in the systematic review. Risk of bias was considerable in several of these studies. The interventions’ content was diverse but generally composed of patient education, symptom assessment and coaching. Results were mixed, both within and across interventions. However, some interventions produced statistically significant and clinically relevant reductions in symptom burden by 10 to 88 %. Conclusions: Some complex nursing interventions have shown promising results in reducing chemotherapy-related symptom burden. However, results are inconsistent and available studies do not allow for Conclusions on vital components, circumstances or preferred target populations. The need for high-quality studies as well as for thorough modeling and piloting of such interventions is imperative.
MASCC-0460 Respiratory distress protocol in pediatric palliative care : clinical use F. Gauvin1, L. Daoust1, S. Stojanovic1, E. Villeneuve2, N. Humbert1 1 Pediatrics, CHU Sainte-Justine Université de Montréal, Montreal, Canada, 2Anesthesia, CHU Sainte-Justine Université de Montréal, Montreal, Canada Introduction: Recently a respiratory distress protocol was established for pediatric palliative care patients at Sainte-Justine University Hospital (SJUH). Objectives: The objective of this study was to evaluate the safety and effectiveness of the protocol. Methods: This epidemiologic descriptive study was based on a retrospective chart review of all the patients for whom a protocol was prescribed between September 2009 and September 2012. The effectiveness of the protocol was assessed using the nurse’s documentation of the patient’s symptoms. The safety of the protocol was evaluated by measuring the time between the administration of the first protocol and the patient’s death. Results: Over 3 years, the protocol was prescribed for 94 patients. Among those, 80 have died and 14 are still alive. In the former group, 70 of the 80 charts have been reviewed so far. Among these 70 patients, 40 (57 %) were girls; median age was 6,9 years (range:14 days–22 years). The protocol was administered in 57 (81 %) patients, at least once. Forty patients received it more than once, 2 patients up to 16 times. A total of 214 protocol administrations occurred in the 70 patients. According to the ward nurses’ notes, relief of symptoms post protocol was obtained in 66 % of all episodes. The median interval between the administration of the first protocol and death was 9 h (range:1 min–6 months). Conclusions: At SJUH, the protocol was administered in 81 % of pediatric palliative care patients for whom it was prescribed. Preliminary data show the protocol to be effective in a majority of patients and safe.
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MASCC-0461 Respiratory distress protocol in pediatric palliative care: medical and nursing staff’s perceptions F. Gauvin1, G. Bidet1, L. Daoust1, M. Duval2, N. Humbert1 1 Pediatrics, CHU Sainte-Justine Université de Montréal, Montreal, Canada, 2Hematology & Oncology, CHU Sainte-Justine Université de Montréal, Montreal, Canada Introduction: Recently a respiratory distress protocol was established for pediatric palliative care patients at SainteJustine University Hospital (SJUH). This protocol, after being prescribed by the attending physician, can be initiated by the nurse whenever the patient presents an episode of respiratory distress. Objectives: The objective of this study was to evaluate the perceptions of the medical and nursing staff towards the use of the protocol. Methods: This study was done using a survey that was distributed to all physicians and nurses working with pediatric palliative care patients, between September 2010 and September 2012. The answers to the survey were anonymous, done on a voluntary basis, and after consent of the participant. Results: The response rate to the survey was 46 % (253 answers/548 distributed surveys) and the distribution of respondents was:22 % physicians; 71 % nurses; 7 % residents/fellows. According to the respondents, the protocol was FREQUENTLY (55 %) or ALWAYS (35 %) effective to relieve the patient’s symptoms. The respondents felt SOMETIMES (16 %), FREQUENTLY (34 %) or ALWAYS (41 %) comfortable in giving the protocol. The 2 most important motivations to use the protocol were: 1) speed of efficacy of the protocol; 2) desire to relieve patient’s distress. The 2 most important obstacles were :1) going against the patient’s wishes or patient’s family wishes; 2) improper evaluation of the patient’s distress. The respondents thought the protocol could NEVER (12 %), RARELY (32 %), SOMETIMES (46 %), FREQUENTLY (8 %), ALWAYS (1 %) hasten death. Conclusions: Data from this survey show that respondents are in favour of using a respiratory distress protocol in pediatric palliative care patients at SJUH and find it effective.
MASCC-0462 Subacute leukoencephalophaty (LE) following high dose (HD) intravenous (IV) and intrathecal (IT) methotrexate (MTX) during treatment of acute lymphoblastic leukemia (ALL) in children L. Fraquelli1, M. Onoratelli1, D. Barsotti1, M. Posadas Martínez1, C. Botana Rodriguez1, S. Evangelista1, L. Peralta1, M. Rebollo1, E. Alfaro2, M. Felice2 1 Day Care Hospital, Hospital Nacional de Pediatria Prof.Dr. J.P. Garrahan, Buenos Aires, Argentina, 2Hematology-Oncology, Hospital Nacional de Pediatria Prof.Dr. J.P. Garrahan, Buenos Aires, Argentina Introduction: MTX is an essential drug in ALL treatment and is associated with neurotoxicity. MTX-induced LE can present similar to acute stroke. Abrupt onset of focal neurological signs in a patient with malignancy is a significant diagnostic challenge. Objectives: Our aim is to alert clinicians to this condition. Methods: We present a case with neurologic complications during chemotherapy.
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Results: We report a 9 years old girl who presented bilateral lower limb pain since 2 months. Bone marrow showed blast cells and immunophenotyping was consistent with B precursor ALL. The cerebrospinal fluid (CSF) was negative for blast cells. She was treated with ALL-BFM therapy protocol that consisted of IV and IT MTX amongst other chemotherapeutic drugs. She achieved complete remission at 33rd day. Ten days after the second cycle of HD IV and IT MTX therapy, she developed sudden onset of right upper limb weakness, ipsilateral facial nerve palsy and aphasia. She was conscious. CSF study revealed no blast cells. Computed tomography and coagulation tests were normal. An electroencephalogram showed right spikes. She recovered within 2 days with no neurological deficits.T2 and FLAIR MRI showed symmetrical bilateral diffuse high intensity areas in corona radiata. The diagnostic was MTX induced subacute LE. She received Protocol II. Four months later, two cycles of IV and IT MTX therapy were given. Follow-up MRI revealed complete resolution. She had no recurrences of neurologic symptoms. Conclusions: Subacute MTX neurotoxicity occurs 2–14 days after IT or HD MTX. Changes in deep cerebral white matter not necessarily indicate an irreversible cytotoxic injury.
MASCC-0463 Incidence and management of infusion-related hypersensitivity reactions (IRHSRS) following discontinuation of remedications in patients receiving paclitaxel based chemotherapy C. De Angelis1 , A. Giotis2, C. Folkins2 , K. Chandrakumaran 2, N. Jamal2, M. Pasetka2 1 Pharmacy, Sunnybrook Odette Cancer Centre Leslie Dan Faculty of Pharmacy University of Toronto, Toronto, Canada, 2 Pharmacy, Sunnybrook Odette Cancer Centre, Toronto, Canada Introduction: Paclitaxel administration is associated with IRHSRs including flushing, rash, dyspnea, hypotension, chest pain and tachycardia. To decrease the incidence of IRHSRs, patients are premedicated with dexamethasone, diphenhydramine and a histamine 2 receptor antagonist (H2RA). A recently published pilot study demonstrated that premedications can be successfully discontinued after the second cycle of paclitaxel, if no IRHSRs are experienced. Objectives: To determine the incidence and management of IRHSRs experienced by patients whose premedications were removed after 2 cycles of IRHSR-free paclitaxel administration. Methods: All patients scheduled to receive paclitaxel-based chemotherapy between March 2012 and December 2012 (n=235) were considered for discontinuation of premedications. Patients scheduled for their 3rd cycle of paclitaxel had premedications discontinued if they experienced no IRHSRs during their first 2 cycles with premedications. All premedications were removed with paclitaxel alone while only H2RAs were removed with paclitaxel + platinum treatments. These patients were then monitored for IRHSRs in subsequent cycles. Results: Fifty-six (23.8 %; 95%CI 18.8–29.7 %) patients experienced IRHSRs during their first 2 cycles of paclitaxel with premedications and were deemed ‘non-eligible’ to have their premedications discontinued. Two of 91 (2.2 % 95 % CI 0.6–7.7 %) patients where only the H2RA was discontinued and 9 of 88 (10.2 % 95 % CI 5.5– 18.3 %) patients with all premedications discontinued experienced an IRHSR on subsequent treatments. Conclusions: No severe IRHSRs occurred in either group. All IRHSRs were managed effectively with rescue medications. Discontinuing premedications for individuals that have not
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experienced prior IRHSAs to paclitaxel is both feasible and safe.
MASCC-0464 Identification of biomarkers of chemoradiotherapy-induced toxicity in upper gastrointestinal (GI) cancers J. Bowen 1 , I. White 2, K. Kristaly 2 , L. Smith3 , S. Thompson 3 , D. Hussey4, D. Watson4, D. Keefe2 1 Medical Sciences, University of Adelaide, Adelaide, Australia, 2 Medicine, University of Adelaide, Adelaide, Australia, 3Surgery, University of Adelaide, Adelaide, Australia, 4Surgery, Flinders University, Adelaide, Australia Introduction: Mucositis is a major clinical problem in oncology which leads to negative patient outcomes. It occurs in roughly half of all patients receiving chemoradiotherapy, however, there is currently no clinical tool to predict which patients are most at risk. We hypothesize that patients most likely to develop severe mucositis will have specific gene expression profiles that can be measured pre-therapy. Objectives: The aim of this study was to measure immune gene expression in upper GI cancer patients as predictive markers of chemoradiotherapy-induced mucositis. Methods: Patients were recruited from 2 study sites and followed during 2 cycles of treatment. Patients were classified as toxic or nontoxic based on severity of mucositis data collected by patient questionnaire and clinical records. RNA was extracted from whole blood collected prior to therapy and analysed using an 84-innate and adaptive immunity gene PCR array. Genes identified as upregulated in toxic patients were subsequently confirmed by RT-PCR. Results: Blood samples were collected from patients diagnosed with oesophageal adenocarcinoma (n=9), oesophageal squamous cell carcinoma (n=4), gastro/oesophageal junction adenocarcinoma (n= 4) and gastric adenocarcinoma (n=7) Mucositis occurred in 15 of 23 patients (65.2 %) receiving chemotherapy/chemoradiotherapy. PCR array found significant upregulation of TNF-a (2.36-fold, p = 0.018), NF-kB (1.80-fold, p = 0.004) and TRAF6 (1.53-fold, p = 0.049) in toxic patients (n = 4) compared to non-toxic patients (n = 5). Conclusions: This study suggests that baseline expression of key mediators of the innate immune response, including proinflammatory cytokines and transcription factors, are measurably different in patients who are at risk of severe mucositis. Analysis is ongoing.
MASCC-0465 Can a predictive model identify hospice patients? R.M. McCabe1, J.Z. Ai1, J. Grutsch1 1 Clinical and Research Informatics, Cancer Treatment Centers of America, Zion, USA Introduction: In the United States, generating accurate predictions of 6-month survival has potentially important ramifications in clinical decision making about whether to admit a patient into hospice. Objectives: To develop a Bayesian network to predict 6-month survival in a heterogenous mix of cancer patients seeking evaluation or treatment of disease in a clinical context using baseline quality-of-life (QoL) and clinical variables. Methods: Data from 7,187 patients who completed the EORTC QLQC30 questionnaire was analyzed. The prognosis for these patients
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ranged from potentially curable to hospice bound. Nine symptom scales, five function scales, global health, site of origin, stage, newly diagnosed/recurrent, number of comorbidities, demographics and survival were variables used to develop the model. Models were developed, tested, and validated on this dataset using 10-fold cross validation. Results: In addition to providing probability-based survival predictions, the Bayesian network graphically illustrates underlying
relationships among QoL, clinical variables and survival. The resulting model structure indicated that stage, newly diagnosed/ recurrent, gender and appetite loss were direct predictors of 6month survival (figure 1). Fatigue had ‘parent-child’ relationships with stage and 11 QoL attributes but had no direct influence on survival. With a threshold of 0.50, the model yielded: accuracy, 0.76; sensitivity, 0.75; specificity, 0.58; precision, 0.85. Area under ROC curve was 0.74.
Conclusions: Using a large scale dataset, the Bayesian network generated accurate survival predictions and a complex of descriptive relationships. Physical functioning, global health, and fatigue have been routinely associated with cancer survival, however in this analysis appetite loss was the only QoL scale to directly influence 6-month survival.
unclear whether symptoms and functioning domains can accurately explain a patient’s evaluation of overall QoL. Objectives Identify determinants of global health–a surrogate variable for patient well being–using baseline symptom and function data from the EORTC QLQ-C30 tool and decision tree algorithms. Methods: Eight thousand four hundred seventy-eight patients completed the survey. 55 % of patients underwent second or subsequent lines of therapy; 65 % of patients had disease diagnosed in lung, breast, colorectal, prostate and pancreas. Input variables for the classification algorithms included nine symptom and five function scales, site of origin, stage, and demographics. Global health scale data were categorized as Low (<34), Medium, or High (>67) for each patient for classification purposes. 20 experiments were conducted using data subsets stratified by newly diagnosed/recurrent status, site of origin and stage. Results: Commonly occurring determinants of global health were physical, role and social functioning domains and fatigue, appetite loss and pain (figure 1 and 2). Fatigue was the most commonly occurring decision node (18 of 20 experiments) and root node (14 of 20). 62 % to
MASCC-0466 Identification of drivers of quality of life in patients with cancer: the case for fatigue R. McCabe1, J. Grutsch1, S. Nutakki1 1 Clinical & Research Informatics, Cancer Treatment Centers of America, Zion, USA Introduction: The Wilson Cleary Quality of Life (QoL) model predicts that symptom-producing pathways (e.g., depression, insomnia) may affect patient health and sense of well being. Currently, it is
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74 % of patients in each experiment were correctly classified by the decision tree.
Experimental Subgroup
N
Physical Role Emotional Cognitive Social Fatigue Appetite Pain Insomnia Prediction Root Loss Accuracy (%) Node
Cut point
All Cancers
8478
x
x
x
x
x
67.1
Fatigue
28
Newly Diagnosed
3767
x
x
x
x
x
68.0
Fatigue
28
Recurrent Cancers
47111 x
x
x
x
x
66.5
Fatigue
39
Newly Lung Diagnosed Breast
730
x
x
x
68.0
Role
75
72.0
Role
92
71.2
Fatigue
28
73.6
Fatigue
28
69.2
Fatigue
47
71.1
Fatigue
28
718
x
x
x
Colocteral 243 Prostate
x
Pancreatic 415 Recurrent Cancers
All others
1134
Lung
682
Breast
1102
x x x
285
x
x
Pancreatic 292 All others
x
1722
x
Newly Stage 1 Diagnosed Stage 2
470
x
Stage 3
644
Stage 4
1434
Unknown
311
908
x x
x
x
x
Colorectal 628 Prostate
x x
527
x
x
x x
x
65.8
Fatigue
50
x
69.1
Fatigue
28 44
x
x
62.3
Fatigue
x
x
71.9
Physical 90
x
x
x x
x
x
x
x
x
x
x
x x
x
x
x x
Conclusions: A set of 20 experiments generating decision trees indicated that fatigue was the most commonly identified domain used to
x x
x
66.1
Fatigue
44
63.0
Role
75
70.9
Social
92
73.7
Role
92
66.3
Fatigue
28
67.5
Role
75
66.2
Fatigue
39
classify global health. This reinforces the conditional importance of fatigue levels in patient evaluation of overall quality of life.
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MASCC-0467 Prognostic ability of three performance status measures in patients with advanced cancer
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Survival Time According To PS Median survival (days)
95 % CI (days)
0
249
231–357
1
192
179–214
2
103
89–118
3
54
45–63
4
25
18–50
80–100
214
189–238
60–70
113
102–128
40–50
51
43–58
10–30
22
13–50
ECOG
R.W. Jang1, V.B. Caraiscos2, L.W. Le3, C. Zimmermann2 1 Medical Oncology, Princess Margaret Hospital, Toronto, Canada, 2 Department of Psychosocial Oncology and Palliative Care, Princess Margaret Hospital, Toronto, Canada, 3Biostatistics Department, Princess Margaret Hospital, Toronto, Canada Introduction: Few studies have compared the prognostic ability of different performance status (PS) measures for patients with advanced cancers. Objectives: To provide estimates of survival by different measures of PS: (1) Eastern Cooperative Oncology Group (ECOG); (2) Palliative Performance Scale (PPS); (3) Karnofsky Performance Scale (KPS), and to compare their ability to predict survival. Methods: Physicians completed all three measures for consecutive new patients attending the Oncology Palliative Care Clinic (OPCC) from April 2007–February 2010. Survival analysis was performed using the Kaplan-Meier method. For each of the performance measures, the log-rank test for trend was used to test for a difference in survival curves for each level of PS, and the concordance index (Cstatistic) was used to test the predictive discriminatory ability. Results: PS measures were completed for 1,773 patients. PS delineated survival well for all scales. This was significant by the log-rank test for trend (p<0.0001 for all scales). Survival times were shorter for each worsening performance level. C-statistics were similar for all scales: 0.6398 for ECOG, 0.6329 for KPS, and 0.6294 for PPS. Survival by ECOG
Survival by PPS
PPS
Conclusions: Performance status was predictive of survival at all PS levels for patients with advanced cancer attending an outpatient OPCC. ECOG, PPS and KPS had equivalent discriminatory ability. MASCC-0468 The current status of cancer rehabilitation in palliative care unit and after discharge to home Y. Izoe1, S. Minegishi1, M. Uesugi1 1 Rehabilitation medicine, Tsukuba Medical Center hospital, Ibaraki Tsukuba, Japan Introduction: Cancer is the 1st place in Japanese cause of death. Disability in patients with advanced cancer often results from deconditioning, neurologic and musculoskeletal complication of cancers. Advanced cancer caused them to a limit on activities of daily living, and walking, decrease the quality of their life. Objectives: Our hospital has started rehabilitation in palliative care unit since 2000. We have investigated the current status of cancer rehabilitation in that unit and outcomes of the patient after discharge to home. Methods: Seven hundred forty-eight patients admitted to Palliative care unit in Tsukuba Medical Center from April, 2009 to March, 2011. We assessed cancer origin, the term between admission, Dietz’classification, the implementation rate and contents of rehabilitation, the rate of cancer rehabilitation after discharge to home. Results: The average rate of the patient who underwent rehabilitation in Palliative care unit was 47 %. In the cases who received rehabilitation, 23 % discharged from hospital to nursing home or recuperating at home. Patients who were discharged to home were 19 %. Among them, the patients who had home-visit rehabilitation were 9 %. Conclusions: Intervention of the rehabilitation in palliative care unit had an effect to the improvement of transfer motion exercises, a range of joint motion exercises, muscle strength exercise, and activities of daily living. There were few rates of home-visit rehabilitation after leaving hospital to home. Home nursing care may partially substitute the need for rehabilitation and reduce the rate of home-visit rehabilitation. The future, we need to analyze in detail the current state of them. MASCC-0469 Telephone delivered nutrition and exercise counselling for cancer survivors following autologous stem cell transplantation—a pilot, randomised controlled trial Y. Hung1, J. Bauer1, P. Horsley2, J. Coll3, J. Bashford4, E. Isenring1 1 School of Human Movement Studies, University of Queensland, Brisbane, Australia, 2Nutrition Services, The Wesley Hospital, Brisbane, Australia, 3The Wesley Research Institute, The Wesley Hospital, Brisbane, Australia, 4Haematology & Oncology Clinics of Australia, The Wesley Medical centre, Brisbane, Australia
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Introduction: Ongoing nutrition and exercise counselling may help reverse the adverse changes in nutritional status, body composition, and quality of life (QoL) after high dose conditioning and stem cell transplant (SCT). Objectives: To evaluate the impact of nutrition and exercise counselling provided at hospital discharge on patients’ QoL, nutritional status and body composition up to 100 days post-transplant. Methods: Consecutive patients from a private haematology clinic in Brisbane, Australia were randomised after transplant. The control group (n=19) received no intervention after discharge; extended care (n=18) received fortnightly telephone-counselling from a dietitian and exercise physiologist up to 100 days post-transplant. Nutritional parameters (patient-generated subjective global assessment, and diet history), QoL (EORTC QLQ-C30 version 3), and body composition (Bod Pod, COSMED USA, Inc.) were assessed at pre-admission, discharge, and 100 days post-transplant. Changes at 100 days post-transplant were compared using independent T-test; results were adjusted using analysis of covariance. Results: Thirty-seven autologous recipients (54 % male; mean age 58.7± 9.5 years; median body mass index 26.8 kg/m2 (range 16.4–47.6)) were recruited. Relative to discharge, extended care group exhibited clinically important improvements in protein intake (+9.1 g; CI95% −11.4, 29.6, p= 0.372), cognitive functioning (+12.4; CI95% −5.5, 30.2, p=0.163), and social functioning (+11.1; CI95% −17.6, 39.7, p=0.429) compared to control group. Relative to pre-admission, fat loss was significantly higher amongst control group (−3.3 kg; CI95% −6.2, −0.3, p=0.030); loss of lean body mass was similar between the groups (0.1 kg; CI95% −1.7, 1.8, p=0.927).
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Conclusions: Ongoing nutrition and exercise counselling may encourage greater protein intake, improve certain QoL components, and prevent further weight loss in SCT patients following hospitalisation.
MASCC-0470 The relationship between intensity of symptoms and unbearable suffering studied in end-of-life cancer patients in Dutch primary care C.D.M. Ruijs1, A.J.F.M. Kerkhof1, G. van der Wal1, B.D. OnwuteakaPhilipsen1 1 EMGO+Institute for Health and Care Research Palliative Centre of Expertise, VU University Medical Center, Amsterdam, Netherlands Introduction: A certain symptom may be unbearable for one patient, yet bearable for another. Unbearable suffering hardly is studied in cancer patients Objectives: To study the relationship between intensity of symptoms and unbearable suffering Methods: Forty four general practitioners during 3 years recruited cancer patients with an estimated life expectancy of half a year or shorter. Intensity of symptoms and related unbearable suffering were assessed with the State-of-Suffering V, a quantitative instrument with a five point rating scale addressing 69 symptoms in five domains: medical signs and symptoms, loss of function, personal aspects, environment and nature and prognosis of disease Results: Seventy six out of 148 patients (51 %) requested to participate consented. Sixty four patients were followed up until death. Symptoms of high intensity were unbearable in some 80 %. Symptoms of low intensity were unbearable in a wide range around 25 %. Symptoms with high rated intensity which most frequently were unbearable were: pain (92 %), loss of control over one’s life (92 %), fear of future suffering (89 %), not being able to do the important things (87 %) and not sleeping well (86 %). Symptoms with low rated intensity which most frequently were unbearable were: loss of control over one’s life (80 %), vomiting (73 %), not being able to do the important things (52 %) and not sleeping well (43 %). Conclusions: Assessment of intensity of symptoms as well as unbearable suffering provides opportunities to improve relief of suffering through combining interventions which diminish the intensity of symptoms with interventions which address the experience of suffering.
MASCC-0471 Irinotecan disrupts occludin in the rat small intestine: implications for chemotherapy-induced mucositis H.R. Wardill1, J.M. Bowen1, R. Gibson1 1 School of Medical Sciences, University of Adelaide, Adelaide, Australia Introduction: Chemotherapy for cancer causes significant gut toxicity. Recently there has been renewed interest in the role tight junctions play in the pathogenesis of mucositis. Objectives: To delineate these underlying mechanisms we aimed to quantify molecular changes in a key tight junction protein, occludin, using a well-established preclinical model of gut toxicity. Methods: Female tumour-bearing dark agouti rats received irinotecan or vehicle control and were assessed for validated parameters of mucositis including diarrhoea and weight loss. Rats were killed at 6 h, 24 h, 48 h, 72 h, 96 h and 120 h post-chemotherapy. Histopathological damage was assessed using standard staining techniques. Occludin protein and mRNA expression in the ileum and jejunum were assessed using semi-quantitative immunohistochemistry and RT-PCR.
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Results: All rats receiving irinotecan developed diarrhoea and significant weight loss. Diarrhoea first appeared 6 h after irinotecan with maximal symptoms seen at 72 h. Peak weight loss occurred at the same time point (p<0.0001). Marked histological evidence of mucositis was seen in the ileum of irinotecan-treated rats. This was accompanied by significant downregulation of occludin protein expression 24 h and 48 h postirinotecan in small intestinal crypt epithelia (p<0.05). Cytoplasmic redistribution of occludin was evident from 24 h post-irinotecan. Occludin mRNA levels remained stable across the time-course of gut toxicity. Conclusions: Irinotecan causes tight junctional occludin defects which lead to mucosal barrier dysfunction and the development of diarrhoea. Disparate protein and mRNA expression suggest irinotecan indirectly modulates occludin protein expression through post-translational regulation. Detailed research is now warranted to investigate posttranslational regulation of tight junction proteins.
MASCC-0472 Expression of TLRS and GFAP in the rat intestine following chemotherapy for cancer and relationship to gut toxicity and central pain behaviour R.J. Gibson1, J.K. Coller1, M.R. Hutchinson1, J.M. Bowen1 1 School of Medical Sciences, University of Adelaide, Adelaide, Australia Introduction: Gastrointestinal mucositis (GM) and pain are major clinical problems caused by the cytotoxic effects of chemotherapy. Previous research has indicated that toll-like receptor (TLR) expression may be altered following chemotherapy and correlate with severity of GM and pain. Objectives: To determine if TLR expression and activation of gut glial cells (GFAP expression) is related to GM and pain behaviour in tumour-bearing rats. Methods: Female DA rats received irinotecan (175 mg/kg, ip n=35) or vehicle control (n=5) Groups of rats (n=5–8) were killed between 6 and 120 h. Immunohistochemistry for TLRs 2, 4, 5, and 9, and GFAP was conducted on sections of jejuna and colon. Results: Irinotecan caused bi-phasic GM, with maximal diarrhoea at 72 h. Similarly peak weight loss occurred at 72 h before recovery at 120 h (P<0.0001). Irinotecan also elevated pain scores peaking at 72 h (P<0.0001). At 96 and 120 h irinotecan significantly decreased jejuna expression of TLR4 and 5 (both P<0.001), but TLR2/9 expression was unchanged. Jejunum GFAP expression also increased significantly, with peak expression by 96 and 120 h (P=0.017). Jejunum expression of TLR4, 5 and GFAP was significantly associated with occurrence of diarrhoea and facial pain scores (P<0.001), and rats with diarrhoea had higher facial pain scores compared to those without (P<0.01). Conclusions: Intestinal innate immunity activation and inflammation caused by chemotherapy potentially modifies central inflammation manifested as pain. As TLR4/5 expression decreased during the GM healing phase, TLR pharmacological inhibition may promote healing in the small intestine following chemotherapy. Impact of tumour-burden on gut TLR expression and glial activation requires further investigation.
MASCC-0473 Health professionals’ knowledge, attitudes and skills in supportive care screening and referral: outcomes of an education program E. Ristevski1, M. Regan1 Rural and Indigenous Health, Monash University, Moe, Australia
1
Introduction: Education is recognised as a mechanism to facilitate implementation of supportive care screening into routine cancer care. For health services in rural areas, building a workforce with appropriate knowledge and skills in supportive care screening is essential to ensure patients receive best practice care
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Objectives: This study examined the impact of an education program on rural health professionals’ knowledge, attitudes and skills in implementing a supportive care screening, assessment, action and referral process into routine care. Methods: Fifty-five health professionals in Gippsland, Australia completed knowledge, attitudes and skills questionnaires pre and posttraining, at 1 month post training, and a case study and interview at 3 months post training. Linear regression, thematic and content analysis were used to analyse the data. Results: Questionnaire data showed significant increases in participants’ overall knowledge, attitudes and skills in supportive care between pre and post training. Knowledge and skills were maintained at 1 month post training, yet attitudes decreased. Analysis of the case study found participant’s knowledge of supportive care screening and assessment was maintained at 3 months post training, yet skills in action and referral decreased. Themes from the interviews revealed positive attitudes to the supportive care process, yet organisational processes and support mechanisms to implement it into their routine work were lacking. Conclusions: The educational program was an effective first step in increasing health professionals’ knowledge, attitudes and skills in supportive care. Helping staff and organisations put processes into place to incorporate supportive care into routine care and practice will help to achieve long term sustainability.
MASCC-0474 Risk of arterial (ATE) and venous thromboembolism (VTE) in a population-based cohort of bevacizumab-treated metastatic colorectal cancer (MCRC) patients W. Cheung1, I. Yu1, L. Chen1 Medical Oncology, British Columbia Cancer Agency, Vancouver, Canada
1
Introduction: Bevacizumab potentiates the risk of ATE and VTE in cancer patients who are in a prothrombotic state. Objectives: Our objectives were to characterize the incidence of ATE and VTE, describe patient and treatment factors associated with thromboembolisms, and examine how ATE and VTE are managed in routine practice. Methods: Patients diagnosed with mCRC from 2006 to 2008, evaluated at 1 of 5 regional cancer centers, and offered bevacizumab were included. Multivariate regression models were constructed to explore the associations between clinical factors and thromboembolisms. Results: A total of 500 patients was identified: median age was 61 years, 59 % were men, 62 % had ECOG 0/1, and 8 % reported prior ATE or VTE. Median number of bevacizumab cycles was 11. After receiving bevacizumab, 18 % patients developed 12 ATE and 88 VTE, with 8 patients experiencing >1 event. Baseline characteristics, such as median age (61 vs 61 years), gender distribution (61 vs 58 % men), and ECOG 0/1 (66 vs 58 %) were similar between patients with and without thromboembolisms, respectively (all p>0.05). In regression models, individuals who experienced ATE or VTE were more likely to have a prior history (14 vs 6 %, p=0.02), reported greater pre-existing cardiac comorbidities (42 vs 32 %, p=0.05), and received a higher median number of bevacizumab cycles (13 vs 9, p<0.01), suggesting a potential dose-related effect. Following ATE or VTE, management varied: bevacizumab was discontinued in 46 %, held temporarily in 14 %, and continued in 40 % of patients. Conclusions: The risk of thromboembolism is high, especially in patients with pre-existing risk factors and those heavily treated with bevacizumab. MASCC-0475 Phase II study of aprepitant and granisetron for the prophylaxis of radiotherapy-induced nausea and vomiting (RINV) following moderately-emetogenic radiotherapy for bone metastases: preliminary results K. Dennis1, C. De Angelis2, F. Jon3, N. Lauzon3, M. Pasetka2, L. Holden3, E. Barnes3, C. Danjoux3, A. Sahgal3, M. Tsao3, E. Chow3
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1
Radiation Oncology, Ottawa Hospital Research Institute University of Ottawa, Ottawa, Canada, 2 Pharmacy, Odette Cancer Centre Sunnybrook Health Sciences Centre University of Toronto, Toronto, Canada, 3Radiation Oncology, Odette Cancer Centre Sunnybrook Health Sciences Centre University of Toronto, Toronto, Canada Introduction: Acute and delayed radiotherapy-induced nausea and vomiting (RINV) are common among patients receiving moderatelyemetogenic radiotherapy for bone metastases1. Objectives: Evaluate the novel combination of Aprepitant and Granisetron for RINV prophylaxis among patients receiving moderately-emetogenic radiotherapy for thoracolumbar bone metastases. Methods: Single fraction patients (8Gy in 1 fraction) received Aprepitant 125 mg and Granisetron 2 mg on the day of radiotherapy and Aprepitant 80 mg on the first 2 days after the day of radiotherapy. Multiple fraction patients (20Gy in 5 fractions) received Aprepitant 125 mg on the first day of radiotherapy, Aprepitant 80 mg on the third and fifth days of radiotherapy, and Granisetron 2 mg on every day of radiotherapy. Symptoms and medication intake were recorded daily during the Acute Phase (the inclusive period from the first day of radiotherapy until the first day after the last day of radiotherapy), and the Delayed Phase (the inclusive period from the second to tenth days after the last day of radiotherapy). Control was defined as no symptom and no use of rescue antiemetics. Results: Symptom control rates:
Single fraction patients (n=13) Multiple fraction patients (n=6)
Acute Phase
Delayed Phase
Combined Phases
Nausea
Vomiting
Nausea
Vomiting
Nausea
Vomiting
100 %
100 %
62 %
85 %
62 %
85 %
67 %
67 %
83 %
83 %
67 %
67 %
Conclusions: Aprepitant and Granisetron were efficacious for the prophylaxis of RINV among patients receiving moderatelyemetogenic radiotherapy for thoracolumbar bone metastases. References: 1. Dennis K et al. Prophylaxis of radiotherapy-induced nausea and vomiting in the palliative treatment of bone metastases. Support Care Cancer 2012;20:1673–1678.
MASCC-0476 Population-based patterns of granulocyte colony stimulating factor (GCSF) use in breast cancer (BRCA) patients receiving myelosuppressive chemotherapy W. Cheung1, M. Lehmkuhl1, L. Chen1 1 Medical Oncology, British Columbia Cancer Agency, Vancouver, Canada Introduction: Prophylaxis with GCSF can reduce hospitalization. Objectives: Our aims were to characterize patterns of GCSF use, determine the rate of neutropenia and neutropenic fever in those who received and did not receive GCSF, and identify factors associated with appropriate GCSF prophylaxis Methods: Patients diagnosed with BrCa and treated with chemotherapy protocols that posed >20 % risk of neutropenic fever were reviewed. Using regression models, the relationship between GCSF
use and 1) various patient and physician characteristics and 2) treatment outcomes were analyzed Results: A total of 525 women was included: median age was 51 years, 38 % reported smoking, 50 % used alcohol regularly, 62 % were ECOG 0, and 26 % had private health insurance. In this cohort, 38 % patients were given GCSF. Among those, 39 % and 61 % individuals received GCSF as primary and secondary prophylaxis, respectively. Overall, neutropenia was noted in 56 % cases while neutropenic fever was experienced by 22 % patients. When compared to those who did not use GCSF, patients who used GCSF experienced a lower rate of neutropenia (15 vs 49 %, p<0.01) and a decreased incidence of neutropenic fever (7 vs 13 %, p<0.01). In regression models, patients lacking extended medical coverage (35 vs 49 %, p=0.02), poor performance status (31 vs 53 %, p=0.03), and those who were evaluated at non-teaching institutions (24 vs 68 % p<0.01) were less likely to receive GCSF. Patients seen at non-teaching institutions were also given primary GCSF prophylaxis less frequently (15 vs 57 %, p<0.01) Conclusions: While GCSF prophylaxis was associated improved neutropenia-related outcomes, use of GCSF was low.
MASCC-0477 Coms eye plaque dosimetry with 125I seeds: heterogeneity effect of plaque components on dose distributions H. Acar1, G. Yavas2, C. Yavas3, I. Ozbay1 Institute of Oncology, Istanbul University, Istanbul, Turkey, 2Radiation Oncology, Selcuk University, Konya, Turkey, 3Radiation Oncology, Konya Training and Research Hospital, Konya, Turkey 1
Introduction: The eye plaques designed by the Collaborative Ocular Melanoma Study (COMS) group are the most frequently used type for brachytherapy of ocular melanomas. Objectives: We report the study of the heterogeneity effect on dose distributions in eye phantom for COMS eye plaques with 125I seeds using TLD dosimetry. Methods: COMS eye plaques, 14, 16, 18 and 20 mm in size, uniformly loaded with 125I seeds were studied. TLDs were positioned in a polystyrene eye phantom above the eye plaque, in two configurations: (1) in the plaque’s central plane, (2) perpendicular to the plaque’s central axis at 5 and 12 mm depth in the eye phantom. The exposure times (from 1.2 to 2.3 h) were adjusted to deliver 100 cGy at 5 mm depth. The TLD dose data were compared with the calculated doses using Plaque Simulator with homogeneous assumption (Homo) and heterogeneity correction (Hetero). Results: The dose ratio (TLD/Homo) and (TLD/Hetero) values along the central axis are shown in Figure 1. The dose ratio (TLD/Homo) values are substantially lower than unity (mostly between 0.8 and 0.9) for all plaque sizes studied, indicating dose reduction by COMS plaque compared with homogeneous assumption. The dose ratio (TLD/Homo) and (TLD/Hetero) values at 5 and 12 mm depth are shown in Figure 2 and 3 respectively. The TLD dose data agree with the Hetero dose values within the uncertainty of the measurement Conclusions: We found significant heterogeneity effect on the 125I dose distributions in an eye for COMS plaques using TLD dosimetry.
MASCC-0478 Dosimetric comparison of dose distributions in episcleral plaque brachytherapy H. Acar1, G. Yavas2, C. Yavas3, I. Ozbay1 1 Institute of Oncology, Istanbul University, Istanbul, Turkey, 2Radiation Oncology, Selcuk University, Konya, Turkey, 3Radiation Oncology, Konya Training and Research Hospital, Konya, Turkey
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Introduction: Brachytherapy of intraocular tumors with 125I eye plaques has become a successful treatment modality and a viable alternative to enucleation. Plaque Simulator (PS) is an eye plaque treatment planning system (TPS) that uses TG-43 dosimetry. Objectives: We aimed to verify the performance of the PS routinely used to plan patients having intraocular tumors. Methods: Relative dose distributions, including central axis depth dose and off axis dose profiles of Collaborative Ocular Melanoma Study (COMS) plaques with 14, 16, 18 and 20 mm in diameter, loaded with model 125I seeds were measured using 1×1×1 mm3 Thermo Luminesans Dosimetry (TLD) cubes and computed using MCNP5 Monte Carlo code and PS. Measurements and calculations were compared by normalizing 5 mm distance at the central axis of the plaque. Results: For the central axis depth doses, the agreement between the measured and calculated dose distributions was within 13 %, whereas deviations up to 22 % were observed in single points far off-axis. For central axis dose distribution, the max difference among the PS, TLD and MCNP5 results was seen at 2 mm from the plaque center for all plaque sizes. For off axis dose distribution the maximum dose difference among the PS, TLD and MCNP5 results were seen at±12 mm from the central axis. Conclusions: The Bebig Plaque Simulator is a reliable TPS for calculating relative dose distributions around realistic multiple 125I seed configurations if one understands its limitations at the first few millimeters around the plaque center and far off axis points.
MASCC-0479 Determining the role of sunitinib and its active metabolite (SU12662) on hand-foot syndrome (HFS) in metastatic renal cell carcinoma (MRCC) patients Y.L. Teo1, X.J. Chong1, X.P. Chue1, N.M. Chau2, M.H. Tan2, R. Kanesvaran2, H.L. Wee1, H.K. Ho1, A. Chan1 1 Department of Pharmacy, National University of Singapore, Singapore, Singapore, 2Department of Medical Oncology, National Cancer Centre Singapore, Singapore, Singapore Introduction: Both sunitinib and SU12662 contribute to the pharmacological activity in treatment of mRCC. However, their role in HFS has yet to be determined. Objectives: To compare the HFS-toxicity potential of sunitinib and SU12662, using both in vivo and in vitro approaches. Methods: Patients receiving sunitinib for the treatment of mRCC were invited to participate. In week 4 of each cycle, HFS was assessed and plasma drug and metabolite levels were quantified using high-performance liquid chromatography. Cell viability assays were conducted on HaCaT keratinocytes to investigate the IC50 of sunitinib and SU12662. Results: Twenty-four patients were recruited, with 40 drug cycles available for analysis. All-grades HFS was observed in 26 drug cycles (65.0 %). Similar sunitinib, SU12662 and total drug concentrations were observed among patients with and without HFS. Patients with HFS manifested higher median sunitinib:metabolite ratio than those without HFS. A lower IC50 was observed in HaCaT cells treated with sunitinib than SU12662. (Table 1) Plasma levels (μg/ml) [median (IQR)] Sunitinib
With HFS (n=26) 0.08 (0.05, 0.11)
Without HFS (n=14) 0.07 (0.06, 0.10)
P
SU12662
0.01 (0.01, 0.02)
0.01 (0.01, 0.02)
0.20
Total
0.09 (0.06, 0.13)
0.09 (0.07, 0.11)
0.84
Sunitinib:metabolite ratio
6.69 (5.12, 9.53)
5.33 (4.86, 7.94)
0.26
Sunitinib
SU12662
IC50 (μM) [mean±SD]
23.3±1.8
35.3±4.9
0.92
0.02
Conclusions: Both clinical and in vitro data suggests that sunitinib is likely more dermatotoxic than SU12662. Patients who are poor metabolizers or receiving drug inhibitors could be at a higher risk for dermatological toxicity.
MASCC-0480 Predictors of fatigue in the year following completion of breast cancer therapies S. Singh-Carlson1, C. Alexander2, S. Smith2 1 School of Nursing, California State University Long Beach, Long Beach, USA, 2Radiation Oncology, British Columbia Cancer Agency, Victoria, Canada Introduction: Fatigue adversely affects quality of life in breast cancer survivors Objectives: To identify patient, tumour and treatment factors that predict for fatigue following completion of breast cancer therapy. Methods: A survey was designed, validated, and sent to women with non-metastatic, invasive breast cancer who were between 9 and 15 months post-completion of active treatment (last surgery/chemotherapy/radiotherapy). They were asked to rank their level of fatigue in the first year following treatment using a 4 point Likert scale: not at all, a little (mild), quite a bit (moderate), or very much (severe). Responses were linked to disease and treatment information. Multivariate analysis using logistic regression was used to identify factors predicting for fatigue. Results: 1,065/2,389 (45 %) responses were received. Fatigue was rated as moderate or severe by 56 % of all respondents. On univariate analysis, factors associated with moderate or severe fatigue included younger age, middle income ($35–$100 k/year), node positive disease, high grade disease, axillary dissection, >10 nodes removed, chemotherapy, and type of chemotherapy (more fatigue with taxanes). On multivariate analysis, patients who received chemotherapy (OR 1.96, CI 1.36–2.81, p<0.0001), and those aged 50–59 at diagnosis (OR 1.80, CI 1.22–2.66, p=0.003) were more likely to have moderate or severe fatigue. In patients aged 50–59 at diagnosis who receive chemotherapy (n=156), 74.4 % rated their fatigue as moderate or severe. Conclusions: Patients aged 50–59 who receive chemotherapy are very likely to experience significant fatigue in the year following therapies for breast cancer.
MASCC-0481 Cervical precancerous lesions and cancer among patients seen in the gynaecology outpatient department at a tertiary hospital in South Africa M. Hoque1, E. Hank2 Graduate School of Business and Leadership, University of KwaZulu-Natal, Durban, South Africa, 2Department of Health, Rahima Moosa Hospital, Johannesburg, South Africa 1
Introduction: In South Africa, cervical cancer is the second leading cause of death among women. HIV infection and cervical cancer among women in South Africa are both important Public Health concerns. Objectives: The purposes of this study are to determine proportional rates of cervical precancerous lesions and cancer, and its association with socio-demographic variables, HIV status, and CD4 Cell Count. Methods: A retrospective comparative study was conducted, targeting the medical records of all women over the age of 18 that were diagnosed histologically through Colposcopy with cervical precancerous lesions and cervical from 01 December 2011 to 30 November 2012
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Results: A total of 313 Patient records were used for data analysis. The average age of the patients was 39.06 (SD=2.04) years. More than a third (37.06 %) of the patients had CIN III or cervical cancer. There was a significant association between Age, CD4 Cell count, HIV status, and cervical lesions (P<0.05). Age was found to be an influential predictor of cervical lesions (OR=0.67, 95 % CI: 0.46–0.98). Conclusions: There exists an association between Age and cervical lesions, indicating the presentation of cervical precancerous lesions and cervical cancer at a younger age among HIV Reactive patients. The National Guidelines should be brought in line with the National HIV Counseling and Testing Policy to offer Pap smears to all sexually active women that test HIV Reactive during routine HIV Testing.
MASCC-0482 Treatment experience of survivors with recurrent colorectal cancer based on interviews E. Shindo1 1 Faculty of Nursing and Medical Care, Keio University, Tokyo, Japan Introduction: The standardization of treatment for recurrent colorectal cancer has led to extended life expectancy. However, support programs for patients are not yet sufficient in Japan. Objectives: To examine the experiences of those currently undergoing the treatment and how they are making sense of it. Methods: A qualitative descriptive study design. The participants were three Japanese females in their 50s and 60s with recurrent colorectal cancer. Data was collected through several continuous semi-structured interviews and analyzed using interpretation of the experiences. IRB of Keio University approved this study. Results: Interviews were conducted 24–27 times to each over 2.5 years. In continuing chemotherapy, they viewed their bodies as toxic and not their own. The treatment was also seen as an obstacle to being oneself and performing their roles in life. They had mixed feelings about the treatment being something that threatened their bodies but at the same time preserved their lives. They were distressed about whether they should continue with the treatment or not. The harsh experience brought about a fear of selfdissolution, yet they persevered because they hoped it would prolong their lives and let them live in their own ways. They maintained a sense that they were weathering it by carefully controlling both self and disease. Conclusions: They maintained a sense of controlling both self and disease through suffering by themselves. That was how they were handling the fear of self-dissolution. These results suggested to be more sympathetic to their suffering and to investigate a customized psychosocial support program.
MASCC-0483 The association of TLR2, TLR4 and proinflammatory cytokines with irinotecan-induced gastrointestinal mucositis in an animal model K. Fakiha1, R. Logan2, J. Coller3, A. Stringer4, J. Bowen5 1 Dscipline of Medicine Faculty of Health Sciences, University of Adelaide, Adelaide, Australia, 2School of Dentistry Faculty of Health Sciences, University of Adelaide, Adelaide, Australia, 3Discipline of Pharmacology Faculty of Health Sciences, University of Adelaide, Adelaide, Australia, 4School of Pharmacy and Medical Sciences, University of South Australia, Adelaide, Australia, 5Discipline of Physiology Faculty of Health Sciences, University of Adelaide, Adelaide, Australia Introduction: Gastrointestinal mucositis (GIM) is a common side effect of irinotecan administration characterised, in animal studies, by the occurrence of diarrhoea. However, in these studies, rats receiving
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irinotecan do not always develop diarrhoea. Previous research has shown that TLR2, TLR9 and proinflammatory cytokines are involved in chemotherapy-induced GIM. Objectives: This study investigated TLR2, TLR4 and proinflammatory cytokine expression following irinotecan administration in rats focusing on diarrhoea occurrence as the marker of GIM. Methods: Seventeen female DA rats received either single dose of irinotecan (200 mg/kg, n=11) or vehicle control (n=6) and were killed at 72 h (irinotecan=5, control=3) or 96 h (irinotecan=6, control=3) post treatment. Jejunum and colon samples were collected. RT-PCR and immunohistochemistry for TLR2, TLR4, IL-1β, IL-6 and TNF were performed and mRNA and protein expression were compared between groups with and without GIM. Results: Two-thirds of irinotecan-treated rats developed GIM with peak diarrhoea at 96 h. TLR2, TLR4, TNF and IL-1β mRNA and protein expression increased significantly in the colon of rats that developed diarrhoea at 96 h compared to rats without diarrhoea (P<0.05). Similarly, protein expression of TLR4 and TNF increased in the jejunum of rats with diarrhoea at 96 h (P<0.05). No significant differences were observed for IL-6. Conclusions: Increased TLR2, TLR4, IL-1β and TNF expression correlated with diarrhoea occurrence and severity. These data support previous work indicating the role of inflammatory mediators in rats at 96 h following irinotecan administration. Therefore, they can be considered as possible mediators for irinotecan-induced GIM.
MASCC-0484 Does abiraterone allow pain relief in castration resistant prostate cancer? A real life experience in a French General Hospital D. Mayeur1, D. Billard1, C. Abraham1, J.F. Geay1, A. Teillet1 Haematology-Oncology, Hôpital Mignot, Le Chesnay, France
1
Introduction: Castration resistant prostate cancer is often associated with moderate to severe pain, especially bone pain. Objectives: To assess pain relief in patients with castration resistant prostate cancer treated by abiraterone. Methods: Retrospective study of all the castration resistant prostate cancer patients treated with abiraterone. Using their charts, identification of patients with a pain treatment coprescription at the start of abiraterone. Evaluation of analgesic consumption during abiraterone treatment and the time during which analgesic consumption is decreased by abiraterone, response evaluation to anticancer treatment. Results: Seventeen patients have been treated by abiraterone. Median age and median PSA at the start of treatment: respectively 71.1 years (57–83) and 354.7 ng/ml (0.1–2108). 5/17 (30 %) patients were pain free. 12/17 (70 %) were treated with analgesics at introduction of abiraterone treatment. No antitumoral effect: 3/17 (18 %) patients. 7 patients out of the 12 (58 %) treated for pain had a decrease of the pain killers during treatment by abiraterone. This decrease lasted 34.3 weeks (8–69.5). Patient 1: decrease of oxycodone from 160 mg/day to 40 mg/day; patient 2: stopped rapid action fentanyl; patients 3, 4 and 5 stopped all analgesic medication; patient 6 decreased transdermal fentanyl from 175 μg/h to 100 μg/h and stopped rapid action fentanyl; patient 7 observed a 50 % decrease in his consumption of tramadol. Increase in pain intensity was, for these entire patients, the first sign of therapeutic loss of efficacy. Conclusions: Abiraterone is able to provide pain relief and a decrease in analgesic consumption in castration resistant prostate cancer patients.
MASCC-0485 Lymph taping in the head and neck region—first experiences J. Büntzel1, G. Danilkina1, H. Büntzel2
Support Care Cancer (2013) 21 (Suppl 1):S1–S301 1 Otolaryngology, Südharz Klinikum, Nordhausen, Germany, 2Palliative Medicine, Südharz Klinikum, Nordhausen, Germany
Introduction: Manual lymph drainage of the head and neck region had been criticized because of possible iatrogenic development of lymphatic metastasis (Herberhold 1993). Elastic lymph taping offers similar anti-edematous effects on the base of patient’s own movements. Objectives: We evaluated the effects and practicability of lymph taping in head neck cancer patients after radiotherapy. Methods: We report about our experiences with elastic lymph taping of the head and neck region about at least 21 days. The three-arming tape (15 cm long) was used on both sides of the neck. The selfmovement of the neck causes the careful and continuous lymph drainage for each individual. 25 patients (18 men, 7 women, mean 57 years) were treated and observed. All had finished their radiotherapy since at least 3 month. To objectify the anti-edematous effect we have performed bioimpedance analysis of the neck region in selected patients. Results: 22/25 patients reported positive effects of the elastic lymph taping. 21 patients continued the lymph taping after the planned 3 weeks. The tape was changed every 3–4 days. Acute side effects were not reported. No patient developed any lymphatic or skin metastasis in a time window of 6 month. The bioimpedance analysis has documented the anti-edematous effect as well. The BIA has still to be validated before it is used in clinical practice for this indication. Conclusions: We offer elastic lymph taping as a comfortable and safe standard in our anti-edematous concept. References: Herberhold C: Manuelle Lymphdrainage im Kopf-HalsBereich? Laryngorhinootol 1993; 72: 580
MASCC-0486 Standard anti-emetic therapy and emend® 7 days after high-dose chemotherapy significantly reduces problems with vomiting for patients undergoing high dose chemotherapy before stem cell transplantation A. Svanberg1, G. Birgegård1 1 Faculty of Medicin, Inst for Medical Sciences, Uppsala, Sweden Introduction: Chemotherapy-induced vomiting, acute and delayed, is a problem for patients treated with high dose chemotherapy (HDCT) before stem cell transplantation (SCT). Chemotherapy-induced vomiting impairs compliance with treatment. There has been major improvement to prevent vomiting with the introduction of 5-hydroxytriptamine-3 (5-HT3). This anti-emetic treatment appears to be ineffective against delayed vomiting. Objectives: To compare the efficacy of standard anti-emetic treatment with standard treatment plus prolonged treatment with aprepitant (Emend®) until 7 days after end of chemotherapy in patients with lymphoproliferative diseases treated with HDCT before autologous SCT at Akademiska University Hospital, Sweden. Methods: Patients (n=96) were randomized between 2011 and 2012, to experiment (EXP) group who received Emend® in addition to standard anti-emetics or control (CTR) group receiving placebo plus standard anti-emetics. Emend® or placebo treatment started 1 h before first HDCT dose and was administrated daily until 7 days after chemo. Vomiting was noted by the patient in a diary starting 24 h after HDCT and until day 16 (end of study). Anti-emetic rescue medication was recorded. Results: Twenty-eight patients in the EXP group compared to 14 in the CTR group experienced complete response (no vomiting) from end of HDCT to end of study regarding vomiting (p=0.0001). There were no significant differences in use of anti-emetic rescue.
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Conclusions: Addition of Emend® to standard anti-emetic treatment during 7 days after chemotherapy gave a significant reduction of chemotherapy-induced vomiting from end of chemotherapy to end of study.
MASCC-0487 Effect of mild exercise program for patients with gynecological cancer undergoing chemotherapy M. Chaen1, E. Shindo1, N. Morita1, N. Yamagishi1, M. Kobayashi1 Faculty of Nursing and Medical Care, Keio University, Tokyo, Japan
1
Introduction: Cancer patients undergoing chemotherapy suffer a reduced overall QOL because treatment side effects result in a decreasing level of activity in daily life. We developed a mild exercise program (MEP) for patients to do easily on the bed or couch whenever they want. Objectives: To examine the effectiveness of MEP for maintaining/ improving QOL of patients undergoing chemotherapy. Methods: Thirty-two patients, with an average of 49.8±10.2 year, with gynecological cancer undergoing chemotherapy at a university hospital in Japan, were recruited. They were asked to complete the assigned MEP for 4 months at home, to complete SF-36v2 and Hospital Anxiety and Depression Scale (HADS) and measure thigh circumference (TC) before and after the period of study. They also were asked to keep a daily diary documenting whether or not they did MEP, their physical conditions, side effects of chemotherapy, the Borg Index of exercise intensity and their experiences during exercising. Data were analyzed using SPSSver.19. Qualitative data were analyzed using content analysis. IRB approved this research. Results: In 50.3 % of targeted days, the assigned MEP was done. On these days, the rate of exercise was 68.5 % among patients in good condition; 31.5 % in bad condition. Even in bad condition, they tried to do exercises. Physical functioning and mental health on the SF-36v2 increased significantly, and HADS scores decreased but not significantly. TC increased significantly, and patients reported feeling comfort after doing exercises. Conclusions: Because of easily access, MEP would be good for cancer patients to keep exercising for improving their QOL.
MASCC-0488 Improving care of patients on oral anticancer therapies S. Decosterd 1 , L. Mercier-Vogel 2 , E. Lavallière 2 , N. Blazek 2 , G. Choupay-Dessard3 1 Direction des soins, HUG, Geneva, Switzerland, 2Oncology Service, HUG, Geneva, Switzerland, 3Medical Direction & Quality, HUG, Geneva, Switzerland Introduction: The development of oral anticancer agents is exponential. It represents a major change with patients being cared for in ambulatory settings and the development of a chronic-disease model of care. To deal with this challenge, experts recommend the development of patient centered educational and support programs, to promote patient adherence to treatment. Objectives: Improving care of patients on oral anticancer agents. Methods: In order to develop an adapted ambulatory care program for patient receiving oral anticancer agents, we designed an actionresearch involving all stakeholders. The data collection was sequential. First we analyzed our prescribing and delivery process for anticancer agents; second we carried out two brainstorming sessions to identify physicians/nurses concerns with oral anticancer treatment; third we carried out three focus groups with patients and relatives to identify their needs.
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Results: The content analysis revealed the interest of health professionals for these new treatments, but some worried about the shift of responsibilities toward the patient and the need to have a coherent care process involving all professionals. Patients and their relatives preferred oral anticancer treatments and encountered little practical difficulties. However the illness and its treatment impacted their quality of life. They needed information about the management of medication side effects and support to deal with the different stages of their illness Conclusions: These results lead to the revision of our process of prescription and delivery of anticancer agents, the development of an educational program for nurses in the ambulatory setting and the introduction of a nursing consultation. These developments will be presented.
MASCC-0489 Expression of matrix metalloproteinase -2 and tissue inhibitor of metalloproteinase-1 in oral mucositis following irinotecan chemotherapy A.R. Al-Azri1, R.J. Gibson2, J.M. Bowen2, A.M. Stringer3, D.M.K. Keefe4, R.M. Logan1 1 School of Dentistry - Oral Pathology, University of Adelaide, Adelaide, Australia, 2School of Medical Sciences, University of Adelaide, Adelaide, Australia, 3School of Pharmacy and Medical Sciences, University of South Australia, Adelaide, Australia, 4Discipline of Medicine - Faculty of Health Sciences, University of Adelaide, Adelaide, Australia Introduction: Changes in expression of matrix metalloproteinases (MMPs) subclasses-3 and -9 have been previously reported in the oral mucosa following irinotecan chemotherapy in a rat model of mucositis (MASCC 2012). Subsequently we have also investigated the tissue expression of MMP-2 and tissue inhibitor of metalloproteinases-1 (TIMP-1) in the oral mucosa. Objectives: To determine whether MMPs may play a role in the pathobiology of irinotecan induced mucositis. Methods: Eighty-one female Dark Agouti rats were either administered with a single dose of irinotecan (200 mg/kg) or had no treatment. Rats were killed at different time points over a 72 h period. Tongue mucosa was examined histologically. The tissue expression of MMP-2 and TIMP-1 in oral mucosa was characterized by standard qualitative immunohistochemistry. Results: The study showed an early reduction of oral epithelium thickness after chemotherapy. This was associated with significant up-regulation of MMP-2 and down-regulation of TIMP-1 in various layers of the oral mucosa. The early changes in MMP-2 and TIMP-1 (and the previously reported MMP-3 and-9) coincided with the previously described early upregulation of mediators of inflammation in oral mucositis, suggesting a relationship between these biological events. Furthermore, the patterns of expression demonstrated by MMPs suggest they are involved in various aspects of the 5-phase model of OM pathophysiology. Conclusions: This study has provided further evidence of MMPs involvement in the pathobiology of oral mucositis. Further research needs to be directed towards interventional therapies aiming to target MMPs and improve the outcome of cancer treatment.
MASCC-0490 Nutrition impact symptoms in cancer patients: results from a point prevalence study in Australia
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Assessment (PG-SGA) is a validated tool to determine malnutrition in cancer patients. The PG-SGA includes 14 patient-reported Nutrition Impact Symptoms (NIS). Objectives: This study aimed to determine the prevalence of malnutrition and NIS’s in cancer patients. Methods: A point prevalence study of adult cancer patients, using the PG-SGA to determine malnutrition and NIS, was conducted in 15 Health Services in Victoria, Australia in March 2012. Results: A total of 1,693 cancer patients were included with 31 % (n=523) identified with malnutrition. Malnourished patients reported more NIS than well-nourished patients (3.8 vs 1.2, p<0.001). Only 8 % of malnourished patients reported ‘no problems eating’ compared to 59 % of those well nourished. The most reported NIS by malnourished patients were ‘no appetite’ (63 %), ‘fatigue’ (49 %), ‘nausea’ (41 %) and ‘feel full quickly’ (41 %). Patients undergoing treatments for upper gastrointestinal, colorectal and gynaecological tumours reported the highest number of NIS. In patients receiving supportive care only (n=51) reported the highest number of NIS with ‘no appetite’, ‘nausea’, ‘vomiting’ and ‘pain’ the most frequently described. Conclusions: Malnutrition is highly prevalent in cancer patients and NIS are more commonly reported in those with malnutrition. This study provides valuable insight that can assist to optimise symptom management and direct nutrition interventions in cancer patients.
MASCC-0491 Malnutrition and clinical outcomes in cancer patients: results from a point prevalence study in Australia K. Marshall1, J. Loeliger1, L. Nolte2 1 Nutrition, Peter MacCallum Cancer Centre, Melbourne, Australia, 2Cancer Strategy, Victorian Department of Health, Melbourne, Australia Introduction: Malnutrition is an important supportive care need for people with cancer. The Patient Generated–Subjective Global Assessment (PG-SGA) is a validated tool to determine malnutrition in cancer patients Objectives: This study aimed to (1) determine the prevalence of malnutrition in cancer patients and (2) investigate the association between malnutrition and clinical outcomes Methods: A point prevalence study of adult cancer patients, using the PG-SGA to determine malnutrition was conducted in 15 Health Services in Victoria, Australia in March 2012. Outcomes were collected at day 30 Results: A total of 1,693 cancer patients were included, with 31 % (n=523) identified as malnourished. Malnutrition prevalence of inpatients was 57 % (191 of 336) and 25 % of ambulatory patients (332 of 1,357). Malnutrition prevalence was higher in patients with tumours of the upper gastro-intestinal tract (62 %), head & neck (40 %) and lung (37 %) but identified in all tumour streams ranging from 14 % to 62 %. Patients with malnutrition had a significantly higher 30-day mortality (6 % vs 1 %, p< 0.001), length of stay (20.3 vs 15.7 days, p<0.001) and rate of hospital admission rate (38 % vs 12 %, p<0.001). Conclusions: Malnutrition is highly prevalent in cancer patients. Malnutrition is associated with poorer clinical outcomes. This study provides valuable insight and direction for the implementation of evidence-based nutrition interventions to address malnutrition in cancer patients and may allow for further assessment of the economic burden of malnutrition.
J. Loeliger1, K. Marshall1, L. Nolte2 1 Nutrition, Peter MacCallum Cancer Centre, Melbourne, Australia, 2Cancer Strategy, Victorian Department of Health, Melbourne, Australia
MASCC-0492 Development of restore; an online intervention to support selfmanagement of cancer related fatigue (CRF)
Introduction: Malnutrition is an important supportive care need for people with cancer. The Patient Generated–Subjective Global
C. Foster1, L. Calman1, M. Breckons2, C. Grimmett1, D. Fenlon3, A. Richardson3, P. Smith4, L. Yardley5, J. Corner3
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Macmillan Survivorship Research Group, University of Southampton, Southampton, United Kingdom, 2Institute of Health & Society, University of Newcastle, Newcastle, United Kingdom, 3Faculty of Health Sciences, University of Southampton, Southampton, United Kingdom, 4 Southampton Statistical Sciences Research Institute, University of Southampton, Southampton, United Kingdom, 5School of Psychology, University of Southampton, Southampton, United Kingdom Introduction: In the UK around 2 million people are living with or beyond cancer, this number is rising by more than 3 % per year. Many survivors experience cancer related fatigue (CRF) following primary treatment. Cancer diagnosis and treatment can leave people feeling vulnerable and lacking in confidence. Selfmanagement can empower patients to act for themselves, increase confidence in their ability to manage problems and enhance quality of life. Objectives: To develop and user-test an online intervention as a form of self-management support to enhance self-efficacy to manage CRF following primary cancer treatment. Methods: Informed by the MRC guidance for developing and evaluating complex interventions, self-efficacy theory and Foster & Fenlon’s conceptual model of recovery following primary cancer treatment, the intervention was developed in partnership with survivors, clinicians and academic experts. It underwent two rounds of user testing with survivors. ‘Think aloud’ interviews were conducted as each session was developed. Secondly, the intervention and outcome measures were tested at home and telephone interviews conducted. Results: The intervention consists of five weekly sessions. Sessions one and two focus on information and goal setting and session three– five home life and work, managing thoughts and feelings and talking to others. Core components include goal setting and evaluation, patient stories, feedback, fatigue diary and assessment of self-efficacy to manage fatigue. User testing revealed the intervention was acceptable and outcome measures not burdensome. Conclusions: A theoretically driven intervention co-created with services users and acceptable to stakeholders has been developed. A randomised controlled feasibility trial is underway.
MASCC-0493 Oral care in the cancer setting: disseminating best practice—a national project B. Quinn1, M. Davies2, J. Horn3, E. Riley4, J. Treleaven 5, D. Houghton6, M. Thomson7, F. Campbell7, S. Hoy8, L. Fulman9, K. Mais2 1 Cancer, Ashford & St Peter’s NHS Foundation Trust, Surrey, United Kingdom, 2Cancer, Christie Hospital NHS Trust, Manchester, United Kingdom, 3Haematology, Aberdeen Royal Infirmary, Aberdeen, United Kingdom, 4Dentistry, Pennines Acute Trust, Manchester, United Kingdom, 5 Haematology, Royal Marsden NHS Foundation Trust, Sutton, United Kingdom, 6Pharmacy, Rivers Hospital, Hertfordshire, United Kingdom, 7 Radiotherapy, Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom, 8Cancer, Royal Marsden NHS Foundation Trust, London, United Kingdom, 9Radiotherapy, Nottingham Universtiy Hospitals NHS Trust, Nottingham, United Kingdom Introduction: It is widely recognised that oral problems including oral mucositis can be very distressing for the individual, making substantial demands on the person’s health and indeed health care resources. However, some of the distressing symptoms and health risks can be greatly reduced by the correct proactive care and treatment of oral problems. Objectives: The United Kingdom Oral Mucositis in Cancer Care Group (UKOMIC), a multi-professional group of oral care experts was set up 2 years ago to promote education and address the often
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under reported impact of oral problems in cancer care. Drawing upon their expertise and the most up to date evidence, the group developed guidance on the prevention and treatment of oral problems secondary to disease and treatments. Methods: A national educational programme was launched to disseminate best practice in oral care across the United Kingdom. Members of UKOMIC have spent the last year disseminating the guidance in a variety of clinical and non-clinical settings, using a variety of teaching modalities including, clinic based teaching, national study days and internet site resources including an on line module. Results: Through the education programme the group has engaged with practitioners and professional groups to advance this often neglected aspect of cancer care and the guidance is now being widely used in cancer centres across the United Kingdom to support and update clinical practice. Conclusions: The work of UKOMIC has also been recognised globally and members of the expert group are working with MASCC, the European Blood and Marrow Transplantation Group and other international organisations to develop best practice.
MASCC-0494 To survey the view of death and hospice education in Chinese cancer patients J. Rao1, Q. Fu1, M. Liu1, S. Yu1 Oncology Department, Tongji Hospital Tongji Medical College Hua Zhong University of Science and Tec, Wuhan, China 1
Introduction: In China, ‘living will’ has been a controversial topic. The condition of the patients’ view of death is unclear. We tried to discussed the possibility of implementation of living will by the questionnaire. Objectives: To study the view of death and hospice educational needs in Chinese cancer patients. Methods: The respondents included medical staff, patients and family dependents accepted a questionnaire survey. The questionnaire consisted of four sections. The first included the respondents’ background information such as sex, age, marital status, etc. In second section, we investigated whether the respondents were willing to talk about death topics. The third showed the views of death. The last was involved hospice educational needs. Results: A total of 289 (96.3 %) questionnaires were collected. 26.64 % of respondents (11.22 % of medical staff, 27.27 % of patients, 43.29 % of family dependents) were minded talking about deathrelated issues, half of them (54.55 %) could accept ‘living will’, but 19.48 % could not understand it. and most of them (70.13 %) at the problem of ‘the attitude of treatment of the dying person’ thought that aggressive treatment should be used. ‘The situation of talk’, ‘level of education’ and ‘age’ were correlated with minding to talk about deathrelated issues. Three groups who didn’t mind talking about death had major differences in the related opinions. Conclusions: The higher expectation for the hospice educational needs were showed in the medical staff and family members of patients, and patients and families dependents tended to aggressive treatment in end-stage, so ‘Living will’ has been remained to be further discussed.
MASCC-0495 Introduction of palliative care (pc) at nursing education of Tajikistan G. Samadova1, N. Abidjonova2 Family Nursing, Tajik Postgraduate Medical Institute, Dushanbe, Tajikistan, 2Public Health, OSI Tajikistan, Dushanbe, Tajikistan 1
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Introduction: In Tajikistan annually registered 3,000 new cases of cancer, including 60–70 % advanced and 75 % patients want to spend their last days at home Objectives: Introduction of palliative care in nursing education Methods: Needs assessment conducted in 2006 showed that education for nurses is important since about ¾ of the population live in rural areas and palliative care will be provided by nurses. Plan of action for implementation of curricula was made on postgraduate level. Results: Analysis and desk review of case plans showed lack of key issues, the distribution of those on courses and system. Knowledge of basics of Palliative Care of teachers was average 36 %, specialists from PHC level was 56 %, and oncology 68 %. Tajik Institute on postgraduate medical education in 2010 got grant from OSI Tajikistan for introduction PC curriculum for nurses. Prior to implementation of the module “Palliative Care” in the educational process, workshops were held for teachers of final year college/school (result of pre and post tests showed knowledge has grown to 85 % on average). Knowledge and skills graduate students passed the module significantly increased (average 75 %) Conclusions: Institunalisation of nursing education on post-graduate level with obligatory compulsory objective structured clinical examination will support efforts to make palliative care a sustainable, essential part of public health system and the country will be able to meet the standards of quality of life of patients and their families MASCC-0496 R1 and R2 for prophylaxis of acute radiation dermatitis: interim results of a randomized multicenter trial (CREAM-1) P. Naumann1, D. Krug1, J. Harsch1, T. Wiegel1, A. Hinke1, V. Tarcea1, M. Haefner1, B. Haas-Rassfeld1, P. Niehoff1, J. Debus1, K. Potthoff1 1 Radiation Oncology, University Hospital, Heidelberg, Germany Introduction: Acute radiation-induced dermatitis (ARD) is a common complication in patients with squamous cell cancer of the head and neck (SCCHN) treated by platin-based chemoradiation. Despite ongoing progress in supportive cancer care ARD remains a major adverse side effect with a severe impact on quality of life. Objectives: Due to convincing clinical experiences with the new lactokine containing topical treatment “R1 and R2” in a pilot case series for management of ARD we launched a multicenter, randomized trial with a recruitment goal of 132 patients in 29 centers to assess its safety and efficacy for prophylaxis of ARD Methods: Patients with SCCHN were randomized to either receive prophylactic topical “R1 and R2” or the standard skin care of the institution. All patients were treated by concomitant platin-based chemoradiation in curative intention. The primary objective was the amount of patients that experience an ARD grade 3 or 4 (NCI CTCAE v. 4.03). All patients were regularly evaluated and the irradiated skin was photographed and graded according to NCI CTCAE. Additionally, patients completed quality of life (QoL) questionnaires. Results: As of January 2013, 84 patients were evaluable for safety analysis. Application of R1 and R2 was well tolerated. No allergic reactions occurred and no grade 3 or 4 toxicities were seen. QoL was maintained in patients applying R1 and R2 Results of the interim analysis will be presented Conclusions: The application of “R1 and R2” is feasible, safe and effective in prophylaxis of ARD. Due to promising initial results active accrual will continue and be completed soon. MASCC-0497 Participative Management (PM): a dynamic looked for by the French onco-hematology teams S. Trager1, G. Nallet2, C. Bauchetet3, C. Préaubert4, V. Tual5, C. Blaizac6, P. Colombat7
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Oncology, Groupe Hospitalier Public du Sud de l’Oise, Soisy sous Montmorency, France, 2Oncology, Reseau Oncolie, Besançon, France, 3 Oncology, Retired Health manager, Paris, France, 4 Oncology, Clinique du Pont de Chaume, Montauban, France, 5Oncology, Hôpital Européen Georges Pompidou, Paris, France, 6Oncology, Hôpital Ste Musse, Toulon, France, 7Oncology, CHRU Bretonneau, Tours, France Introduction: Participative Management (PM) is a kind of organization of the departments based on the research of the quality of life at work. This dynamic concept gathers every professional in a common logic of recognition, respect, listening and partnership. It is based on four pillars: caregivers support, project approach, training, and multiprofessional meetings Objectives: To Evaluate the concept of PM in onco-hematology departments Methods: An anonymous internet questionnaire has been sent to one doctor, one health manager and one caregiver of numerous oncohematology departments Results: 144 professionals returned the questionnaire. 67 % of the respondents are aware of the concept of PM. 55 % of the caregivers consider that the organization of the departments is participative. Department’s projects are mainly elaborated by both health managers (86 %) and doctors (81 %) followed by nurses (49 %). Multi-professional meetings are present in 86 % of departments with mainly clinical meetings (88 %) and organization meetings (89 %). According to respondents, speech is sufficiently free (99 %) and taken into account (92 %). 63 % have multiprofessional training inside their department. Caregivers support is set up for 50 % of the respondents. 65 % of the respondents are interested in a PM training Conclusions: A participative dynamic is found in the French oncohematology department. This course towards the PM is still incomplete in particular for the supporting care professionals and their implication in the project of department. A strong demand in PM is noticed. It will allow the development of this global approach aiming at preventing suffering at work and caregivers burnout syndrome.
MASCC-0498 General health and wellbeing of colorectal cancer patients at diagnosis: characteristics of crew (colorectal wellbeing) cohort and baseline findings D. Fenlon1, K. Chivers Seymour2, A. Richardson3, P. Smith4, J. Corner3, J. Winter5, L. Calman2, C. Foster2 1 Faculty of Helath Sciences, University of Southampton, Southampton, United Kingdom, 2Macmillan Survivorship Research Group, University of Southampton, Southampton, United Kingdom, 3Faculty of Health Sciences, University of Southampton, Southampton, United Kingdom, 4 Southampton Statistical Sciences Research Institute, University of Southampton, Southampton, United Kingdom, 5Southampton Colorectal Unit, Southampton General Hospital, Southampton, United Kingdom Introduction: Studies suggest most people return to near pre-diagnosis status following surgery for colorectal cancer (CRC). However research has been small scale or narrowly focused. There is a need for a large, longitudinal study exploring the impact of cancer and treatment on everyday life and how this affects recovery Objectives: CREW is a prospective cohort study established to explore patterns of recovery of health and wellbeing following CRC and what influences this, including: who is at risk of poor/protracted recovery; health service use; and confidence to self-manage. Methods: Participants were recruited prior to surgery from 30 centres throughout Great Britain. Measures have been completed at baseline, 3 and 9 months and longer term assessments are underway.
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Results: Of 1,350 eligible patients 1,055 consented and 911 agreed to complete questionnaires. Demographics 59.2 % men; 71.3 % married/cohabiting; 93.5 % White British; 68.0 % retired; and 3.3 % sick leave. The age range is 32–95 (median 68). Participants reported mean Personal Wellbeing Index total scores of 77.4 (SD 15.9) compared to normative range of 70–80 in Western populations. The Centre for Epidemiologic Studies Depression Scale mean score was 13.2 (SD 8.9). 33.8 % of the sample met a threshold for depressive symptoms (CES-D≥16); compared to 20 % in the general population Conclusions: CREW participants’ baseline scores for PWI are similar to normative scores. This may reflect that this is prior to surgery or cancer treatment. It is less surprising that we detected a high level of depression at this time. We expect a reduction in personal wellbeing scores after treatment has started.
MASCC-0499 Patient health records for supportive care in cancer N. Shklovskiy-Kordi1, B.V. Zingerman1 1 Hematology, National Center for Hematology, Moscow, Russia Introduction: Supportive Care can be effectively realized only in contest of the medical history of the patient. Medical records—the key question of the integrity of Medicine. Doctor has to record the results of his research and reflections—it is the fundament of the continuity and development in Medicine. No one but the patient can collect ALL the records relating to his health. Objectives: Electron Medical Records and Patient Health Records in particular, becoming widely accepted method of patient care, have to be efficient instrument of interdisciplinary cooperation in medicine and tracing of drugs and other agents of influence interaction Methods: System of electronic health records, constructed to be patientdriven (patient takes responsibility for the collection, storing, and policies of use of his personal medical records) and comfortable for doctor Results Results: Based on our experience in creating the National Standard of Electron Medical Records, developed the Internet-based System for Patient Health Records. The System accepts records in any format. The main features are: 1. ensuring the origin and credibility of records. 2. Integral representation of all data (particular, presentation on a single time axis allows estimation of the real-time correlations of dynamic changes in clinical parameters). This approach is the way to take into account number of curative and supportive interventions addressed to oncology patient in modern medicine. Fig.1. Conclusions: The system of electron medical records permits to track interaction between multiple agents of action, facilitating development of the Integrative Image of Disease. References: N. Shklovskiy-Kordi, B. Zingerman, «EHR for Blood Count Analysis and Clinical Trials», Platelets 2010, ?.134
MASCC-0500 Rational use of aprepitant based on the individual chemotherapy regimen among highly emetic risk category H. Fujii1, H. Iihara1, M. Nishigaki1, A. Suzuki1, M. Ishihara1, Y. Itoh1 1 Parmacy, Gifu University Hospital, Gifu-shi, Japan Introduction: Several clinical practice guidelines recommend the use of antiemetics based on the emetic risk of chemotherapy. However, the emetogenicity appears to considerably vary even among the same emetic risk category
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Objectives: For prevention of chemotherapy-induced nausea and vomiting (CINV) associated with high-emetic chemotherapy (HEC), 5-HT3 antagonist, aprepitant and dexamethasone is used in combination before chemotherapy, aprepitant and dexamethasone on the subsequent 3 days. Moreover, several risks for CINV, including age and gender, should be considered for prevention of CINV Methods: The rate of complete response (no emesis without rescue treatment) was examined among 5 single-treatment HEC (GEM/CDDP for bladder cancer,R-CHOP for non-Hodgkin lymphoma, EPI/CPA for breast cancer,PEM or VNR/CDDP for lung cancer, and ABVd for Hodgkin lymphoma) and 2 repeated-treatment HEC (5-FU/CDDP for head-and-neck cancer and BEP for germ cell cancer), before the introduction of aprepitant. Subsequently, the effect of aprepitant was evaluated in EPI/CPA and 5-FU/CDDP regimens Results: Based on the rates of complete response during overall period obtained in the absence of aprepitant, which varied ranging from 8 % (ABVd) to 74 % (R-CHOP), we considered that aprepitant should be included as the standard antiemetic therapy in HEC regimens except for R-CHOP and GEM/CDDP. We also found that the emetic control was greatly improved, when aprepitant was administered for 5 but not 3 days in repeated treatment regimens Conclusions: These findings suggest that appropriate antiemetic medication should be determined based on the individual chemotherapy regimen even among the same emetic risk category.
MASCC-0501 Epidemiology, resistance profile and origin of bacteremia in non-neutropenic patients with solid tumor M. Merad1, E. Chachaty2, A. Alibay1, B. Gachot3, M. Di Palma1, S. Antoun1 1 Ambulatory Department, Gustave Roussy Institute, Villejuif, France, 2 Microbiology, Gustave Roussy Institute, Villejuif, France, 3Infectious Diseases department, Gustave Roussy Institute, Villejuif, France Introduction: In oncology, and especially for solid tumors, the principal studies describe bacteriema in patients with neutropenia, Few microbiological data are available without neutropenia. Furthermore, bacteria resistance in immucompromised patients is increasingly reported Objectives: The aim of this study is to describe the bacteremia occurring in solid tumors and to identify a potential association with other sites of infection Methods: This retrospective study was conducted in patients visiting an emergency oncology department for acute onset symptoms. Urinary, skin and/or sputum samples were analyzed according to clinical symptoms. Central venous catheter infection (CVC) was defined with the differential time to positivity between hub-blood and peripheral-blood cultures Results: We reported 290 bacteremia, Gram-positive represented 58 %: coagulase-negative staphylococci (CNS) (n=105), Staphylococcus aureus (SA) (n=38) (one methicillin-resistant), Streptococcus sp (n=36). The majority of gram-negative were Enterobacteria (E) (n=97) and most of them were E coli (n=62). Only 2 (E coli) developed extended spectrum beta-lactamases resistance. Two ore more microorganisms were found in 41 bacteremia. When CNS, SA and Candida sp. were isolated it was most often related to CVC, and, 25/98 of E bacteremia were also attributed to a catheter infection. It is important to highlight that all the bacteremia were associated with another site of infection Conclusions: In patients with solid tumors without the context of neutropenia, all the bacteremias are associated with documented sites of infection. Bacteria resistance is the exception (1 %), 58 % of the bacteremia are Gram-positive microorganisms and catheter infection could be with Enterobacteria microorganisms.
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MASCC-0502 Development of a multidisciplinary platform for the screening of new preventive and therapeutic drugs against mucositis B. Vanhoecke1, J. Bowen2, T. Deryck1, T. Van de Wiele1, D. Keefe2 1 Department of Biochemical and Microbial Technology, Ghent University, Ghent, Belgium, 2Mucositis Research Group, The University of Adelaide, Adelaide, Australia Introduction: Both from ECVAM and worldwide, there is a general call for the reduction, refinement or replacement of the use of laboratory animals. However, while in vivo animal models of chemotherapy and radiotherapy-induced mucositis have been successfully established, alternative Methods such as in vitro tools for mucositis are still missing. These are urgently required to allow a rapid and highthroughput screening of new-generation anti-mucositis candidate molecules Objectives: The aims of the platform are: 1. Generation of innovative high-throughput in vitro models of mucositis; 2. In vivo validation of the in vitro models using established animal models of chemo/radiotherapy-induced mucositis; 3. Exploration of the in vitro and in vivo tools to identify new biomarkers, risk factors and new drugs Methods: The generation of in vitro mucositis models will be based on our recently developed full mucosa model that allows long-term coculturing of oral biofilms and the underlying mucosa (Ghent University). Proof-of-concept will be achieved by validating these in vitro models in vivo by means of well-established rat mucositis models (The University of Adelaide). Correlation between in vitro and in vivo endpoints will be estimated. Results: Conclusions: The in vitro and in vivo tools provided by the platform will enable a rapid identification and validation of new biomarkers, risk factors and potential anti-mucositis drugs. Further, the platform generates an opportunity to achieve a substantial reduction of animal experiments in mucositis assessments. -
MASCC-0503 Chronic fatigue development in men treated with localized radiation therapy for prostate cancer M. Araneta1, N.L. Lukkahatai1, L.S. Saligan1 1 Nursing Research, National Institutes of Health, Bethesda MD, USA Introduction: Fatigue develops in 80 % of patients during external beam radiation therapy (EBRT). No study reports the association between fatigue development during EBRT and persistent fatigue post treatment. Objectives: To describe acute and chronic fatigue levels of men treated with EBRT for prostate cancer. To determine the strength of association between the development of chronic fatigue post EBRT from subjects with acute fatigue during EBRT. Methods: Fatigue was measured in 37 men with prostate cancer, by the Functional Assessment of Chronic Illness-Fatigue (FACIT-F, low score = high fatigue) at baseline, midpoint (day21), completion (day42), and 1 year-post EBRT. Subjects were categorized into high (HF) and low fatigue (LF) groups based on a 3-point change in FACIT-F score from baseline to either day21 or day42 of EBRT. Descriptive statistics using ttests compared the groups and odds-ratio predicted incidence of chronic fatigue. Results: FACIT-F scores significantly decreased from baseline (mean=44.9±7.0) to day21 (mean=34.9+9.0, p<.01) and day42
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of EBRT (mean=35.6+9.0, p<.01) in HF subjects (n=22, mean age=65.8+7.1), while no significant change in FACIT-F scores was noted in LF subjects (n=15, mean age =63.2±7.5). Sixteen HF men (73 %) developed high fatigue 1 year post EBRT (mean FACIT-F=38.7±10.9). HF men are 20.8 times (SE=.92, p<.001) more likely to develop high fatigue 1 year post treatment than LF men. Conclusions: Development of high fatigue during EBRT significantly increases the risk of chronic fatigue development post treatment. Early assessment and management of fatigue during EBRT may prevent development of chronic fatigue.
MASCC-0504 The epidemiology of long-term and short-term survivors in a population based cohort of cancer patients L. Jarlbaek1, L. Christensen2, E. Bruera3, D.G. Hansen4 1 Danish Knowledge Centre for Palliative Care (PAVI), The Danish National Institute of Public Health (NIPH), Copenhagen, Denmark, 2Department of Oncology, Odense University Hospital, Odense, Denmark, 3Department of Palliative Care and Rehabilitation Medicine, M.D. Anderson Cancer Center, Houston, USA, 4 National Research Centre for Cancer Rehabilitation Research Unit of General Practice, Institute of Public Health University of Southern Denmark, Odense, Denmark Introduction: In order to plan rehabilitation and palliative care, it is important for the health care system to rely on estimates based on the epidemiology of the cancer population. Objectives: To characterise the epidemiology of long-term and shortterm survivors in a population based cohort of incident cancer patients. Methods: All cancer patients, diagnosed in 1993–2003 from a 470.000 large population were identified using registry linkage, and followed individually from diagnosis to death or until 31 December 2008. Longterm survivors were patients, who lived beyond 5 years after the time of the cancer diagnosis (TOCD), and short-term survivors were those, who died less than 5 years after TOCD. Results: Of 24,162 incident cancer patients, 41 % became long-term survivors (N=9,813). Short-term survivors’ (N=14,349) median survival was 0.6 years, and 78 % died less than 2 years after TOCD. The median age at TOCD was 60 years for long-term and 72 years for short-term survivors, and 80 % of short-term survivors were 60+. Females comprised 64 % of long-term, and 46 % of short-term survivors. The proportion of breast and lung cancers differed between the groups: Long-term survivors: 31 % breast cancer, 2.4 % lung cancer. Short-term survivors: 21 % lung cancer, 7.2 % breast cancer. Conclusions: Long-term and short-term survivors differed with regard to age at TOCD, cancer types and sex. 2-years crude cancer survival could seem as a clinically relevant cut point for estimating ‘denominator-populations’ for rehabilitation or palliative care. Knowledge of the epidemiology of the two groups could help to target the programs of care to the participants.
MASCC-0505 Skeletal muscle radiation attenuation predicts prognosis in metastatic renal cell carcinoma treated by target therapies S. Antoun1, E. Lanoy2, R. Iacovelli3, L. Albiges4, Y. Loriot4, M. Merad-Taoufik5, K. Fizazi4, M. DiPalma5, V.E. Baracos6 1 Ambulatory care, Institute Gustave Roussy, Villejuif, France, 2 Biostatic and Epidemiology, Institute Gustave Roussy, Villejuif, France, 3Oncology and Human Pathology, Sapienza University, Rome, Italy, 4Cancer Medicine, Institut Gustave Roussy, Villejuif,
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France, 5Ambulatory Care, Institut Gustave Roussy, Villejuif, France, 6Oncology, University Alberta, Edmonton, Canada Introduction: Previous studies have shown that body components i.e. skeletal muscle (SM) and adipose tissue (AT) are linked to overall survival (OS) and progression free survival (PFS) Objectives: The aim of our study was to analyze whether SM and AT have a prognostic role in metastatic renal cell carcinoma (mRCC). Methods: We investigated body mass index (BMI), SM and AT in mRCC patients. Analysis of CT images was used to evaluate crosssectional areas of SM, AT, and mean Hounsfield units (HU). High level of mean HU reflects high quality of SM. Population was divided in: patients with values <= or > median observed in patients of the same gender. OS and PFS were estimated using Kaplan-Meier method and compared with the log-rank test. Multivariable Cox proportional hazards model were adjusted for modified MSKCC risk group and treatment Results: In the 149 patients (113 men), the median OS was 21.4 (95%CI: 18.4–23.9) months and was strongly associated with attenuation of SM: the median OS in patients with low mean HU (14 months) was half that in patients with high mean HU (29 months, p=.0011). After adjustment for MSKCC score and for treatment, high mean HU was associated with longer OS (HR =1.85, 95%CI=[1.22;2.82], p=.004) and longer PFS (HR=1.81, 95%CI=[1.22;2.65], p=.002) Conclusions: High muscle quality as measured by high mean HU is independently associated with improved OS and PFS in mRCC. None of the other parameters: SM, AT or BMI was associated with OS or PFS
MASCC-0506 The role of humour during nurse–patient interactions on an adult cancer ward: an ethnographic study
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MASCC-0507 The situation of oral care in Tohoku University Hospital after national health insurance coverage to oral management T. Tamahara1, R. Hosokawa1, E. Yoshida1, N. Tanda2, E. Ito1, T. Koseki1 1 Graduate School of Dentistry, Tohoku University, Sendai, Japan, 2 Preventive Dentistry, Tohoku University Hospital, Sendai, Japan Introduction: Oral management including oral care and oral hygiene is efficient to prevent side effects such as oral mucositis during chemotherapy and radiotherapy (CRT). Japanese national health insurance has covered oral management during CRT since April 2012 Objectives: In this report, we report the change of situation in dental management due to national health insurance coverage. And we also report the effect of kanpomedicine, which is a kind of oriental herb in Japan, to the patient who suffering from mucositis. Methods: We analysis medical record of patients who were in ward of Tohoku University hospital and visited our department dental office at 2011 and 2012, such as 1) medial diagnosis 2) treatment plan, 3) side effect related to oral region. And we apply kanpomedicine, Hangeshashinto (TJ-14) to the patients suffering from mucositis due to radiotherapy in head and neck region. Results: The number of cancer patients visiting our office was increasing (154 at 2011 and 278 at 2012). Of 278 patients at 2012, 96 was head and neck cancer patients. The patients who had radiotherapy in head region were suffering from oral mucositis, grade 2 or grade 3. Furthermore, there were no patients belonged to grade 3 in the patients group who took Hangeshashinto (TJ-14) Conclusions: Our date reveal that national health insurance support cancer patients to visit dental office for oral care. And Hangeshashinto (TJ-14) may inhibit oral mucocitis during radiotherapy in head region.
M. Tanay1, J. Roberts1 1 School of Nursing, King’s College London, London, United Kingdom Introduction: The literature highlights the multi-dimensional value of humour on a person’s well-being. The diagnosis of cancer is extremely stressful and treatments are difficult. Patients and nurses may use humour as a coping mechanism to contend with the stresses caused directly or indirectly by cancer. Objectives: The study investigated the nature of humour which took place during interactions between patients and nurses in an adult cancer ward. It explored ways of how patients and nurses use humour as a coping strategy. Methods: This study used an ethnographic methodology that included fieldwork participant observations (30 h), patient interviews (n=5) and nurse interviews (n=5). Data were analysed using thematic content analysis. Results: Results highlighted the importance of humour in nurse–patient interactions. Patients and nurses use humour to reduce tension and stress, to manage negative emotions and to help manage grief. Patients perceive having a sense of humour as a positive attribute for a nurse. Nurses expressed concerns regarding compromising professionalism when using humour and felt the need for guidance from senior staff. Patients consciously use humour during nurse–patient interactions as an attempt to help nurses cope with the stress they encounter in clinical practice. Conclusions: The benefits of humour are recognised by both cancer patients and nurses. A deeper understanding of patient and nurse perceptions of the use of humour, can inform strategies for its therapeutic use in the clinical setting. References: Olsson H, Backe H, Sorensen S, Kock M (2002) The essence of humour and its effects and functions: a qualitative study. Journal of Nursing Management 10: 21–26.
MASCC-0508 Analysis of hydrogen sulfide, methyl mercaptan, and acetaldehyde in oral health care for perioperative patients of lung cancer N. Tanda1, N. Ishida2, Y. Hoshikawa3, T. Sato2, N. Takahashi2, R. Hosokawa4, T. Koseki4 1 Division of Preventive Dentistry, Tohoku University Hospital, Sendai, Japan, 2Division of Oral Ecology and Biochemistry, Tohoku University Graduate School of Dentistry, Sendai, Japan, 3Department of Thoracic Surgery, Institute of Development Aging and Cancer Tohoku University, Sendai, Japan, 4Division of Preventive Dentistry, Tohoku University Graduate School of Dentistry, Sendai, Japan Introduction: Importance of oral health care (OHC) for hospitalized patients is widely known. One of the questions to be answered is how oral environment is influenced by the OHC. Objectives: To analyze the effect of OHC on gases and oral bacteria of perioperative patients of lung cancer. Methods: Seven hospitalized patients of lung cancer (4 men, 3 women, mean age 73.4 years) agreed with the research. Hydrogen sulfide, methyl mercaptan, and acetaldehyde in breath and in mouth air of the patients were measured by portable gas chromatographs before breakfast on T1 (before OHC), T2 (after OHC but before lung operation), and T3 (1 week after lung operation) in Tohoku University Hospital. Saliva was collected by chewing a paraffin pellet and analyzed for oral bacteria by selective Mitis Salivarius (MS) and non-selective CDC blood agar (CDC) under anaerobic and aerobic conditions. The ratio of colony-forming units on the MS to those on the CDC was calculated.
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Results: Hydrogen sulfide, methyl mercaptan, and acetaldehyde were observed only in mouth air. Acetaldehyde was observed in 6 patients on T1 and disappeared in 5 patients on T2. Hydrogen sulfide was observed in 5 patients on T1 and decreased in 4 patients on T2. Methyl mercaptan was observed in 4 patients on T1 and disappeared on T2. The ratio of MS/CDC was highest on T2 in 6 patients. Conclusions: The OHC for perioperative patients of lung cancer decreased odorous gasses in mouth air and increased the ratio of salivary streptococci, usually known as healthy-associated bacteria.
MASCC-0509 Early palliative care for patients with metastatic non-small-cell lung cancer in Khyber Pakhtunkhwa S. Salman1, J. Idrees2, M. Idrees3, M. Anees4, F. Idrees4, A.A. Khattak5 1 Department of Pharmacy, University of Peshawar, Peshawar, Pakistan, 2Department of Zoology, Islamia College University Peshawar, Peshawar, Pakistan, 3Department of Chemistry, Islamia College University Peshawar, Peshawar, Pakistan, 4Khyber Medical College, Khyber Medical Institute, Peshawar, Pakistan, 5Pediatric Unit, Lady Reading Hospital Post Graduate Medical Institute, Peshawar, Pakistan Introduction: Patients with metastatic non-small-cell lung cancer have a considerable symptomatic burden and undergo substantial generalized anxiety and depression Objectives: The primary objective was to assess the change in the quality of life and mood at baseline till 12th week. Methods: Quality of life and mood were assessed at baseline and at 12 weeks with the use of the Functional Assessment of Cancer Therapy–Lung (FACT-L) scale and the Hamilton Anxiety and Depression scale were used respectively Results: Of the 163 patients who underwent randomization assigned to early palliative care had a better quality of life than did patients assigned to standard care (mean score on the FACT-L scale 88.0 vs. 83.5; P=0.04). Fewer patients in the palliative care group than in the standard care group had depressive symptoms (26 % vs. 47 %, P=0.02) Conclusions: Early palliative care provided to metastatic non-smallcell lung cancer led to significant improvements in both quality of life, adherence, compliance and mood as compared to those patients who received standard care References 1. Anthony J A, Jean G F and Jonathan M S. Epidemiology of lung cancer: ACCP Evidence- based clinical practice guidelines. Chest 2007; 4: 29–55 2. Follwell M, Burman D, Le LW, et al. Phase II study of an outpatient palliative care intervention in patients with metastatic cancer. J Clin Oncol 2009;27:206–13. 3. Zimmermann C, Riechelmann R, Krzyzanowska M, Rodin G, Tannock I. Effectiveness of specialized palliative care: a systematic review. JAMA 2008;299: 1698–709.
MASCC-0510 Are there differences in the therapeutic effects of complex decongestive therapy on edema, quality of life and level of satisfaction between upper- and lower-extremity lymphedema? S. Noh1, T. Yoon1, J. Hwang1, J. Kim1, M. Ahn1, H. Chang1, I. Chu1 1 Department of Physical and Rehabilitation Medicine, Samsung Medical Center Sungkyunkwan University School of Medicine, Seoul, Korea
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Introduction: There is increasing interest in the quality of life (QOL) of patients with lymphedema. Nonetheless, few studies have specifically compared the physical and psychological impacts of complex decongestive physical therapy (CDPT) between upper-extremity lymphedema (UL) patients and those with lower-extremity lymphedema (LL). Objectives: To compare UL and LL patients for the therapeutic effects of CDPT on edema, QOL, and level of satisfaction. Methods: One hundred and twenty-one (121) patients with mild to moderate chronic secondary UL (n=53) or LL (n=68) undergoing treatment at a physical medicine and rehabilitation outpatient clinic of a university hospital were enrolled in the study. Treatment involved ten sessions of manual lymph drainage, low-stretch bandage, elastic sleeve, and sequential pneumatic pump 90 min per day, 5 days per week, for 2 weeks. The percentage excess volume (PCEV), the Korean version of the Short Form 36-Item (SF-36) Health Survey, the DASH (Disabilities of arm, shoulder & hand) score, and a self-developed satisfaction survey were assessed at baseline, 2 weeks, and 3 months after CDPT. Results: For the LL patients relative to those with UL, there was a statistically significant improvement in physical functioning and mental health of the Korean version of the SF-36 Health Survey, a degree of improvement of the self-developed satisfaction survey results, as well as a greater PCEV reduction, after CDPT. Conclusions: The results of this study suggest that PCEV reduction, QOL, and level of satisfaction after CDPT differ between UL and LL; therefore, each condition demands specific management and patient consultation approaches.
MASCC-0511 The prevalence of opioid-related adverse events in cancer pain: analysis of discrepancy between investigator and patient-reported prevalence—this study was funded by Mundipharma Korea Ltd S.J. Koh1, Y.S. Hong2, S.W. Shin3, S.Y. Kim4, H.S. Song5, H.Y. Kim6, H.J. Kim6, J.H. Kwon7, K.H. Lee8, D.S. Hong9, Y.J. Choi10, S.J. Sym11, M.Y. Choi12, J.S. Jang13, S.N. Lee14, E.M. Lee15, I.S. Woo16, S.Y. Kim17, H.S. Oh18, J.I. Lee19, Y.J. Yuh20, H.M. Ryoo21, E.K. Song22, K.T. Lee23, J.B. Ahn24, D.R. Choi25, S.Y. Oh26, I.J. Chung27, B.W. Kang28, S.J. Gong29, H.J. Jung30, N. Bahadur31 1 Hematology-Oncology, University of Ulsan College of Medicine Ulsan University Hospital, Ulsan, Korea, 2Oncology, Seoul St. Mary’s Hospital, Seoul, Korea, 3Hematology-Oncology, Korea University Anam Hospital, Seoul, Korea, 4Hematology-Oncology, Chungnam National University Hospital, Daejeon, Korea, 5Hematology-Oncology, Keimyung University Dongsan Medical Center, Daegu, Korea, 6 Hematology-Oncology, Hallym University Sacred Heart Hospital, Anyang, Korea, 7Hematology-Oncology, Kangdong Sacred Heart Hospital, Seoul, Korea, 8Hematology-Oncology, Yeungnam University Medic al Center, D aegu, Korea, 9 Hematology -Oncology, Soonchunhyang University Bucheon Hospital, Bucheon, Korea, 10Hematology-Oncology, Busan National University Hospital, Busan, Korea, 11 Hematology-Oncology, Gachon University Gil Hosptial, Incheon, Korea, 12Hematology-Oncology, Inje University Busan Paik Hospital, Busan, Korea, 13Hematology-Oncology, Chung-Ang University Hospital, Seoul, Korea, 14Hematology-Oncology, Ewha Womans University School of Medicine, Seoul, Korea, 15Hematology-Oncology, Kosin University Gospel Hospital, Busan, Korea, 16HematologyOncology, Yeouido St. Mary’s Hospital, Seoul, Korea, 17HematologyOncology, KyungHee University Medical Center, Seoul, Korea, 18Hematology-Oncology, GangNeung Asan Hospital, GangNeung, Korea,
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Hematology-Oncology, Wonju Christian Hospital, Wonju, Korea, Hematology-Oncology, Inje University Sanggye-Paik Hospital, Seoul, Korea, 21Hematology-Oncology, Daegu Catholic University Medical Center, Daegu, Korea, 22Internal Medicine, Chonbuk National University Medical School, Jeonju, Korea, 23Hematology-Oncology, Sooncheonhyang University Cheonan Hospital, Cheonan, Korea, 24 Oncology, Yonsei University Severance Hospital, Seoul, Korea, 25 Internal Medicine, Chuncheon Sacred Heart Hospital, Chuncheon, Korea, 26Internal Medicine, Seoul Medical Center, Seoul, Korea, 27Hematology-Oncology, Chonnam National University Hwasun Hospital, Hwasun, Korea, 28Hematology-Oncology, Kyungpook National University Medical Center, Daegu, Korea, 29Hematology-Oncology, Eulji 20
Results: Of the 2,395 patients recruited, the most common opioidrelated AEs as reported by investigators were constipation (29.7 %), dry mouth (17.2 %), and somnolence (14.7 %). Patients, however, reported common AEs as dry mouth (61.1 %), asthenia (52.2 %), somnolence (49.4 %) and constipation (49.2 %). In addition to the difference in prevalence rates, results indicated a wide discrepancy in reporting of AEs between patients and investigators. Rates of patient-reported AEs which were not reported at all by investigators were as follows: dry mouth 1,054 (44 %), asthenia 1,040(43 %), somnolence 831(35 %), and constipation 489(20.4 %). On the contrary, the differences in rates of AEs reported by investigators and not reported by patients were extremely small. (Figure 1) Conclusions: The study demonstrates the magnitude of discrepancy in reporting opioid-related adverse events between physicians and patients which highlights the importance of patient-reported outcomes. There is a need for improved assessment of patients’ AEs, not only to
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Medical Center, Seoul, Korea, Mundipharma,, Singapore
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Mundipharma, Seoul, Korea,
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Introduction: Although opioid therapy has been the mainstay of treatment for cancer pain, the prevalence of opioid-related adverse events (AEs) has not been reported in Korea. Objectives: The study aimed to investigate the prevalence of opioidrelated AEs amongst cancer pain patients and compare the difference in AEs reported by investigators and patients. Methods: A cross-sectional analysis of patients’ charts and questionnaires from 30 teaching hospitals was performed. Clinical characteristics and prevalence for AEs were assessed.
actively manage AEs, but also to improve patients’ pain and quality of life pertinent to cancer pain.
MASCC-0512 Embracing life after prostate cancer. a male perspective of treatment and rehabilitation K.B. Dieperink1, L. Wagner2, S. Hansen1, O. Hansen1 1 Department of Oncology, University Hospital Odense, Odense, Denmark 2 Research Unit of Nursing, University of Southern Denmark, Odense, Denmark Introduction: Rehabilitation after cancer treatment has been in focus recent years, but the majority of studies have evaluated rehabilitation in breast cancer patients.
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Objectives: The aim of this qualitative study was to examine experiences of disease and rehabilitation in men treated for prostate cancer with radiotherapy and androgen deprivation therapy. The study explored the male perspective of rehabilitation and the men’s approach to spousal involvement. Methods: Two focus group interviews were conducted with patients aged 66–77 years. All had completed a rehabilitation programme with individual nursing and physiotherapist counselling. One focus group included men (n=6) who involved their spouses in the rehabilitation, and one focus group included men (n=7) who came alone. Meaning condensation inspired by Giorgi was used as analysis. Results: To be treated with radiotherapy was like having a fulltime work, but the worst adverse effects were due to the androgen deprivation therapy influencing masculinity and identity. The men were grateful, and embraced life with a particular sense of humour. Whether the rehabilitation programme was supportive depended on: the professional’s approach, the patient motivation and effort to contribute to health promotion, and how experiences were converted into coping strategies. The supportive role of the spouse was emphasized, but some men preferred to handle the process alone. Conclusions: Attention must be drawn to the information presented about adverse effects of androgen deprivation therapy since it severely influenced everyday life. Rehabilitation was a mutual challenge of patient and professionals. Spousal involvement reflected the relationship the couple had beforehand.
MASCC-0513 Risk and benefit of pregabalin for the treatment of chemotherapyinduced peripheral neuropathy H. Iihara1, C. Yoshimi1, M. Yamada1, H. Fujii1, M. Nishigaki1, M. Ishihara1, M. Takahashi2, S. Kurahashi2, T. Takahashi3, K. Yoshida3, Y. Itoh1 1 Pharmacy, Gifu University Hospital, Gifu-shi, Japan, 2Nursing, Gifu University Hospital, Gifu-shi, Japan, 3Surgical Oncology, Gifu University Hospital, Gifu-shi, Japan Introduction: Chemotherapy-induced peripheral neuropathy (CIPN) is the dose-limiting toxicity of cancer treatment. Objectives The aim of the present study was to assess safety and efficacy of pregabalin for treatment of CIPN, and to determine the optimal dosage and administration. Methods: We reviewed retrospectively the medical records of patients treated with pregabalin for CIPN between October 1, 2010 and August 31, 2011 at the outpatient cancer chemotherapy clinic in Gifu University Hospital. The incidence and severity of CINP were compared before introduction of pregabalin and 4 weeks after attainment of the maintenance dose. The symptom severity was assessed as the grade according to the CTCAE v4.0 and as the patients reported Numeric Rating Scale (NRS). The incidence of ADRs associated with pregabalin, including dizziness, edema limbs and headache, was checked from the medical record. Results: Thirty-two patients were studied. The incidence of grade≥2 CIPN was significantly (P<0.01) reduced from 59 % to 22 % after pregabalin administration. The average of NRS also decreased significantly (P<0.01) from 5.5 to 3.6. For initial dose (150 mg/day and <150 mg/day), the effect at 150 mg/day was superior to that at lower doses (grade ≥2 symptom: 53 % versus 23 %). For maintenance dose (≥200 mg/day, 150–199 mg/day and <150 mg/day), the therapeutic effect was dose-dependent (grade≥ 2 symptom: 83 %, 59 %, and 29 %). However, the incidence of ADRs associated with pregabalin was not different among initial and maintenance doses.
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Conclusions: Our findings suggest that sufficient initial and maintenance doses of pregabalin are required from the view point of safety and efficacy.
MASCC-0514 Morphine metabolites ability to inhibit lymphocytes proliferation M. Chojnicki 1 , B. Poniedzialek 1 , P. Rzymski 1 , A. KotlinskaLemieszek2, W. Leppert2, K. Wiktorowicz1 1 Department of Biology and Environmental Protection, Poznan University of Medical Sciences, Poznan, Poland, 2Department of Paliative Medicine, Poznan University of Medical Sciences, Poznan, Poland Introduction: Morphine is the most commonly used opioid medication to relieve moderate to severe acute and chronic pain in patients of all ages. Both active metabolites of morphine, morphine 6βglucoronide (M6G) and morphine 3β-glucoronide (M3G), play a role in pain relief and probably also in the side-effects of morphine. Objectives: The following study was undertaken in order to determine whether morphine or its metabolites can be responsible for potential immunosuppresion in patients selected for pain treatment. Methods: We investigated different concentrations (10–1,000 ng/ml) of morphine, M3G and M6G upon the proliferation of human peripheral blood lymphocytes in vitro Results: We have demonstrated that moprhine metabolites can inhibit lymphocytes proliferation. Conclusions: It would therefore appear to be good practice to avoidsuch agents in patients already immunosuppressed by disease orpharmacotherapy. P ower ful opioi d a nal ges ics wit hout immunosuppressiveproperties can be selected and should be used in such situations and asthese agents can offer additional benefits in addition to theirnon-immunosuppresive analgesia, it should be considered whether to usethem at all times in preference to immunosuppressive opioids.
MASCC-0515 A modified exercise protocol may promote continuance of exercise after the intervention in lung cancer patients—a pragmatic uncontrolled trial A. Andersen1, A. Vinther1, L.L. Poulsen2, M. A2 1 Department O, Copenhagen University Hospital, Herlev, Denmark, 2 Department R, Copenhagen University Hospital, Herlev, Denmark Introduction: A previous study investigated the effects of a welldocumented COPD exercise protocol in lung cancer patients. The study showed improvements in physical fitness, but poor adherence to continued exercise after intervention Objectives: The aim of the present study was to investigate the effect of an exercise intervention on post intervention adherence, and physical fitness in lung cancer patients Methods: Fifty-nine patients enrolled in a 9-week exercise program. Eligibility criteria were limited to presence of motivation, and absence of comorbidities that could jeopardize safety. The intervention included 3 times 3 weeks of exercise (3 weeks supervised, 3 weeks home-based and 3 weeks supervised). VO2 max was estimated at baseline, and at the end of intervention. Self-reported quality of life was recorded before and after the exercis program. Post-intervention exercise activity was assessed by telephone interviews 4 weeks after intervention Results: Fifty-one patients initiated the exercise intervention and 29 patients successfully completed the exercise program. Twenty-six of the 29 were available for follow-up with respect to continuance of physical activity. Among the 26 who completed the 9 week training program, 18
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(69 %) continued to be physically active on a daily basis. No change in estimated VO2-max was observed (N=25). A trend towards increased quality of life and better symptom control was noted Conclusions: The present study showed an increased level of continuance of physical activity compared to the previous study. The present study could not repeat the improvements in estimated VO2-max from the previous study.
MASCC-0516 A validated questionnaire on end-of-life concerns and preferences of Filipino women with advanced or recurrent gynecologic cancer in a government tertiary hospital J. Toral1, N. Castillo-Carandang2, L. Amarillo2, A. Habana2, E. Domingo3, A. Bausa4 1 Section of Gynecologic Oncology Department of OB-GYN, University of the Philippines-Philippine General Hospital, Caloocan City, Philippines, 2Department of Clinical Epidemiology, University of the Philippines, Manila, Philippines, 3Section of Gynecologic Oncology Department of OB-GYN, University of the Philippines-Philippine General Hospital, Manila, Philippines, 4Department of Family Medicine, University of the Philippines-Philippine General Hospital, Manila, Philippines Introduction: Gynecologic cancers are important causes of mortality among Filipino women. Knowing their concerns and preferences will enable the health provider to give holistic care to them. Objectives: To develop a valid and reliable questionnaire on the above construct Methods: A study was conducted among women ages 18–60; with advanced stage/recurrent disease; able to read and understand Tagalog; good performance status; no altered state of consciousness; asymptomatic; with informed consent; with oncological disclosure from their physicians. The qualitative phase involved case studies and focus group discussions with patients and physicians. The scale construction and pretesting (n= 189) ascertained the validity and reliability of the questionnaire. Results: A 63-item questionnaire was developed with good reliability (Cronbach’s alpha 0.89) and validity. It had discriminatory ability having seen differences between patients according to their age groups, status of disease, educational attainment, and marital status. Factor analysis showed that the items needed to be distributed into a 13factor structure which better described the patterns of relationships among the variables. The concerns and preferences are put into the following domains: Achieving peace, taking charge, achieving aims and fulfilling roles, fears for self, desires of the sick, health provider issues, decisions at the end of life, matters related to wealth, physical effects of the disease and treatment, fears with external dimension, processing eventual outcome issues, reproductive issues, and letting go. Conclusions: A valid and reliable questionnaire was created which identified the end-of-life concerns and preferences of Filipino women with advanced or recurrent gynecologic cancer in a government tertiary hospital.
MASCC-0517 Aprepitant (AP) versus dexamethasone (D) for preventing delayed emesis induced by chemotherapy (CT) in breast cancer patients (PTS): a double-blind, multicenter, randomized study F. Roila1, E. Ballatori2, A. Fabi3, S. Fatigoni1, S. Chiara4, M.T. Ionta5, M. Aieta6, M. Clerico7, M.A. Palladino8, M. Indelli9, O. Garrone10, S. Bustreo11, B. Ruggeri12
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Medical Oncology, S. Maria Hospital, Terni, Italy, 2Medical Statistics University, University L’Aquila, L’Aquila, Italy, 3Medical Oncology, Regina Elena National Cancer Institute, Rome, Italy, 4Medical Oncology Unit, National Cancer Institute, Genoa, Italy, 5Medical Oncology II, Medical Oncology II, Cagliari, Italy, 6Oncology, Rionero in Vulture, Potenza, Italy, 7Oncology, Ospedale Degli Infermi, Biella, Italy, 8Medical Oncology, Hospital, Piacenza, Italy, 9 Medical Oncology, Arcispedale Sant’Anna, Ferrara, Italy, 10Medical Oncology, Santa Croce General Hospital, Cuneo, Italy, 11Medical Oncology, Molinette, Torino, Italy, 12Clinical Government, ASUR Marche, Ascoli Piceno, Italy Introduction: A combination of AP + a 5-HT3 receptor antagonist + D and AP alone is recommended, respectively, for the prophylaxis of acute and delayed emesis induced by anthracyclines plus cyclophosphamide (AC) CT in breast cancer pts. The role of AP in delayed emesis was not defined in the published studies. Objectives: Aim of this study was to compare the efficacy of AP versus D in preventing delayed emesis in pts receiving the same prophylaxis of acute emesis Methods: A randomized double-blind study comparing AP versus D was completed in naive breast cancer pts treated with A+C. Before CT, all pts were treated with intravenous palonosetron 0.25 mg and D 8 mg, and oral AP 125 mg. On days 2 and 3 pts randomly received D 4 mg bid or AP 80 mg qd. Primary endpoint was rate of complete response from days 2–5 after CT. Results: 580 pts were enrolled; 551 were fully evaluated, 273 in arm D and 278 in arm AP. Day 1 complete response rates were similar: 239/273 (87.6 %) in D arm and 236/278 (84.9 %) in AP arm. From day 2–5, complete response was the same with both antiemetic prophylaxes (79.5 %). During the delayed phase, incidence of insomnia (2.9 % vs. 0.4 %) and heartburn (8.1 % vs. 3.6 %) was significantly superior in D arm. Conclusions: In breast cancer pts submitted to A+C CT and receiving the same antiemetic prophylaxis for acute emesis, D and AP present similar efficacy and toxicity.
MASCC-0518 Acute inpatient cancer rehabilitation in the oldest patients K. Shin1 Palliative and Rehabilitation Medicine, University of Texas MD Anderson Cancer Center, Houston, USA
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Introduction: The oldest of old or those over the age of 85 is the fastest growing age demographic in the United States. People are living longer and living longer with cancer. They are seeking and receiving more aggressive cancer treatment. These patients can be left with significant functional deficits and acute medical issues which can benefit from acute inpatient rehabilitation. Concerns for geriatric patients receiving inpatient rehabilitation can include decreased tolerance to intensive rehab therapies, fewer functional gains, and frequent discharge to institutionalized settings. Objectives: To describe cancer inpatients over the age of 85 who were referred and accepted to an acute inpatient rehabilitation unit at a major tertiary national cancer center. Methods: Retrospective chart review of medical records for age, cancer diagnosis, length of stay, discharge disposition, and functional measure scores. Results: Between 2007 and 2012, 4,432 patients were referred for inpatient rehabilitation evaluation. 45 of these patients were over the age of 85. 29 were accepted for acute inpatient rehabilitation. For these 29 patients, average age was 87.9. Median age 87. 19
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were referred from surgical services, 8 from medical oncology services, 2 from Internal Medicine. Average length of stay was 10.8 days. 22 patients were discharged home, 6 to a long term acute care facility, one patient to an outside rehab facility. Conclusions: A selected cohort of inpatients over the age of 85 were able to complete an acute inpatient rehabilitation stay and be safely discharged to the home setting. References: Balducci L. Rehabilitation of older cancer patients. Acta Oncologica 2013; 52: 233–238.
MASCC-0519 Nurses’ assessments of the illness perception of cancer patients with a poor prognosis: association with nurses’ attributes Y. Izoe1, M. Mizuno2 1 Graduate School of Comprehensive Human Sciences Master’s Program in Nursing Science, University of Tsukuba, Ibaraki Tsukuba, Japan, 2Graduate School of Comprehensive Human Sciences, University of Tsukuba, Ibaraki Tsukuba, Japan Introduction: In order to provide personalized care for cancer patients with a poor prognosis, nurses must understand patients’ specific perceptions regarding their illness. Objectives: The purposes of this study were to investigate nurses’ Methods for assessing the illness perception of cancer patients with a poor prognosis and identify the nurses’ attributes related to these assessments Methods: A self-administered questionnaire was completed by 197 nurses (Response rate 70 %) working in wards at general hospitals in Japan. The relationships between the information sources used by preference to assess the illness perception of cancer patients and the nurses’ attributes were statistically examined Results: Average age of the respondents was 31.6 (SD=6.7) years. Pancreatic cancer was the most frequently (22 %) imagined disease of patients with a poor prognosis. Patients’ illness perception was least frequently (14 %) assessed using information that nurses directly got from a patient, while dialogue started on patients’own initiative were used most frequently as information to assess (34 %). A significant difference in the mean number of years of cancer nursing experience was observed among nurses’ preference for the information sources using to assess patients’ illness perception Conclusions: Nurses most frequently imagined pancreatic cancer as having a poor prognosis. When nurses imagine cancer patients with a poor prognosis, younger nurses may infrequently use information that nurse directly got from a patient about their illness perception.
MASCC-0520 Best-practice model for multiprofessional cancer medication management A. Wilmer1, A. Tasar2, K. Fleckenstein3, C. Hack3, K. Ruberg2, Y.D. Ko3, U. Jaehde1 1 Clinical Pharmacy, Institute of Pharmacy, Bonn, Germany, 2Kronen Pharmacy Marxen, Kronen Pharmacy Marxen, Wesseling, Germany, 3 Non-surgical Oncology, Johanniter-Hospital, Bonn, Germany Introduction: The complex cancer medication is frequently associated with drug-related problems. To improve patient safety an efficient cooperation between all health care professions is crucial. Objectives: Aim of this project is to enhance patient safety by structured and standardized outpatient cancer care in a multiprofessional best-practice model. Methods: A module-based model was developed in a multiprofessional quality circle in order to define ‘best practice’. All care modules include evidence-based recommendations for supportive care, written patient
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information, and an algorithm illustrating the care process. Among others, the effectiveness of the model is evaluated using the patient-reported outcome (PRO) version of the CTCAE criteria. The newly developed instrument was tested in a pilot study. Results: Care modules were developed for medication review and interaction check, malnutrition, and for the management of four common adverse events: nausea/emesis, mucositis, fatigue, and pain. They can be applied individually for each patient according to medication and toxicity. In the pilot study 30 outpatients with solid tumors were surveyed Results: show that approximately 73 % of the patients suffered from severe or very severe toxicity according to PRO-CTCAE. Fatigue was the most frequent adverse event (87 %) followed by sleep disorders (70 %) and nausea (57 %). Conclusions: The efficacy of the model is currently being evaluated in a randomised two-arm interventional trial at the Johanniter-Hospital, Bonn. About 106 patients are allocated either to the control group or to the intervention group receiving modular medication management. Primary endpoint is the time to first occurrence of severe toxicity according to PRO-CTCAE.
MASCC-0521 Nationwide survey on CINV associated with MEC and HEC and primary care medical staffs’ perception on CINV. The CINV study group of Japan survey K. Aiba1, K. Tamura2, T. Saeki3, Y. Nakanishi4, T. Kamura5, H. Baba6, N. Yamamoto7, Y. Kitagawa8, K. Yoshida9, J. Furuse10, Y. Kakeji11, G. Wakabayashi12, T. Sugiyama13, Y. Ito14, K. Hatake15, K. Hirata16, Y. Maehara11, M. Kitajima17 1 Department of Internal Medicine Division of Clinical Oncology and Hematology, The Jikei University School of Medicine, Tokyo, Japan, 2 Division of Oncology Hematology and Infectious Diseases Department of Internal Medicine, Fukuoka University, Fukuoka, Japan, 3 Saitama International Medical Center, Saitama Medical University, Hidaka, Japan, 4Institute of Diseases of the Chest, Kyushu University, Fukuoka, Japan, 5Department of Gynecology and Obstetrics, Kurume University, Kurume, Japan, 6Department of Gastroenterological Surgery Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan, 7Division of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka, Japan, 8Department of Surgery, Keio University School of Medicine, Tokyo, Japan, 9Department of Surgical Oncology, Gifu University School of Medicine, Gifu, Japan, 10Department of Medical Oncology, Kyorin University Hospital, Tokyo, Japan, 11Department of Surgery and Science, Kyushu University, Fukuoka, Japan 12 Department of Surgery, Iwate Medical University School of Medicine, Morioka, Japan, 13Department of Gynecology and Obstetrics, Iwate Medical University School of Medicine, Morioka, Japan, 14 Department of Medical Oncology Breast Oncology Center, Cancer Institute Hospital Japanese Foundation for Cancer Research, Tokyo, Japan, 15Department of Medical Oncology/Hematology, Cancer Institute Hospital Japanese Foundation for Cancer Research, Tokyo, Japan, 16 First Department of Surgery, Sapporo Medical University School of Medicine, Sapporo, Japan, 17International University of Health and Welfare, International University of Health and Welfare, Tokyo, Japan Introduction: There has been no nationwide survey on CINV in Japan. Objectives: An investigation of CINV seen in cancer patients (pts) having chemotherapy for the first time. Medical staffs’ perception on CINV is also studied Methods: We performed a nationwide survey on CINV in 108 institutions throughout Japan. A 7-day diary for CINV was provided to the pt to record daily occurrence and severity of CINV Results: A total of 2,068 pts were registered Apr. 2011 through Dec. 2012. 1,536 pts’ diaries and their medical staffs’ reports were obtained by the end of Dec 2012. Underlying diseases were GI (466 pts), lung
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(400), breast (345), gynecological cancer (185) and hematological malignancy (140). There were 833 females (med. age 58) and 703 males (65), respectively. MEC was given to 608 pts as was HEC to 924. Acute vomiting (AV) was noted in 9(1.5 %) pts with MEC as was in 52(5.6 %) with HEC, while delayed vomiting was seen in 81(13.3 %) with MEC and 84(9.1 %) pts with HEC, respectively. Acute nausea (AN) was experienced in 37(6.1 %) with MEC and in 200 (21.7 %) pts with HEC, while was noted delayed nausea in 243(40 %) with MEC and in 427(46.2 %) with HEC, respectively. Antiemetics were given along the guideline to 402 (66.1 %) with MEC and to 687(74.4 %) pts with HEC. The staff estimated the occurrence of AN and AV in 882(57.4 %) and 204 (13.3 %) pts, while their pts actually experienced 184(20.9 %), and 18(8.8 %), respectively Conclusions: CINV seems to be well controlled by the guideline. Medical staffs overestimated the incidence of CINV unexpectedly.
MASCC-0522 Impact of a hospital policy to improve use of life sustaining treatments on code status orders at an academic medical center P. Perez-Cruz1, D. Finkelstein2, E. Robinson3, S. Brackett4, J. Serna5, P. Montgomery6, E.L. Krakauer7 1 Medicina Interna, Pontificia Universidad Catolica de Chile - Facultad de Medicina, Santiago, Chile, 2Biostatistics, Massachusetts General Hospital, Boston MA, USA, 3Optimum Care Committee, Massachusetts General Hospital, Boston MA, USA, 4Surgical Intensive Care Unit, Massachusetts General Hospital, Boston MA, USA, 5Oncologia Medica, Hospital Vall d’Hebron, Barcelona, Spain, 6, Center for Medical Simulation, Boston MA, USA, 7Palliative Care, Massachusetts General Hospital, Boston MA, USA Introduction: Decisions regarding life sustaining treatments (LST) for patients are difficult. Determination of a patient’s ‘code status’ is used as a way to translate patients’ preferences regarding use of LST into clinical practice. However, not all the hospitalized patients have a code status order (CSO) and physicians usually delay this conversation until patients are in critical condition Objectives: To describe the impact of a hospital policy to improve use of LST on CSO documentation, time between admission and first CSO, and patient–physician communication regarding use of LST at an academic medical center. Methods: We retrospectively reviewed charts of patients who died on an intensive care unit or an oncology floor before and after a hospital policy, that included a CSO electronic form, was implemented. We reviewed written CSO for hospitalized patients before the policy implementation and the electronic CSO form after the implementation Results: 175 patients were analyzed, 88 pre and 87 post policy implementation. There were no differences in patients’ demographics among the groups. The percentage of patients who had a CSO at death increased from 60 % to 86 % (p<.001, chi2). The median time from admission to first CSO decreased from 10 to 3 days post intervention (p=.0053, chi2). The percentage of LSTs received with a prior patient-physician discussion about use of LST increased from 13 % to 32 % (p<.001, chi2). Conclusions: The implementation of a hospital policy on LST increased documentation of CSO, decreased time to first CSO and increased patient-physician communication regarding use of LST.
MASCC-0523 Clinical implications of malnutrition in childhood cancer patients—infections and mortality E.A.H. Loeffen1, A. Brinksma2, K.G.E. Miedema1, G.H. Bock de3, W.J.E. Tissing1
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Department of Pediatric Oncology/Hematology, Beatrix Children’s Hospital University Medical Center Groningen University of Groningen, Groningen, Netherlands, 2UMCG School of Nursing and Health, University Medical Center Groningen University of Groningen, Groningen, Netherlands, 3Department of Epidemiology, University Medical Center Groningen University of Groningen, Groningen, Netherlands Introduction: In childhood cancer patients, malnutrition has been proposed to increase infection rates and reduce survival. However, little is known about this possible association. Objectives: We investigated if malnutrition at diagnosis and during treatment is a prognostic factor for infection rates and survival, within a heterogeneous childhood cancer population Methods: Children≤18 years of age diagnosed between October 2004 and October 2011 were retrospectively included in this study (n=269). Medical records were searched for prospectively included data regarding BMI, infections and survival. Patients with BMI z-scores at diagnosis lower than −2.0 were classified as malnourished. Weight loss more than 5 % in the first 3 months after diagnosis was considered relevant Results: At diagnosis, 5 % of all patients were malnourished. These patients showed worse survival than those who were well nourished, independent of expected survival based on diagnosis. Weight loss of more than 5 % in the first 3 months after diagnosis was related to increased occurrence of febrile neutropenic episodes with bacteraemia in the first year after diagnosis. When corrected for intensity of treatment, this association persisted. Conclusions: Regarding nutritional status of childhood cancer patients at diagnosis, survival differed significantly between malnourished patients and well nourished patients. With regard to infections, we found for the first time that childhood cancer patients who lose weight more than 5 % in the first 3 months after diagnosis experience more febrile neutropenic episodes with bacteraemia in the first year after diagnosis. This underlines the importance of optimal feeding designs in childhood cancer patients.
MASCC-0524 Japanese evidence-based guidelines for cancer rehabilitation T. Tsuji1, K. Ikoma2, M. Mizuma3, A. Tanuma4, T. Tsurukawa5, K. Muraoka6, K. Miyakoshi7, R. Saura8, K. Mizuochi9 1 Department of Rehabilitation Medicine, Keio University School of Medicine, Tokyo, Japan, 2Department of Rehabilitation Medicine, Hokkaido University Hospital, Sapporo, Japan, 3Department of Rehabilitation Medicine, Showa University School of Medicine, Tokyo, Japan, 4 Department of Rehabilitation Medicine, Shizuoka Cancer Center Hospital and Research Institute, Mishima, Japan, 5Department of Rehabilitation Medicine, National Hospital Organization Kagoshima Medical Center, Kagoshima, Japan, 6Department of Rehabilitation Medicine, Kawasaki Municipal Hospital, Kawasaki, Japan, 7 Department of Rehabilitation Medicine, Kameda Medical Center, Kamogawa, Japan, 8Department of Rehabilitation Medicine, Division of Comprehensive Medicine Osaka Medical College, Takatsuki, Japan, 9 Department of Rehabilitation Medicine, Yokohama City University Hospital, Yokohama, Japan Introduction: Cancer care in Japan is currently lacking in comprehensive support that covers all aspects from treatment aimed at recovery to rehabilitation focusing on quality of life (QOL). This is partly due to the lack of guidelines, which precludes the establishment of evidence-based rehabilitation programs. Objectives: The objective was to establish Japanese evidence-based guidelines for cancer rehabilitation edited by the Committee on
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Japanese Guidelines for Cancer Rehabilitation of the Japanese Association of Rehabilitation Medicine (JARM). Methods: The present project was funded by the Grant for Cancer Control from the Ministry of Health, Labour and Welfare of Japan. Clinical issues related to cancer rehabilitation were classified by primary lesion, treatment objective, and disease stage into the following eight areas. The databases used for literature searching were MEDLINE, Cochrane Library, and PEDro, etc. Results: A total of 61 clinical questions (CQ) was ultimately selected. Each CQ was reflected in the guidelines by drafting a recommendation and an explanation and gathering public comments from members of the JARM. A total of 427 articles was used as the basis for discussion. Recommendation grades were Grade A (strongly recommended) for 24 CQs, B (recommended) for 27 CQs, and C (may be considered but lacks sufficient scientific evidence) for 10 CQs. Conclusions: While there were differences by area, a high recommendation grade was obtained for many CQs. We plan to publish the present guidelines in Japan, release it on our website, and widely disseminate it to medical professionals involved in cancer care and rehabilitation medicine, while also promoting their understanding of the guidelines.
Methods: The CAREER has targeted medical professionals at cancer care hospitals. Participants in a team of 4 people include a doctor, a nurse, and rehabilitation therapists. A postal questionnaire was sent to all participants in the CAREER in 2011–2012. The questionnaire was based on items related to the effect of the seminar and included four desirable aspects: reaction (Level 1), learning (Level 2), behavior (Level 3), and results (Level 4) based on Kirkpatrick’s four levels. Results: Of the 1,320 participants who received the questionnaire, 1,200 (91 %) responded. Of these, 25 % each were doctors and nurses, 28 % were physical therapists, 17 % were occupational therapists, and 5 % were speech language therapists. Most participants were satisfied and obtained the knowledge and skills well (Levels 1 and 2) and had some change in action (Level 3); 60 % reported changes in the workplace (Level 4). Conclusions: The survey demonstrated that the CAREER was excellent for reaction, learning, and behavior and fair for results. Given the results of this survey, the training curriculum will be improved and efforts will continue to develop specialized cancer rehabilitation professions.
MASCC-0525 Promotion of cancer rehabilitation in Japan: effect of a training seminar that targeted rehabilitation staff in hospitals for treating cancer patients
B. Yu1, X.L. Xu1, Q. Du1, B. Zhu1 Department of Pharmacy, Fudan University Shanghai Cancer Center, Shanghai, China
T. Tsuji1, K. Mizuochi1, T. Koyama1, Y. Takakura1, H. Onoda1, T. Kobayashi1, K. Horaiya1, T. Kanda1, N. Sugimori1, E. Sasaki1, K. Masuoka1, K. Abe1, M. Kurihara1 1 The Cancer Rehabilitation Training Committee, a project commissioned by the Ministry of Health Labour and Welfare, Tokyo, Japan Introduction: Cancer rehabilitation resources are insufficient in Japan. In 2006, the National Cancer Control Act was approved. As part of its measures, the CAREER (Cancer Rehabilitation Educational Program for Rehabilitation Teams), which is a cancer rehabilitation training workshop, was launched in 2007 as a project commissioned by the Ministry of Health, Labour and Welfare. Objectives: The aim of this study was to evaluate the effect of the CAREER.
MASCC-0526 Economic analysis of standard therapies in preventing emesis in Chinese patients following highly emetogenic chemotherapy 1
Introduction: Two pivotal phaseIII trials compared the efficacy of palonosetron between ondansetron and granisetron. However, the economic-effectiveness between these three drugs is not clear. Objectives: To estimate, from the perspective of the Chinese healthcare-system, the economic-effectiveness of four standard strategies among patients following highly-emetogenic chemotherapy Methods: A Marcov decision-analytic model was developed to simulate the nausea-vomiting disease course following highly-emetogenic chemotherapy (Fig1). The health and economic outcomes of 0.75 mg palonosetro (0.75P) compared to 0.25 mg palonosetron (0.25P) and 32 mg ondansetron (O), and 40 μg/kg granisetron (G) were estimated. The clinical and utility data were taken from published studies. The cost data were estimated from local charge data and current Chinese practices. Sensitivity analyses were used to explore the impact of uncertainty regarding the results.
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Results: The base-case analysis (Table1) showed that the 0.75P strategy yielded the maximum health benefits. The marginal cost-effectiveness (ICER, cost per additional hours without emesis) gained was $3.46 (undominated). The probabilistic
G
Cost ($) 89.79
ΔCost ($) –
Effectiveness (as hours) 50.46
ΔEffectiveness (as hours) –
0.25P
119.03
29.24
65.33
14.87
1.97
O
152.34
62.55
48.91
−1.55
−40.35
0.75P
153.47
63.68
68.88
18.42
3.46
Strategy
sensitivity analysis demonstrated that the 0.75P strategy was the most cost-effective approach when the willingness-to-pay threshold was over $10 (0.23 % of per capita GDP of China) (Fig2).
ICER –
Conclusions: Our analysis suggests that 0.75 mg palonosetron therapy is the cost-effective option in the Chinese healthcare setting. In some relatively undeveloped regions, granisetron might be a favorable cost-effective alternative for patients following highly-emetogenic chemotherapy. References: Lancet Oncol 2009;10:115; Ann Oncol 2006;17:1141
MASCC-0527 Prevalence of iron deficiency in severe anemia for cancer patients visiting the emergency unit for acute onset symptoms M. Merad1, R. Miron1, S. De Botton2, L. Zakin3, M. Bertoncello3, A. Alibay1, C. Martin1, M. Di Palma1, S. Antoun1 1 Ambulatory Department, Institut Gustave Roussy, Villejuif, France, 2 Hematology department, Institut Gustave Roussy, Villejuif, France, 3 Research and Development Department, Vifor Pharma, Paris, France Introduction: Anemia in cancer is a common biological abnormality and etiological research is often not conducted. Iron deficiency is rarely explored Objectives: The objective is to determine the prevalence of absolute (A) or functional (F) iron deficiency (ID) in severe anemia for cancer patients Methods: All cancer patients who visited the emergency unit for acute symptoms were included prospectively during 3 months if hemoglobin level was <10 g/dl. Three groups were defined using serum ferritin (SF) and transferrin saturation (TSAT): Absolute ID: TSAT<20 % and
SF<100; status unknown for ID (UID) or Functional ID: TSAT<20 % and SF>100 ng/ml and a group without ID (WID): TSAT >20 % Results: Severe anemia was observed for 85 patients; 11.8 % of the patients had AID. Asthenia and dyspnea were reported in 76 % and 62 % of the patients, respectively. A gastrointestinal localization was found for only 44 % of the patients with AID. Anemia had another cause than ID in 18.8 %. ID status was difficult to define for 69.4 % of the patients (CS<20 %, 100>SF). For 61 % of the patients in UID, inflammatory syndrome (C reactive protein >60 mg/l) might explain the functional ID, but for the remaining patients (39 %), there are probably other explanations for the TSAT less <20 % Conclusions: Absolute ID was observed in almost 1/10th of cancer patients visiting for acute onset symptoms. There are more than 2/3rd of the patients with an ID status difficult to determine and it might be that the reticulocytosis response after an iron supplementation could be of help for diagnosis.
MASCC-0528 An interprofessional education (ipe) approach to group patient education in the head & neck cancer population T. Fansabedian1, A. Gomes2, M. McQuestion3 Clinical Nutrition, Princess Margaret Cancer Centre, Toronto, Canada 2 Speech Language Pathology, Princess Margaret Cancer Centre, Toronto, Canada, 3Nursing, Princess Margaret Cancer Centre, Toronto, Canada 1
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Introduction: Limited human resources to deliver personalized, standardized and timely education to patients with Head and Neck cancer undergoing (chemo)radiation. Objectives: A group ‘prehab’ class by RD, SLP and CNS to empower patients and caregivers with knowledge on managing acute side effects, maintaining swallow, nutrition and hydration throughout treatment as well as the prevention of late effects Methods: All patients were booked into a group class within the first 2 weeks of treatment. All participants are provided with patient education material reinforcing the class content. In true IPE format, the class began with three professionals delivering their own portions and has evolved to alternating sessions among professionals with each delivering the full content of the class. Results: Attendance has been maintained at approximately 50 %. In evaluations 86 % felt the session answered their questions, 83 % felt that they learned something new and 71 % felt it was delivered at the right time. Being open to friends and family members allows for loved ones to also be involved in their care and the group setting allows for a group dynamic and sense of camaraderie to evolve. Conclusions: Anticipated implications include increased awareness of side effects, improvement in personal symptom management and prevention of associated complications. Future directions include research into identifying differences in outcomes between patients who choose to attend and those who did not.
MASCC-0529 Enhancing the role of carers in the outpatient chemotherapy setting: a participatory action research project V. Tsianakas1, A. Richardson2, G. Robert3, R. Verity3, C. Oakley3, E. Ream3 1 Florence Nightingale School of Nursing and Midwifery, King’s College London, London, United Kingdom, 2Faculty of Health Sciences, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom, 3Florence Nightingale School of Nursing and Midwifery, Kings College London, London, United Kingdom Introduction: Supporting someone through outpatient chemotherapy can be stressful. Evidence suggests that carers are at risk of mental and physical illness if they have unmet needs or perceive themselves illequipped to care. However, research has yet to establish the type of support carers require and how to provide this. Objectives: A participatory action-research approach, Experiencebased Co-design (EBCD), was used to develop and test an intervention for carers in the chemotherapy outpatient setting. Methods: EBCD combines a user-centred orientation (by adopting a filmed, narrative story-telling approach) with a collaborative codesign process. Interviews were conducted with 20 carers and 20 staff, and 30 h of observation was undertaken in two clinical settings. Through a facilitated three-stage process drawing on the fieldwork findings, carers and staff designed components of a carer intervention that took the form of a DVD and leaflet. The delivery and impact of the intervention was tested in a feasibility trial. Forty-three carers were recruited to the trial, randomised between the intervention (n = 21) and control (n = 22) groups. Standardised psychometrically sound measures, completed preand post-intervention, provided preliminary evidence of beneficial impact on carer experience. Staff and carer focus groups confirmed the feasibility and acceptability of the intervention. Results: Carers and staff developed components of the ‘Take Care’ intervention. This was delivered to carers in nurse-led consultations. Feasibility trial results indicated an improvement in carers’ knowledge of chemotherapy and their perceived confidence with their care-giving situation.
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Conclusions: These preliminary data are encouraging and support the development of interventions using a co-design process, to improve carer experience.
MASCC-0530 Delirium and symptom distress among cancer patients receiving home hospice care in the last week of life A. Noguera1, M. de la Cruz2, M. San Miguel-Arregui2, J. Williams2, G. Chrisholm3, E. Bruera2 1 Palliative Care, Hospital Centro de Cuidados Laguna, Madrid, Spain, 2 Palliative Care, M. D. Anderson Cancer Center, Houston, USA, 3 Statistics, M. D. Anderson Cancer Center, Houston, USA Introduction: Knowledge of symptom prevalence and adequate assessment of such symptoms at the end of life are important in clinical practice as it enables health care providers to focus, anticipate and address medical issues as they arise. Objectives: Our objective was to determine the frequency and severity of symptom distress and delirium among patients admitted to hospice in the last week of life. We also sought to determine the clinical utility of the NuDESC as scored by the caregiver as a screening tool for delirium. Methods: We conducted a secondary analysis of the data from a previous randomized controlled trial on parenteral hydration at the end of life of patients admitted to home hospice. We collected the Edmonton Symptom Assessment Scale (ESAS), Memorial Delirium Assessment Scale (MDAS), and Nursing Delirium Screening Scale (Nu-DESC). Sensitivity and specificity of Nu-DESC was calculated. Results: 78 of 261 patients were included in this study. 62 (80 %) patients have at least 4 moderate to severe symptoms which corresponded to ESAS score≥4. Delirium was diagnosed in 34 (44 %) of patients using the MDAS. Nu-DESC was found to have a sensitivity of 35 %, specificity of 80 %, PPV 58 %, and NPV 61 % when used by caregiver Conclusions: Hospice patients at the end of life have a high rate of symptom distress. Nu-DESC is not a reliable tool for screening delirium when scoring is conducted by the caregiver. This study illustrates the need for routine use of assessment tools at the end life to improve care.
MASCC-0531 Organization of supportive care in onco-hematology French departments S. Trager1, C. Bauchetet2, C. Préaubert3, G. Nallet4, V. Tual5, C. Blaizac6, P. Colombat7 1 Oncology, Groupe Hospitalier Public du Sud de l’Oise, Senlis, France, 2 Oncology, Retired Health Manager, Paris, France, 3Oncology, Clinique du Pont de Chaume, Montauban, France, 4Oncology, Réseau Oncolie, Besançon, France, 5Oncology, Hôpital Européen Georges Pompidou, Paris, France, 6Oncology, Hôpital Ste Musse, Toulon, France, 7Oncology, CHRU Bretonneau, Tours, France Introduction: Supportive cares are part of the common health services for cancer patients. Its usefulness has been proven but its organization remains heterogenous. Objectives: Current situation of the supportive care organization in onco-hematology French departments Methods: An anonymous Internet questionnaire is sent to one doctor, one health manager and one caregiver of numerous onco-hematology departments Results: 144 health professionals returned the questionnaire. 44 % of the departments have no internal supportive care coordination. Coordinators are mainly doctors (43 %), nurses (29 %) or health managers (19 %). Supportive care coordination is predominantly requested by patients themselves
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(66 %), by their relatives (50 %) or their regular doctor (37 %). Supportive care multi-professionnal meetings are held in 25 % of the institutes. The main participants are: doctors (96 %), psychologists (90 %), social workers (79 %), health managers (72 %), nurses (65 %), dietitians (65 %), junior doctors (62 %). 47 % of the institutes or departments have tools to evaluate the needs of supporting care. According to 56 % of the respondents, there are no specific case for supportive care in their department. 54 % of the respondents relate an efficient collaboration with home caregivers Conclusions: Interdisciplinarity is highly represented. Identification and coverage of the needs are provided by a set of participants. Supportive care meetings have to be developed, particularly for complex care where social workers help is needed. Coordination is underdeveloped: lack of evaluation tools, of traceability and of coordination within the departments. An AFSOS workgroup is studying the possibilities of organization and coordination of supportive care in and outside the hospital
MASCC-0532 A meta-analysis on the interest of exercise in adjuvant breast cancer patients: are the guidelines based on evidence? M. Carayol1, C. Delpierre2, G. Ninot1 1 Epsylon Laboratory EA4556, University of Montpellier, Montpellier, France, 2INSERM UMR 1027, Paul Sabatier University, Montpellier, France Introduction: Exercise has been recommended to relieve fatigue as category 1 in cancer patients with active treatment by the National Comprehensive Cancer Network [NCCN, 2011]. A recent meta-
Fatigue Intervention length (wk) No. of experiment patients Total targeted dose (MET.h) Journal Inpact factor Intent-to-treat analysis Quality-of-life Intervention length (wk) No. of experimental patients No. of sessions/week Intent-to-treat analysis Depression Intervention length (wk) Supervised exercise sessions (%) Individual exercise sessions Journal impact factor Intent-to-treat analusis Concealed randomization
*
analysis reported significant improvements on fatigue, depression and quality-of-life (QoL) in patients with exercise intervention compared to controls [Carayol et al., 2013]. However, significant amount of heterogeneity among pooled randomized controlled trials (RCTs) was observed, suggesting that some characteristics regarding study methodology and/or intervention may influence the effect of exercise interventions Objectives: To identify methodological and intervention factors that influence exercise efficacy on fatigue, QoL and depression in breast cancer patients receiving chemotherapy and/or radiotherapy Methods: RCTs testing exercise intervention were systematically identified. Characteristics regarding exercise intervention and methodological quality were coded and tested as moderators of exercise effect estimates in meta-regression models. Psychological outcomes summary effect sizes were then computed by pooling subgroup of RCTs based on categorized identified moderators. Results: Nineteen RCTs were included. Intervention length, use of intention-to-treat analysis and journal impact factor were significantly and negatively associated with exercise interventions efficacy on the improvement of psychological factors. Number of experimental patients was also negatively related to fatigue and QoL (P<0.10). Significant impact of exercise intervention on these psychological factors was observed in RCTs with intervention length<18 weeks, no intentto-treat analysis, impact factor<3 and less than 40 experimental patients (see Table 1). Table 1: Moderators and related summary effect sizes of exercise interventions efficacy on fatigue, quality-of-life and depression
Meta-regression β P-value
Subgroup summary effect sizes P-value Group− Effect estimate*
−0.244 −0.519 −0.577 −0.796 −0.672
0.095 0.089 0.051 0.003 0.014
<18 <40 <150 <3 No
−0.47 −0.64 −0.65 −0.96 −0.80
−0.301 −0.451 −0.484 −0.529
0.024 0.075 0.077 0.029
≤18 <40 ≤4 No
−0.203 −0.145 0.319 −0.343 −0.343 −0.413
0.044 0.097 0.094 0.049 0.049 0.030
<18 <50 No <3 No No
Summary effect sizes were estimated by weighting SMDs by the inverse of their variance based up on random effects models. Negative effect sizes represent fatigue, quality-of-life of depression improvements. Conclusions: Exercise evidence and recommendations for improving fatigue, QoL and depression in adjuvant breast cancer patients mainly rely on lowest methodological quality and shortest intervention length RCTs.
Group+
Effect estimate*
P-value
0.012 0.021 0.006 0.002 0.004
≥18 ≥40 ≥150 ≥3 Yes
−0.09 −0.07 −0.03 −0.05 −0.04
0.542 0.356 0.725 0.417 0.532
−0.55 −0.57 −0.48 −0.61
0.017 0.025 0.002 0.009
>18 ≥40 >4 Yes
−0.17 −0.11 0.00 −0.08
0.127 0.142 0.986 0.292
−0.47 −0.38 −0.15 −0.44 −0.44 −0.55
0.000 0.010 0.085 0.001 0.001 0.000
≥18 ≥50 Yes ≥3 Yes Yes
−0.06 −0.17 −0.46 −0.10 −0.10 −0.15
0.561 0.089 0.002 0.259 0.259 0.072
MASCC-0533 C-reactive protein and prognosis in solid tumors: a systematic review S. Shrotriya1, N. Bennani-Baiti1, S. Thomas1, D. Walsh1 1 The Harry R. Horvitz Center for Palliative Medicine, Cleveland Clinic Taussig Cancer Institute, Cleveland, USA
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Introduction: C-reactive protein (CRP) linked to shorter survival in some cancers. Objectives: Systematic literature review to examine CRP and prognosis in solid tumors. CRP on treatment response and tumor recurrence also determined. Methods: Related MeSH (Medical Subject Heading) terms used to search electronic databases (PubMed, EMBASE, Web of Science, SCOPUS etc.). Quality Assessment (QA) score devised and utilized. Studies with QA scores <50 % were excluded. Inclusion/Exclusion criteria developed. Two reviewers independently reviewed selected research papers. Results: Ninety-two articles selected for final review. 70 % prospective; 24 % retrospective. Median (min, max) QA score: 60 (50, 80). 55 % of studies were either in gastrointestinal (GI) malignancies or renal cell carcinoma (RCC). Elevated CRP predicted prognosis; 78 % of studies by multivariate analysis, 13 % univariate analysis, 11 % non-prognostic. CRP predicted prognosis in 80 % of GI and RCC studies. Studies in other solid tumors also positive (high CRP-worse prognosis). Conclusions 1. High CRP prognostic in 80 % of studies. 2. CRP may help determine treatment response and tumor recurrence. 3. Most studies were in GI malignancies and RCC. 4. CRP be widely used and investigated to determine prognosis.
MASCC-0534 C-reactive protein (CRP) and prognostication in solid tumors S. Shrotriya1, N. Bennani-Baiti1, A. Aktas1, B. Estfan1, D. Walsh1 1 The Harry R. Horvitz Center for Palliative Medicine, Cleveland Clinic Taussig Cancer Institute, Cleveland, USA Introduction: CRP, a non-specific marker of inflammation may help cancer prognostication. CRP is secreted by liver due to interleukin-1 (IL-1), IL-6 and tumor necrosis factor (TNF). It has been linked to shorter survival in some cancers. Objectives: We examined associations between CRP levels and prognosis in solid tumors. Methods: Retrospective study of electronic medical records (EMR). Multiple CRP levels at a tertiary cancer center reviewed (2006–2011). Hematological cancer diagnoses excluded. Survival defined from the date with highest CRP to date of death. CRP reported as median (25th, 75th percentile). CRP reference range 0–10 mg/L. Results: N=6809 with solid tumors identified. 56 % males. 83 % Caucasian, 15 % African American. Common cancers—genitourinary (GU) 29 %, breast 14 %, gastrointestinal (GI) 14 %, lung 7 %. Highest CRP for GI, GU, lung, breast=8 (2, 15); 6 (2, 15); 3 (1, 8); 2 (1, 5) respectively. Median survival (months)=13 (8, 30); 18 (11, 33); 16 (8, 27) and 25 (15, 41) respectively. Conclusions 1. Higher median CRP in GI, GU, lung and breast cancers. 2. Higher CRP associated with shorter prognosis across primary sites (even within reference range). 3. Inverse relationship between absolute CRP values and survival. 4. High CRP—an adverse prognostic indicator in most solid tumors.
MASCC-0535 Prevalence and incidence of difficulty swallowing in advanced cancer S. Shrotriya1, S. Thomas1, R. Trimmer1, D. Walsh1 1 The Harry R. Horvitz Center for Palliative Medicine, Cleveland Clinic Taussig Cancer Institute, Cleveland, USA Introduction: Difficulty swallowing is an independent predictor of cancer survival. Regular evaluation of swallowing is critical for adequate nutrition and patient care.
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Objectives: Our objective was to establish incidence and prevalence of difficulty swallowing in acute palliative medicine unit. Also, to evaluate formal clinical swallow test. Methods: Electronic medical records (EMR) from acute palliative medicine unit retrospectively reviewed (2008–2011). Formal clinical swallow test comprised: I. Routine swallow screen II. Pre-swallow test questionnaires III. Clinical swallow test. Clinical swallow test includes: 1. Sip of water without aspiration 2. 3 oz cup of water without aspiration Results: N=249 with solid tumors; Mean (±SD) age = 68 ± 13 years; 57 % females. 71 % Caucasians; 25 % African Americans. Common among lung, gastrointestinal (GI), renal cancers. 47 % had metastatic disease. Mean (±SD) length of stay = 10 ± 8 days. Prevalence of difficulty swallowing on admission—6 %. 12 failed routine swallow screen, 3 pre-swallow test questionnaires, and 1 clinical swallow test. Prevalence=6 % on discharge. Incidence of difficulty swallowing during hospital admission=21 %. Pneumonia/respiratory symptoms, gastrointestinal problems common among those with difficulty swallowing. Conclusions 1. 6 % prevalence at admission and discharge. 2. 21 % incidence during the admission. 3. Most who underwent formal clinical swallow test failed routine swallow screen. 4. Pneumonia/respiratory and GI problems common. 5. Formal clinical swallow test critical in acute cancer care.
MASCC-0536 Weight loss: predictors and prognostic importance in solid tumors S. Shrotriya1, A. Aktas1, B. Estfan1, L. Rybicki1, D. Walsh1 1 The Harry R. Horvitz Center for Palliative Medicine, Cleveland Clinic Taussig Cancer Institute, Cleveland, USA Introduction: Large cancer databases provide valuable information on weight changes and clinical parameters. Weight loss (WL) in adults with solid tumors examined. Objectives: Objective was to determine if demographics, clinical and biochemical indices predicted WL. Examine if WL and related parameters were predictive for survival. Methods: Outpatients’ Electronic medical records (EMR) from a tertiary cancer center retrospectively reviewed. First visit (V1) within a year after diagnosis compared to last visit (V2) ≥3 weeks after V1. Body weight and other clinical parameters (BMI, BP, REE) at V1 and V2. WL: V2 to V1 categorized as ≤5 %, 5.01–10 %, >10 %. Logistic regression and Cox proportional hazards analysis identified risk factors for WL and prognosis. Results: N=5901; 58 % Male; Mean (±SD) age: 61±12 years; 82 % Caucasians; 16 % African Americans. Common cancers: genitourinary (GU) 31 %; gastrointestinal (GI) 16 %; breast 15 %; lung 15 %; head and neck 6 %, others 12 %. Metastatic disease in 18 %. WL: V1 to V2: ≤5 % (73 %), 5.01–10 % (13 %), >10 % (14 %). WL risk factors: multivariable analysis—primary site, metastatic sites, treatment-related variables, BMI category. Median survival >10.0 %=5.3 months, 5.01– 10.0 %=9.4, not observed ≤5 %; WL prognostic in multivariable analysis (p<0.001). Conclusions 1. Major WL≤5 % by V2. 2. Head & Neck and GI cancers (primary)—the greatest risk of WL; breast –lowest. 3. More metastatic sites Λ WL risk. 4. Overweight and obese = Λ WL; underweight = Less WL. 5. ≤5 % WL survival advantage compared to 5.01–10 %, >10 %. 6. WL prognostic after adjustment for other prognostic factors.
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MASCC-0537 Literature review on the effectiveness of web-based interventions on health outcomes of caregivers of cancer patients W.ie.P.Y. Tang1, C.en.W.H. Chan1, S.ne.S.M. Ho1 1 The Nethersole School of Nursing, The Chinese University of Hong Kong, Hong Kong, Hong Kong China Introduction: Combating with cancer is a long journey, as caregivers, they are under high level of stress, distress and worries, influencing their physiological and psychological well-being. With advanced technology, Internet becomes an important source of health information and support for the caregivers of cancer patients. Studies reported psychoeducation and psychological interventions were beneficial to cancer caregivers, however, the effects of interventions deliver by web-based format were unclear Objectives: This review aims to critically review existing literatures related to the effectiveness of web-based interventions in health related outcomes in caregivers of cancer patients. Methods: Relevant citations were searched from MEDLINE, EMBASE, PsycINFO, Scopus and EBM Reviews from inception to December 2012. Keywords including ‘web-based’, internet, caregiver, cancer were used in each electronic database search. Articles written in English and Chinese were included. Studies focused on only patient outcomes were excluded. The characteristics and the findings of the relevant studies were critically appraised Results: Nine studies were included in the review. Six of them were experimental studies. All studies were conducted in Caucasian or Western populations. Outcomes examined include quality of life, negative mood, anxiety, perceived mutual support and coping effectiveness. Conclusions: Preliminary evidence demonstrated web-based intervention approach might be an effective way in delivering health information and support to the caregivers. However, limited randomized controlled studies were done to evaluate the effectiveness of Internet-based interventions. Future studies can employ randomized controlled trials as study method and focus on the impact of web-based interventions in caregivers.
MASCC-0538 Pharmacists-led symptom management program of Asian breast cancer patients: experience at an ambulatory cancer center K.M. Foo1, V. Shih2, A. Chan3, R.A. Dent4, Y.S. Yap5 1 Pharmacy, National University of Singapore/KK Women’s and Children’s Hospital, Singapore, Singapore, 2Pharmacy, National Cancer Centre Singapore, Singapore, Singapore, 3Pharmacy, National University of Singapore/National Cancer Centre Singapore, Singapore, Singapore, 4Medical Oncology, National Cancer Centre Singapore/Duke NUS GMS Singapore, Singapore, Singapore, 5 Medical Oncology, National Cancer Centre Singapore, Singapore, Singapore Introduction: As more cancer patients receive outpatient chemotherapy, it is pertinent to assess their symptom periodically for prompt, effective symptom management which pharmacists play an important role. Objectives: The study was designed to assess the incidence and severity of symptoms experienced by Asian breast cancer (BC) patients receiving chemotherapy. Secondary objective was to evaluate patientrelated characteristics that may predispose patients to chemotherapyinduced symptoms.
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Methods: This is a prospective, single institution, cohort study conducted between Jan2012 and Jan2013. Newly diagnosed nonmetastatic BC patients receiving chemotherapy at the ambulatory cancer center were recruited. M. D. Anderson Symptom Inventory (MDASI), a validated patient-reported outcome-based multisymptom assessment tool, was administered by a pharmacist 1 week after every cycle via telephone throughout their entire course of chemotherapy. Results: Sixty-nine patients were assessed. Majority (82.6 %) were Chinese, 69.1 % had Stage II BC and below and mean age was 49.8 (±9.83) years. The most common symptoms experienced were fatigue (48.7 %), lack of appetite (37.8 %) and disturbed sleep (32.1 %). These lead to interference of general activity (31.8 %), work (29.4 %) and mood (23.4 %). Younger patients (≤50 years) reported higher intensity of pain and nausea (p=0.023 and p=0.035 respectively). Patients with higher education had greater tendency for work and relations with others to be affected (p = 0.008 and p =0.003 respectively). Married patients reported worse mood (p=0.037). Conclusions: This pilot study has elucidated common symptoms that afflict BC patients on chemotherapy. Pharmacists can proactively identify patients at higher risk for chemotherapyinduced symptoms and to assist them in effective symptom management.
MASCC-0539 Prophylactic naproxen or loratadine for bone pain in breast cancer patients receiving chemotherapy and pegfilgrastim: a randomized, phase 2 study (NOLAN) AMGEN:20110147 - NCT:01712009 F.D. Vogl1, A.S. Guinigundo2, C. Maxwell3, L. Vanni4, S. Badre5, P.K. Morrow6 1 Global Development, Amgen (Europe) GmbH, Zug, Switzerland, 2 Medical Hematology and Oncology, Oncology Hematology Care Inc., Cincinnati OH, USA, 3Infusion Department, Advanced Medical Specialties, Miami FL, USA, 4Pain Management, Providence Hospital, Southfield MI, USA, 5Global Biostatistical Sciences, Amgen Inc., Thousand Oaks CA, USA, 6Global Development, Amgen Inc., Thousand Oaks CA, USA Introduction: Mild to moderate bone pain is the most commonly reported adverse event (AE) associated with pegfilgrastim. NSAIDs and antihistamines are being used increasingly in the oncology community to reduce this AE; however, there are limited data to support the safety and efficacy of these interventions (Kirshner 2011, 2012). Evidence regarding the effectiveness of these treatments in patients receiving pegfilgrastim and chemotherapy would be of value to both patients and providers. Objectives: To estimate the difference in cycle 1 bone pain among treatment groups (naproxen, loratadine, or no prophylactic therapy) captured as a part of AE reporting, and secondarily, in patient-reported bone pain surveys across cycles. AEs associated with prophylactic administration of naproxen and loratadine are being evaluated. Methods: Six hundred patients will be enrolled. Female patients with newly diagnosed, chemotherapy-naïve, stage I–III breast cancer, planning ≥4 cycles of neoadjuvant or adjuvant chemotherapy with pegfilgrastim support are eligible. Exclusions include: ongoing chronic pain or chronic pain treatment; a history of GI bleeding or ulcers. Patients are randomized 1:1:1 to naproxen 500 mg BID versus loratadine 10 mg QD versus no prophylaxis × 5 days starting the day of pegfilgrastim administration. Analyses will be stratified by age (<65 years versus ≥65 years) and chemotherapy received (taxane versus non-taxane). The clinical hypothesis is that an absolute reduction of 10 % in all grade
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bone pain in the intervention arms as compared to the control arm could suggest a clinical benefit.
Results: Current enrollment (Feb 2013) is 28 patients Results are expected mid-2014. Conclusions: Pending results.
MASCC-0540 Concepts and definitions for “actively dying”, “end-of-life”, “terminally ill”, “terminal care” and “transition of care”: a systematic review D. Hui1, Z. Nooruddin1, N. Didwaniya1, R. Dev1, M. De La Cruz1, S.H. Kim2, J.H. Kwon3, R. Hutchins4, C. Liem4, E. Bruera1 1 Palliative Care and Rehabilitation Medicine, University of Texas MD Anderson Cancer Center, Houston, USA, 2Family Medicine, Myong Ji
MASCC-0541 The effect of patient education on reported bone pain in breast cancer patients receiving chemotherapy and pegfilgrastim: a randomized, single-blind study (VINE) AMGEN:20110148 – NCT:01752907 F.D. Vogl1, A.S. Guinigundo2, C. Maxwell3, L. Vanni4, S. Badre5, P.K. Morrow6
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Hospital, Gyeonggi, Korea, 3Medical Oncology, Kangdong Sacred Heart Hospital, Seoul, Korea, 4Research Medical Library, University of Texas MD Anderson Cancer Center, Houston, USA Introduction: The terms ‘actively dying’, ‘end-of-life’, ‘terminally ill’, ‘terminal care’, and ‘transition of care’ are commonly used but rarely and inconsistently defined. Objectives: We conducted a systematic review to examine concepts and definitions for these terms. Methods: We searched MEDLINE, PsycInfo, EMBASE and CINAHL for published peer reviewed articles from 1948 to 2012 that conceptualized, defined or examined these terms. Two researchers independently reviewed each citation for inclusion, and then extracted the concepts/definitions when available. We also searched 10 dictionaries, 4 palliative care textbooks and 12 organization websites. Results: ‘Actively dying’, ‘end-of-life’, ‘terminally ill’, ‘terminal care’ and ‘transition of care’ were defined and/or conceptualized in 1/16, 3/134, 3/44, 2/93 and 4/17 retrieved articles, respectively. ‘Actively dying’ was defined as ‘hours or days of survival’. We identified 2 key defining features for ‘end-of-life’, ‘terminally ill’ and ‘terminal care’: life-limiting disease with irreversible decline and expected survival in terms of months or less. ‘Transition of care’ was discussed in relation to changes in (1) place of care (e.g. hospital to home), (2) levels of professions providing the care (e.g. acute care to hospice), and (3) goals of care (e.g. curative to palliative). Definitions for these 5 terms were rarely found in dictionaries, textbooks and organizational websites. However, when available, the definitions were generally consistent with the concepts discussed above. Conclusions: We identified unifying concepts for 5 commonly used terms in palliative care, and proposed a preliminary conceptual framework (Figure) toward building standardized definitions.
1
Global Development, Amgen (Europe) GmbH, Zug, Switzerland, Medical Hematology and Oncology, Oncology Hematology Care Inc., Cincinnati OH, USA, 3Infusion Department, Advanced Medical Specialties, Miami FL, USA, 4Pain Management, Providence Hospital, Southfield MI, USA, 5Global Biostatistical Sciences, Amgen Inc., Thousand Oaks CA, USA, 6Global Development, Amgen Inc., Thousand Oaks CA, USA 2
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Introduction: Patient education has been used in many disease states, but it has not been specifically studied in the modulation of pegfilgrastim-related bone pain (Ferrell 1993, de Wit 1997, Oldenmenger 2011). In this single-blind study, patients receiving chemotherapy and pegfilgrastim are randomized to receive one of two educational DVDs, and the effects of these DVDs on reported bone pain will be estimated. Objectives: Primary: to estimate the difference between arms of mean maximum patient-reported bone pain in cycle 1. Secondary: to evaluate patient-reported bone pain, area under the curve (AUC) for bone pain, analgesic use, and bone pain captured as part of adverse event (AE) reporting across cycles.
Methods: Three hundred patients will be enrolled. Female patients with newly diagnosed, chemotherapy-naïve, stage I-III breast cancer, able to understand English, and planning four cycles of neoadjuvant or adjuvant chemotherapy with pegfilgrastim are eligible. Exclusions include ongoing chronic pain or pain treatment. Patients are randomized 1:1 to receive one of two educational DVDs (either general or bone-pain-specific chemotherapy and pegfilgrastim AE information) to watch twice at the clinic on two separate days, up to and including the first visit for pegfilgrastim administration. Bone pain data are collected using patient-reported surveys and as part of standard AE reporting. The clinical hypothesis is that a difference in mean maximum pain of 0.5 (scale 1–10) in favor of bone pain education is clinically relevant.
Results: Current enrollment (Feb2013) is 2 patients Results are expected at the end of 2014. Conclusions: Pending results.
−0.4]; P= 0.02), dyspnea NRS at rest 15 min after drug administration (−0.9 [−1.8, −0.04]; P= 0.04), fatigue Borg Scale at the end of 6MWT (−1.3 [−2.4, −0.2], P= 0.04), 6MWT distance (+37.2 m [5.8 m, 68.6 m]; P= 0.03) and respiratory rate (−2.4 [−4.5, −0.3]; P= 0.03). Non-statistically significant improvements were also observed in the placebo arm, with no difference between the two arms. No significant adverse events were observed. Conclusions: Prophylactic SCF was safe and significantly improved dyspnea, walk distance and respiratory rate. We also observed a nonsignificant but large placebo effect. Our results justify larger randomized controlled trials to confirm these findings.
MASCC-0542 Prophylactic subcutaneous fentanyl for exercise-induced breakthrough dyspnea: a preliminary double-blind, randomized controlled trial D. Hui1, A. Xu1, S. Frisbee-Hume1, G. Chisholm1, E. Bruera1 1 Palliative Care and Rehabilitation Medicine, University of Texas MD Anderson Cancer Center, Houston, USA Introduction: Dyspnea is one of the most common and distressing symptoms in cancer patients, and often worsens with breakthrough episodes on exertion. We hypothesized that subcutaneous fentanyl (SCF) given prophylactically before exertion may alleviate breakthrough dyspnea. Objectives: We examined the effects of SCF on dyspnea, walk distance, vital signs and adverse events in cancer patients before and after intervention. Methods: In this double-blind randomized controlled trial, we asked ambulatory patients with breakthrough dyspnea to perform a baseline 6 min walk test (6MWT), and then assigned them to either SCF (15– 25 % of total daily dose) or normal saline 15 min before a second 6MWT. We documented the change in dyspnea numeric rating scale (NRS), walk distance, vital signs and adverse events between the first and second 6MWTs. Results: Twenty patients were enrolled (1:1 ratio) without attrition. SCF was associated with significant improvements in dyspnea NRS at the end of 6MWT (mean [95 % CI]: −1.8 [−3.2,
MASCC-0543 Designing and testing interventions that address barriers to delivering evidenced based symptom managment A. O’Mara1, A. Denicoff2, D. St. Germain1, M. Good1 1 Division of Cancer Prevention, National Cancer Institute, Bethesda, USA, 2 Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, USA Introduction: Results from a number of studies have consistently reported high levels of cancer treatment morbidities, while other studies have shown that patients are not receiving evidence based treatments for these morbidities. In response to this gap and recommendations from the Institute of Medicine on improving palliative care, the National Institutes of Health released a request for applications (RFA) in 2004 to encourage research directed at reducing barriers to the delivery of cancer symptom magement (RFA CA/NR-05-013). Interventions were to target (1)
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MASCC-0544 Evaluation of communication of patients laryngectomized
Objectives: To identify the HRQoL domains affected, and to correlate them with socio-demographic and clinical-therapeutic data of the sample. Methods: A descriptive and correlational study performed with 61 hematological cancer patients at the University of São Paulo at Ribeirão Preto Medical School Hospital das Clínicas. The instrument Quality of Life Questionnaire-Core 30 (QLQ-C30) was used. Results: The sample was composed mostly by men, over 40 years. The types of blood cancer were: non-Hodgkin lymphoma (36.07 %), Hodgkin’s lymphoma (31.15 %), leukemia (24.59 %) and others (8.20 %). The general quality of life was considered good (mean= 64.6), the functions ranged from fair to good: physical (61.1), social (54.4), cognitive (53.5), role (49.0) and emotional function (47.3). In symptom scales, loss of appetite, fatigue, pain, insomnia and constipation, the mean ranged from 42.9 to 55.0; nausea and vomiting, diarrhea and dyspnoea the mean ranged from 9.8 to 35.3. The result of Fisher’s exact test indicated that insomnia is associated with age (P=0.03) nausea and vomiting associated with cancer (P=0.03). The variable social function was associated with occupation (P=0.01) and income (P=0.04). Conclusions: It is important the knowledge of the healthcare team about the impact that the treatment causes in the lives of oncohematological patients in chemotherapy, considering the domains of HRQoL affected in the rehabilitation process.
N. Sawada1, J.M. Paula1, A.C. Nicolussi1, H.M. Sonobe1, J.A.P. Morero1, V. Andrade1 1 General of Specialized, College of Nursing at Ribeirão Preto at University of São Paulo, Ribeirão Preto São Paulo, Brazil
MASCC-0546 Evaluating the effects of denosumab on pain and analgesic use in giant cell tumor of bone (GCTB)
patient/family, (2) health care providers, and/or (3) health care system. Objectives: Summarize the outcomes from the funded RFA projects by describing targeted barriers, types and targets of tested interventions, and highlighting key findings. Methods: Final progress reports and published data from seminal articles emanating from the funded research projects were reviewed and summarized. Results: Sixteen intervention studies were funded and all but three completed the projects and provided final reports. Data for this presentation were derived from the 13 completed projects. Approximately 3,000 patients and families and 60 professional and lay health providers participated in the studies. Seven of the thirteen studies reported improvements in patient outcomes as a result of changes to the delivery of symptom management. Conclusions: All of the projects were labor intensive, with over 10,000 patients and families screened in order to achieve targeted sample sizes. A wide variety of outcome measures were used. Accruing patients and families from hospice settings was very challenging. Implications for future research and practice will be discussed.
Introduction: The main responsible for the breakdown of social interaction in people laringectomizadas, is the loss of verbal communication. Cancer of the larynx is one of the most common among those who reach the head and neck, representing approximately 25 % of malignant tumors that affect this area, and 2 % of all malignancies. Objectives: To evaluate the satisfaction of patients’ communication after total laryngectomy. Methods: Exploratory, cross-sectional, conducted with 50 laryngectomized patients in ambulatory head and neck of the “Hospital of Ribeirão Preto”. Data were collected using the Communication Assessment Questionnaire after Total Laryngectomy and quantitatively analyzed using the Statistical Package of Social Science Program Results: Analyzing the frequency distribution of the subscales, we found regarding the evaluation of functional communication, 33.6 % are in the maximum score, indicating they were satisfied with the functional issue, which evaluates voice quality in terms of intelligibility, volume, tone, fluency and intelligibility by phone. As for satisfaction assessment, which evaluates the satisfaction of communication after laryngectomy patients reported having a regular communication satisfaction, and most are between scores 3 and 4. Conclusions: This study showed that despite the patients being satisfied as to the functional assessment, are less satisfied with the new way to communicate. Therefore, the rehabilitation process is essential for laryngectomy patients can return to their daily lives and are able take satisfaction in communicating after surgery.
MASCC-0545 Assessment of health-related quality of life of hematological cancer patients during chemotherapy N. Sawada1, V. Andrade1, A.C. Nicolussi1, J.M. Paula1, G.P. Guerrero1, D.A. Saraiva1 1 General of specialized, College of Nursing at ribeirão Preto at University of São Paulo, Ribeirão Preto São Paulo, Brazil Introduction: The cancer diagnosis has affected the Health-Related Quality of Life (HRQoL) of cancer patients, including during chemotherapy.
J. Engellau1, J. Broto2, C. Cleeland3, K. Skubitz4, A. Staddon5, R. Blum6, M. Dominkus7, K. Ganjoo8, A. Feng9, I. Jacobs10 1 Department of Oncology, Lund University Hospital, Lund, Sweden, 2 COTMES (Comité de Tumores Músculo-Esqueléticos) Sarcoma and Melanoma Units, Hospital Universitari Son Espases, Palma de Mallorca, Spain, 3Department of Symptom Research Division of Internal Medicine, MD Anderson Cancer Center, Houston TX, USA, 4Masonic Cancer Center, University of Minnesota, Minneapolis MN, USA, 5 University of Pennsylvania School of Medicine, Philadelphia PA, USA, 6Beth Israel Medical Center, New York NY, USA, 7Medizinische Universitaet Wien, Wien, Austria, 8Stanford University Cancer Center, Stanford CA, USA, 9Biostatistics, Amgen Inc., Thousand Oaks CA, USA, 10Global Develoment-Oncology, Amgen Inc., Thousand Oaks CA, USA Introduction: GCTB is a rare, osteolytic tumor associated with severe pain. Denosumab inhibits RANKL, which is involved in the pathogenesis of GCTB. Objectives: To describe pain and analgesic use from a prespecified interim analysis of a phase 2 study of denosumab in GCTB patients. Methods: Patients (N=281) received denosumab 120 mg SC Q4W (loading doses, days 8 and 15). The Brief Pain Inventory-Short Form (BPI-SF) (0–10 points) was administered before each denosumab dose for 6 months and then Q3M. Analyses included the proportion of patients with clinically meaningful improvement in worst pain (≥2point decrease in BPI score in patients with baseline ≥2 points), proportion with no/mild worst pain (≤4 points) at baseline shifting to moderate/severe worst pain (>4 points), proportion with moderate/severe worst pain at baseline shifting to no/mild worst pain, and shift from baseline analgesic score on the Analgesic Quantification Algorithm (AQA) (0:no analgesics–7:strong opioids). Results: Starting at week 5, >50 % of patients had pain improvement at each visit through month 22. Throughout the study, ≤16 % (range: 0 %– 16 %) worsened from no/mild pain to moderate/severe pain. Up to 39 % (range: 4 %–39 %) of patients decreased analgesic use from strong opioids (≥3 points) at baseline to no/low analgesic use (≤2 points) at some time on study; very few (range: 0 %–4 %) increased from no/low analgesic use at baseline to strong opioid use.
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Conclusions: Denosumab was associated with clinically meaningful improvement in pain in GCTB patients. Pain improvement did not appear to be associated with increased analgesic use.
MASCC-0547 ‘Time to think about carers’ preparing and meeting the needs of family and friends who support people having chemotherapy R. Verity1, J. Sturt1, A. Metcalfe1 1 Florence Nightingale School of Nursing and Midwifery, King’s College London, London, United Kingdom Introduction: Most cancer patients receive chemotherapy as outpatients. Family and friends (carers) are relied upon to support them at home through toxic and lengthy treatments. Little is known about how health professionals could intervene to ensure that carers are equipped with the relevant skills and knowledge to support the patient. Objectives: This study aimed to identify potential interventions and strategies that health professionals could utilise to enhance the support they provide to carers. Methods: A collaborative, multi-strategy design was utilised, following the initial two iterative phases of the uk mrc (2008) framework for development and evaluation of complex interventions. The pre-clinical phase included a systematic review of carers needs, over 250 h of participatory observation, in-depth interviews exploring the perspectives of health professionals, carers and patients and identification of a theoretical base through a second review. The modelling phase aimed to develop components of an educational intervention for health professionals as well as potential tools that can be used to engage with carers. Results: The findings from the pre-clinical phase indicate that carers have numerous needs which are largely ignored in practice however health professionals’ needs and numerous challenges to effectively support carers is a neglected area in practice and research. Barriers to supporting carers include included lack of consultation skills and training to manage difficult family dynamics and patient/carer agendas. Conclusions: This presentation will discuss the barriers that can prevent carers receiving support from clinicians and offer strategies that could enable health professionals to engage and communicate with carers more effectively.
MASCC-0548 A prospective study of thyroid dysfunction following supraclavicular irradiation in the management of carcinoma of the breast S. Akyurek1, I. Bablioglu2, S. Yuksel3, S. Cakir Gokce2 1 Radiation Oncology, Ankara Üniversity Faculty of Medicine, Ankara, Turkey, 2Radiation Oncology, Ankara Üniversity Faculty of Medicine, Ankara, Turkey, 3Biostatistic, Ankara Üniversity Faculty of Medicine, Ankara, Turkey Introduction: Thyroid dysfunction is usually underestimated in patients with breast cancer following supraclavicular irradiation. Objectives: To evaluate the relationship between irradiation and early thyroid dysfunction, focusing on radiation dose-volume factors. Methods: Twentyone patients with breast cancer received supraclavicular irradiation were evaluated. Thyroid function tests, including serum thyroid stimulating hormone (TSH), free thyroxine (fT4), free triiodothyronine (fT3), were analyzed prior to irradiation and every 3 months the first year and then 18th month after radiotherapy. Dose volume histogram (DVH), mean radiation dose the thyroid and percentages of thyroid volume which received radiation doses 10–60Gy (V10–V60) were considered for statistical analysis Results: Mean TSH levels before irradiation, at 3, 6, 9, 12 and 18 months were 1.4 μIU/ml, 1.6 μIU/ml, 1.7 μIU/ml, 3.6 μIU/ml,
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5.05 μIU/ml, and 5.32 μIU/ml respectively. Serum TSH levels did not change significantly at 3 and 6 months after irradiation (p =0.1). However, significant elevation was noted at 9 months (p=0.013). Mean thyroid dose was 32 Gy (19–48 Gy) and mean thyroid volume was 35 cc (24–64 cc). Median values of V10–20–30–40–50–60 were 68 %, 58 %, 55 %, 53 %, 48 % and 0 %, respectively. We could not show significant relationship between the dose-volume factors and development of hypothyroidism. The median follow-up was 18 months (range, 12–24 months). Four patients (19 %) were diagnosed with hypothyroidism, 1 (5 %) developed clinical hypothyroidism and 3 (14 %) had subclinical hypothyroidism Conclusions: Irradiation of supraclavicular region in breast cancer patients may lead to early thyroid dysfunction. This damage is initially manifested within 9 months after radiotherapy.
MASCC-0549 In vivo monitoring of cisplatin-induced substance P release in the medulla of rats measured by brain microdialysis K. Yamamoto1, A. Tasaka1, S. Kim1, A. Yamatodani1 1 Graduate School of Allied Health Sciences Faculty of Medicine, Osaka University, Suita Osaka, Japan Introduction: Neurokinin NK1 receptor antagonists clinically improved antiemetic outcomes in patients receiving cisplatin. Since they act centrally to inhibit the emesis, it has been postulated cisplatin-induced emesis is mediated by a substance P (SP) pathway in the central nervous system, however, the precise etiology remains unclear. Objectives: To elucidate a role of SP in the central regulation of cisplatin-induced emesis, we investigated the effect of cisplatin on time-dependent changes in SP release in the medulla of rats measured byin vivo brain microdialysis. Methods: A guide cannula was implanted and fixed into the medulla of rats. After recovery, a microdyalysis probe was inserted through the cannula and it was perfused with artificial cerebrospinal fluid. Following an equilibration period, rats were injected with cisplatin (6 mg/kg, i.p.) with or without 5-HT3 receptor antagonist, granisetron (0.1 mg/kg, i.p.), and dialysate samples were continuously collected for 24 h. SP contents in samples were analyzed by an ELISA assay kit. Results: Cisplatin significantly increased in medullary SP release after 12 h of the injection and the increase was continued throughout the sampling period. Treatment with granisetron completely inhibited the cisplatin-induced increase of SP release. Conclusions: We have already found that cisplatin (6 mg/kg) induced pica behavior, which correlates with emesis in humans, in rats within 12 h and the behavior was effectively inhibited by granisetron (0.1 mg/kg) and NK1 receptor antagonist, aprepitant (2 mg/kg) Results suggest the SP release in the medulla via 5-HT3 receptor and the activation of NK1 receptor are involved in the development of cisplatin-induced emesis in rats.
MASCC-0550 Relationship between shoulder mobility, fatigue and quality of life among post mastectomy patients—results of 6 month surveillance from premiere regional cancer centre in India S. Madhavan Sasidharan1 , V. Srinivasan 1 , V. Surendran 2 , N. Vasumathy1 1 Physiotherapy, Cancer Institute (WIA), Chennai, India, 2Psycho-Oncology, Cancer Institute (WIA), Chennai, India Introduction: Breast cancer is one of the most common malignancies affecting women worldwide. The incidence rate of breast cancer at our
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Cancer Institute in 2007–08 is 23.5 %. In Chennai the Breast cancer has significantly raised from 14.3 % in 1982 to 24.4 % in 20041. Post mastectomy complications can be a significant factors resulting in discomforts in daily living and decreasing the Quality of Life (QOL). Objectives: To assess the QOL and Shoulder Range of Motion (ROM) of Mastectomy patients and also to explore the relationship between shoulder ROM, Fatigue, Body image and QOL. Methods: Post mastectomy female patients (n=95), age range between 23 and 78, who reported to Physiotherapy OPD from July to December 2012 were assessed for their Shoulder ROM using Goniometer and Cancer Institute-QOL questionnaire2. Data analysed using SPSS 13 Software. Results: 3.2 % of patients had vey low QOL, 12.6 % of them reported low QOL, 44.2 % had average QOL, 32.6 % found to have high QOL and 7.4 % had very high QOL. 61.1 % achieved full ROM, 57.9 % of patients had fatigue. QOL, Body Image, Physical well being, Psychological well being, Sexual and personal ability were significantly related to Fatigue. QOL, Body image and Physical well being were significantly related to ROM Conclusions: Most patients had Better QOL. References 1. Swaminathan R, Shantha V, Balasubramaniam S & Sampath P. (2010). Cancer Incidence and Mortality in Chennai, India: 2006–2008. National Cancer Registry Program, Cancer Institute (WIA), Chennai. 2. Vidhubala.E., et al., Cancer Institute Quality of life Questionnaire (CI-QOL), Indian Journal of Cancer, 2005.
MASCC-0551 Relationship between oral health perception and nutritional status in senior cancer patients: preliminary results N. El Osta1, L. El Osta1, H.R. Kourie2, M. Hennequin1, S. TubertJeannin1, M. Ghosn2 1 Public Health, Faculty of Medecine Saint Joseph University, Beirut, Lebanon, 2Hematology-Oncology Department, Faculty of Medecine Saint Joseph University, Beirut, Lebanon Introduction: Malnutrition is a major cause of morbidity and mortality in elderly. The role of anticancer treatment in inducing oral problems and thus malnutrition in aging patients has not been studied so far Objectives: This study aims to investigate the relationship between oral health perception and nutritional status in this population Methods: Patients were recruited from an oncologic and primary care outpatient units in Lebanon. They completed the Lebanese version of the Geriatric Oral Health Assessment Index questionnaire and the Arabic version of the Mini Nutritional Assessment index, to assess respectively the oral health perception and the nutritional status during the last 3 months. Results: Ninety five patients participated in our study: 22 cancer patients on active chemotherapy, 23 patients on hormonal treatment, 18 cancer patients in complete remission, and 32 non-cancer patients. Mean age was 71 years (range, 65–86 years). Oral health perception and nutritional status were significantly different between groups (-pvalue<0.05). They were significantly worse in cancer patients on hormonal treatment, and the worst in chemo-treated patients. These patients reported limiting kinds and amount of food (-p-value=0.009), trouble biting or chewing (-p-value=0.005), and felt uncomfortable while eating in front of others (-p-value=0.046), due to oral problems. Significant association was found between oral health perception and nutritional assessment (-p-value=0.001) Conclusions: Elderly cancer patients on treatment need better mouth care. Their oral health perception might be an additional risk factor of malnutrition. Thus, oncologists must be aware about oral problems and their effects in elderly while receiving anticancer treatment.
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MASCC-0552 Characteristics and outcomes of patients admitted to the acute palliative care unit (APUC) from the emergency center (EC) versus inpatient transfers (IP) S. Seonghoon1, E. Bruera2, D. Hui2, G.B. Chisholm3, J.H. Kwon4, M.T. San-Miguel5, J.A. Allo2, S. Yennurajalingam2, S.E. Frisbee-Hume2 1 Hemato-Oncology Internal Medicine, Kosin University Gospel Hospital, Busan, Korea, 2Department of Palliative Care and Rehabilitation Medicine, The University of Texas MD Anderson Cancer Center, Houston, USA, 3Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, USA, 4Department of Internal Medicine, Kangdong Sacred Heart Hospital Hallym University, Chuncheon, Korea, 5Department of Palliative Medicine, Clinica Universidad de Navarra, Nvarra, Spain Introduction: We hypothesized that EC admissions have different characteristics. Objectives: We compared the symptom burden and survival between both groups. Methods: Among all 2,568 patients admitted to our APCU between September 1, 2003 and August 31, 2008, 312 (12 %) were EC patients. We randomly selected 298 IP patients as controls. We retrieved the patient demographics, cancer diagnosis, ESAS, discharge outcomes, and overall survival from time of admission. Results: EC patients were more like to be black (22 % v 11 %, p=0.0006) and less likely to have hematologic cancer (5 % v 14 %, p=0.0003). EC patients had higher pain (5.4 v 4.6, p=0.0004), fatigue (6.7 v 6.1, p= 0.0049), nausea (2.7 v 1.6, p<0.0001), insomnia (4.8 v 4.2, p=0.03) and were less likely to be delirious (41 % v 55 %, p=0.001). EC patients had more public insurance (44 % v 38 %, p=0.0142), more home discharge (29 % v 11 %, p=0.0001), longer admission (8 v 7 days, p=0.0002), and were 2.3× as likely to be discharged alive as compared to IP patients (p< 0.0001). Kaplan–Meier plots and log-rank test for Survival from admission of APCU for EC and IP groups were not statistically significant (Median survival after admission were 34 v 31 days, p=0.08). In multivariate analysis, EC admission (OR=1.9, 1.2–3.0), wellbeing (OR=1.12, 1.02–1.23), dyspnea (OR=0.85, 0.79–0.92) and delirium (OR=0.39, 0.24–0.64) were independently significant for being discharge alive. Odds Ratio Estimates (c-statistic=0.71) Effects
OR
95 % Wald Confidence Limits
Group (EC v IP)
1.9
1.2
3.0
Delirium (Yes v No)
0.4
0.24
0.64
Wellbeing (per point increase)
1.12
1.02
1.23
Shortness of Breath (per point increase)
0.85
0.79
0.92
Conclusions: EC patients have higher acute symptom burden, but more likely to be discharged alive as compared to IP patients. The APCU is successful at managing symptoms and facilitating discharge to community for EC patients. MASCC-0553 Supportive social care for oncologic patients in Lebanon: family and volunteers single institution experience. H.R. Kourie1, L. EL OSTA2, S. Achkar1, J. Antoun1, S. Faddoul1, O. Salameh1, M. Ghosn1 1 Hematology-Oncology Department, Faculty of Medecine Saint Joseph University, Beirut, Lebanon, 2Public Health, Faculty of Medecine Saint Joseph University, Beirut, Lebanon Introduction: Many aspects of the supportive care were studied and discussed in different studies but the importance of the families and volunteers role was rarely elaborated. The family
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unity and solidarity characterizes the Middle Eastern and Lebanese societies. Tight family members’ relationship and volunteers activities, affect positively the psychological and social status of oncologic patients. Objectives: We aim in this study to evaluate and quantify the impact of the family and volunteers on the quality of life of the oncologic patients socially, psychologically and morally Methods: One Hundred patients with hematologic or solid tumor malignancies, aged between 18 and 70 years old, admitted to the department of hematology and oncology in Hotel Dieu de France University Hospital Beirut, were included in our study. Patients in different stages of evolution, including the palliative care, were interviewed Results: Preliminary results of the study showed that the majority of patients evaluated positively the role of the family and volunteers on their quality of life. Females, married persons, patients at extreme ages (18–25 years old and >60 years old), and patients having more than one sibling highlighted the positive impact of the familial support on their disease evolution. Singles and patients having one sibling or less considered that volunteers support was primordial to face their illness. Detailed results are still under process Conclusions: Social and moral support provided by families and volunteers are integrant part of the supportive care and have a direct influence on the quality of life of oncologic patients.
MASCC-0554 Changes of functional status and quality of life in Limb Salvage surgery for lower limb bone tumors S. Madhavan Sasidharan 1, V. Srinivasan 1, N. Kathiresan2, V. Surendran3 1 Physiotherapy, Cancer Institute (WIA), Chennai, India, 2Surgical Oncology, Cancer Institute (WIA), Chennai, India, 3Psycho-Oncology, Cancer Institute (WIA), Chennai, India Introduction: Medical advancements in the management of bone tumors have markedly improved the morbidity following Limb Salvage surgery (LSS) Objectives: The Purpose of the study were to (1) Evaluate the Quality of Life (QOL) at 6 months post surgery, (2) Explore the 1 year changes of QOL and (3) Identify the Correlation between QOL and Functional Status among patients with primary bone tumors of lower limb treated with LSS Methods: Disease Free Status Patients who underwent LSS (n=96) age range between 18 and 53, diagnosed with osteosarcoma (81.3 %) and other bone tumors (18.7 %); reconstructed with prostheses were assessed for QOL and functional status using Cancer Institute QOL Questionnaire1 and Musculo Skeletal Tumor Society (MSTS) scale2 at 6 months. A follow up assessment was taken between 12 and 15 months (n=85). Descriptive statistics and paired ‘t’ test were used for analysis Results: At 6 months, 50 % of the patients had average QOL, 41.7 % reported as high, 4.2 % as very high and 4.2 % as low. There is a significant improvement in the QOL and functional status between the two assessments of QOL, General Well Being, Physical Well Being, Cognitive well Being, Body image and MSTS Score. However, Psychological wellbeing had decreased significantly at the follow-up assessment Conclusions: Though majority of patients report better QOL, future studies can compare subjective report of QOL and objective physical assessments over different time periods following surgery References: 1. Vidhubala.E., et al., Indian Journal of Cancer, 2005. 2. Enneking WF., et al., Clin Orthop Relat Res.1993.
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MASCC-0555 Viscum Album [L.] extract therapy versus no antineoplastic therapy in patients with locally advanced or metastatic pancreatic cancer: a randomized confirmatory clinical trial (ISRCTN 70760582) W. Tröger1, M. Reif2, D. Galun3, A. Schumann2, N. Stankovic4, M. Milicevic5 1 Med. Writing, Clinical Research Dr. Tröger, Freiburg, Germany, 2 Statistics, Institute for Clinical Research, Berlin, Germany, 3HBP Surgical Department, First Surgical Clinic of the Clinical Centre of Serbia (CCS), Belgrade, Serbia, 4Monitoring, Clinicobss, Belgrade, Serbia, 5Belgrade School of Medicine, University of Belgrade, Belgrade, Serbia Introduction: The prognosis of advanced pancreatic cancer is devastating. Viscum album extract (VaL) has cytotoxic and immunomodulating properties and is licensed in Central Europe for cancer treatment Objectives: To compare overall survival (OS) and quality of life (QoL) of patients with locally advanced or metastatic adenocarcinoma of the pancreas receiving VaL or no antineoplastic therapy Methods: In an open-label, group-sequential, randomized controlled trial patients, ineligible for Gemcitabine or other therapies, were stratified for good/poor prognosis—a composite index of age, UICC and ECOG—and received best supportive care alone or additional s.c.injections of VaL (Iscador® Qu special) up to 10 mg thrice weekly. Primary endpoint was OS. Secondary efficacy parameters were the dimensions of the EORTC QLQ-C30. Tumour-related symptoms and body weight were recorded at each visit Results: This first interim analysis examined 110 control and 110 VaL patients (mean age 63.3 years, 128 male patients, 99 UICCIV, 108 ECOG≥2). Median OS of VaL versus control was 4.8 vs. 2.7 months (HRadjusted =0.485; p<0.0001). For 13 of the 15 QoL dimensions a significant advantage of VaL was observed (p < 0.001). Ten dimensions showed a clinically relevant improvement of ≥10 units, from 11.4 (nausea/vomiting) and 23.5 (global health status/QoL) to 43.5 (appetite loss). Analysis of tumour-related symptoms, and change in body weight (post-hoc), confirmed the favourable effects on QoL. No VaL-related adverse events (AE) or serious AE were observed Conclusions: VaL therapy led to a relevant increase of OS and QoL without causing severe side-effects. VaL may provide comprehensive supportive care for advanced pancreatic cancer patients.
MASCC-0556 Latent trait examination of the patient satisfaction with interpersonal relationship with navigator scale in a multicultural sample: an item response theory analysis approach C. Shao1, P. Jean-Pierre1, Y. Cheng1, E. Paskett2, K. Fiscella3 1 Psychology, University of Notre Dame, Notre Dame, USA, 2Ohio State University Research Foundation Comprehensive Cancer Center, Ohio State University, Cleveland, USA, 3Family Medicine Research, University of Rochester Medical Center, Rochester, USA Introduction: Patient Navigation is an important tool to reduce cancer disparities. We previously developed and validated a PatientSatisfaction-With-Interpersonal-Relationship-With-Navigators (PSNI) scale using classical test theory Methods. Objectives: To calibrate items of the PSN-I using item-responsetheory-analysis (IRT) and determine item-level psychometric properties to facilitate immediate latent trait scoring Methods: We applied unidimensional-IRT to data from 751 participants (82.48 % female; age 18 to 86 years) using an unconstrained Graded Response Model (GRM), and a Rasch Model (RM) with the
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MASCC-0557 Meta-analysis of plasma proteins effects on food intake and growth rate, in weanling animals: implications for dietary improvement in clinical involuntary weight loss
Objectives: To address gaps in the current state of science related to lymphedema in HNC patients. Methods: We are undertaking a series of studies related to lymphedema in this population exploring prevalence, symptoms, measurement techniques, and symptom assessment tools. Study 1: A cross-sectional study of HNC patients ≥3 months or more post-treatment. Study 2: Measurement comparison of swelling pre-treatment and 6 and 12 weeks post treatment using CTCAE v.4.02 criteria and digital photography with grid overlay for external swelling and endoscopic examination with use of Patterson Scale for internal swelling. Study 3: Longitudinal study of patterns of internal and external swelling. Study 4: Symptom assessment tool development. Results: Study 1: (N=81). 75.3 % had late-effect lymphedema. Of these 9.8 % only had external lymphedema, 39.4 % only had internal lymphedema, and 50.8 % had both types. Study 2: (N=25). At baseline, digital photography identified external swelling more often than CTCAE criteria (p=0.010). Internal swelling was identified in 10 patients at baseline, of whom only 4 had prior surgery. Ultimately, case identification merged among all measures at 6 and 12 weeks post-treatment. Digital photography captured 100 % of the internal cases and 92 % of the cases identified by CTCAE criteria. Study 3: Data will be presented from those enrolled in the study as of 4-1-2013. Study 4: (N=30). 10 symptoms were reported by over 50 % of patients Conclusions: A majority of HNC patients experience problematic lymphedema. Non-invasive assessment Methods can inform clinical practice.
G. Klein1, E.W. Weaver1, R. Kuchibhatla2, A. Shaw3 1 R & D, Entera Health, Cary, USA, 2Biostatistics, QED, Cary, USA, 3 Clinical Research, Entera Health, Cary, USA
MASCC-0559 Hepatitis C virus screening prior to chemotherapy
discrimination parameter set to be equal across items. We obtained fit indices and performed models comparison using likelihood ratio (LR)test and information criteria. We computed item/latent trait parameter estimates, category/operating characteristic curves, and tested information curves for the better-fitting model. Results: Log-Likelihood for the RM and GRM were −3470.653 and −3445.966. The LR-test (LR=49.37, df=8, p<0.001) supported the GRM. The AIC of the RM vs. GRM were 7015.305 vs. 6981.932, and the BIC were 7186.297 vs. 7189.986, respectively. The very small margin of difference for the BIC across models, large calibration sample, item parameter estimates (IPEs) with substantial variations in items’ discrimination parameters (1.7 to 2.9), and LR-test supported the fit of the GRM. Albeit a slightly larger BIC due to its complexity, the GRM fits better Conclusions: The GRM provides precise IPEs to enable scores comparison across subsets of items. IPEs can be adopted to estimate patient’s satisfaction with navigators. The findings will inform the development of a PSN-I Computerized Adaptive Testing (CAT) system, where patients will receive optimally selected items to measure their satisfaction level.
Introduction: Early weaned animals are immunocompromised, exhibiting increased inflammatory markers, (IL-1, IL-6, TNFα, INFγ) with associated decreased food intake, weight loss, and increased mortality. Studies administering PP to these animals report improvements in these conditions. A meta-analysis was undertaken to determine the efficacy of PP on early weaned animals. Cancer patients are also immunocompromised, and may develop cachexia with similar symptoms, including increased mortality. Objectives: This meta-analysis evaluated plasma proteins’ ability to promote food intake and weight gain in early weaned animals. Methods: MEDLINE, EMBASE, and PubMed were searched from 1980 through August, 2012 for specific terms and keywords. 57 articles retrieved through this process were included. The meta-analysis included descriptive analyses and Methods for combining p-values for the primary endpoint (Average Daily Growth [ADG] at Week 1) and secondary endpoints ADG, Average Daily Feed Intake [ADFI], and Gain/Feed Ratio [G:F] at Weeks 1, 2, and End-of-Study [EOS]) Results: Primary and secondary endpoint analyses werestatistically significant (p<0.05) with one exception. ADG, ADFI, and G:F increasedwith PP in all species combined, and in pig studies alone versus control Conclusions: Plasma proteins produced consistently positive effects across multiple species on increased food intake, body weight, and growth. Additional research in patients experiencing involuntary weight loss with compromised nutritional status will further characterize the benefits of plasma protein in clinical populations.
MASCC-0558 Lymphedema in patients with head and neck cancer S. ridner1, J. deng1, B.A. murphy2, A.J. moore2, M.S. dietrich1 1 School of Nursing, Vanderbilt University, Nashville, USA, 2School of Medicine, Vanderbilt University, Nashville, USA Introduction: Little is known about lymphedema in patients with head and neck cancer (HNC).
J. Hwang1, M. Suarez-Almazor1, S. Palla2, D. Huang1, H. Torres3, M. Fisch4, A. Lok5 1 General Internal Medicine, The University of Texas MD Anderson Cancer Center, Houston, USA, 2Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, USA, 3Infectious Diseases, The University of Texas MD Anderson Cancer Center, Houston, USA, 4 General Oncology, The University of Texas MD Anderson Cancer Center, Houston, USA, 5Internal Medicine, University of Michigan, Ann Arbor, USA Introduction: The US Centers for Disease Control recommends hepatitis B virus screening before chemotherapy to prevent reactivation. Hepatitis C virus (HCV) reactivation can also occur during chemotherapy. There are no recommendations on HCV screening prior to chemotherapy. Objectives: To determine predictors of HCV screening prior to chemotherapy. Methods: We conducted a retrospective cohort study in adult patients with cancer seen at MD Anderson between 1/2004–4/2011. Screening was defined by HCV antibody test ordered before second chemotherapy cycle. Multivariable logistic regression model was fit for the odds of screening. Results: Of 16,898 patients, 2,345 (13.9 %) were screened, more frequently in patients born after 1,965 (OR 1.9;1.6–2.2) compared to those born between 1945 and 1965. Screening was less common among black (OR 0.7,0.6–0.9) compared to white patients. Patients with HCV risk factors had significantly higher odds of screening. Screening was more frequent among patients with hematologic malignancies than patients with solid tumors (OR 60.8, 52.7–70.2). Patients who received rituximab had higher odds (OR 16.8, 12.5–22.7) of screening than those receiving chemotherapy. Overall, 1.5 % of those screened had HCV antibody. HCV antibody was positive in a higher percent of black (2.2 %) vs. white (1.6 %) patients and in patients born in 1945–1965 (2.4 %) vs. after 1965 (0.7 %). Conclusions: Approximately 14 % of patients had HCV screening prior to chemotherapy. Current screening strategies failed to target
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patients who were more likely to test positive. Future work is necessary to determine the incidence of HCV reactivation and the need for HCV screening prior to chemotherapy.
MASCC-0560 Adiponectin: a novel biomarker for cancer related fatigue? D. Barton1, H. Liu2, A. Tan2, J. Sloan2, S.R. Dakhil3, C.L. Loprinzi1 1 Cancer Center, Mayo Clinic, Rochester, USA, 2Biostatistics, Mayo Clinic, Rochester, USA, 3Oncology, Wichita Community Clinical Oncology Program, Wichita, USA Introduction: Fatigue is a prevalent and bothersome symptom experienced by cancer survivors. There are no known fully effective treatments, likely due to incomplete knowledge of critical physiologic targets. Adiponectin, a protein secreted by adipocytes, has a role in energy, inflammation, and the metabolism of glucose and lipids. Based on its function, we evaluated adiponectin’s association with cancer related fatigue (CRF). Objectives: To evaluate the role of adiponectin in CRF. Methods: EDTA blood was collected as part of Alliance N07C2, a phase III randomized controlled trial evaluating American Ginseng for CRF. Participants in this correlative study were not concurrently receiving anticancer therapy and had to have at least moderate fatigue (4+ on 0–10 scale). Fatigue was measured with the Multidimensional Fatigue Symptom Inventory-Short Form, General Fatigue Subscale and both adiponectin (analyzed by radioimmunoassay, ng/ml) and fatigue were measured before and after 4 weeks of ginseng/placebo. Exploratory descriptive and spearman correlational analyses were done. Results: One hundred seventy-three participants contributed blood. At baseline and 4 weeks, adiponectin concentrations were significantly correlated with fatigue, r=0.25, p.006, r=.23, p=.02, respectively. In the ginseng arm (N=75), those reporting at least a 10 % fatigue improvement had a mean increase in adiponectin (904 units), versus a mean decrease (274 units), in those reporting no improvement (p=0.12). In multivariate analysis, controlling for several variables including BMI and exercise, adiponectin significantly predicted baseline fatigue (p=.03). Conclusions: These exploratory data provide support for the hypothesis that adiponectin levels may be an important biomarker/target for fatigue. Future longitudinal studies should clarify its role, be it energy balance or anti-inflammatory.
MASCC-0561 Distress experience in women with newly diagnosed breast cancer A. Nirenberg1, L. Almond1, A. Swistel2 1 Hunter-Bellevue School of Nursing, Hunter College, New York, USA 2 Breast Surgery Center, Weill-Cornell Medical College, New York, USA Introduction: We have observed that patients with solid tumors who have positive biopsies awaiting definitive surgery for staging and grading appear to be anxious and stressed during this time, not knowing the extent of disease or what further treatment regimen will be Objectives: In order to begin to characterize time course, range and acute consequences of distress and anxiety in women in early phases of breast cancer care we aim to explore, describe, examine relationships of distress during the time interval between a biopsy-proven diagnosis of breast cancer and definitive surgery. Methods: This descriptive pilot study uses prospective, repeated measures design to examine changes in self-reported distress and anxiety in women with newly-diagnosed breast cancer awaiting definitive breast cancer surgery. We obtain demographic information and satisfaction with social support. On day of enrollment and at timed intervals within
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this time frame, the Distress Thermometer (DT) and Hospital Anxiety Depression Scale (HADS) are administered Results: Relationships of variables relevant to psychological distress between timed responses for each subject, differences by HADS and DT scale cut-off scores and problem categories with each of the dependent variables across time are examined. Comments from the participants that inform significant relationships are categorized. Pathology reports from the definitive surgery are examined to investigate relationships between extent of disease, biomarkers and mitotic indices to investigate instrument score correlations Conclusions: This study provides preliminary data for a larger study incorporating biologic markers that may influence breast cancer progression. Psychosocial factors may play roles in cancer progression.
MASCC-0562 Can gabapentin improve control of delayed nausea and vomiting (n/v)? A phase III placebo controlled trial, N08C3 (alliance) D. Barton1, J.A. Sloan1, P.J. Novonty1, J. Fuloria2, L. Kottschade1, A.P. Lyss3, A.J. Jaslowski4, M.A. Mazurczak5, S.C. Blair6, S.A. Terstriep7, C.L. Loprinzi1 1 Cancer Center, Mayo Clinic, Rochester, USA, 2Cancer Center, Ochsner Clinic, New Orleans, USA, 3Cancer Center, Missour Baptist Medical Center, St. Louis, USA, 4Cancer Center, St. Mary’s Hospital Medical Center, Green Bay, USA, 5Cancer Center, Sanford Cancer Center Oncology Clinic, Sioux Falls, USA, 6Cancer Center, Columbus Oncology & Hematology Associates, Columbus, USA, 7Cancer Center, Sanford Medical Center, Fargo, USA Introduction: Effective treatments for delayed chemotherapy induced nausea and vomiting (CINV) are needed. Pilot data support further evaluation of gabapentin delayed CINV. Objectives: To evaluate the effectiveness of gabapentin for CINV due to highly emetogenic chemotherapy (HEC). Methods: Patients receiving HEC were randomized to prophylaxis with 20 mg dexamethasone + 5HT3 receptor antagonist on the day of chemotherapy, followed by dexamethasone with gabapentin 300 mg BID or placebo, first cycle. Gabapentin/placebo began the evening of chemotherapy through day 5. Dexamethasone was 8 mg BID days 2–3, then 4 mg BID day 4. Primary endpoint, complete response (CR), was defined as no emesis, no rescue medication days 2–6, per nausea/vomiting diary. Percent CR were compared between groups by Fisher’s exact test. Secondary outcomes included the FLIE, satisfaction, and side effects. Results: 430 patients were enrolled. There was no significant difference in CR between gabapentin (47 %) and placebo (41 %) (p=.23). Per the FLIE and diary, there were no differences in nausea days 2–6 between arms. Overall mean nausea, days 2–6, was 1.1 and 1.2 (0–10 scale) for the gabapentin and placebo arms, respectively. Altogether, 17 % of patients reported nausea ≥2.5 during days 2–6. Mean diary nausea satisfaction was 8.3 for gabapentin/dexamethasone and 8.1 for placebo/dexamethasone (p =.33). There were no differences in unwanted side effects. Conclusions: Overall, gabapentin was well tolerated but does not appear to improve delayed nausea and vomiting significantly over dexamethasone alone. Nausea severity was low for the group as a whole and patients were satisfied with nausea control.
MASCC-0563 The role of the meaning system in the adjustment to cancer N.F. Uwland1, A. Visser1, A. Garssen1, G.J. Westerhof2 1 Research, Helen Dowling Institute, Bilthoven, Netherlands, 2Department of Psychology Health & Technology, University of Twente, Enschede, Netherlands
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Introduction: The meaning system of the person may facilitate or impede his/her adjustment to the experience of cancer. Objectives: We have investigated if and how spiritual meaning systems (meaning systems that contain elements that relate to the transcendent) facilitate the adjustment to cancer Methods: Twenty persons took part in semi-structured interviews on their experiences with cancer during the past year. Using a grounded theory approach, information on the interviewees’ meaning system, coping style and well-being was coded. The relationships between these concepts were investigated with a narrative approach. Results: Four types of meaning system emerged: Omnipresent Transcendent (OT), Accompanying Transcendent (AT), Enclosed Transcendent (ET), and Absent Transcendent (NT). The persons with the OT meaning system seemed to be well-adjusted to the experience of cancer (they described integration of the experience in their lives and a positive outlook). The persons with the AT and NT seemed to be somewhat adjusted, while those with the ET meaning system showed the least adjustment. Interestingly, each type of meaning system appeared to have elements that might impede adjustment to cancer. For example, persons with an OT meaning system who described that they were not able to ascribe Transcendent Meaning to the experience of cancer seemed to have trouble adjusting to it. Conclusions: Although the persons with a more spiritual meaning system seemed better adjusted to the experience of cancer, having such a meaning system does not guarantee adjustment. Awareness of the pitfalls of each meaning system might help cancer caregivers to facilitate their patient’s adjustment to cancer.
MASCC-0564 Randomized prospective double-blind placebo-controlled trial of celecoxib for radiation-induced oral mucositis R.V. Lalla1, L.C. Choquette1, K.F. Curley2, R.J. Dowsett3, R.S. Feinn4, U.P. Hegde5, C.C. Pilbeam6, A.L. Salner7, S.T. Sonis8, D.E. Peterson1 1 Oral Medicine, University of Connecticut Health Center, Farmington, USA, 2Clinical Research Center, University of Connecticut Health Center, Farmington, USA, 3Radiation Oncology, University of Connecticut Health Center, Farmington, USA, 4 Medical Sciences, Quinnipiac University, Hamden, USA, 5Medical Oncology, University of Connecticut Health Center, Farmington, USA, 6Medicine, University of Connecticut Health Center, Farmington, USA, 7Radiation Oncology, Hartford Hospital, Hartford, USA, 8Oral Medicine, Brigham and Women’s Hospital, Boston, USA Introduction: Oral mucositis (OM) is a painful complication of radiation therapy (RT) for head and neck (H&N) cancer. OM can compromise nutrition, require opioid analgesics and hospitalization for pain control, and lead to treatment interruptions. Evidence suggests that inflammatory pathways contribute to pathogenesis of OM. Objectives: To investigate the effect of cyclooxygenase-2 (COX-2) inhibition during RT on severity and morbidity of OM. Methods: Forty H&N cancer patients were randomized to daily use of 200 mg celecoxib or identical placebo, for the duration of RT. The planned sample size of 20 per arm provided 80 % power to detect a 1 point difference in mean Oral Mucositis Assessment Scale (OMAS) score (range 0–5) at 5,000 cGy RT (primary endpoint), when applying a two-tailed, two-sample t-test at the 5 % level of significance. Clinical OM, normalcy of diet, pain scores and pain medication use were assessed 2–3 times per week by blinded investigators during the 6– 7 week period of RT, using validated scales. Results: Twenty subjects were randomized to each arm. Intent-to-treat analyses demonstrated no significant difference in mean (SD) OMAS scores at 5,000 cGy [celecoxib 1.32 (0.71), placebo 1.27 (0.86), p=
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0.83]. In addition, there was no difference between the celecoxib and placebo groups in mean OMAS scores over the period of RT, mean worst pain scores, mean normalcy of diet scores, or mean daily opioid medication use in IV morphine equivalents. Conclusions: Daily use of a selective COX-2 inhibitor did not reduce severity of radiation-induced OM, pain, dietary compromise or opioid analgesic use.
MASCC-0565 The effect of radiotherapy on the primary deciduos enamel: analyses μ-EDXRF and FT-Raman E.M. Ferreira1, H.S. Antunes2, S.T. Uemura1, P.S. Barbosa1, H. Salmon3, A.A. Martin4, L.E. Soares4, G.R. Sant’Anna1 1 Odontologia, Universidade Cruzeiro do Sul, São Paulo, Brazil, 2 Pesquisa Clínica, Instituto Nacional de Câncer, Rio de Janeiro, Brazil, 3 Radioterapia, Clínicas Oncológicas Integradas (COI), Rio de Janeiro, Brazil, 4 Laboratório de Espectroscopia Vibracional Biomédica (LEVB), IP&D, São José dos Campos, Brazil Introduction: Radiation-induced caries is a major complication after the treatment of head and neck cancer patients undergoing radiotherapy. It has a rapid development resulting destruction and tooth loss. Objectives: Investigate the molecular and compositional structure of primary enamel subjected to radiotherapy. Methods: Caries free deciduous molars were used and longitudinally sectioned. Teeth were evaluated at two moments: before radiotherapy (1G1) and after (2G1). The irradiation protocol was 54 Gy, 2 Gy/day, 5 days, 6 weeks, the dose was delivered to the teeth buccal surface with a linear accelerator (6 Mv). For evaluation of organic and inorganic of primary enamel components was used two Methods: Fourier transformed spectroscopy (FT-Raman) and by micro energydispersive X-ray fluorescence (μ-EDXRF). Results: The study power test was 0.80. Paired t Student test was used for statistical analysis. The FT-Raman evaluation demonstrated that the relative area of the organic content (2,940/960 cm−1) was 3.83 (1G1) and 3.42 (2G1), p=0.000; carbonate (1,070/960 cm−1), 1.26 (1G1) and 1.23 (2G1), p=0.220, phosphate (430/960 cm−1), 1.02 (1G1) and 1.01 (2G1), p=0.661. Using μ-EDXRF analysis, the average of weight percentage of calcium was 26.80 (1G1) and 28.44 (2G1), p=0.438; phosphorus, 15.54 (1G1) and 16.03 (2G1), p=0.411, oxygen, 57.68 (1G1) and 55.52 (2G1), p=0.318 and the Ca/P ratio, 1.71 (1G1) and 1.77 (2G1), p=0.115. Conclusions: The primary enamel after radiotherapy showed a significant reduction of the organic content however, there was no change in mineral structure, showing that the enamel structure can not interfere directly as a determinant risk factor for the development of radiation caries, which warrants further studies.
MASCC-0566 Associations between medications and hyposalivation among hematopoietic stem cell transplantation (HSCT) recipients M. Mauramo1, L. Rohde2, T. Waltimo2, A. Rovo3 1 Department of Oral and Maxillofacial Diseases, Institute of Dentistry, University of Helsinki, Finland, 2School of Dental Medicine, Institute of Preventive Dentistry and Oral Microbiology, University of Basel, Switzerland, 3University Hospital Basel, Division of Hematology, Basel, Switzerland Introduction: We have shown hyposalivation and subjective oral dryness to be common in HSCT recipients.1,2 Oral dryness predisposes recipients to oral diseases and correlates with poor quality of life. Thus, studies focusing on the etiology of hyposalivation are needed.
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Objectives: Medications are a common cause of hyposalivation. As a large variety of medications are required in HSCT, this study examines the associations of medications with saliva flow rates in HSCT recipients. Methods: One hundred forty allogeneic HSCT recipients where included in this prospective follow-up study. The whole saliva flow rates were measured and the medications prescribed for the recipients were recorded at 0, 6 and 12 months post-HSCT. The associations of different medication groups and the quantity of medications taken by an individual with saliva flow rates were statistically analyzed Results: None of the studied groups of medications including glucocorticoides, cytostatics, antibodies, immunophilines, antidepressants, anxiolytics and other medications were associated with saliva flow rates. In addition, only a weak, non-significant tendency towards low saliva low rates by an increasing number of medications was observed Conclusions: Hyposalivation in HSCT recipients is independent of the medications used. References: 1. Laaksonen M, Ramseier AM, Rovo A, Jensen SB, Raber-Durlacher JE, Zitzmann NU, et al. Longitudinal assessment of hematopoietic stem cell transplantation and hyposalivation. J Dent Res. 2011;90:1177–82. 2. Daikeler T, Mauramo M, Rovó A, Stern M, Halter J, Buser A, et al. Sicca symptoms and its impact on quality of life (QoL) among very long-term survivors after hematopoietic stem cell transplantation (HSCT) in comparison with their respective sibling donors. Bone Marrow Transplant. In press. MASCC-0567 Relationship between intestinal mucositis, neutropenia and bacteraemia among hematopoietic stem cell transplant recipients A.H.E. Herbers1, A.F.J. De Haan2, W.J.F.M. Van de Velden1, J.P. Donnely1, N.M.A. Blijlevens1 1 Haematology, Radboud University Nijmegen Medical Centre, Nijmegen, Netherlands, 2Department of Epidemiology Biostatistics and HTA, Nijmegen Institute for Infection Inflammation and Immunity (N4i), Nijmegen, Netherlands Introduction: Since the 1960s infectious complications have been regarded as the main cause of fever during neutropenia following haematopoietic stem cell transplantation (HSCT). More recently, it has been recognised that mucositis is an important determinant of inflammatory and infectious complications. Objectives: The objective of this prospective study was to compare the impact of intestinal mucositis as measured by citrulline levels, and neutropenia on the systemic inflammatory response and the occurrence of bacteraemia among patients who received either a myeloablative or a non-myeloablative regimen. Methods: The course of neutropenia, citrulline, axillary temperature, C-reactive protein and the occurrence of bacteraemia were intensively studied in a cohort of 37 HSCT recipients. Eighteen patients received an autologous HSCT after preparation with the myeloablative regimen high-dose melphalan and 19 patients were given an allogeneic HSCT following the non-myeloablative regimen fludarabine and cyclophosphamide. Blood cultures were obtained (almost) daily. Results: The myeloablative regimen induced severe intestinal mucositis manifest by citrullinaemia <10 μmol/L accompanied by an inflammatory response. Bacteraemia affected 8 (44 %) of 18 patients and coincided with the nadir of citrullinaemia. By contrast, those who had been treated with the non-myeloablative regimen did not develop severe intestinal mucositis, had a moderate inflammatory response and only 2 (11 %) of the 19 patients developed bacteraemia. Though both groups experienced profound neutropenia, its duration was significantly longer for those receiving the non-myeloablative regimen. Conclusions: This study shows that severe intestinal mucositis (citrullinaemia <10 μmol/L) defines the period of risk of bacteraemia
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better than does neutropenia. Measuring citrulline may prove useful in deciding who needs empirical antimicrobial therapy and when.
MASCC-0568 Cost-effectiveness of low-level laser therapy (LLLT) in head and neck cancer patients submitted to concurrent chemoradiation H.S. Antunes1, D. Herchenhorn2, I. Small1, C. Araujo3, E. Cabral4, M. Rampini1, P. Rodrigues5, T. Silva4, E. Ferreira6, F. Dias7, N. Teich8, V. Teich9, L. Schluckebier1, C. Ferreira1 1 Coordination of Clinical Research, Instituto Nacional de Câncer (INCA), Rio de Janeiro, Brazil, 2Clinical Oncology Division, Instituto Nacional de Câncer (INCA), Rio de Janeiro, Brazil, 3Radiotherapy Division, Instituto Nacional de Câncer (INCA), Rio de Janeiro, Brazil, 4 Nursing Division, Instituto Nacional de Câncer (INCA), Rio de Janeiro, Brazil, 5Therapy and Technology Development Section, Instituto Nacional de Câncer (INCA), Rio de Janeiro, Brazil, 6Oral Medicine, Clínicas Oncológica Integradas (COI), Rio de Janeiro, Brazil, 7Head and Neck Surgery Division, Instituto Nacional de Câncer (INCA), Rio de Janeiro, Brazil, 8Education and Research Institute, Clínicas Oncológica Integradas (COI), Rio de Janeiro, Brazil, 9Decisions in Health Care, Medinsight, São Paulo, Brazil Introduction: Oral mucositis is a main factor for increasing treatment costs in head and neck squamous cell carcinoma (HNSCC) patients treated with chemoradiation (CRT) Objectives: This study was designed to estimate the cost-effectiveness of LLLT to prevent oral mucositis in HNSCC patients submitted to CRT. Methods: From June 2007 to Dec 2010, 94 patients with HNSCC of nasopharynx, oropharynx and hipopharynx entered a prospective, randomized, double blind, placebo-controlled, phase III trial (47 LLLT (LG) and 47 placebo (PG)). CRT consisted of conventional RT 70.2 Gy (1.8Gy/d, 5 times/week) + concurrent cisplatin 100 mg/m2 every 3 week. The LLLT used daily was a diode InGaAlP (660 nm100 mW-4 J/cm2). The cost per laser session was US$ 34.00 for the baseline analysis.. Hospitalization rates associated with the treatment of oropharyngeal or oral mucositis were not documented in the study and were estimated according to previously published data. Results: Under the perspective of the Brazilian public healthcare system (SUS), total costs were higher in PG than LG on opioide use (LG = US$ 29.45; PG = US$143.72, gastrostomy (LG = US$ 41.69; PG=US$107.22) and hospitalization (PG=US$ 63.59). In LG costs were higher with laser therapy (US$ 1.549,50). The total incremental cost associated with the use of LLLT was US$ 1.306,61 per patient. The incremental cost-effectiveness ratio (ICER) was US$ 3.838,16 per case of grade 3–4 mucositis avoided when compared with no treatment. Conclusions: Our results indicate that laser group had a smaller morbidity during treatment and LLLT is cost-effective when compared to pacebo under a threshold of at least US$ 4,000 per avoided mucositis case.
MASCC-0569 European Union (EU) pharmacovigilance requirements for biologic medicines: considerations for oncologists and hematologists W. Brugger1, M. Farouk2, A. Fox3, H. Mellstedt4 1 Department of Hematology Oncology & Palliative Care, Schwarzwald-Baar Klinikum Academic Teaching Hospital University of Freiburg, Villingen-Schwenningen, Germany, 2International Development, Amgen Inc., Zug, Switzerland, 3Regulatory Affairs, Amgen Inc., Uxbridge, United Kingdom, 4 Department of OncologyPathology, Cancer Centre Karolinska/Karolinska Institute/Karolinska University Hospital Solna, Stockholm, Sweden
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Introduction: New EU pharmacovigilance requirements for biologic medicines became effective July 2012. Objectives: To identify key considerations for accurate pharmacovigilance of biologic medicines used by oncologists/hematologists, given requirements of the Pharmacovigilance Directive. Methods: Directive 2010/84/EU, Regulation (EC) 1235/2010, and guidelines were reviewed. Results: The new directive requires additional monitoring for biologic medicines (including biosimilars). The legislation requires clear identification of any biologic medicine that may be the cause of a suspected adverse event (AE) and inclusion of brand/trade name and lot number in AE reports. It advises that member states may impose specific obligations on healthcare professionals to ensure that biologic medicines are clearly identified in AE reports. Furthermore, biosimilars will be identified by a black symbol on prescribing information. How these legislated requirements will be communicated to ensure compliance and how they will affect oncology practice is unclear. Conclusions: Because physicians are the primary AE reporters, requiring prescription of biologic medicines (including biosimilars) by brand/trade name would ensure that the suspected product is known when an AE report becomes necessary. Such a policy would need to be complemented by national policies and practices and backed by member state medical societies to ensure that prescribed biologic medicines are not substituted without oncologist/hematologist consent. Because the primary packaging with lot number is infrequently available when AEs are reported, use of lot numbers may require electronic system changes at the pharmacy level and convenient provider access to this information. Physicians should be encouraged to submit otherwise-complete AE reports using brand names when lot numbers are unavailable.
MASCC-0570 An update on a systematic review of the use of geriatric assessment for older adults in oncology M. Puts1, B. Santos1, J. Hardt1, J. Monette2, V. Girre3, E. Springall4, S.M.H. Alibhai5 1 Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, Toronto, Canada, 2Division of Geriatric Medicine, Jewish General Hospital, Montreal, Canada, 3Department of Oncology-Hematology, Centre Hospitalier Departemental, La Roche sur Yon, France, 4 Gerstein Science Information Centre, University of Toronto, Toronto, Canada, 5Department of Medicine, University Health Network, Toronto, Canada Introduction: Cancer is a disease that mostly affects older adults. The use of Geriatric Assessment (GA) has been recommended for older adults with cancer. Objectives: The aims of review: 1) To provide an overview of the use of GA instruments in the oncology setting; 2) To examine feasibility and psychometric properties; 3) To systematically evaluate the effectiveness of GA in predicting/modifying outcomes (impact on treatment decision, toxicity of treatment, mortality and use of care). Methods: A systematic review of literature published between November 2010 and July 2012. Articles published in 5 databases in English, Dutch, French and German were included. Results: Thirty-four manuscripts reporting on 33 studies were identified. The quality of most studies was moderate to good. Of all studies, 14 were prospective, 8 cross-sectional, 5 retrospective and 7 others (mostly phase II trials of a new treatment regimen). A GA was shown to be feasible, the time needed to complete ranged between 5 and 120 min, were mostly conducted in the outpatient oncology setting by nurses, and most often included the domains activities of daily living, comorbities, cognitive function, depression, medications, and fall risk assessment. Four studies examined psychometric properties of the GA with satisfactory results and
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18 studies examined the predictive ability of the GA and showed that components of the GA predicted treatment toxicity and overall survival Conclusions: Although the studies showed that GA was feasible and had predictive validity, there has not been a randomized controlled trial showing the effectiveness of the GA in improving outcomes for older adults with cancer.
MASCC-0571 Adherence to antiemetic guidelines for prophylaxis of chemotherapy-induced nausea and vomiting (CINV) in a haematology unit and evaluation of patients’ satisfaction C. Raynaud1, N. Chaumard-Billotey1, P. Rey2, J.F. Latour1 1 Pharmacy, Centre Léon Bérard, Lyon, France, 2Hematology, Centre Léon Bérard, Lyon, France Introduction: Nausea and vomiting (N/V) during chemotherapy can have profound clinical consequences. Regional, national and international organizations issue antiemetic guidelines, regularly updated to harmonize antiemetic treatment. Objectives: The aim of the study was to assess the adherence to regional recommendations for prophylaxis of CINV in a haematology unit. The secondary outcome was the evaluation of patients’ satisfaction. Methods: We prospectively reviewed the data related to antiemetic prescriptions for all adults haematological patients undergoing chemotherapy over a 3-month period. Patients who received stem cell transplant were excluded. Adherence to guidelines was evaluated. The patient satisfaction was measured by a Satisfaction Questionnaire. Results: Among 161 prescriptions analysed, adherence rate for antiemetic treatment was 24 %. B cell lymphoma was the most frequent pathology (60 %). The chemotherapy was highly emetogenic (HE) in 42 % and moderately emetogenic (ME) in 55 %. The use of aprepitant was inappropriate in 58 % of the prescriptions: omission (41 %) or too short-use (17 %). An overuse of serotonin antagonists was demonstrated for prophylaxis of delayed CINV in 8 % of HE chemotherapy and in 14 % of ME chemotherapy. The satisfaction rate of 47 patients was evaluated. For 62 % of them, management of CINV was excellent (score 10/10). Conclusions: Compliance to regional antiemetic guidelines is suboptimal. The study highlighted an inappropriate use of aprepitant and serotonin antagonists for prophylaxis of delayed CINV. Nevertheless, patient satisfaction remains high and seems unaffected. Adherence’s rate could be improved upon by developing practisers’ awareness of these results and integrating a computerised decisionsupport-therapy.
MASCC-0572 Evaluation of clinical pharmacists’ follow-up service in an oncology pain clinic N. Ryan1, C. Chambers1, C. Ralph1, D. England1, F. Cusano1 1 Pharmacy, Tom Baker Cancer Centre, Calgary, Canada Introduction: Patients who present with pain in an oncology setting are often complex and require a multidisciplinary approach for symptom control. The Pain and Symptom Control Clinic at Tom Baker Cancer Center includes two pharmacists who participate in weekly multidisciplinary clinics and provide a follow-up service to patients. Objectives: This study will assess the impact of the pharmacists’ follow-up service with respect to activities performed as well as patient
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and health care professional satisfaction. The activities performed will also be compared to defined objectives for pharmacy practice in a hospital setting. Methods: Activities performed by the pharmacists over a ten-week period were recorded and tabulated. Online surveys were completed by health care professionals and telephone surveys were completed by patients one-month post clinic visit Results: Over 6 weeks, 44 patients assessed in clinic required follow-up from a pharmacist. There was an average of 2.3 interactions per patient and an average time of 85 min was spent on each patient outside of clinic. The three activities that occurred most frequently included: (1) interacting with other health care professionals, (2) making alterations to patients’ medication regimens, and (3) organizing refills. All health care professionals surveyed felt that the pharmacists’ follow-up service was a valuable component of the Pain and Symptom Control Clinic and nearly all patients surveyed reported a positive experience with the service received Conclusions: The inclusion of pharmacists in the Pain & Symptom Control Clinic is favoured by patients and health care professionals and provides increased efficiency to the clinic. References: Published in: JOPP (Online 09/27/12) DOI: 10.1177/1078155212457805
MASCC-0573 Chemotherapy induces fatigue and increases TNF- a in breast cancer patients F.M. Cruz1, B. Munhoz1, T.G. Lerner1, A. Del Giglio1, A. Del Giglio1 1 Clinical Oncologist, ABC Foundation School of Medicine, Santo André, Brazil Introduction: Chemoterapy induced fatigue (CRF) is a common complain and few studies assessed so far the role of inflammatory biomarkers as predictors of CRF Objectives: The primary objective of our study is to evaluate potential biomarkers of CRF in breast cancer (BC) patients receiving adjuvant Chemotherapy (CHT). Methods: Thirty-seven localized BC patients (clinical stages I–III) consecutively treated at the oncology service of Faculdade de Medicina da Fundação ABC were enrolled in this study. All patients received doxorubicin and cyclophosphamide based chemotherapy. Before the beginning of chemotherapy and before the second cycle, all patients answered the BFI (Brief Fatigue Inventory) questionnaire. The following inflammatory markers were collected: C-reactive protein (CRP), tumor necrosis Factor alpha (TNF-α) and interleukin 6 (IL-6). We correlated these inflammatory markers with BFI scores of each patient before and after cycle 1 and cycle 2 of chemotherapy Results: The mean values of the inflammatory markers were: CRP 4.58 mg/dL (IC 95 % 3.17–5.90), TNF-α 11 mg/dL (IC 95 % 8.84– 13.79) and IL-6 3.74 (IC 95 % 1.93–5.54). We observed a positive correlation between the BFI scores and TNF-α (p=0.0201) Conclusions: TNF-α may represent a potential CRF biomarker. Future studies may elucidate the potential usefulness of TNF-α for monitoring the anti-fatigue effects of new drugs for the treatment of CRF References: Bennett B, Goldstein D, Lloyd A, Davenport T, Hickie I. Fatigue and psychological distress—exploring the relationship in women treated for breast cancer. European Journal Cancer. 2004; 40 (11): 1689–1695 Iop A, et. al.. Fatigue in cancer patients receiving chemotherapy: an analysis of published studies. Ann Oncol. 2004; 15 (5): 712– 720.
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MASCC-0574 Predictors of overall survival following an opioid rotation (OR) in cancer patients presenting to an outpatient supportive care center (SCC) A. Reddy1, S. Yennurajalingam1, K. Pulivarthi1, S. Palla2, X. Wang2, J.H. Kwon1, S. Frisbee-Hume1, E. Bruera1 1 Palliative Care and Rehabilitation Medicine, University of Texas MD Anderson Cancer Center, Houston, USA, 2Department of Biostatistics, University of Texas MD Anderson Cancer Center, Houston, USA Introduction: Limited data exist on cancer outpatients undergoing OR. We report the analysis of predictors of overall survival following an OR. Objectives: The aim of this study was to compare patient characteristics and survival of patients with and without follow-up after OR, and survival in patients with successful and unsuccessful OR. Methods: In an ad-hoc analysis of previously reported data, we reviewed consecutive patients in the SCC in 2008 for OR, demographics, Edmonton Symptom Assessment Scale(ESAS), Memorial Delirium Assessment Scale(MDAS), indications for OR, and outcomes. Successful OR was defined as 2 point or 30 % reduction in ESAS score or resolved opioid-induced neurotoxicity and continuation of new opioid at follow-up. Results: The Median age was 55 years, 56 %(106/190) male, 72 %(136/190) white, median(Q1-Q3) ECOG performance status(PS) was 2(1–3), most common cancer type was gastrointestinal 24 %(45/190) and 86 %(163/190) had advanced disease. Of 190/938(20 %) patients who underwent OR, 120/190(63 %) had follow-up visit. OR was successful in 79/120(66 %). Follow-up visits occurred more frequently in patients with localized disease 89 %(24/27; P=.0023), history of substance abuse 100 %(12/12; P= .0085), PS ≤ 2, 66 %(97/146; P= .0002), uncontrolled pain 66 %(97/146; P=.036), higher ESAS scores of fatigue(P=.0036), appetite (P=.025) and lower MDAS score(P=.0009). Follow-up after OR(P<.001) and successful OR(P=.012) were predictors of longer overall survival with difference in median survival of 4.3 and 3 months respectively Conclusions: Patients who followed up after OR are more likely to have localized disease, better PS, history of drug abuse, uncontrolled pain, better MDAS scores and longer overall survival. Successful OR is significant predictor of longer overall survival.
MASCC-0575 The relationship of self-rated health with measures of functional status and mortality: results of a prospective pilot study with older newly-diagnosed cancer patients M. Puts1, J. Monette2, V. Girre3, C. Wolfson4, J. Monette5, G. Batist6, H. Bergman7 1 Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, Toronto, Canada, 2Division of Geriatric Medicine, Jewish General Hospital, Montreal, Canada, 3Department of Oncology-Hematology, Centre Hospitalier Departemental, La Roche sur Yon, France, 4Research Institute, McGill University Health Centre, Montreal, Canada, 5 Solidage Research Group on Frailty and Aging, Jewish General Hospital, Montreal, Canada, 6Segal Cancer Centre, Jewish General Hospital, Montreal, Canada, 7Division of family medicine, McGill University, Montreal, Canada Introduction: In the general older population, self-rated health (SRH) has been shown to be a strong predictor of functional status but this has less often been studied in older adults with cancer.
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Objectives: The aim of this study was to determine the association between SRH and functional status, comorbidity, toxicity of treatment and mortality in older newly diagnosed cancer patients. Methods: Patients aged 65 and over, newly diagnosed with cancer recruited at the Jewish General Hospital, Montreal. SRH and functional status were evaluated prior to treatment, and at 3, 6 and 12 months. Functional status (Instrumental Activities of Daily Living (IADL), Basic Activities of Daily Living (ADL), ECOG Performance Status (ECOG PS) and frailty markers (low grip strength, mobility impairment, physical inactivity, cognitive impairment, mood impairment, and poor nutritional status). Treatment toxicity and mortality data were abstracted from the chart. Chi-square tests and t-tests were used to compare patients who rated their SHR as fair/poor/very poor to those very good/good with regard to functional status, frailty, and comorbidity. Logistic and Cox regression were used to examine the association between baseline SRH and treatment toxicity/time to death. Results: There were 112 participants, median age 74.1. At baseline, 74 (66.1 %) had a good SRH and 38 (33.9 %) had poor SRH and those had more comorbidities, more frailty markers present, lower ECOG PS and IADL impairments. We found no association between SRH and toxicity or mortality. Conclusions: There was a moderate correlation between SRH and the number of frailty markers, IADL disability and comorbidities but SRH did not predict outcomes.
MASCC-0576 A systematic review of factors influencing older adults’ decision to accept or refuse cancer treatment M. Puts1, S. Novak1, D. Howell2, M. Fitch3, M. Krzyzanowska4, N. Leighl4, J. Monette5, D. Wan-Chow-Wah5, E. Springall6, S.M.H. Alibhai7 1 Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, Toronto, Canada, 2Oncology Nursing Research, Princess Margaret Hospital, Toronto, Canada, 3Oncology Nursing, Odette Cancer Centre, Toronto, Canada, 4Medical Oncology, Princess Margaret Hospital, Toronto, Canada, 5Division of Geriatric Medicine, Jewish General Hospital, Montreal, Canada, 6Gerstein Science Information Centre, University of Toronto, Toronto, Canada, 7Department of Medicine, University Health Network, Toronto, Canada Introduction: Cancer is a disease that mostly affects older adults. The treatment decision for older adults may be complicated as older adults often have significant comorbidities which impact on life expectancy as well as treatment tolerability. Objectives: The primary objective of this systematic review is to synthesize all studies which identify the factors influencing older adults’ decisions to accept or refuse the cancer treatment proposed by their physician across studies. Methods: Two independent reviewers are reviewing eligible studies. Inclusion criteria: Publications reporting on factors influencing the cancer treatment decision of older patients aged 65 and over diagnosed with cancer (any type of study both qualitative and quantitative) published in English, French, Dutch or German and the search used key words/mesh terms such as decision making, patient decision making, treatment refusal, treatment preferences AND neoplasms/cancer AND Aged, 65 and over. Databases searched include Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, Cumulative Index to Nursing and Allied Health (CINAHL), Allied and Complementary Medicine (AMED), Psych INFO, Ageline, Sociological Abstracts, Web of Science, Applied Social Sciences Index and Abstracts (ASSIA) databases. We will use the Mixed Methods Appraisal Tool to score the quality of all included studies. Results: The 2 reviewers are currently reviewing the abstracts and will follow with reviewing full text citations and data abstraction. The
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number of abstracts under consideration is significant in volume (over 15,000). The results will be forthcoming. Conclusions: The review is in proces and results will be presented at the conference.
MASCC-0577 The development of a questionnaire to measure reasons for accepting or refusing cancer treatments by older adults with cancer in Ontario M. Puts1, S. Novak1, M. Fitch2, A. Tourangeau1, M. Krzyzanowska3, N. Leighl3, S.M.H. Alibhai3 1 Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, Toronto, Canada, 2Oncology Nursing, Odette Cancer Centre, Toronto, Canada, 3Department of Medical Oncology, Princess Margaret Hospital, Toronto, Canada Introduction: Cancer is a significant health problem in older persons. Little is known concerning which factors influence the acceptance or refusal of treatment. Currently, there is no instrument available to measure reasons for accepting or refusing cancer treatment. Objectives: The aim of this study is to generate a framework which delineates the factors that are important for accepting or refusing cancer treatment by older adults undergoing chemotherapy and/or radiation therapy. In subsequent steps we will develop and test a new instrument measuring reasons for accepting or refusing cancer treatments in older adults with cancer. Methods: In the first phase of the project in-depth interviews are conducted with older adults undergoing chemotherapy and/or radiation therapy recently diagnosed with breast, lung, colorectal or prostate cancer to generate possible items for the instrument. The data is analyzed using content analysis. Results: So far 10 participants have been included, 9 who have accepted treatment recommended and one that has refused partial cancer treatment. Older adults find the ease of treatment, expected risks and benefits, and anticipated side-effects important in making the treatment decision. Patients interviewed to this point have perceived the guidance of their primary care physician and/or oncologist as the most crucial factor in accepting or declining treatment. If the patient had an established trusting and respectful relationship with a health care provider, typically the patient would choose to accept the suggested treatment. Conclusions: The project is ongoing and final results will be presented at the conference.
MASCC-0578 A systematic review of factors influencing treatment adherence in older adults with cancer M. Puts1, H.A. Tu1, A. Tourangeau1, D. Howell2, M. Fitch3, E. Springall4, S.M.H. Alibhai5 1 Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, Toronto, Canada, 2Oncology Nursing Research, Princess Margaret Hospital, Toronto, Canada, 3Oncology Nursing, Odette Cancer Centre, Toronto, Canada, 4Gerstein Science Information Centre, University of Toronto, Toronto, Canada, 5Department of Medicine, University Health Network, Toronto, Canada Introduction: Cancer is a disease that mostly affects older adults. Treatment adherence is defined by the World Health Organization (WHO) (2003) as “the extent to which a person’s behaviour- taking medication, following a diet, and/or executing lifestyle changes, corresponds with agreed recommendation from a health care provider”. Cancer treatment adherence is crucial in order to obtain optimal health outcomes such as cure or improvement of quality of life.
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Objectives: The objective of this systematic review is to synthesize all studies with regard to the following research question: What factors influence adherence to cancer treatment in older adults diagnosed with cancer? Methods: Two independent reviewers are reviewing eligible studies published in English, French, Dutch or German currently and the search used key words/mesh terms such as medication adherence, guideline adherence, compliance, treatment preferences, medication management, and perceptions of medication AND neoplasms/cancer AND Aged, 65 and over, elderly, older adult. Databases searched include Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, Cumulative Index to Nursing and Allied Health (CINAHL), Allied and Complementary Medicine (AMED), Psych INFO, Ageline, Sociological Abstracts, Web of Science, Applied Social Sciences Index and Abstracts (ASSIA) databases. We will use the Mixed Methods Appraisal Tool to score the quality of all included studies Results: Two reviewers are reviewing the abstracts and this will be followed by full text citations and data abstraction. The number of abstracts to review is significant (over 15,000). Conclusions: The review is in process and the results will be presented at the conference.
MASCC-0579 FATIGUE IN LOW RISK FEBRILE NEUTROPENIA (FN) TREATED AS OUTPATIENTS (OPS) C.P. Escalante1, J.T. Patlan1, E. Manzullo1, X. Wang2, S. Gao1, M.B. Row3, X.S. Wang4, P.K. Morrow5, M.N. Richardson1, R. Abisaid Baker1, S.J. Yeung3 1 General Internal Medicine, University of Texas MD Anderson Cancer Center, Houston, USA, 2Biostatistics, University of Texas MD Anderson Cancer Center, Houston, USA, 3Emergency Medicine, University of Texas MD Anderson Cancer Center, Houston, USA, 4Symptom Research, University of Texas MD Anderson Cancer Center, Houston, USA, 5 Hematology/Oncology Therapeutic Area, Amgen, Thousand Oaks, USA Introduction: OP management of FN in low risk cancer patients is standard of care. Frequently, these patients complain of fatigue. Objectives: To describe patient population and determine whether fatigue improves as patients are treated for FN as OPs. Methods: Low risk cancer patients enrolled in our OP FN pathway were eligible for the study if Brief Fatigue Inventory (BFI) question #3 was ≥4 at pathway d#1. Patients were enrolled on d#2 of the pathway and completed the BFI on d# 2, 3 and 7. Demographic and diagnostic information was collected. Results: Sixty-eight patients were enrolled. 38 (56 %) were females with mean age 52 years (18–80). 37 (54 %) had sarcoma and 67 (98 %) were on chemotherapy with a mean maximum temperature of 38.8oC, mean absolute neutrophil count of 0.18 k/ul (0–0.98), mean Hgb of 9.9 g/dl at d#1 and mean Hgb of 10.4 g/dl at d#7. 20 (29 %) patients required transfusion. Mean duration of antibiotic treatment was 9 days and 54 (79 %) had resolution of symptoms on initial antibiotics. 11 (16 %) were admitted to the hospital. The mean score on question #3 of the BFI at d#1 was 7.3 (SD=1.9). The mean BFI score on d#2 was 5.2 (SD=2.0) and 2.7 (SD=2.3) on d#7 (p<0.0001). Conclusions: Patients with FN had significant improvement in fatigue as they were treated over 1 week. There are likely multiple factors contributing. This is the first report correlating the NF trajectory and fatigue in cancer patients.
MASCC-0580 Getting your life back after cancer: findings from a feasibility study of life coaching for cancer survivors R. Wagland1, D. Fenlon1, R. Tarrant2, A. Richardson3, J. Lee4, I. Van der Venn4
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Faculty of Health Sciences, Macmillan Survivorship Reserch Group, Southampton, United Kingdom, 2Oncology, University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom 3 Faculty of Health Sciences, University of Southampton, Southampton, United Kingdom, 4Lylac Coaching, Lylac Coaching, Southampton, United Kingdom Introduction: Growing evidence demonstrates that life coaching can empower people to manage chronic illness and create sustainable behaviour change. However, little is known about how this might apply in the context of cancer survivorship, where people frequently experience reduced confidence following treatment. We hypothesise that life coaching could provide cancer survivors with a means to regain confidence, enhance quality of life and sustain positive lifestyle behaviour change. Objectives: To determine the acceptability, feasibility and practicality of conducting research into life coaching for cancer survivors. Methods: A one group pre-test, post-test feasibility study was conducted, recruiting participants from community organisations. Eligibility criteria included: within 1 year of completion of primary cancer treatment; over 18; no metastases; no mental health problems. One face to face and five telephone sessions were given over 3 months. Outcome measures included quality of life, self-efficacy, coping and goal attainment. Interviews explored the feasibility and acceptability of life coaching and research issues. Results: Nine women and two men were recruited, representing varying cancer diagnoses. All outcome measures were sensitive to change and indicated positive trends post intervention. Participant interviews indicated that the intervention was well received and had a positive impact. Lessons were learnt about study design, recruitment and acceptability of the intervention type and delivery. Conclusions: This study showed that cancer survivors are prepared to be recruited into research about life-coaching and shows promise with regard to helping people regain confidence following cancer. It merits further evaluation through conducting an exploratory randomised controlled trial.
MASCC-0581 Phase ii randomized, placebo-controlled trial of phytotherapeutic product Catuama® for breast cancer women undergoing adjuvant radiation therapy F.M. Cruz1, D.I.G.C. Cubero1, P.X. Santi1, A.S. Tamashiro1, L.R. Soares1, A. Del Giglio1 1 Clinical Oncology, ABC Foundation School of Medicine, Santo André, Brazil Introduction: Catuama® is a registered phytotherapic that contains 4 brazilian herbs: Trichilia catigua, Ptychopetalum olacoides, Paullinia cupana and Zingiber officinale. Objectives: Evaluate the Catuama® potential anti-fatigue effects in BC women undergoing adjuvant Radiation Therapy (RxT). Methods: This is a double blinded, randomized, placebocontrolled, Phase II cross-over trial. Patients with BC with the indication of adjuvant RxT, older than 18 years of age, with ECOG PS 0 or 1, without a history of cardiac, renal, hepatic or psychiatric decompensation, received Catuama® 1 capsule twice daily versus a matching placebo for the first 2 weeks of RxT treatment, followed by a week of wash out, followed by an additional 2 weeks of treatment with crossover of experimental arms. Patients were evaluated on days 1, 15 and 36 with the Brief Fatigue Inventory (BFI), Hospital Anxiety and Depression Scale (HADS), Quality of Life FACIT-F, FACIT-ES questionnaires, and Chalder Fatigue scale.
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Results: We enrolled 90 patients with a median age of 53 years (26– 80). We saw no statistically significant differences of FACIT ES, FACIT F, HADS, Chalder or BFI scores treated with Catuama® or Placebo when we considered all included patients. When we selected only patients with a BFI score above 30, Catuama® significantly decreased BFI scores as compared to baseline (p<0.0001). We observed one instance of grade 3 hypermagnesemia in the Catuama® arm and one patient had hyperglicemia grade 3 both in the Catuama® and in the placebo arm. No grade 4 toxicities were seen. Conclusions: Catuama® may help selected patients who already start RxT with evidence of fatigue.
MASCC-0582 Swallowing problems in head and neck cancer: developing a cognitive behavioural intervention J. Patterson1, E. McColl1, V. Deary2 1 IHS, Newcastle University, Newcastle upon Tyne, United Kingdom, 2 Health Psychology, Northumbria University, Newcastle upon Tyne, United Kingdom Introduction: Chronic swallowing difficulties are a common side effect of advanced head and neck cancer treatment. Much of the evidence for interventions focuses on muscle conditioning exercises. Objectives: This preliminary study is the first step in developing an intervention which addresses both the biological and psychological processes of dysphagia. Methods: A speech and language therapist, with intermediate skills in cognitive behavioural therapy(CBT) conducted a small series of structured assessments with head and neck cancer patients with swallowing difficulties following chemoradiotherapy treatment. Data were compiled and analysed in consultation with CBT experts. Results: Ten patients agreed to an in-depth interview to explore their swallowing problem. Seven patients had a feeding tube in situ. Patients’ goals included increasing oral intake and re-joining social eating situations. All described on-going mouth and throat discomfort. Many experienced choking sensations and food sticking in the throat. A commonly held belief was that swallowing was no longer safe and the throat no longer worked. There was high avoidance of attempting solid foods. Social lives were severely restricted with most patients preferring to eat and drink alone. Points for pschosocial intervention were identified. Conclusions: We present a structured exploration of the psychosocial impact of a swallowing difficulty. We identified a cycle of symptom and emotional distress which suggests that working on cognitions and behaviours could have an impact on patient’s adjustment and physical functioning. This cognitive behavioural approach could be used alongside traditional swallowing therapy techniques. This forms the basis of our ongoing research.
MASCC-0583 Introduction of l-type calcium antagonists as broad-spectrum antiemetics N. Darmani1, S. Chebolu1, T. Alkam1, M. Vaezi1, W. Zhong1 1 Basic Medical Sciences, COMP/WUHS, Pomona, USA Introduction: Neuroransmitter release requires calcium. Diverse channels allow calcium entry into cells. Activation of 5-HT3Rs can increase calcium influx through both 5-HT3Rs and L-type channels. The induced influx can be blocked by both L-type and 5-HT3 antagonists. We predicted the L-type calcium agonist FPL 64176 should induce emesis, and it did. Subsequently we investigated the antiemetic potential of the L-type calcium antagonist nifedipine either alone or in combination with the 5-HT3 antagonist, palonosetron.
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Objectives: This study provides evidence for broad-spectrum antiemetic efficacy of nifedipine. Methods: Agonists of serotonergic 5-HT3 (e.g. 5-HT or 2-Me-5-HT; both at 5 mg/kg)-, tachykinin NK1 (GR73632; 5 mg/kg)-, dopamine D2 (apomorphine or quinpirole; 2 mg/kg)-, cholinergic M1 (McN-A343; 2 mg/kg)-receptors, FPL 64176 (10 mg/kg), or cisplatin (10 mg/kg), were administered in the least shrew to induce vomiting. The antiemetic potential of nifedipine (1–10 mg/kg) was evaluated. Results: FPL 64176-induced vomiting was suppressed by nifedipine or palonosetron. Combination of their non-effective doses attenuated the vomiting. Nifedipine also attenuated vomiting caused by 2-Me-5-HT, 5HT, GR73632, apomorphine, quinpirole and McN-A343. By itself nifedipine was ineffective against cisplatin, but potentiated the efficacy of palonosetron Conclusions: FPL 6417-induced vomiting was suppressed by nifedipine or palonosetron. Their combined non-effective doses reduced the emesis. Similar effects were observed against 2-Me-5-HT. The antiemetic potential of nifedipine extends against vomiting caused by dopamine D2, tachykinin NK1, and cholinergic M1-receptors. Nifedipine was ineffective against cisplatin but a combination of non-effective doses of nifedipine and palonosetron attenuated the vomiting. These findings demonstrate nifedipine possess broad-spectrum antiemetic efficacy.
MASCC-0584 Regional differences in reported febrile neutropenia (FN), adverse events (AES), and serious AES (SAES) in a multinational phase 3 trial J. Decaestecker1, A. Cesas2, Y. Hotko3, E. Abella4, M. Mo5, W. Rogowski6 1 Gastroenterology, H.-Hartziekenhuis Roeselare-Menen, Roeselare, Belgium, 2 Department of Oncology, Klaipeda University Hospital, Klaipeda, Lithuania, 3Department of Oncology, Uzhgorod National University, Uzhgorod, Ukraine, 4Global Development, Amgen Inc., Thousand Oaks, USA, 5Global Biostatistical Science, Amgen Inc., Thousand Oaks, USA, 6Oncology Department, Gdynskie Cancer Center, Gdynia, Poland Introduction: Regional differences in reported FN and AEs were observed during conduct of a randomized, double-blind, multicenter, placebo-controlled trial to evaluate efficacy of pegfilgrastim (Neulasta®) in reducing FN incidence in patients with locally-advanced or metastatic colorectal cancer (mCRC) receiving first-line treatment with bevacizumab and FOLFOX or FOLFIRI Objectives: To determine reported incidences of FN, AEs, and SAEs in North America (NA) vs rest of world (ROW) Methods: Key eligibility criteria: age ≥18 years and measurable, nonresectable CRC (RECIST v1.1). Patients were randomly assigned 1:1 to receive chemotherapy/bevacizumab plus either placebo or 6 mg pegfilgrastim. Study treatment period was four Q2W cycles. Stratification factors: region (NA/ROW), stage (locally-advanced/mCRC), and chemotherapy (FOLFOX/FOLFIRI). Grade 3/4 FN was defined as, within ±1 day, temperature ≥38.0 °C/100.4 °F and absolute neutrophil count (ANC) <1.0 × 10 9 /L or ANC <1.0 × 10 9 /L and sepsis/infection or neutropenia-related hospitalization, Results: 422 patients received pegfilgrastim; 423 received placebo. The study met its primary endpoint: Pegfilgrastim significantly reduced overall incidence of grade 3/4 FN in the first four chemotherapy cycles (2.4 % vs 5.7 %; P=0.014). Grade 3/4 FN incidences were higher in NA vs ROW in the placebo (8.9 % [95%CI: 3.6–17.4] vs 4.9 % [2.9–7.8]) and pegfilgrastim groups (5.2 % [1.4–12.8] vs 1.7 % [0.6–3.7]). Similar patterns were seen with AE and SAE incidences (Table). Conclusions: Regional differences in FN, AE, and SAE reporting may complicate comparisons of trials from different regions. Further exploration is needed to understand causes of regional differences.
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Introduction: There are limited studies about actigraphic sleep, wakefulness, activity and fatigue and treatment in advanced cancer patients.
Objectives: The objective of this study was to evaluate the changes in the nocturnal sleep/rest, and daytime wake/activity and subjective measures of fatigue before and after treatment with MP+/− NTI. Methods: An adhoc analysis of previous reported placebo controlled RCT of MP and/or NTI for CRF was conducted. Subjective and objective assessments were analyzed at Day-8 and Day-15 as a result of treatment with MP and/or NTI or their control arms. Actigraphic sleep measures assessed were total sleep time (TST), sleep efficiency, and wake after sleep onset (WASO). Additionally, activity (mean day-time activity), and fatigue (FACIT-F, ESAS-Fatigue item) were included in the multivariate analysis. Results: A total of 60 (MP=30, Placebo=30; NTI=35; CTI=25) patients were evaluated. The median age was 56, 62 % were female; most common cancer type was breast 13/60(22 %). The baseline mean FACIT-F subscale, ESAS Fatigue item, TST, WASO, sleep efficiency and day-time activity were 22.4 (9.33), 6.5(1.74), 437(162.4), 139(121.4), 71(16.4), 202(438). Multivariate outcomes at Day8 showed significant change from baseline (η2 =0.38, p<0.001) and interaction effect between MP and NTI (η2 =0.26, p=0.015). WASO had an interaction effect (β=−101.4, p=0.009; Fig. 1), an MP effect (β=80.4, p=0.002) and reduction in time (β=−52.1, p= 0.003). FACIT-F and ESAS-Fatigue item showed improvement in time (β=6.9, p=0.010; β=−2.4, p<0.001). Conclusions: WASO was significantly lower in patients receiving methylphenidate and nursing telephone intervention. Further larger studies are needed to validate these findings.
MASCC-0586 Tamoxifen & antidepressant drug interactions in a cohort of breast cancer survivors cared for in large healthcare delivery systems in California
Kaiser Permanente Riverside Medical Center, Riverside, USA, 5Pharmacy Analytical Service, Southern California Kaiser Permanente Downey Medical Center, Downey, USA, 6Division of Research, Northern California Kaiser Permanente, Oakland, USA
R. Haque1, J. Shi1, S.W. Fletcher2, J. Schottinger3, S.A. Ahmed4, T.C. Cheetham5, J. Chung1, C. Avila1, L.A. Habel6, M.L. Kwan6 1 Research and Evaluation, Southern California Kaiser Permanente, Pasadena, USA, 2Population Medicine, Harvard Pilgrim Health Care Institute, Boston, USA, 3Internal Medicine, Southern California Kaiser Permanente, Pasadena, USA, 4Genetic Services, Southern California
Introduction: Controversy exists whether certain antidepressants, such as paroxetine, can reduce tamoxifen’s effectiveness on breast cancer recurrence. However, previous studies were limited by small samples or poor medication measurement. Objectives: To determine whether taking tamoxifen and antidepressants concomitantly is associated with an increased subsequent breast cancer risk
NA (N=156)
Grade ≥3 AEs, % SAEs, %
ROW (N=689)
Placebo N=77
Pegfilgrastim N=77
Placebo N=344
Pegfilgrastim N=343
44.2
45.5
24.7
23.3
22.1
23.4
11.0
14.6
MASCC-0585 Actigraphy findings and cancer related fatigue (CRF) in advanced cancer patients treated with methylphenidate (MP) and nursing telephone intervention (NTI) S. Yennu1, D. Balachandran2, N.S. Padhye3, J.L. Williams1, S. Frisbee-Hume1, E. Bruera1 1 Palliative Care and Rehab Medicine, University of Texas MD Anderson Cancer Center, Houston, USA, 2Pulmonary and Sleep Medicine, University of Texas MD Anderson Cancer Center, Houston, USA, 3 Biostatistics, University of Texas Health Sceince Center of Houston, Houston, USA
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Methods: We assembled a cohort of 16,887 breast cancer patients (Stage 0–II) from 1996 to 2007, treated with tamoxifen, and followed through 12/31/09. The main independent variables were antidepressant type and percent overlap when both tamoxifen and antidepressants were used. Women were followed through subsequent breast cancer, health plan disenrollment, death or study’s end. Multivariate adjusted hazard ratios (HR) and 95 % confidence intervals (CI) were estimated using Cox models using timevarying medication variables. Results: Overall, 2,946 women developed subsequent breast cancer during the 14-year study period. Of the 16,887 total women, about half used antidepressants (n=8,099, Table 1). We observed a small nonsignificant increased risk of subsequent breast cancer in women who concurrently used paroxetine and tamoxifen in the first year (HR= 1.06, 95 % CI: 0.98–1.14). For every 25 % increase in percent overlap, the risk increased insignificantly by 6 %. However, the risk attenuated with longer tamoxifen duration (Table 2). For the other antidepressants, we found no such trend Conclusions: Using one of the most complete pharmacy databases of insured patients, we observed a slight increased risk of subsequent breast cancer in women who concurrently used paroxetine in the first year of endocrine therapy. Nevertheless, taking tamoxifen for a longer duration mitigated such risks. Table 1: Distribution of antidepressant use in the cohort of 16,887 breast cancer patients
Antidepressant
N
Paroxetine only
481
% 3.0
Fluoxetine only
1032
6.0
Other SSRIs
272
2.0
Tricyclics
1163
7.0
Other types
1259
7.0
Multiple types
3892
23.0
No antidepressants
8788
52.0
Table 2: HRs for subsequent breast cancer risk among women who had 25 % days of concominant paroxetine and tamoxifen use by year of endocrine treatment Adj HR
(95 % CI)
P-value
Tam 1 year
1.06
(0.99 1.14)
0.09
Tam 2 year
1.03
(0.97 1.10)
0.32
Tam 3 year
1.00
(0.93 1.09)
0.95
Tam 4 year
0.97
(0.87 1.09)
0.64
Tam 5 year
0.94
(0.81 1.10)
0.46
MASCC-0587 Distress and quality of life in early stages of cancer diagnosis—are there significant gender differences? M. bernardo1, S.R. Ouakinin1, G. Gonçalves1, I. Nabais1, M.J. Costa1 1 Hematology-Oncology Unit, hospital CUF infante santo, Lisbon, Portugal Introduction: Distress seems to be a common psychological reaction to cancer, particularly in early stages of the adaptation process. However, emotional experience and expression, facing disease, can be determined not only by the threat that cancer represents, but also by individual and contextual differences.
Objectives: The aim of our study is the evaluation of distress levels and its relationship with Quality of Life (QoL), according to gender, in a screening of recent diagnosed cancer patients, in a Day Care Hemato/Oncology Unit. Methods: Patients were enrolled during admission. After informed consent, they completed a basic sociodemographic and medical questionnaire, the Distress Thermometer (Roth et al, 1998), the Brief Symptom Inventory (Derogatis, 1993) and a Quality of Life Questionnaire (QLQ-C30, Aaronson et al, 1993). Results: Sample included 124 subjects, 61.5 % females. Mean age was 59.1 years; breast (28 %) and colo-rectal (19 %) were the most frequent cancers. Comparing genders, there were significant differences in several BSI and Symptoms Index scales, all higher in women. Differences in Distress (DT) and Global Quality of Life did not reached statistical significance, although QoL was lower in women. Correlation analysis points to a pattern of relationship between global QoL and emotional distress in women and a relationship between age, emotional distress and health related QoL in men, using the sub scale of Global Health/QoL from QLQ-C30. Conclusions: Emotional distress and QoL are clearly related in all patients, but these results may reflect gender diversity in disease evaluation, as well as in health concerns and expectations.
MASCC-0588 Validity, reliability, responsiveness and measurement equivalence of the English and Chinese versions of the functional assessment of cancer therapy-cognitive (FACT-Cog) in breast cancer patients Y.T. Cheung1, S.R. Lim2, Y.L. Foo2, W.K. Chui2, Y.P. Tan3, A. Chan1 1 Pharmacy, National University of Singapore/National Cancer Centre Singapore, Singapore, Singapore, 2Pharmacy, National University of Singapore, Singapore, Singapore, 3Psychosocial Oncology, National Cancer Centre Singapore, Singapore, Singapore Introduction: Subjective neuropsychological tools are often used to evaluate perceived cognitive changes in cancer patients. Objectives: To examine the psychometric properties and measurement equivalence of the English and Chinese versions of FACT-Cog in breast cancer patients. Methods: This prospective, longitudinal study involved 330 breast cancer patients (187 English-speaking and 143 Chinese-speaking). Concurrent and convergent validities, reliability and responsiveness of FACT-Cog were determined. Multiple regression analysis was performed to investigate the comparability of the mean scores obtained from both versions after adjusting for clinically-relevant covariates. Equivalence was established if the 95 % confidence interval (CI) of the adjusted mean difference fell within the equivalence margin of ±0.5 standard deviation (SD). Results: Both the English and Chinese FACT-Cog total scores correlated strongly with the validated EORTC-cognitive functioning scale (r=0.725 and 0.646, respectively). Convergent validity with fatigue, anxiety and global health status were moderately strong (|r|=0.376 to 0.589). Internal consistencies within the cognitive domains were high (Cronbach’s α=0.707 to 0.929), and test-retest reliability was satisfactory (ICC=0.762 and 0.697). For patients who reported a minimal deterioration in cognitive functioning in the follow-up visit, responsiveness measured by Cohen’s effect size, standardized response mean, and Guyatt’s responsiveness index ranged from −0.58 to −0.72. The 95 % CIs for the adjusted difference between English and Chinese scores fell within the ±0.5 SD margins, except for the multitasking domain. Conclusions: FACT-Cog is a valid, reliable and responsive instrument for evaluating perceived cognitive changes in breast cancer patients. English and Chinese FACT-Cog results are equivalent and can be pooled for future epidemiological and clinical trials.
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MASCC-0589 Oral glutamine and chemotherapy induced mucositis in patients with colon cancer
setting countries as Morocco where poor dental hygiene and oral selfcare education are needed.
M.M. Vaslamatzis1, A. Laskarakis1, N. Alevizopoulos1 1 Medical Oncology, “Evaggelismos” General Hospital, Athens, Greece
MASCC-0591 Intestinal Lactobacillus spp. increase following radiotherapy in rats: an unusual finding
Introduction: Cancer related glutamine deficit seems to influence patients’ tolerance to chemotherapy due to mucositis. Objectives: The aim of the study was to investigate whether oral glutamine intake in patients with colon cancer could decrease chemotherapy induced diarrhea and dysphagia, thus preventing weight loss and the need for hospitalization due to dehydration. Methods: In a prospective study between 10/2011–12/2012, 15 of the patients who were consecutively admitted in our department with colon cancer, exposed to segmental colectomy and treated adjuvantly or for metastatic disease with FOLFOX ± AVASTIN as first line chemotherapy, received 30 gr glutamine per os daily from day one of chemotherapy until the end of treatment period. Hepatic and renal function were assessed before glutamine oral administration. Results: Patients’ median age, disease stage and weight were 65 years, stage IV and 74 kgrs respectively. All patients were estimated before and after 6 cycles of chemotherapy (3 months of glutamine consumption). During first cycle of chemotherapy, 5 reported dysphagia and we observed 3 episodes of grade II diarrhea and one of grade III, with one patient requiring hospitalization. At the subsequent cycles, no dysphagia and episodes of diarrhea were reported and no patient required hospitalization or lost weight due to chemotherapy induced mucositis. No side effects related to glutamine consumption were reported. Conclusions: Oral glutamine administration seems to reduce, without side effects, the severity of chemotherapy induced mucositis in patients with colon cancer.
MASCC-0590 Oral and dental supportive care in children with cancer: 13 years experience in the pediatric hemato-oncology center of Rabat N. Otmani1, L. Hessissen1, M. Khattab1, F. Msefer Alaoui2 1 Hemato-Oncology, Pediatric Hemato-Oncology Center, Rabat, Morocco, 2Association Avenir, Association Avenir, Rabat, Morocco Introduction: Oral and dental supportive care is an important component in children with cancer. To improve the quality of this care, a dental unit was created at the Pediatric Hematto-Oncology Center CHOP of Rabat in 2000. Objectives: The aim of this study was to investigate oral and dental supportive care in patients admitted to the CHOP during the past 13 years. Methods: Medical records of patients seen at the dental unit between January 2000 and December 2012 were retrospectively reviewed. Studied variables were: total number of patients, type of disease, treatment regimen and type of oral care. Results: Out of the 5,522 newly admitted patients to the CHOP, 3,593 (65.1 %) were referred to the dental unit. Patients with acute leukemia and lymphoma represented more than 64 %. As a consequence, up to 20 580 dental consultations were performed for in- and out-patients, and during pre- and post-cancer treatment. Most dental procedures in patients with tooth decay were fillings (53.9 %) and tooth extraction (35.9 %). Special supportive care was provided during cancer therapy by prevention and/or treatment of mucositis, infection, dysphagia, pain and radiation caries. Conclusions: Results have shown that integrating dental unit for cancer patients at the CHOP has proven their worth, especially in poor
M. Radzuan1, E. Bateman2, J. Bowen3, A. Wignall2, D. Keefe2, A. Stringer1 1 School of Pharmacy and Medical Sciences, University of South Australia, Adelaide, Australia, 2School of Medicine, University of Adelaide, Adelaide, Australia, 3School of Medical Sciences, University of Adelaide, Adelaide, Australia Introduction: Mucositis is a common side-effect of radiotherapy. Toll like receptor (TLR)-9 is involved in maintaining immune gut homeostasis and recognizing bacterial DNA, involved in mucositis. Objectives: To investigate composition of intestinal microbiota and TLR-9 expression following radiotherapy. Methods: Dark Agouti (DA) rats received 45 Gy (18 fractions of 2.5 Gy), 54 Gy (18 fractions of 3.0 Gy), 68.25 Gy (15 fractions of 3.5 Gy), or 67.2 Gy (12 fractions of 4.0 Gy). Rats were killed at the end of radiotherapy (acute), or 22 weeks post-radiotherapy (chronic). Controls were sham-irradiated. Ileum, and caecum and colon contents were collected. H&E, TLR-9 immunohistochemistry and real-time PCR were completed. Statistical analysis was completed using Kruskal-Wallis and Mann–Whitney U tests (Bonferroni correction applied). Results: Villous fusion and blunting, and crypt ablation were observed in the ileum (acute and chronic). TLR-9 expression increased significantly in rats receiving 68.25 and 67.2 Gy (p< 0.05). Significant differences in bacterial levels were observed. Bifidobacterium spp. levels decreased significantly (p < 0.05; 67.2 Gy, caecum). Enterococcus spp. levels significantly increased (p<0.05; 54 and 67.2 Gy, caecum and colon), as did Bacteroides spp. (p<0.05; 68.25 Gy, colon), and Lactobacillus spp. levels (p< 0.05; 54, 68.25 and 67 Gy, caecum and colon), the latter unexpected. Conclusions: Intestinal microbiota and TLR-9 are altered following radiotherapy. Of interest is the increase in Lactobacillus spp., a probiotic organism expected to decrease. These results suggest mechanisms affecting host-microbe interactions may be affected by radiotherapy, highlighting the importance of characterizing microbiota if they are to become successful therapeutic targets.
MASCC-0592 Psychosocial care for cancer patients as identified by nurses in the EHR in an acute setting H. Tseng1 1 College of Nursing, University of Utah, Salt Lake City, USA Introduction: Psychosocial problems are common in patients throughout the cancer journey. Objectives: The purpose of this study was to identify the psychosocial care needs of cancer patients as documented by nurses in the electronic health record. Methods: In this descriptive retrospective study, we included 2,237 patients with cancer admitted on four oncology units in a tertiary hospital over 7 months. Data collection included diagnoses, interventions, and outcomes. Data were retrieved from medical records, the nursing documentation system, and the tumor register.
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Results: The sample was primary female(63 %), white(89 %), with a major group undergoing investigation of cancer diagnosis(42 %) in current visit, and a diagnosis of cancer in gynecological site, head and neck (13 %). Psychosocial concerns were rarely documented by nurses in the EHR. The most common psychosocial problem documented was anxiety, but it only occurred in 192 inpatient stays of the 2,237 patient records samples. Other psychosocial problems documented included Coping(53, <1 %), Grief Resolution(49, <1 %), and Dignified Life Closure(18, <1 %). Progress in problem resolution was tracked using a 5-point-Likert scale(105). For Anxiety, patients providing at least two time points of assessment during hospitalizations showed decreased anxiety in 49 %, unchanged in 37 % and 14 % became worse. For Coping concerns(29), 45 % improved, 31 % remained same scores, and 24 % became worse. Conclusions: Study findings suggest that cancer patients in the inpatient setting rarely have psychosocial needs documented by nurses in the EHR. Future studies should describe current systems for delivering psychosocial care to cancer patients by primary care health providers.
MASCC-0593 Influence of anaemia on clinical symptoms, quality of life and cognitive functions in chemotherapy naive cancer patients R. Dobrila-Dintinjana1, D. Petranovic2, A. Nacinovic-Duletic2, D. Petranovic3, M. Dintinjana4 1 Radiotherapy and Oncology Clinic, University Hospital Rijeka, Viskovo, Croatia, 2Internal Clinic, University Hospital Rijeka, Rijeka, Croatia, 3Internal Clinic, Private Hospital, Rijeka, Croatia, 4Ambulance, General Practice, Rijeka, Croatia Introduction: Anaemia, bad Quality of Life (QoL) and cognitive dysfunctions are commonly present in cancer patients (pts). Previous studies mainly evaluated these problems during chemotherapy (CHT) or under influence of eritropoetic agents (EPO). Objectives: We evaluated influence of anaemia “per se” on QoL, clinical symptoms and especially on cognitive functions in chemotherapy naïve cancer patients and if correction of anaemia could improve this functions. Methods: Two hundred pts (100 anaemic and 100 without initial anaemia) in very early phase of diagnostic procedure which finally resulted in diagnosis of malignancies were evaluated by FactAn QoL Questionnary and five point scale for subjective clinical symptoms. Cognitive functions have been measured by Complex Reactiometer Drenovac (CRD). Patients without malignant disease presented control group. All parameters have been measured twice: before and after therapy for anaemia. Results: When statistically analysed, the effects of gender, age, education and Haemoglobin level showed that Haemoglobin level is the most effective variable on cognition functions analysed by beta weights. Anaemia and cancer have additive negative effect. Correction of anaemia in cancer pts significantly improve QoL and cognitive functions but not in all categories (visual orientation and memory). Conclusions: Anaemia in cancer pts profoundly affects cognition, psychological well-being and QoL. Correction of anaemia in cancer patients has positive influence on their cognitive functions and QoL. References: Holzner B, Kemmler G, Greil P i sur. The impact of hemoglobin levels on fatigue and quality of life in cancer patients. Ann Oncol 2002; 13(6):965–73
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Meyers CA. Neurocognitive dysfunction in Cancer Patients. Oncology 2000;14(1):75–81.
MASCC-0594 Exploring oncology care in an acute setting: the impact of the use of electronic standardized nursing terminology H. Tseng1 College of Nursing, University of Utah, Salt Lake City, USA
1
Introduction: We need a simple and intense tool to evaluate patient outcomes for cancer patients in acute settings. As main workforce for cancer patients, nurses are the best resource to evaluate patient outcomes. Objectives: The study aimed to evaluate patient outcomes documented by nurses using standardized terminology in electronic health records for oncology care. Methods: In this descriptive retrospective study, we included patients with cancer admitted in four oncology units in a tertiary hospital over 7 months. Data collection included demographics, diagnoses, interventions, and outcomes. Patient outcomes were tracked using a 5-pointLikert scale. Data were retrieved from medical records, and the nursing documentation system. Results: The sample (2,237) was primary female (63 %) and white (89 %) with a major group undergoing investigation of cancer diagnosis(42 %) in current visit, and a diagnosis of cancer in gynecological site, head and neck (13 %). We found 70 patient outcomes documented in the study. For Pain Level, patients providing at least two time points of assessment during hospitalizations showed decreased pain in 49 %, unchanged in 39 % and 12 % became worse. The health problems differed by unit and length of stay(LOS). Age and LOS are associated with patient outcomes. We also found that patient safety, such as Fall Prevention, was common among the top ten concerns in the study. Conclusions: The study findings suggest that patient outcomes recognized by nurses for inpatient care setting with the use of electronic standardized terminologies provide a valuable overview of evaluation of patient care for all healthcare providers.
MASCC-0595 Characteristics and length of stay on oncology specialty units H. Tseng1 1 College of Nursing, University of Utah, Salt Lake City, USA Introduction: Length of stay has been regards a quality indicator related to cost. Exploring characteristics of oncology patients, and how they being cared in acute care assisted in disclose hidden problems in current acute care for oncology population. Objectives: The study is to understanding the relationship of characteristics and length of stay in acute oncology care. Methods: We conducted a retrospective medical records review in a Midwestern tertiary hospital and 2,237 patients were selected from their first records of all oncology admissions from June 1 to December 31, 2010.A descriptive analysis addressed the relationship and characteristics and length of stay in an acute setting during the study period. Results: Certain characteristics showed longer length of stay, such as, adult leukemia and bone transplant unit, radiotherapy or multiple treatments. Insured patients showed obvious shorter length of stay. In the earlier admission day, patients reported more health
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concerns related to respiratory problems, and as hospitalization stay, patients tend to have more health problems in Risk for Infection, Nausea, Risk for Falls. Activities, Deficient Knowledge Disease Process, Imbalanced Nutrition: Less than Body Requirements, and Anxiety. Conclusions: The study findings that patients reported different primary health problems during hospitalization. Insured patients tended to have shorter length of stay; however, the quality of care at discharge for this population discarding financial pressure is questioned. Future studies should examine specific characteristics related to length of stay in an acute oncology setting may lead to interventions that shorten length of stay.
MASCC-0597 Oncology therapy at the end of the life: benefit or harm? R. Dobrila-Dintinjana1, A. Redzovic2, J. Peric2 1 Radiotherapy and Oncology Clinic, University Hospital Rijeka, Viskovo, Croatia, 2Radiotherapy and Oncology Clinic, University Hospital Rijeka, Rijeka, Croatia Introduction: The number of patients receiving chemotherapy at the end of their life is increasing. According to ESMO reports from 2005, the proportion of patients starting a chemotherapy regimen within 3 months and 1 month before death was 67 % and 25 %, respectively. Objectives: We sought to determine the proportion of our admitted patients in terminal phase of ilness who recieved some kind of active oncological therapy. Methods: We conducted a pilot study on the records of patients who died in the University Hospital. We assessed the percentage of mortality, a therapeutic approach in terms of treating the underlying disease, and access to palliative treatment. Results: Of 2,097 patients hospitalized in the UHC Rijeka Department of Radiation Therapy and Oncology during 2010 and 2011, 44 pts died which accounts for 2.1 %. Ten (22.7 %) patients were admitted exclusively to receive palliative care, while others (34–77.3 %) were admitted for planned active chemo- and/or radiotherapy administration. Within 3 months before death, 18 (40.9 %) patients underwent chemotherapy treatment Conclusions: The number of patients hospitalized due to providing palliative care is extremely low, which could indicate a good supply of out-patient treatment of cancer patients in the terminal stage of the disease. However, concerned about the high percentage of patients who tried to provide oncology treatments in the 3 months before his death. References: Chastek B, Harley CR, Kallich JD, Newcomer LN, Paoli JC Teitelbaum A, J Clin Oncol, 29 (2011).
MASCC-0598 Post-chemotherapy cognitive changes in Asian breast cancer patients: a prospective cohort study Y.T. Cheung1, M. Shwe2, Y.C. Kee3, H.K. Ho2, W.K. Chui2, G. Fan4, W.S. Yong5, P. Madhukumar5, W.S. Ooi6, W.Y. Chay6, R.A. Dent7, S.F. Ang6, S.K. Lo6, Y.S. Yap6, R. Ng7, A. Chan1 1 Pharmacy, National University of Singapore/National Cancer Centre Singapore, Singapore, Singapore, 2Pharmacy, National University of Singapore, Singapore, Singapore, 3Pharmacy, National Cancer Centre Singapore, Singapore, Singapore, 4Psychosocial Oncology, National Cancer Centre Singapore, Singapore, Singapore, 5Surgical Oncology, National Cancer Centre Singapore, Singapore, Singapore, 6Medical Oncology, National Cancer Centre Singapore, Singapore, Singapore,
S209 7 Medical Oncology, National Cancer Centre Singapore/Duke-NUS Graduate Medical School, Singapore, Singapore
Introduction: Emerging evidence shows that Asian breast cancer patients suffer post-chemotherapy cognitive impairment. Objectives: To evaluate the prevalence, severity and psychosocial determinants of post-chemotherapy cognitive changes in Asian breast cancer patients. Methods: This is a prospective, cohort study conducted at the largest cancer center in Singapore. Early-stage Asian breast cancer patients receiving anthracycline and/or taxane-based chemotherapy were recruited. A computerized neuropsychological assessment (Headminder®) was administered to evaluate patients’ cognitive performances prior to chemotherapy (T1) and at end of chemotherapy (T2). Changes of the Headminder® scores were calculated by the reliable change index(RCI) for repeated cognitive measurements. Fatigue and anxiety were measured by the Brief Fatigue Inventory and Beck Anxiety Inventory, respectively. Results: Seventy-nine patients were recruited (mean age 49.7 ± 8.5 years; 72.2 % Chinese; 50.6 % post-menopausal). Impairments in attention and response speed were the most prevalent (Table 1). Overall, 48.4 % of patients experienced impairments in 2 or more cognitive domains. Hogher degree of anxiety was associated with poorer response speed performance (r=−0.230, p=0.030), and more severe fatigue was associated with poorer attention span (r=−0.201, p=0.061). Table 1: Proportion of patients with cognitive impairment on Headminder® from T1 to T2 (n=79)
Mild impairment (%) 1 Severe impairment (%) 2 Total (%)
Memory
Attention
Response speed
Processing speed
19.0
21.5
22.8
19.0
13.9
17.7
16.5
13.9
32.9
39.2
39.3
32.9
Defined as a RCI of −1.5 to −2.5, and lower than −2.5, respectively Conclusions: Half of Asian breast cancer patients experience more than one domain of post-chemotherapy cognitive changes. Fatigue and anxiety are determinants of cognitive deterioration.
1,2
MASCC-0599 Fatigue and anxiety-related dimensions in early-stage breast cancer patients: a prospective cohort study Y.T. Cheung1, Y.C. Kee2, M. Shwe3, W.K. Chui3, G. Fan4, W.S. Yong5, P. Madhukumar5, W.S. Ooi6, W.Y. Chay6, R.A. Dent7, S.F. Ang6, S.K. Lo6, Y.S. Yap6, R. Ng7, A. Chan1 1 Pharmacy, National University of Singapore/National Cancer Centre Singapore, Singapore, Singapore, 2Pharmacy, National Cancer Centre Singapore, Singapore, Singapore, 3Pharmacy, National University of Singapore, Singapore, Singapore, 4Psychosocial Oncology, National Cancer Centre Singapore, Singapore, Singapore, 5Surgical Oncology, National Cancer Centre Singapore, Singapore, Singapore, 6Medical Oncology, National Cancer Centre Singapore, Singapore, Singapore, 7 Medical Oncology, National Cancer Centre Singapore/Duke-NUS Graduate Medical School, Singapore, Singapore Introduction: Early-stage breast cancer patients (ESBC) commonly experience anxiety and fatigue from chemotherapy treatment.
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However, the correlation between fatigue and anxiety-related dimensions has not been explored. Objectives: To elucidate the correlation between fatigue and anxietyrelated dimensions in Asian ESBC patients Methods: This is a prospective, cohort study conducted at the largest cancer center in Singapore. Stages I to III ESBC patients receiving anthracycline and/or taxane-based chemotherapy were recruited. Fatigue and anxiety were measured by the Brief Fatigue Inventory (BFI) and Beck Anxiety Inventory (BAI), which contains four anxiety-related dimensions (Table 1). Patients were assessed prior to chemotherapy (T1) and 12 weeks after the inception of chemotherapy (T2). Results: Seventy-nine patients were recruited (mean age 49.7 ± 8.5 years; 72.2 % Chinese). From T1 to T2, patients reported more fatigue [median(IQR): 1.30(0.1–2.3) vs 1.74(0.8–3.6), p=0.005] and higher degree of anxiety [5.5(2.3–10.0) vs 7.0(3.0–15.0), p=0.017]. Changes in fatigue severity were moderately correlated with anxiety symptoms within the neurophysiological- and subjective-related anxiety dimensions (Table 1). Table 1: Correlation between change in fatigue (BFI scores) and change in anxiety-related dimensions (BAI scores) (n=79) Anxiety dimension Autonomic Neurophysiological Panic Subjective
Examples of dimension-specific anxiety symptoms Indigestion, flushed face, hot/cold sweats Numbness, wobbliness, hands trembling, shaky, faintness Heart pounding, breathing difficulty, fear of dying Terrified, nervousness, scared, fear of losing control
Correlation (rs)
p-value
0.270
0.019
0.333
0.003
0.264
0.023
0.383
0.001
Conclusions: ESBC patients experience fatigue and anxiety throughout their chemotherapy treatment, and results show that the fatigue symptoms overlap and correlate well within the neurophysiologicaland subjective-related anxiety dimensions.
MASCC-0600 Intestinal injury induced by fractionated radiotherapy in a rat model is dependent upon fraction dose in the acute phase and total dose in the chronic phase E. Bateman1, J. Bowen1, A. Wignall1, E. Plews1, D. Keefe1 1 Mucositis Research Group, University of Adelaide, Adelaide, Australia Introduction: Radiation causes both acute and chronic damage to the Gastrointestinal Tract (GIT). We have developed a model in rats that investigates the differences between acute (< 6 weeks) and chronic (22 weeks) radiation damage, using clinically-based dose schedules. We found that bodyweights of all irradiated animals were significantly lower than those of control animals. Only animals receiving lowest dose recovered this loss during the chronic phase. Objectives: To explore the relationship between severity of tissue damage and radiation dose, according to acute versus chronic time points.
Methods: Histological, immunohistochemical and morphometric analyses were performed on jejunum and colon collected previously, to assess tissue architecture and composition, cell death and proliferation. Radiation injury was scored according to histopathological observations. Results: Injury scores of irradiated animals were significantly higher than controls, particularly in animals that received the highest fraction dose in the acute phase, and the highest total dose in the chronic phase (P<0.0001). Apoptotic cell counts showed a significant fraction dosedependent increase in jejunum (P=0.0072) and colon (P<0.0001) in the acute phase, and a significant decrease in proliferative cell numbers in chronic phase jejunum (P=0.0199). Morphometric analyses revealed significantly increased colon crypt length in the highest acute phase fraction dose group (P=0.0003) and the highest chronic total dose group (P=0.0095). Conclusions: Tissue analysis showed that severity of acute damage is dependent upon fraction dose and is linked to apoptosis, inflammation and direct damage, whereas chronic damage is dependent upon accumulated dose and tissue changes comparable to a complex wound.
MASCC-0601 Utility of PROMIS and LASA to measure impact from minimally invasive surgical procedures J. Bingener1, D. Seisler1, D. Farley1, M. Truty1, J. Sloan1 Surgery, Mayo Clinic, Rochester, USA
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Introduction: Measuring the impact of minimally invasive surgical procedures is complex and the optimal approach is unknown. Objectives: We tested the performance of an NIH-sponsored PatientReported Outcomes Measures Information System (PROMIS) and Linear Analog Self-Assessment (LASA) for use with laparoscopic surgery. Methods: From May 2011 through Nov 2012, of 84 enrolled patients 81 undergoing laparoscopic procedures completed PROMIS global health short form, LASA and Visual analog pain scale (VAS) preoperatively, 4 h., 1 day and 1 week after surgery. Composite scores and single item responses were compared over time using the KruskalWallis test. Results: At perioperative time points 81, 66, 59 and 59 patients provided scores for analysis (mean age 55, 56 % female). For group mean comparisons, clinically meaningful differences from baseline were encountered in the PROMIS physical subscale and physical T-score (14.2 ±2.9/46.8±7.7) to POD 1 (12.6±3/41.8±8.3) (p=0.0067/0.0038), driven by everyday physical activity (p=0.0001). Mean LASA scores revealed worsening pain frequency (p=0.0017) and severity (p=0.0009). VAS revealed clinically worse pain from baseline (mean 1.8±2.4) to POD1 and 7 (mean 4.5±2.5/2.4±2.1; p<0.0001). The within subject changes are depicted in the table.
LASA individuals worse POD 1
Overall well-being
PROMIS individuals worse POD1 (EQ5D/T-scores) 32 %
Physical well-being
32 %
17 %
Mental well-being
14 %
13 %
fatigue
–
29 %
pain
–
30 %
33 %
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Conclusions: Mean composite QOL scores had limited discrimination for the impact of minimally invasive procedures. Single items and subscales appear more promising. Change from baseline within subject revealed clinically meaningful fluctuation for all domains/items.
MASCC-0602 the effect of the new selective GLP-2 agonist, Elsiglutide, on irinotecan-induced diarrhoea and mucositis in the rat B. Mayo1, E. Bateman2, A. Stringer1, E. Plews2, K. Pishas2, C. Pietra3, S. Cantoreggi3, D. Keefe2 1 School of Pharmacy and Medical Sciences, University of South Australia, Adelaide, Australia, 2Discipline of Medicine, University of Adelaide, Adelaide, Australia, 3Research and Development, Helsinn Healthcare SA, Lugano, Switzerland Introduction: Mucositis, a debilitating gastrointestinal (GI) sideeffect of cancer treatment, affects cancer patients’ quality of life and treatment regimens. Glucagon-like peptide-2 (GLP-2), a growth-promoting GI peptide, is a potential agent for mucositis treatment and prevention. Objectives: We aim to test a longer-acting synthetic derivative of GLP-2 in a model of mucositis (Elsiglutide (Helsinn Healthcare, Switzerland)), which could improve GI damage and diarrhoea caused by chemotherapy. Methods: A Dark Agouti rat model of irinotecan (IRI)-induced mucositis was used to characterise effects of Elsiglutide on IRIinduced diarrhoea, GI pathology, cell proliferation and inflammation. Animals were given 200 mg/kg intraperitoneal IRI, followed by daily subcutaneous dosing of 0.9 or 1.8 mg/kg Elsiglutide, then killed at 6, 72 or 120 hours post-chemotherapy. Sections of jejunum and ileum were taken for analysis. Results: Elsiglutide treatment significantly ameliorated incidence of IRIinduced diarrhoea. It also significantly (p<0.05) increased small intestinal wet weight of IRI-treated rats receiving 0.9 mg/kg Elsiglutide (4.3±0.5 g at 72 h, 8.6±0.3 g at 120 h) when compared with controls (3.2±0.09 g at 72 h, 6.4±0.5 g at 120 h). Small intestinal histology showed that villous blunting, crypt ablation and enterocyte disruption was improved in the jejunum of IRI-treated rats in combination with 0.09 mg/kg Elsiglutide at both 6 h and 72 h. Plasma endotoxin levels showed a trend towards decreasing at 6 h and 72 h in response to Elsiglutide. Conclusions: These preliminary results indicate that Elsiglutide can improve IRI-induced diarrhoea and damage from as early as 6 h after treatment. Investigation and dose refinement of Elsiglutide is ongoing in order to provide further evidence of mucositis prevention and amelioration.
MASCC-0604 Hyperthyroidism and thyroid carcinoma: Puerto Rican experience E. Vazquez-Quintana1, D. Vazquez2 1 Surgery Department, University of Puerto Rico, San Juan, Puerto Rico, 2 Surgery Department, University of Tampa, Tampa, USA Introduction: The association of hyperthyroidism and carcinoma of the thyroid had been controversial throughout the literature. The incidence of thyroid cancer varies from 0.1 % to 21 %. Objectives: The objective of this study is to analyzed the frequency of coexisting hyperthyroidism and thyroid carcinomas in a private endocrine surgery practice.
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Methods: We analyzed the demographic, clinical and pathological data from 174 patient/medical records diagnosed with hyperthyroidism from January 1, 2000 to December 31, 2012. Results: Total thyroidectomy was done on all the 174 patients followed by radioactive iodine 1 month postoperatively. The association of hyperthyroidism and thyroid cancer was observed in 36 patients (20.68 %). Seven (7) were males and 29 females. Age ranged from 32 to 81 years of age, average age was 56 years. Conclusions: The association of hyperthyroidism to thyroid carcinoma is higher than previously reported. Patients with hyperthyroidism and thyroid nodules should not be treated with radioactive iodine, instead all should be submitted to total thyroidectomy. References: Gul, K., Di Ri Koc, A., Ki Yak, G., Ersoy, P., Ugras, N., Ozdemi, D., & … Cakir, B. (2009). Thyroid carcinoma risk in patients with hyperthyroidism and role of preoperative cytology in diagnosis. Minerva Endocrinologica, 34(4), 281–288.
MASCC-0605 The multi-institutional, randomized, double-blind, placebocontrolled trial to assess the efficacy of MuGard in mitigating oral mucositis (OM) in chemoradiation-treated (CRT) head and neck cancer patients R.R. Allison1, A.A. Ambrad2, Y.M. Arshoun3, D.F. Carmel4, D.F. Ciuba5, E. Feldman6, S.E. Finkelstein7, R.B. Gandhavadi8, D.E. Heron9, S.C. Lane10, J.M. Longo11, C.J. Meakin12, D. Papadopoulos13, D.E. Pruitt14, L.M. Steinbrenner15, M.A. Taylor16, W.M. Wisbeck17, G.E. Yuh18, D.P. Nowotnik19, S.T. Sonis20 1 Radiation Oncology, 21st Century Oncology Carolina Radiation Medicine, Greenville, USA, 2Radiation Oncology, Ironwood Cancer and Research Centers, Mesa, USA, 3Radiation Oncology, Allegheny General Hospital, Pittsburgh, USA, 4Radiation Oncology, John Muir Health Medical Center, Concord, USA, 5Radiation Oncology, John B. Amos Cancer Center, Columbus, USA, 6Thoracic/Head and Neck Cancers, MD Anderson Cancer Center, Orlando, USA, 7Translational Research Consortium (TRC), 21st Century Oncology, Scottsdale, USA, 8Radiation Oncology, Columbia St. Mary’s Hospital, Milwaukee, USA, 9Radiation Oncology, University of Pittsburgh Medical Center, Pittsburgh, USA, 10Radiation Oncology, Signature Healthcare Brockton Hospital, Brockton, USA, 11Radiation Oncology, Missouri Valley Cancer Consortium, Omaha, USA, 12Radiation Oncology, CaroMont Health Comprehensive Cancer Center, Gastonia, USA, 13Radiation Oncology, Vassar Brothers Medical Center, Poughkeepsie, USA, 14 Radiation Oncology, St. Joseph’s Mercy Cancer Center, Hot Springs, USA, 15Radiation Oncology, VA Western New York Health System, Buffalo, USA, 16Radiation Oncology, Peace Health St. Joseph Cancer Center, Bellingham, USA, 17Radiation Oncology, Providence Regional Medical Center, Everett, USA, 18Radiation Oncology, Enloe Medical Center, Chico, USA, 19Research and Development, Access Pharmaceuticals Inc., Dallas, USA, 20Consultant, Clinical Assistance Programs LLC, Boston, USA Introduction: OM is a frequent debilitating adverse side effect of concomitant CRT used to treat HNC for which there is no accepted prophylaxis or therapy. MuGard™ was granted CE Mark certification in Europe based on data from a small prior clinical study, and is indicated for the prevention and management of oral mucositis. Objectives: A multi-institutional, randomized, double-blind, placebocontrolled study was performed to assess the true efficacy of MuGard™ for the management of OM. The ability of MuGard™ to attenuate OM symptoms in HNC patients receiving CRT was compared with a saline bicarbonate rinse (SBC) packaged identically. SBC is recommended by the NCI as standard of care for HNC patients.
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Methods: Patients rinsed up to six times daily while during CRT (6– 8 weeks) and completed the validated Oral Mucositis Daily Questionnaire (OMDQ) daily, reporting mouth and throat soreness (MTS) and other parameters. The primary efficacy end point compared the effectiveness of MuGardTM vs. SBC on reducing OM symptoms, as determined by the area-under-the-curve (AUC) of MTS as defined by the OMDQ MTS. Results: An interim data analysis of the first 70-patients were reported at MASCC 2012 and showed that for the primary objective, the MuGard™ group had a mean AUC of 58.9 in patients completing treatment compared with 92.1 in the SBC group; p= 0.041. MuGard™ was also significantly superior in several other key parameters. Results of data analysis of 120+ patients will be presented. Conclusions: An interim analysis data indicated that MuGard™ was safe and effective in mitigating OM.
MASCC-0606 Measuring cancer fear in older Chinese adults: an application to colorectal cancer screening D.Y.P. Leung1, E.M.L. Wong1, W.K.W. So1, K.S. Wong1, C.W.H. Chan1 1 The Nethersole School of Nursing, The Chinese University of Hong Kong, Hong Kong, Hong Kong China
Support Care Cancer (2013) 21 (Suppl 1):S1–S301 1
Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute, Boston, USA, 2Biomedical engineering, Duke University Medical Center, Durham, USA, 3Cantor Center for Research in Nursing and Patient Care, Dana-Farber Cancer Institute, Boston, USA, 4Medical Oncology, Dana-Farber Cancer Institute, Boston, USA, 5Thoracic Oncology, Boston Medical Center, Boston, USA, 6 Medical Oncology, Dana-Farber Cancer Intitute, Boston, USA, 7 Biomedical informatics, University of Utah, Salt Lake City, USA, 8Medicine Thoracic Oncology, Boston Medical Center, Boston, USA, 9NICHQ, National Initiative for Children’s Health Care Quality, Boston, USA Introduction: Adequate symptom management is essential to ensure quality cancer care, but symptom management is not always evidencebased. Adapting, automating, and personalizing national guidelines and delivering these guideline-based therapeutic recommendations to clinicians in real time at the point-of-care is a way to operationalize guideline use. Objectives: This paper reports a process of adapting research evidence for use in a clinical decision support system that provided individualized symptom management recommendations to clinicians at the pointof-care. Methods: Using a modified ADAPTE process, panels of local experts adapted national guidelines and integrated research evidence to create computable algorithms with explicit, personalized recommendations for patients with the most common symptoms associated with lung cancer (pain, fatigue, dyspnea, depression, and anxiety).
Introduction: Older people are more susceptible to colorectal cancer (CRC). Previous studies suggest that cancer fear may be a key predicotr of cancer prevention related behaviors such as participation in cancer screening. Yet there is a lack of validated measuring tools of cancer fear for the Chinese older adult population. Objectives: This study aims to test the psychometric properties of a Chinese translation of the Champion’s 7-item Breast Cancer Fear Scale with an adaption to CRC in a Chinese older adult sample. Methods: The CRC Cancer Fear Scale was translated into Chinese by the research team who are fluent in both English and Chinese. A convenience sample of 250 community-dwelling adults aged ≥60 were recruited from three non-government organizations between May and July 2012 in Hong Kong. Factor structure, reliability and construct validity of the scale were assessed by confirmatory factor analysis (CFA), Cronbach’s alpha and correlations with perceived risk of developing CRC respectively. Results: CFA results revealted that the one-factor model provided an adequate fit to the data (R-χ2 = 46.98, df = 20, R-CFI = 0.988, RRMSEA=0.974 and SRMR=0.029). The factor loadings ranged from 0.72 to 0.88 and all were statistically significant. Cronbach’s alpha value of the scale was 0.95. Positive and signficiant correlations of CRC cancer fear with susceptibility (r=0.14), severity-fear (r=0.61) and severity-life impact (r=0.49) were observed. Conclusions: The findings provide support for the psychometric properties of a Chinese version of the Champion Cancer Fear with an adaption to CRC in a sample of community dwelling Chinese older adutls.
MASCC-0607 Creating evidence-based computable algorithms providing real-time specific symptom management suggestions in both a community and an academic outpatient thoracic oncology setting J.L. Abrahm1, D.F. Lobach2, B. Halpenny3, M.S. Rabin4, K. Finn5, P. Calarese6, G. Del Fiol7, K. Zaner8, I.L. Berenbaum8, E. Johns2, T.A. Saunders9, D.L. Berry3, M.E. Cooley3
Results: Multidisciplinary small groups that included content experts, and a consensus panel, using a nominal group technique, modified and subsequently approved computable algorithms for fatigue, dyspnea, moderate pain, severe pain, depression and anxiety. The approved algorithms represented consensus of multidisciplinary clinicians on pharmacological and behavioral interventions tailored to the patient’s age, co-morbidities, laboratory
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values, current medications, and patient-reported symptom severity. Algorithms were reconciled with one another to enable simultaneous
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management of several symptoms and delivery of a report in real time to clinicians.
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Conclusions: A modified ADAPTE process and nominal group technique enabled the development and approval of locally adapted computable algorithms for individualized symptom management in lung cancer patients. The process was more complex and required more time and resources than initially anticipated, but resulted in computable algorithms that operationalized expert consensus.
MASCC-0608 Carbamazepine for the prevention of chemotherapy-induced nausea and vomiting: a pilot study using Simon’s optimal two-stage design T. Aragão Santana1, D. Trufelli1, F. Silva Melo Cruz1, A. DelGiglio1 1 Clinical Oncology Department, ABC Medical School, SÃO PAULO, Brazil Introduction: Nausea and vomiting have been a major drawback to patients undergoing chemotherapy. Despite standard preventive treatment, chemotherapy-induced nausea and vomiting (CINV) rates can still reach 50 %. Objectives: In pursuit of ameliorating prevention of CINV at lower costs, we studied the efficacy of addition of carbamazepine to a regimen of corticosteroid plus 5-hidroxitriptamine-3 receptor antagonist, as well as its side effects and influence on patients’ quality of life (QoL) Methods: A prospective open label phase II nonrandomized study was carried out in a Brazilian Oncology service. Patients allocated for their first cycle of highly emetogenic chemotherapy received, besides the current standard antiemetic treatment, carbamazepine, p.o., with staggered doses, from the third day before until the fifth day after chemotherapy. Considering sparse evidence about the anticonvulsants’ efficacy in CINV prevention, we adopted Simon’s optimal two-stage design, which should include 43 patients unless overall complete prevention was not achieved in 9 out of the first 15 entries. Functional Living Index-Emesis questionnaire was used to measure impact on QoL Results: None of ten studied patients (0 %) had overall complete prevention and nine needed rescue medication. Three quitted carbamazepine therapy because of somnolence and vomiting before chemotherapy infusion. Seven were able to take medication for the entire period and none were responsive, so the study was closed. There was no impact on patients’ QoL. Conclusions: Carbamazepine was ineffective for prevention of CINV. Simon’s optimal design allowed us to stop the trial for futility, minimizing the amount of patients possibly exposed to an inactive agent.
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Methods: Enrolled pts underwent CMR at baseline, after 1 cycle of DOX, and immediately after completion of DOX. Repeated measures analysis of variance modeled changes in cardiac markers over time. CMR at ≥12 months post DOX exposure is planned in a subset of patients. Results: Forty-two pts were enrolled. The average age was 52 years (range 33–68). Twenty-nine patients (69 %) had CMR examinations at the first three time points (Table 1). Maximum T2 measures increased (p=0.09), corresponding to acute tissue edema, and systolic strain rates significantly decreased (p=0.001), corresponding to lower contractility, by the end of therapy. Nearly 54 % of patients had abnormal troponin levels (median: 0.03, 0.02–0.17). A trend toward lower systolic strain was present in patients with elevated troponins, consistent with early LV dysfunction (Figure 1). LVEF was not significantly decreased immediately following treatment completion. Results: of LVEF changes after ≥12 months post DOX exposure are currently pending. Table 1 Patient Characteristics
N (%)
Enrolled
42 (100)
Enrolled and cardiac biomarkers×3
36 (86)
Enrolled and CMR×3
29 (69)
Median age (range)
52 (33–68)
Stage I
5 (14)
II
21 (58)
III
10 (28)
Menopausal status Pre
9 (25)
Post
27 (75)
Tobacco use
16 (44)
Diabetes
3 (8)
Hypertension
14 (39)
Hyperlipidemia
13 (37)
Median heart age (Range)
54 (30–80)
Figure 1 MASCC-0609 Prediction of anthracycline-induced cardiac injury R.E. Reinbolt1, S.V. Raman2, A.S. Ruppert3, S. Carothers4, C.L. Shapiro4, M.B. Lustberg4 1 Medical Oncology, The Ohio State University Comprehensive Cancer Center, Columbus, USA, 2Cardiology, The Ohio State University, Columbus, USA, 3Hematology, The Ohio State University Comprehensive Cancer Center, Columbus, USA, 4Stefanie Spielman Breast Center, The Ohio State University Comprehensive Cancer Center, Columbus, USA Introduction: Cardiac toxicity from anthracyclines including doxorubicin (DOX) needs to be better characterized. Cardiac magnetic resonance imaging (CMR) may better predict early DOX-related cardiotoxicity. Objectives: We prospectively obtained serial CMRs and Troponin I (Ti) levels in patients (pts) with breast cancer receiving DOX chemotherapy.
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Conclusions: We observed cardiac tissue changes that are suggestive of acute injury after DOX. These may be predictive of future functional impairments. By obtaining an additional CMR study at ≥12 months post treatment, we intend to clarify if these effects are permanent. The results from this subset analysis will be reported.
MASCC-0610 Family support for outpatients undergoing cancer treatment N. Hira1, F. Karatsu1, I. Tanaka2, H. Narui3 1 Nursing and Social Services, Health Sciences University of Hokkaido, Tobetsucho, Japan, 2Nursing division, Teine Keijinkai Hospital, Sapporo, Japan, 3Nursing, Aomori University oh Health and Welfare, Hirosaki, Japan Introduction: It’s not clear how support program can be organized to help the families in Japan. The future direction of this study will be one that encompasses the program of support group for care of families Objectives: To understand how families of cancer outpatients support the patients as caregivers. Methods: The subjects are 16 people who are family members of cancer outpatients. Data was collected from semi-structured interviews and was analyzed qualitatively and inductively. The results are summarized as follows: Results: - Family members say that, when spending time with cancer patients, they are aware that the patients have little time left to live, and the family members look for ways to spend everyday life with them. - To care for the cancer patients physically and to respond to changes in their physical condition, family members prepare for emergencies, pay close attention to the patients’ condition, avoid putting physical and mental strain on them, try to find time to stay with them as much as possible, help them or let them do things by themselves at the right moment and receive necessary information. - Family members feel that, as caregivers, they are not enough to meet the patient’s expectations. - Family members have ways of communicating smoothly with the patients (e.g., they suggest ideas and ask the patients to understand them). Conclusions: This study shows that family members of cancer outpatients support the patients by responding to changes in the patient’s physical condition and their desire to maintain good family relationships.
MASCC-0611 Fractionated radiotherapy in a rat model causes dose-dependent changes in collagen deposition, and expression of transforming growth factor ?1, smad3 and smooth muscle actin ?1 E. Bateman1, C. Wilson1, C. Keefe1, J. Bowen1, A. Wignall1, E. Plews1, D. Keefe2 1 Mucositis Research Group School of Medicine, University of Adelaide, Adelaide, Australia, 2Cancer Centre, Royal Adelaide Hospital, Adelaide, Australia Introduction: Radiation-induced fibrosis is a common treatment-related toxicity in the gastrointestinal tract (GIT). It is largely mediated by upregulation of transforming growth factor beta 1 (TGF-β1) and phosphorylation of signal transducer Smad3, which induces proliferation and increased deposition of collagen within the GIT wall by mesenchymal cells. Objectives: To assess the degree of radiation-induced fibrosis, and the expression patterns of TGF-β1/Smad3 and smooth muscle actin alpha-1 (SMA-α1) in a rat model of acute and chronic radiation-induced GIT injury[1]. Methods: Tissue sections of 4 μm of colon and jejunum were stained with Masson’s Trichrome/Verhoeff’s stains to assess changes in
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connective tissue (CT). Measurements relating to wall thickness were analysed using the Kruskal Wallis test (with Dunn’s post hoc analysis). Immunohistochemistry was performed, using heat-mediated antigen retrieval, and optimised titres. Results: Colon and jejunum of irradiated animals showed a significant fraction dose-dependent disruption of CT architecture within the acute phase of injury (P<0.05). Within the chronic phase, there was a significant total dose-dependent deposition of dense collagen and elastic fibres, mostly in submucosa (P<0.05). Immunostaining of SMA-α, TGF-β1 and Smad3 showed a similar fraction dose-dependent increase in acute phase groups and a total dose-dependent increase in chronic phase groups. Conclusions: Increased TGF-β1/Smad3-mediated collagen deposition and smooth muscle cell proliferation is dependent upon fraction dose in the acute phase, and accumulated dose in the chronic phase of radiation injury. Since the pathways involved are complex and multifactorial, further investigation into quantified protein and mRNA expression patterns may be useful. References: [1] Support. Care Cancer, 2012; 20(Suppl1): 1–283.
MASCC-0612 The accuracy of clinicians’ prediction of survival and prognostic factors indicative of survival: a systematic literature review M. Zhou1, N. Lao1, R. Chow1, L. Zeng1, H. Lam1, E. Chow1, L. Holden1 1 Rapid Response Radiotherapy Program Department of Radiation Oncology, Sunnybrook Health Sciences Odette Cancer Centre, Toronto, Canada Introduction: Terminally ill patients may want to accomplish certain tasks or consider different alternatives for palliative care before their death. However, predicting and disclosing the remaining duration of survival is a difficult task for health care professionals. Objectives: The purpose of this study was to review the literature and examine the accuracy of clinicians’ prediction of survival as well as prognostic factors predictive of shorter survival. Methods: A literature search was conducted to obtain studies that examined the accuracy of prediction of survival and prognostic factors indicative of survival in patients with terminally cancer. Descriptive statistics summarized the extracted data. Results: A total of 85 studies were identified published from 1972 to 2012 with a study cohort of 30–5256. Clinicians’ prediction of survival was determined to be correlated with patient’s actual survival although tending to be too optimistic. The ability of varying members of the health care professionals to estimate survival was contradictory amongst studies. The estimations were also reported to be more accurate during certain time ranges such as the ‘horizon effect’. Few assessment tools to assist in predicting duration of survival in patients were developed and validated. Conclusions: Demographic information and clinical symptoms can assist in determining the remaining length of survival in terminally ill cancer patients. Even with the application of instruments, error cannot be completely eliminated. Physicians’ should warn the patient and their family and friends of the uncertainty in the predictions. Keywords: prediction of survival, review, advanced cancer, terminally ill, prognostic factors
MASCC-0613 Hospital utilization in last 6 months of life for cancer patients: a novel method and implications for supportive care B. Cassel1, E. Del Fabbro1 1 Massey Cancer Center, Virginia Commonwealth University, Richmond, USA
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Introduction: In the US, organizations such as the National Quality Forum (NQF) have developed metrics to assess the quality of cancer care, and several are specific to care near the end of life. Cancer centers need feasible Methods for selfevaluating the quality and cost of their cancer care, the results of which may highlight the unmet need for supportive care for these patients. Objectives: To devise a new method for retrospective evaluation of quality and cost of care for cancer patients toward the end of life; and by assessing those metrics to infer the possible contribution that outpatient supportive care could make. Methods: Social Security Death Index (SSDI) data were acquired and linked to claims data for our center’s cancer patients. 3,128 adult cancer patients died between January 2009 and July 2011 and had contact with our center in their last 6 months. Results: Bone marrow transplant and hematological malignancy patients had higher hospital utilization, greater costs, and lower NQF quality metrics than solid tumors. There was a dramatic increase in ICU days, hospital days, and costs in each of the last 6 months of life. Inpatient palliative care was used by 27.5 %, at a median of 22 days before death. Earlier inpatient palliative care was associated with greater use of hospice (p<.001) and lower rate of in-hospital death (p=.041). Conclusions: Once date of death is known, end-of-life quality and cost metrics can be assessed relatively easily. This makes salient the inability of inpatient palliative care to prevent hospitalizations.
MASCC-0614 Psychosocial analysis of cancer survivors in rural NSW, Australia Z. Ansari1, M. George2 1 Medical Oncology, Calvary Mater Newcastle, Newcastle, Australia, 2 Medical Oncology, Tamworth Rural Referral Hospital, Tamworth, Australia Introduction: Psychosocial aspects of cancer and their management occupy an important place in oncology, but often ignored by clinicians in day-to-day practice. Such issues vary from urban to rural areas, survival period and according to the type of cancer. Objectives: In this study we aimed to analyse the psychosocial aspects of various cancers in patients who have visited a rural oncology clinic in New England region, Australia. Methods: All patients with various cancers have participated the study. The inclusion criteria included 3 years after diagnosis of cancers. Excluded were those who were having active cancer treatment. Three domains were studied using a standardised and validated tool. This includes demographic parameters, quality of life, treatment information and wellbeing. Results: Most of the participants were under 65 years of age and females (64.7 %). 49 % were breast cancer followed by colo-rectal cancer (39.2 %). Regarding the psychological functions 49 % reported feeling happy often and 25.5 % always; 41.2 % felt depressed rarely. 56.9 % reported that they enjoyed life always. 31.4 % were never bothered by pain. Majority of patients reported positive outlook on life. Although 25.5 % stated that they were always and 33.3 % sometimes worried about dying. 45 % reported that they appreciated life more because of cancer diagnosis. 33 % never worried and 15.7 % rarely worried about their appearance. 33.3 % always worried that cancer would come back. 50 % had no financial issues because of cancer. Conclusions: Psychosocial aspects of cancer patients who survived for more than 3 years in a rural setting have shown reasonably good quality of life in all domains.
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MASCC-0615 Systematic review of pooled series analyses of phase I clinical trials for cancer: implications for ethics and supportive care B. Cassel1, E. Del Fabbro1 Massey Cancer Center, Virginia Commonwealth University, Richmond, USA 1
Introduction: Each year, hundreds of thousands of cancer patients reach the point where they have exhausted conventional therapies. At that point, some of them turn to Phase I studies, which represent a key translational step in the expensive process of developing new agents or combinations of agents. Objectives: To review the performance status, survival, and prognostic factors for patients in phase I trials; to draw out the evolution of ethical issues for phase I trials over the past 20 years and to discuss how supportive care could be involved more systematically for these patients Methods: Systematic literature review of pooled series analyses of phase I clinical trials for cancer Results: 29 studies met criteria, representing >550 trials and nearly 18,000 patients. 0 % to 32 % (median: 6 %) had an ECOG performance status of >=2. Median survival ranged between 5 and 10.5 months (median: 8.4). 90-day mortality ranged from 9.8 % to 27 % (median: 16.5 %). A small set of prognostic factors including albumin, lactate dehydrogenase, and metastatic disease provides an adequate prediction of early mortality. The few studies that included patients referred, but not enrolled, indicate that referrals are often made for patients who are too debilitated and symptomatic to participate. Conclusions: Low toxicity rates, stable disease, and extremely rare deaths have changed the ethical landscape of recruiting phase I trial participants. Supportive care should be engaged for all patients referred for phase I trial consideration, to address symptoms, improve chances of enrolling in and completing phase I trials, and meeting their end-oflife needs.
MASCC-0616 Envoy service, a form of dignity therapy, to assist to express personal values and communication with family members and care givers: a preliminary report S. Lee1, S. Shin1, S. Whang2, S. Kim1, S. Cho3, S. Oh4 1 Medical Oncology, Korea University Medical Center, Seoul, Korea, 2 Department of Psychiarty, Korea University Medical Center, Seoul, Korea, 3Hospice Team, Seoul Medical Center, Seoul, Korea, 4Oncology and Hematology, Seoul Medical Center, Seoul, Korea Introduction: Patients with incurable illness could have difficulties to express and communicate regarding their wishes, personal values and end of life care option. Objectives: ‘Envoy Service’ was designed to assist the patients with incurable disease, to deliver a detailed message to family members and care givers. Methods: The assigned patients were helped by trained dialogist to express in narrative form regarding the personal values and end of life care options. The dialogue could be videotaped, voice recorded, or wrote down by the dialogist, upon the patients’ choices. The dialogue was carefully edited by the Envoy Service team. The final products were delivered to family members and caregivers and their responses were collected. Results: Ms. N, 53 of age, treated with advanced myelofibrosis for over 20 years and having prognosis of limited life expectancy, agreed to have ‘Envoy Service’. She had an hour talk with dialogist, regarding her life values and emotional expression of suffering and end-of- life care options. The dialogue was dictated by the clinical psychologist in her case. Detailed report regarding the life of her and her wishes in end-
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of-life care was made. We will present around 10 patients experiences of ‘Envoy Dialogist Services’ at the meeting. Conclusions: ‘Envoy Service’ could be valuable for patients with incurable disease to help to express regarding their personal life values and communication in end-of- life options between the patients, family members and care givers and might help to facilitate early palliative care.
MASCC-0617 Biphasic response of pro-inflammatory cytokines and Chemokines expressions in a radiation-induced glossitis model T. Nakashima1, N. Uematsu2, M. Shibamori2, M. Sato2, K. Sakurai2, T. Ishida1, H. Kiwada1 1 The University of Tokushima, Institute of Health Biosciences, Tokushima, Japan, 2Otsuka Pharmaceutical Co. Ltd., Third Institute of New Drug Discovery, Tokushima, Japan Introduction: Oral mucositis is one of major side effects of chemoradiotherapy for patients with head and neck cancer. Objectives: We developed a glossits model induced by X-ray irradiation and studied the expression of inflammatory cytokines and chemokines during the development of glossits in rats. Methods: Rats were received a single dose of 15 Gy of X-ray with a vertical beam to the entire snout under double shielding the body with 0.5 mm-thick lead plate (Day 0). The tongue injuries were analyzed by digital photoimagings from Day 1 to Day 28. The halves of tongue specimens were assessed general histology by H&E and Azan stain. The others were measured gene expression level of inflammatory cytokines (IL6, IL1b, TNF-a) and chemokines (Gro-a, MCP-1) by a quantitative real-time PCR method. In the initiation phase (0 to 24 h after X-ray irradiation), these gene expressions were also analyzed. Results: In the initiation phase without both injuries and inflammation, the transient expressions of inflammatory cytokines and chemokines genes were observed within 1–4 h after X-ray irradiation. After that, the dramatic elevations of these gene expressions were observed on Day 7 when the ulcer and inflammation emerged. The changes of gene expression of these inflammatory cytokines and chemokines were associated with the time course after the sever tong injury. Conclusions: Our finding suggests that pro-inflammatory cytokines and chemokines in tongue epthelial cells produced by X-ray irradiations may trigger the development of glossitis.
MASCC-0618 Olvanil interferes with the anti-emetic action of ondansetron, but not dexamethasone, in ferrets J.A. Rudd1, K.M. Chu1, M.P. Ngan1, M.K. Wai1, C.K. Yeung1 1 Emesis Research Group, Chinese University of Hong Kong, Shatin, Hong Kong China Introduction: Pungent TRPV1 channel activators have broad inhibitory anti-emetic activity against centrally- and peripherally-acting challenges, but at doses having adverse effects on the cardiovascular system and on temperature homeostasis. Objectives: In the present studies, we investigated whether combining the ‘non-pungent’ TRPV1 activator, olvanil, with ondansetron or dexamethasone, could improve the control of cisplatin-induced acute and delayed emesis in the ferret. Methods: Ferrets were implanted under general anaesthesia with DSI radiotelemetry transmitters to record heart rate (HR) and body temperature. Seven days later, they received cisplatin (5 mg/kg, i.p.) alone or in combination with ondansetron (1 mg/kg, i.p.), dexamethasone (1 mg/kg,
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i.p.), and/or olvanil (0.5 mg/kg, s.c.). Dosing of anti-emetics and/or olvanil or vehicles continued at 8 h intervals until the end of the experiment (n=3–5). Results: Vehicle-treated animals (HR 260.6±3.7; basal temperature, 37.7±0.3 °C) that did not receive cisplatin exhibited transient emesis. Cisplatin induced a weak acute (24 h) emetic response (31.0±10.8 retches + vomits; RV). However, the delayed (48–72 h) response comprised 198.5±27.9 RV, which was reduced by ondansetron and dexamethasone by 75.2 and 87.2 %, respectively (P<0.05). Olvanil failed to antagonize the response and prevented the anti-emetic action of ondansetron but not dexamethasone. None of the treatments affected HR or body temperature. Conclusions: Concomitant administration of non-pungent TRPV1 activators with anti-emetic drugs may not be useful for the treatment of acute and delayed emesis induced by cisplatin. These studies were fully supported by the Research Grants Council of Hong Kong (CUHK4527/05M).
MASCC-0619 Caring for palliative patients: impact on caregivers C. Shunmugam1, S. Veeraiah1, V. Elangovan1 Psycho-Oncology, Cancer Institute (WIA), Chennai, India
1
Introduction: Cancer not only affects patients but also their carers. It is reported that carers of cancer patients have depression (32 %), worry (71 %), tiredness (11 %), loss of work productivity (22.9 %), distress (15.4 %), hopelessness (68 %) and heavy burden (90 %). Objectives: To understand the impact of caregiving on the life of caregivers of palliative care patients. Methods: A cross sectional study design using purposive sampling was employed on the caregivers (n=24) of consecutive patients attending the palliative outpatient department. Semi-structured interview was conducted to explore their concerns. In addition, they were assessed for their Fatigue, Distress, Anxiety and Quality of Life using appropriate tools. Results: Preliminary analysis revealed that more than half (58 %) of the caregivers were females and 37 % of the primary caregivers were patients’ children. Reactions to diagnosis were sadness (62.5 %), helplessness (45.8 %), and shock (54.2 %). Only 62.5 % of the caregivers were aware of the patient’s prognosis and their reactions were sadness (79 %), uncertainty about patient condition (52.6 %), worry about their future (37 %) and fear (47.3 %). About two-third of the caregivers were employed, of which 62.5 % faced work-related issues such as absenteeism, poor concentration, and loss of pay. Since the patient’s diagnosis, 54 % of them underwent significant life changes. Caregivers experienced financial problems (70.8 %), sleep problems (46 %), adjustment issues (50 %), high anxiety (50 %), average fatigue (50 %), severe distress (58.3 %) and moderate quality of life (66.7 %). Conclusions: Emotional, physical and economic well-being is disrupted in caregivers of palliative patients. These unmet needs should be identified and addressed using appropriate intervention.
MASCC-0620 An evaluation of the implementation of the Liverpool care pathway in rural western Australia A.M. Wilkinson1, C. Johnson2, H. Walker3, V. Colgan3 1 Western Australia Centre for Cancer and Palliative Care, Edith Cowan University, Perth, Australia, 2Cancer and Palliative Care Research and Evaluation Unit, The University of Western Australia, Perth, Australia, 3 The Western Australian Cancer and Palliative Care Network, Government of Western Australia Department of Health, Perth, Australia
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Introduction: While most people would prefer to die at home; approximately 50 % to 70 % of patients worldwide still die in a hospital. Objectives: The Liverpool Care Pathway (LCP), a widely recognized clinical guideline for the optimal management of the terminally ill in the last 72 h of life, was introduced in 16 rural/regional hospitals in Western Australia. This study aimed to evaluate whether the systematic use of the LCP improved the quality and cost of end of life care in rural WA. Methods: Patient, caregiver and health services outcomes were evaluated pre/post implementation of the LCP. Data included medical record audits of the last admission for 415 deceased patients (223 pre/192 post) who were in hospital for more than 24 h prior to death; a survey of the primary nurse involved in the patient’s care; and a telephone interview with the caregiver (3 months after the patient’s death). Results: Mean length of stay was 10 days (range 1–121) prior to death. The mean time on the LCP was 5.58 days (range 0–44). Analyses document significant improvements in the appropriate identification of dying patients and documentation of their care pre/post. Communication improved between health professionals and with the patient and their family. Use of the LCP resulted in improved symptom management, improved caregiver satisfaction with care, and a reduction costs through a reduction in inappropriate procedures and investigations. Conclusions: Use of the LCP appears to improve end of life care, reduce the use of inappropriate or burdensome life-sustaining interventions and reduce costs once implemented.
MASCC-0621 Improving efficacy and safety of docetaxel in second line lung cancer G.S. Bhattacharyya1, A.A.B. Bhushan2, G. Biswas3, H. Malhotra4, K. Govindbabu5, S. Basu6, N. Bascomb7 1 Medical Oncology, Fortis Hospital, Kolkata, India, 2Medical Oncology, Deenanath Mangeshkar Hospital, Pune, India, 3Medical Oncology, Sparsh Hospital, Bhubaneshwar, India, 4Medical Oncology, SMS Hospital, Jaipur, India, 5Medical Oncology, Kidwai Memorial, Bangalore, India, 6Radiation Oncology, AMRI, Kolkata, India, 7Drug Development, Vicus Therapeutics, New Jersey, USA Introduction: Docetaxel is an accepted second line drug for NSCLC not used frequently for its side effects. VT122 (propanolol and etodolac) which has anti-angiogenic COX-2 inhibition properties. Modifying the tumor-microenvironment and sympathetic system has anticancer activity as well as ameliorates toxicity of anticancer drugs. Docetaxel efficiency can be improved with VT122 which possesses the above property. Objectives: To increase efficacy of docetaxel and safety profile using VT122 Methods: Twenty (10 in each arm) patients (55–65 years) were treated with docetaxel (75 mg/m2) with or without VT122. VT122 was started 7 days before giving docetaxel. Propanolol doses were titrated to maintaining heart rate around 60. Etodolac was titrated on the basis of CRP to a maximum of 1,200 mg/m2. Results: Overall Response seen in 4 patients (VT122 arm) and 2 patients (docetaxel arm). 6 patients in VT122 arm completed 6 cycles of docetaxel while in non-VT122 4 patients completed the 6 cycles. 1 year survival was 30 % vs 10 %; p=0.025. Grade III/IV hematologic toxicity was decreased by 50 % ie 6 cases in docetaxel arm and 3 in VT122. In non-hematological toxicity this trend was seen for asthenia, neuropathy, skin and nail changes and weight loss. Conclusions: Addition of VT122 (propanolol and etodolac) increases efficacy of docetaxel and is cost effective.
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MASCC-0622 The implementation of a care partner program and its effects on oncology caregiver stress J. Peckham1, S. Singh-Carlson1 1 Graduate Nursing, California State University Long Beach, Long Beach, USA Introduction: It has been identified that lack of communication with health care providers leaves oncology patients and their caregivers feeling unprepared and can lead to increased caregiver stress. Objectives: The objective of this study is to identify if the implementation of a Care-Partner Program on an acute oncology unit will decrease caregiver stress. It is anticipated that increased communication and the integration of the family caregiver into the care of the patient while in the hospital will prepare the oncology caregiver for discharge and thereby decrease their stress. Methods: This study will involve two phases, a standard care phase and an interventional phase. Each phase will have a minimum of 38 subjects. A survey will be completed by the caregiver on admission to assess the level of comfort in caring for the oncology patient and again on the day of discharge. The standard care group will receive no intervention and serve as a baseline group while the interventional group will participate in a program that integrates the identified family caregiver into the care of the patient while in the hospital. The two groups will be compared to see of the intervention decreased oncology caregiver stress. Results: Preliminary results indicate that a care-partner program does decrease caregiver stress as well as health care provider stress, however there a whole host of other factors that interplay that needs further analysis Results will be complete at presentation. Conclusions: It is anticipate that the implementation of a Care Partner Program on an acute oncology unit will decrease caregiver stress.
MASCC-0623 The role of palliative care in mass casualty and disaster events with scarce resources A. Wilkinson1 1 Western Australia Centre for Cancer and Palliative Care, Edith Cowan University, Joondalup, Australia Introduction: Catastrophic mass casualty events (MCEs) can yield thousands of victims whose needs overwhelm local and regional health care systems, personnel, and resources requiring difficult decisions regarding the allocation of scarce resources and the alteration of standards of care in all care settings. Guidance regarding preparation for, management, and provision of medical care under such circumstances remains limited Objectives: Although the primary goal of a coordinated response to an MCE is to maximize the number of lives saved, a comprehensive response should also seek to minimize the suffering of those who may not survive. The purpose of this paper is to explore the role of palliative care in the support of individuals not expected to survive an MCE and to provide recommendations for specific actions for a coordinated disaster response plan. Methods: Semi-structured telephone discussions with key stakeholders and an expert group meeting identified five domains of importance: (1) the role of palliative care in a mass casualty event; (2) the triage and ensuing treatment decisions for those “likely to die;” (3) the critical palliative care services, personnel and settings vital to provision; (4) the pragmatic plans needed for ensuring training, supplies, and organizational/jurisdictional arrangements; and (5) unusual issues affecting palliative care under MCE scenarios.
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Results: Palliative care minimizes the suffering of those who will not survive and may free up resources to optimize survival of others. Conclusions: Planning to provide palliative care during mass casualty events should be part of the current state and local disaster planning/training guidelines, protocols, and activities.
MASCC-0624 Validation of the head and neck patient symptom checklist as a nutrition impact symptom assessment tool for head and neck cancer patients K. Schmidt1, K. Olson2, C. Kubrak3, M. Parliament3, S. Ghosh3 1 Head and Neck Tumor Group, Cross Cancer Institute, Edmonton, Canada, 2Faculty of Nursing, University of Alberta, Edmonton, Canada, 3Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Canada Introduction: Individuals with head and neck cancer (HNC) often present with reduced nutritional intake prior to treatment. Many authors have shown that reduced dietary intake is associated with decreased clinical response to treatment, quality of life, and survival. Objectives: The purpose of this study was to test the validity of the Head and Neck Patient Symptom Checklist (HNSC). Methods: Three hundred and sixty-eight treatment naïve individuals diagnosed with HNC completed the HNSC and the Patient Generated Symptom Global Assessment (PG-SGA). The predictive validity was determined by comparing the HNSC symptoms interference scores to the PG-SGA scores. Additionally, logistic regression was used to determine the HNSC symptoms scores predicting reduced dietary intake, weight, and functional performance (FP). Results: HNSC sensitivity (79–98 %), specificity (99–100 %), positive predictive value (92 %–100 %), and negative predictive value (94 %–100 %) were excellent. The multivariate logistic regression showed that advanced tumor stage, pain, loss of appetite (LOA), and difficulty swallowing significantly predicted dietary intake. Advanced tumor stage, LOA, and difficulty swallowing were also significant predictors of ≥5 % weight loss over 6 months. LOA, difficulty swallowing, feeling full, and lack of energy were significant predictors of reduced FP. Conclusions: The HNSC appears to be a valid tool for determining symptoms interfering with dietary intake of HNC patients. This instrument may aid in early identification of symptoms that place HNC patients at risk for reductions in dietary intake, weight, and functional performance.
MASCC-0625 Physician perspective on incorporation of oncology patient quality of life (QOL), fatigue, and pain assessment into clinical practice J. Hubbard1, A. Grothey1, R. McWilliams1, J. Sloan1 1 Medical Oncology, Mayo Clinic, Rochester, USA Introduction: Patient reported outcomes such as pain, fatigue and QOL are important for morbidity and mortality in cancer patients. However, systematic approaches to collect and incorporate PROs in clinical practice are still evolving. Objectives: We set out to determine the impact of PRO assessment on routine clinical practice. Methods: Beginning in July 2010 the symptom assessment questionnaire (SAQ) was administered to every patient in a solid tumor oncology practice at an academic center. The SAQ measures pain, fatigue, and QOL each on a 0–10 point scale. Results are available to providers before each visit in the electronic medical record. 18 months after the SAQ was implemented,
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an online survey was sent to 83 oncology care providers regarding the use of the SAQ and how it impacted their clinical practice, including the discussion with patients, duration of visits and work burden. Results: Fifty-three percent of the care providers completed the online survey, producing 44 evaluable surveys. 86 % of care providers reported using information from the SAQ. Over 90 % of the care providers indicated that the SAQ did not change the length of clinic visits or contribute to increased work burden. Over 78 % of care providers indicated that the SAQ had helped or enhanced their practice. Providers overwhelmingly endorsed the SAQ for facilitating communication with their patients. Conclusions: This study indicates that simple single-item measures of pain, fatigue and QOL can be incorporated into oncology clinical practice with positive implications for both patients and physicians without increasing duration of visits or work burden. MASCC-0626 prevalence of factor V leiden and prothrombin G20210A mutations and the risk of venous thromboembolism: data from a cohort of 258 consecutive cancer patients A. Vargas1, A. Fernandez-Martinez2, M. Selvi2, G. Luengo-Gil2, A. Carmona-Bayonas2, C. Font2, D. Tàssies3, J.C. Reverter3 1 Radiation Oncology, Hospital Clinic de Barcelona, Barcelona, Spain 2 Medical Oncology, Hospital Clinic de Barcelona, Barcelona, Spain 3 Hemostasis and Hemotherapy, Hospital Clinic de Barcelona, Barcelona, Spain Introduction: Factor V Leiden and the prothrombin G20210A are the two most common genetic polymorphisms associated with an increased risk of VTE. There is little information on the prevalence and contribution of these mutations to increase the underlying thrombotic risk in cancer patients. Objectives: To determine the prevalence of factor V Leiden and prothrombin G20210A mutations in a cohort of cancer patients with VTE and to evaluate its influence on the development of arterial and venous rethrombosis. Methods: From May 2006 to April 2008, 258 consecutive cancer patients who developed VTE were recruited. A group of 200 healthy blood donors (HC) and 142 cancer patients without VTE matched by age, sex and tumour type, were used as controls (CC). Results: The prevalence of heterozygous factor V Leiden was 3.9 % (10 patients) in the group with VTE and 1.3 % (2 patients) in CC (p = NS). In the group with VTE, prothrombin G20210A mutation was found in 5.9 % (15 patients) vs. 3.9 % (6 patients) in CC (p = NS). A total of 50 cancer patients with VTE developed rethrombotic events (19.4 %) during follow-up. No differences in the prevalence of factor V Leiden (3.9 % vs. 3.9 %; p = NS) and in prothrombin G20210A mutations (2 % vs. 6.9 %; p = NS) according to the development of rethrombosis. In HC the prevalence of factor Leiden and prothrombin G20210A mutations were 3 % and 2.5 %, respectively. Conclusions: The low prevalence of factor V Leiden and prothrombin G20210A argues against a pathogenic role in the development of thrombosis in this setting.
MASCC-0627 Experimental validation of peripheral dose distribution for electron beams H. Acar1, G. Yavas2, C. Yavas3 Radiation Oncology, Medipol University, Istanbul, Turkey, 2Radiation Oncology, Selcuk University, Konya, Turkey, 3Radiation Oncology, Konya Training and Research Hospital, Konya, Turkey 1
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Introduction: In radiation therapy, the peripheral dose is important when anatomical structures with very low dose tolerances are involved. Objectives: In this study, the two available calculation algorithms of the Varian Eclipse treatment planning system(TPS), the electron montecarlo algorithm(eMC) and general gaussian pencil beam algorithm (GGPB) was used to compare measured and calculated peripheral dose distribution of electron beams. Methods: Peripheral dose measurements were carried out for 6, 9, 12, 15, 18 and 22 MeV electron beams using parallel platei onization chamber in the slab phantom. Measurements were performed for 6× 6, 10×10 and 25×25 cone sizes at dmaxof each energyup to 20 cm beyond the field edges. Peripheral dose was further computed using two different algorithms of a TPS. The measured and calculated data were then compared to find which algorithm calculates peripheral dose distribution more accurately. Results: The agreement between measurement and eMC was better than GGPB. The TPS may have underestimated the out of field doses. The difference between measured and calculated doses increase with the cone size. The largest deviation between calculated and measured dose distribution is less than 10.37 % using theeMC, but can increase up to 14.52 % of the distribution using GGPB. Conclusions: Our results show that the Monte Carlo algorithm for electron planning in Eclipse is more accurate than previous algorithms for peripheral dose distri-butions. It must be emphasized that the use of GGPB for planning large field treatments with 6 MeV could lead to inaccuracies of clinical significance.
MASCC-0628 Irinotecan-induced mucositis is associated with mucus dysregulation and enteric nerve depletion D. Thorpe1, A. Stringer1, R. Butler1 1 School of Pharmacy and Medical Sciences, The University of South Australia, Adelaide, Australia Introduction: Irinotecan–induced mucositis is a major oncological problem. Goblet cells secrete mucus, protecting the intestinal mucosa, with secretion altered during mucositis. The enteric nervous system is involved in regulating gut motility and secretion. Objectives: To determine whether enteric nerves and goblet cells are altered following chemotherapy. Methods: Dark Agouti rats were administered a single dose of 175 mg/kg of irinotecan intraperitoneally and 0.01 mg/kg atropine subcutaneously before being killed at times 6, 24, 48, 72, 96 and 120 h after treatment. Haematoxylin and eosin staining, Alcian BluePAS staining, and immunohistochemistry with S-100 antibody (nerve marker) were carried out. Goblet cells (intact and cavitated) and nerve bundles and axons were counted. Statistical analysis was carried out using a Kruskal-Wallis test with Dunns post test. Results: The percentage of cavitated goblet cells increased compared to controls in the duodenum at 48 h, and in the jejunum at 72 h. The villous percentage of cavitated goblet cells increased significantly (p<0.05) between control and 72 h in the ileum. The percentage of cavitated goblet cells decreased compared to all other time points at 120 h in the colon. The number of axons in the myenteric plexus decreased compared to controls. Nerve bundles in the myenteric plexus of the jejunum also decreased at 24 h and 96 h compared to controls. Conclusions: Irinotecan-induced mucositis is associated with increases in mucus secretion, and depletion of enteric nerves. These changes are likely to contribute to the pathophysiology of mucositis and associated diarrhoea through the dysregulation of neural signalling following enteric nerve damage.
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MASCC-0629 Nutrition screening and risk factors prior to chemotherapy in cancer patients 65 years and older A. McCarthy1, E. Isenring2, S. Baumann2, P. Yates1, H. Skerman1, E. Walpole3, D. Thomson3 1 School of Nursing, Queensland University of Technology, Brisbane, Australia, 2School of Human Movement Studies, University of Queensland, Brisbane, Australia, 3Cancer Care Services, Princess Alexandra Hospital, Brisbane, Australia Introduction: The largest proportion of cancer patients are aged 65 years and over. Increasing age is also associated with nutritional risk and multi-morbidities—factors which complicate the cancer treatment decision-making process in older patients. Objectives: To determine whether malnutrition risk and Body Mass Index (BMI) are associated with key oncogeriatric variables as potential predictors of chemotherapy outcomes in geriatric oncology patients with solid tumours. Methods: In this longitudinal study, geriatric oncology patients (aged ≥65 years) received a Comprehensive Geriatric Assessment (CGA) for baseline data collection prior to the commencement of chemotherapy treatment. Malnutrition risk was assessed using the Malnutrition Screening Tool (MST) and BMI was calculated using anthropometric data. Nutritional risk was compared with other variables collected as part of standard CGA. Results: Over half of the 175 geriatric oncology patients were at risk of malnutrition (53.1 %) according to MST. BMI ranged from 15.5 to 50.9 kg/m2, with 35.4 % of the cohort overweight when compared to geriatric cutoffs. Malnutrition risk was more prevalent in those who were underweight (70 %) although many overweight participants presented at risk (34 %). Malnutrition risk was associated with a diagnosis of colorectal or lung cancer (p= 0.001), dependence in activities of daily living (p =0.015) and impaired cognition (p=0.049). Malnutrition risk was positively associated with vulnerability to intensive cancer therapy (rho= 0.16, p=0.038). Larger BMI was associated with greater number of multi-morbidities (rho=.27, p=0.001). Conclusions: Malnutrition risk is prevalent among geriatric patients undergoing chemotherapy, is more common in colorectal and lung cancer diagnoses, is associated with impaired functionality and cognition, and negatively influences ability to complete planned intensive chemotherapy.
MASCC-0630 Association of CYP3A5 polymorphism with toxicities in metastatic renal cell carcinoma patients (MRCC) receiving an alternative dosing (AD) regimen of sunitinib Y.L. Teo1, H.L. Wee1, X.P. Chue1, N.M. Chau2, M.H. Tan2, R. Kanesvaran2, H.L. Wee1, H.K. Ho1, A. Chan1 1 Department of Pharmacy, National University of Singapore, Singapore, Singapore, 2Department of Medical Oncology, National Cancer Centre Singapore, Singapore, Singapore Introduction: Sunitinib is metabolized by CYP3A4 and the highly polymorphic CYP3A5 enzyme. Expression of the *3 allele, which is abundant in Asians, leads to the expression of non-functional enzyme. An AD regimen of 37.5 mg daily in repeated 4-weeks on, 2-weeks off cycle has been proposed to ameliorate frequent dose modifications due to toxicities observed with the approved dosing regimen. Objectives: This study aims to determine the effect of CYP3A5 polymorphism on toxicities in patients receiving this regimen. Methods: All mRCC patients starting on sunitinib were invited to participate. In week 4 of each cycle, toxicities were assessed and
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graded according to CTCAE. Blood was obtained for genotype determination via restriction fragment length polymorphism. Results: Twenty patients were available for analysis. After 1 cycle, common all grades toxicities were anemia (80 %), fatigue (76 %), hypertension (75 %), altered taste (71 %), mucositis (57 %) and hand-foot syndrome (HFS) (57 %). Those with functional CYP3A5 appear to have increased risk for hypertension and decreased risk for anemia, fatigue, altered taste and mucositis. However, these differences were not statistically significant. (Table 1)
antibiotics correlated to a shorter fever duration (4 days (2–7) versus 8 days (6–12), p =0.017). Total NF Episodes (N=165) Demographics: Male
97 (58.8 %)
Median age
56 (IQR: 46–64)
Subjects with age ≥60 years old
59 (35.8 %)
Malignant Disease Types: Functional vs. Non-functional CYP3A5 for all grade toxicities RR
95 % CI
P
Leukemia
71 (43.3 %)
Lymphoma
80 (48.8 %)
Anemia
0.60
0.36–1.00
0.09
Multiple Myeloma
Fatigue
0.83
0.53–1.30
0.60
Others
Hypertension
1.67
0.40–6.97
0.46
9 (5.5 %) 4 (2.4 %)
Cancer Management:
Altered Taste
0.62
0.34–1.14
0.18
Chemotherapy documented
118 (72 %)
Mucositis
0.61
0.28–1.30
0.35
Supportive care
18 (11 %)
HFS
1.02
0.51–2.05
1.00
Newly diagnosed
5 (3 %)
No chemotherapy documented
23 (14 %)
Baseline Characteristics:
Functional CYP3A5: Carrier of *1*1 or *1*3 Non-functional CYP3A5: Carrier of *3*3 Conclusions: CYP3A5 polymorphisms seem to have varied effect on different toxicities. Further studies with a larger sample size would be required to confirm this association.
ANC<100cells/min3
67 (43.8 %)
ANC<500cells/mm3
46 (30.1 %)
ANC>500cells/mm3
40 (26.1 %)
Impaired Liver Function (ALT>180 IU/L) Impaired Rental Function (CrCL<30 ml/min)
4 (2.8 %)
MASCC-0631 Management of neutropenic fever in patients with hematologic malignancy in a Hong Kong Teaching Hospital K. Zhou1, K.K. Chiu1, M.C. Wong1, R. Wong2 1 School of Pharmacy, The Chinese University of Hong Kong, Shatin, Hong Kong China, 2Department of Medicine & Therapeutics, Prince of Wales Hospital, Shatin, Hong Kong China Introduction: Neutropenic fever (NF) can cause substantial morbidity and mortality in patients with hematologic malignancies. IDSA has recently updated the guideline on the management of NF. However, local practice in Hong Kong and the compliance to the guideline have never been measured. Objectives: To assess the current management of NF in a Hong Kong teaching hospital, with focus on compliance to the existing international guideline. Methods: Retrospective review of all medical records of patients with febrile neutropenic episodes who received inpatient management at the Prince of Wales Hospital (PWH) from 2007 to 2011 was done. Only patients with hematologic malignancies were included. Comparisons on treatment outcomes were done between the guideline compliant versus non-compliant cases using non-parametric Fisher’s Exact test and Mann–Whitney U test. Results: One hundred and sixty-five NF episodes were evaluated. Most patients were given a combination of piperacillintazobactam and an aminoglycoside antibiotic as the empiric treatment upon the onset of NF. Overall compliance to guideline was 49 %. Individual compliance rates were 69 % for empirical antibiotic treatment regimen, 76 % for antibiotic treatment modification, 90 % for vancomycin initiation, 50 % for antifungal treatment modification, 92 % for usage of G-CSF, 89 % for discontinuation of empirical treatment, and 99 % for IV-PO switch. No significant difference was found between compliant versus non-compliant cases, while an appropriate switch of
6 (4.6 %)
Fever Duration (Days) Compliant Cases Overall Compliance (N=66) Empiric Antibiotic Regimen (N=66) Antibiotic Treatment Modification (N=64) Antifungal Treatment Modification (N=28)
P-value
4 (2–7)
Noncompliant Cases 5 (2–11.25)
5 (2–12)
4.5 (2–7)
0.436
4 (2–7)
8 (6–12)
0.017
12.5 (7.5–19.25)
12 (8–15.25)
0.804
0.315
Conclusions: This study identified the areas with potential for improvement in management of NF in patients with hematologic malignancy at PWH.
MASCC-0632 Short and longterm outcomes of cancer patients with incidental and symptomatic pulmonary embolism (PE): data on a prospective cohort of 138 consecutive patients A. Fernandez-Martinez 1, M. Selvi1 , A. Vargas2, A. CarmonaBayonas3, J. Aibar1, C. Beato1, C. Font1 1 Medical Oncology, Hospital Clinic de Barcelona, Barcelona, Spain, 2 Radiation Oncology, Hospital Clinic de Barcelona, Barcelona, Spain, 3Medical Oncology, Hospital Morales Meseguer, Murcia, Spain Introduction: Incidental pulmonary embolism (IPE) has become a common clinical presentation of venous thromboembolic disease in
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cancer patients. Information on clinical outcomes of IPE is based on retrospective and small observational series. Objectives: To compare the short and longterm clinical outcomes of patients with IPE and ‘acute symptomatic PE’ (SPE) in cancer patients. Methods: From May 2006 to December 2009 a prospective observational study of consecutive unselected cancer patients with newlydiagnosed PE (IPEs and SPEs) was performed in our Medical Oncology Department. All patients were routinely anticoagulated irrespective of IPE or SPE according to international guidelines. Results: A total of 138 patients with PE were recruited (62 IPE and 76 SPE). The mortality rate at 7-day was 0 in IPE vs. 8 (10.7 %) in SPE (p=0.008), at 1-month was 2 (3.2 %) in IPE vs. 13 (17.1 %) in SPE (p=0.01) and at 3-months of follow-up was 9 (14.5 %) in IPE vs. 23 (30.3 %) in SPEs (p=0.02). Conclusions: Cancer patients with IPE had better clinical outcomes compared to those with SPE in our prospective cohort. Further studies are needed to better define the clinical relevance and optimal management of IPE. References: [1] Font C, Farrús B, Vidal L, et al. Incidental vs. symptomatic venous thrombosis in cancer patients. Analysis of a prospective observational series with 340 consecutive patients. Ann Oncol 2011; 23 (9): 2101–2106 [1] den Exter PL, Hooijer J, Dekkers OM, Huisman MV. Risk of recurrent venous thromboembolism and mortality in patients with cancer incidentally diagnosed with pulmonary embolism: a comparison with symptomatic patients. J Clin Oncol. 2011 Jun 10;29(17):2405–9.
MASCC-0633 Factors affecting patient’s perception of anticancer treatments side-effects: an observational study S. Russo1, L. Gerratana1, M. Cinausero1, C. Bozza1, D. Iacono1, R. Sottile1, G. Fasola1, F. Puglisi2 1 Department of Oncology, University Hospital of Udine, Udine, Italy, 2 Department of Oncology Department of Medical and Biological Sciences, University Hospital of Udine University of Udine, Udine, Italy Introduction: Analysis of relative importance of side-effects of anticancer therapy is extremely useful in the process of clinical decision making. Objectives: Aim of this study was to evaluate the perceptions of physical and non-physical side-effects of contemporary anticancer therapy and their association with clinical and social features of the patients. Methods: Participants were asked to rank their side-effects in order of distress by using two sets of cards naming physical and non-physical effects, respectively. The association between the first five cards chosen and clinical or social features of patients was estimated by calculating Odds Ratios (OR) through uni- and multi-variate logistic regression. Results: Four hundred and sixty-four patients (153 men and 311 women) entered the study. Median age was 63 years. Patients ranked the nonphysical side-effect “Affects my family or partner” first (40.1 % of the total population). “Constantly tired” (32.5 %) and “Loss of hair” (20.7 %) were ranked second and third, respectively. These concerns were selected as the most important in the majority of the subgroups. Interestingly, marital status was the predominant characteristic in driving patient’s perception, being associated with several side-effects(Constantly tired, Loss of appetite, Affects my work, Affects my social activities, Infertility, Diarrhea). Other significant factors influencing patient’s perception of side-effects included age, disease characteristics and ongoing anticancer therapy Conclusions: This study identified crucial factors that may influence patient’s perception of anticancer treatments side-effects. Therefore,
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these results could be use in pre-treatment patient’s education and counseling.
MASCC-0634 Supportive care management in cancer: a 2 years assessment of a prospective multidisciplinary in care model F. Scotté1, S. Richard1, P. Leroy2, S. Hans3, C. Hervé4, N. Pelicier5, C. Vulser6, C. Sauvajot7, F. Tetelin1, E. Nariana2, S. Oudard8, D. Brasnu8 1 Department of Oncology and Supportive Care Unit, Georges Pompidou European Hospital, Paris, France, 2Department of Supportive Care Unit, Georges Pompidou European Hospital, Paris, France, 3Cancerology Federation, Georges Pompidou European Hospital, Paris, France, 4Department of Ethics, University of Paris Descartes, Paris, France, 5Psycho-oncology Department, Georges Pompidou European Hospital, Paris, France, 6Pain Evaluation and Treatment Department, Georges Pompidou European Hospital, Paris, France, 7Cancerology Federation, Georges Pompidou European Hospital, Paris, France, 8Department of Oncology, Georges Pompidou European Hospital, Paris, France Introduction: Supportive care depends on multidisciplinary coordination. Their institutional organization has to be developed. Objectives: To improve the management of patients in complex situations during and after cancer care, a four-bed inpatient unit for supportive care in cancer (SCCU) was created. The activity of this unit over a two-year period is assessed. Methods: The 2 years of activity (347 stays) were analyzed in an observational prospective study. Quality of care and costs were assessed throughout this period. Results: Over this 2 years period, we observed a 23 % admission enhancement. Of the patients admitted, 64 % came directly from home, avoiding emergency admission. Average length of stay was 10.2 days with a majority of patients with high levels of disease severity. An interdisciplinary approach was used (i.e. psychooncology, pain management, palliative care, etc.). The main diagnostic groups were: health statement alteration (30 %), pain (21 %), palliative care (11.5 %), and nutritional disorders (10.2 %). Discharge of patients was organized with return home for 60 % of patients. During the first year of activity, this SCCU generates a financial income of 750,896.96 €, which includes 240,954.88 € for institution’s expenses. Conclusions: Improved management of patients is feasible despite complex conditions of supportive cancer care. We attempted to show bases on this organizational structure, the ability and efficacy of a specific unit to promote supportive care management.
MASCC-0635 Actual and expected treatment-related side-effects predict low health related quality-of-life in prostate cancer survivors F. Drummond1, H. Kinnear2, K. O’Brien1, A. Gavin3, L. Sharp1 1 Research, National Cancer Registry Ireland, Cork, Ireland, 2Research, Northern Ireland Cancer Registry, Belfast, Ireland, 3Director, Northern Ireland Cancer Registry, Belfast, Ireland Introduction: Most prostate cancer (PCa) treatments are associated with significant side-effects, but the extent to which side-effects impact on health-related quality-of-life (HRQoL) longer term is poorly understood. Objectives: In a population-based study of PCa survivors, we investigated associations between treatment-related side-effects and HRQoL.
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Methods: Six thousand nine hundred thirty-seven PCa (ICD10 C61) survivors, 1.5–15 years post-diagnosis, were identified from the National Cancer Registry Ireland and Northern Ireland Cancer Registry and invited to complete postal questionnaires, including questions on socio-demographic characteristics, treatment received, side-effects expected and experienced (including incontinence, impotence, bowel problems, hot flushes, fatigue) and HRQoL. Low HRQoL was defined as an EORTC QLQ30 global health score in the lowest quartile (≤38.1±14.2). Predictors of low HRQoL were investigated using multivariate logistic regression. Results: Three thousand eight hundred two3,802 men participated (response rate = 55 %). In multivariate analysis of the first 1,344 respondents, the significant socio-demographic predictors of low HRQoL were age, marital status, educational level and employment status. Risk of low HRQoL was: higher in men with comorbidities; varied by treatment received; and increased with time since diagnosis. Men who currently experienced treatment-related incontinence had increased risk of low HRQoL (OR = 2.90,95%CI 1.90–4.43). Risk was increased in men whose side-effects were worse than expected (OR = 1.82,95%CI 1.17–2.84), and reduced in those whose sideeffects were not as bad as expected (OR = 0.54,95%CI 0.34 0.86). Conclusions: Actual and expected side-effects predicted risk of low HRQoL. If confirmed in analysis of all respondents, these findings suggest that men with PCa may benefit from realistic information pretreatment on risk of side-effects and long-term support in managing side-effects.
MASCC-0636 A web-based tool to monitor chemotherapy induced peripheral neuropathy and quality of life C. Eeltink1, I. Verdonck- de Leeuw2, M. Minnema3, M. Eurelings4, G. Kunst5 1 Haematology, VU University Medical Center, Amsterdam, Netherlands, 2 Clinical Psychology, VU University Medical Center, Amsterdam, Netherlands, 3Haematology, University Medical Center Utrecht, Utrecht, Netherlands, 4Neurology, Spaarne Hospital, Hoofddorp, Netherlands, 5 Medical Affairs Department Pharmaceutical Compagnies of Johnson&Johnson, Janssen Pharmaceutical Compagnies of Johnson&Johnson, Tilburg, Netherlands Introduction: Treatment with neurotoxic chemotherapy in patients with hematological malignancies like Multiple Myeloma may cause Chemotherapy-Induced Peripheral Neuropathy (CIPN). CIPN can induce functional disability which can diminish patients’ quality of life (QoL) significantly. Although standardized measures of CIPN are available, they do not grade the seriousness of CIPN, and they do not assess the impact of CIPN on daily living and QoL. Objectives: To develop and evaluate a web-based tool including CIPN and QoL questionnaires to be used in clinical practice. Methods: In a multidisciplinary setting a new CIPN questionnaire was developed, comprising 31 items. A web-based tool, named ‘Monitor Klinisch Beeld’, was developed and build including the CIPN questionnaire, the EORTC QLQ-C30, EORTC QLQ-MY20 Module, EORTC QLQ-ELD15 for elderly patients, and the Hospital Anxiety and Depression Scale (HADS). Patients complete the questionnaires via the internet at home or in the hospital. Results: It had been shown to be feasible to apply the web-based tool in clinical practice. The web-based tool is used by nurses. In
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case of CIPN, the hematologist is informed and may consider treatment dose adjustments to avoid progression of CIPN and to reduce existing complaints. It is important that patients are informed that adjustment of treatment does not necessarily lead to reduced effectiveness but enables continuation of treatment. Conclusions: This web-based tool can help nurses and hematologists to identify patients at risk for neuropathy and limitations in daily functioning and compromised QoL. Further research is planned to validate the CIPN questionnaire. Conflict of interest: This project is supported by Janssen, pharmaceutical companies of Johnson&Johnson.
MASCC-0637 Dramatic and durable response to denosumab given for humoral hypercalcemia with malignancy refractory to weekly zoledronic acid M. Tsuda1, H. Ishiguro2, T. Sugie1, A. Yasoda1, M. Toi1 1 breast surgery, Kyoto University Hospital, Kyoto, Japan, 2Outpatient Oncology Unit, Kyoto University Hospital, Kyoto, Japan Introduction: Denosumab sometimes causes severe and fatal hypocalcemia as an adverse event. Conversely, if used safely, denosumab has the potential to become a key drug for treating severe hypercalcemia refractory to bisphosphonates. However, the optimal dose and treatment frequency for hypercalcemia have not been determined. Objectives: To report a case of humoral hypercalcemia with malignancy refractory to weekly zoledronic acid dramatically and durably treated with denosumab. Methods: A 47-year-old woman with bone metastases from breast cancer presented with hypercalcemia. Her serum parathyroid hormone-related protein (PTHrP) level was high, and her kidney function was normal. As her hypercalcemia was refractory to aggressive hydration, furosemide, and weekly zoredronic acid, we decided to try denosumab. We monitored pharmacodynamics (PD) markers to control serum calcium levels safely. Results: A single dose of denosumab (120 mg) immediately and durably normalized serum calcium levels for more than 8 weeks (Figure 1). During the period, PTHrP levels were consistently high. No calcium or vitamin D supplements were given because they might have re-elevated serum calcium levels, so careful monitoring of PD markers was performed. Conclusions: Denosumab has potential to become an effective agent for treating hypercalcemia refractory to bisphosphonates. Further studies are warranted to understand the optimal dose and frequency to avoid severe and fatal hypocalcemia.
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MASCC-0638 Personalized medicine: from bench to bed F. Scotte1 , M.F. Mamzer 2, P. Leroy3, M. De Jesus Cabral2, C. Bommier2, M.L. Viallard2, C. Herve2 1 Department of Oncology and Supportive Care Unit, Georges Pompidou European Hospital, Paris, France, 2Department of Ethics, University of Paris Descartes, Paris, France, 3Department of supportive Care Unit, Georges Pompidou European Hospital, Paris, France Introduction: The development of personalised medicine in oncology requires a better understanding of targeted therapies to improve the management of patients. This includes a constant sharing of knowledge between clinicians, research platforms and patients, based on patient consent as well as ethical reflection. Objectives: In order to facilitate an exchange between researchers, clinicians and patients, a practical model must be created. Methods: Research objectives will be to the development research information and to assess its impact for patients and professionals, in order to facilitate their participation in research. Results: Based on this methodology we developed a four stages model : 1/For each phase of the course, analysis of the exchange of information and the link between teams assessing the fluidity of data until target diagnosis and treatment decisions are made. 2/Development of information materials and consent procedures, validated in the context of head and neck cancer and shared with all oncological disciplines. Two committees will validate these elements: one with patients and the other with health professionals (researchers and clinicians). 3/A major conference will be organised for all patient care teams including a video presentation of the patient’s course with a media outlet for each intervention. A website will be set-up and dedicated to bringing together professionals and patients. 4/Building a cross-disciplinary consultation meetings even a functional unit ensuring consistency of decision making from research to therapy. Conclusions: This model promotes the sharing between research platforms, physicians and patients to enhance decision understanding and subsequent treatment efficacy.
MASCC-0639 Cancer fatalism in older chinese adults: a validation study D.Y.P. Leung1, E.M.L. Wong1, S.S.M. Ho1, J.W.H. Sit1 1 The Nethersole School of Nursing, The Chinese University of Hong Kong, Hong Kong, Hong Kong China Introduction: Qualitative studies suggest that cancer fatalism may have an impact on participation in cancer screening among Chinese people. A previous study has provided a preliminary support of reliability and factorial validity of a 15-item modified version of a Cancer Fatalism Scale with an adaption to colorectal cancer screeing in older Chinese people. Objectives: To further examine the psychometric properties of the 15item modified Cancer Fatalism Scale in general in older Chinese adults. Methods: The original 20-item Cancer Fatalism Scale was administered to a convenience sample of 257 community-dwelling
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adults aged ≥60 at four non-governmental organizations between June and July 2012 in Hong Kong. Confirmatory factor analysis (CFA), Cronbach’s alpha, and ANOVA and correlations were used to assess factorial structure, reliability and concurrent validity of the scale respectively. Participants with MMSE score >17 were included in the analysis (n=257). Results: CFA revealed that the three-factor model provided an adequate fit to the 15-item modified Cancer Fatalism Scale (R-χ 2 = 225.43, df = 87, R-CFI = 0.917, R-RMSEA= 0.078 and SRMR=0.078); all the factor loadings were >0.30 and statistically significant. Cronbach’s alpha values of the three subscales (Predetermination, Fatalistic voluntarism and Luck) were >0.8. ANOVA results shwo that participants with higher education level socred significantly lower in the three subscales, and positive significant correlations were obtained between age and the three subscale scores. Conclusions: The findings provide further support for the psychometric properties of the 15-item version of the Cancer Fatalism Scale; suggesting that the modified scale can be used to assess cancer fatalism in community-0dwelling older Chinese adults.
MASCC-0640 Health resource utilisation (HRU) associated with pathologic fracture (PF) in eight European countries: results from a retrospective study J. Body1, Y. Acklin2, G. Hechmati3, J. Pereira4, N. Maniadakis5, E. Terpos6, J. Finek7, H. Sleeboom8, R. von Moos9 1 Department of Medicine, C.H.U. Brugmann, Brussels, Belgium, 2 Surgery, Kantonsspital Graubünden, Chur, Switzerland, 3Health Economics, Amgen (Europe) GmbH, Zug, Switzerland, 4Escola Nacional de Saúde Pública, Universidade Nova de Lisboa, Lisbon, Portugal, 5Department of Health Services Management, National School of Public Health, Athens, Greece, 6Department of Clinical Therapeutics, University of Athens School of Medicine Alexandra General Hospital, Athens, Greece, 7 Department of Oncology and Radiotherapy, University Hospital, Plzen, Czech Republic, 8 Department of Medical Oncology, HAGA Hospital, The Hague, Netherlands, 9 Department of Medical Oncology/Haematology, Kantonsspital Graubünden, Chur, Switzerland Introduction: There is a paucity of health-resource utilisation data relating to the impact of bone metastases. Objectives: Evaluate HRU associated with PF in patients with bone metastases secondary to breast/lung/prostate cancer or multiple myeloma. Methods: Eligible patients: ≥1 skeletal-related event (SRE); from Austria, Czech Republic, Finland, Greece, Poland, Portugal, Sweden or Switzerland. HRU data were extracted from patients’ charts at baseline (pre-SRE period: 3-month SRE-free period, beginning 3.5 months before the SRE) and post-SRE (14-day diagnosis period pre-SRE to 3 months post-SRE). Data presented are mean (bootstrapped 95 % confidence interval [CI]) HRU changes from baseline per PF for long bone and for other bone. Results: Of 1,022 enrolled patients, 359 had PF, key HRU data are listed in the table. A PF required an additional 0.8–1.23 inpatient stays (varying according to fracture site and countryspecific treatment practices). Inpatient stays generally required
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treatment in orthopaedic, oncology, internal medicine or haematology wards/units with a mean total duration (change from baseline) of 20.9 days for long bone PF and 12.3 days for other bone PF. Inpatient stays were more frequent and lasted longer for long bone PF than for other bone PF. Number of outpatient visits
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increased by a mean of 2.58 visits per PF for long bone PF and 3.96 visits for other bone PF. Number of procedures increased by a mean of 6.10 and 5.85 per PF for long bone and other bone, respectively.
Mean Total Change (95 % CI)
Long bone (N=118)
Number of inpatient stays
1.23 (1.02, 1.44)
Other bone (N=241)
Number of inpatient stays for most common unit/ward
Orthopaedic
0.54 (0.44, 0.65)
Internal Medicine
0.19 (0.12, 0.27)
Other*
0.14 (0.00, 0.28)
Oncolody
0.18 (0.10, 0.27)
Oncology
0.11 (0.06, 0.16)
Haematology
0.10 (0.04, 0.16)
0.80 (0.65, 0.95)
Duration of inpatien stays, days
20.9 (16.9, 24.9)
12.3 (9.7, 14.8)
Duration of inpatient stays for unit/ward with largest mean duration, days
Orthopaedic
7.72 (5.88, 9.56)
Internal Medicine
2.74 (1.66, 3.82)
Oncology
1.85 (0.31, 3.38)
Oncolody
1.45 (0.64, 2.26)
Pneumology
1.68 (0.28, 3.09)
Orthopaedic
1.44 (0.62, 2.25)
Mean number of outpatient visits
2.58 (1.70, 3.46)
3.96 (3.22, 4.71)
Mean number of outpatient visits for most common providers
Radiation oncology/ radiotherapist Medical oncologist
0.99 (0.53, 1.44)
Orthopaedic surgeon
1.52 (1.04, 2.00)
0.51 (0.17, 0.85)
Radiation oncologist/ radiontherapist Medical oncologist
0.29 (0.17, 0.42)
Radialogist
0.60 (0.38, 0.83)
Mean number of procedures
6.10 (4.80, 740)
Mean number of most common precedures
Other†
2.29 (1.61, 2.98)
External bean radiation to bone Surgery to bone - extremities
0.81 (0.53, 1.08)
5.85 (5.03, 6.67)
2.08 (1.38, 2.78)
External beam radiation to bone Other†
2.58 (2.00, 3.17) 1.67 (1.25, 2.08)
0.49 (0.40, 0.58)
Computed Tomography
0.62 (0.48, 0.77)
* e.g.,trauma surgery, casualty ward, cardiology, nursing unit, etc.; †e.g., bone marrow biopsy, brain CT, bronchoscopy, chest x-ray, radioisotope bone scanning, thorax, x-ray, etc.
Conclusions: PF is associated with increased HRU burden, including inpatients stays, outpatient visits and procedures.
MASCC-0641 Patterns of treatment with bone-modifying agents (BMA) in patients with bone metastases (BM) in the US J. Arellano1, J. Quigley2, R. Hernandez3, K. Cetin3, M. Pirolli2, D. Quach2, A. Liede4 1 Health Economics, Amgen Inc., Thousand Oaks, USA, 2Health Economics, IMS Health, Plymouth Meeting, USA, 3Center for Observational Research, Amgen Inc., Thousand Oaks, USA, 4 Center for Observational Research, Amgen Inc., San Francisco, USA Introduction: BM can lead to serious and debilitating skeletalrelated events (SREs: fracture, spinal cord compression, and surgery or radiation to bone). Three BMAs are approved in the US for prevention of SREs in cancer patients with BM: two intravenous bisphosphonates (IV BP) with recommended dosing every
3–4 weeks (pamidronate and zoledronic acid), and one RANK ligand inhibitor with subcutaneous injection every 4 weeks (denosumab). Objectives: To examine characteristics and treatment trends among patients with BM treated with BMAs in US clinics. Methods: A retrospective cohort was defined from the Oncology Services Comprehensive Electronic Records (OSCER) database, which includes medical records from >500 K patients treated at 76 US oncology practices. Adult solid tumor patients with BM who initiated treatment with a BMA Jan 2011–Oct 2011 were included and followed for 12 months after treatment initiation. Patients were either naïve (no BMA in previous 6 months) or transition (different BMA received in previous 6 months). Results: The cohort included 1445 denosumab (62 % naïve) and 1807 IV BP (99 % naïve) patients. Patient characteristics were similar, although denosumab patients were more likely to receive regular treatment during follow-up and less likely to switch treatment than IV BP patients (Table). Trends were consistent across tumor types and for naïve and transition patients.
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Table. Patterns of treatment for BMA patients during 1 12-month follow-up period. Denosumab
IV BP
(N=1445)
(N=1807)
Switched treatment n (%)
89 (6 %)
245 (14 %)
Received 12 treatment administrations n (%) # treatment administrations
373 (26 %)
301 (17 %)
Mean (range)
7.3 (1, 14)
5.8 (1,18)
Median (25 %, 75 %)
8.0 (3, 12)
4.0 (2, 10)
Conclusions: Certain SM channels (YouTube, Wikipedia) are popular among oncology practitioners. Practitioners are supportive of patients using SM for health information but are concerned regarding its quality. Therefore, patients should be educated on how to utilize these channels appropriately to supplement their cancer care.
MASCC-0643 Screening of epidermal fish mucus extract (Channa striatus) for different pharmacological activities S. dahham1, S. Al Rawi1, A.S.I.F. Muhammad1, L. Hassan1, A. Abdul Majid1 1 Pharmacology, University Science Malaysia(USM), Pinang, Malaysia
Conclusions: Denosumab represented almost halfDenosumab represented almost half (44 %) of patients initiating a BMA and onethird of patients naïve to treatment. Uninterrupted treatment was more common for denosumab versus IV BP patients. Trends, including reasons for and consequences of treatment interruption, should be monitored as the patient experience develops.
MASCC-0642 Social media perceptions of oncology practitioners for supportive cancer care K. Yap1,2 Department of Pharmacy, National University of Singapore, Singapore, Singapore, 2Academic Informatics Office, National University Health System, Singapore
1
Introduction: Little is known about oncology practitioners’ attitudes towards, and usage of, social media (SM) channels for supportive cancer care. Objectives: A cross-sectional study was done from May-July 2012 to obtain the perceptions and SM usage patterns of oncology practitioners, and their views on how SM can potentially affect clinical practices. Methods: An online survey (14 questions) was sent via an invitation email to MASCC/ISOO members. Participants’ demographics, SM usage behavior, perceptions regarding health information on SM channels and on patients’ use of SM for supportive care information were obtained. Responses were analyzed using SPSS (v19). Results: Response rate was 16 % (128 people). Most were from Europe (38 %) and America (34 %). Participants were mainly physicians (33 %), nurses (32 %) and pharmacists (12 %). Over half (54 %) had 11–30 years of practice experience. The most popular SM channels were YouTube (69 %) and Wikipedia (68 %). Over half (57 %) encountered patients who searched SM for health information in their practices. Majority felt that SM channels often recommended unproven treatment Methods: and could potentially cause harm to patients (63 % each). However, similar proportions (61 % each) agreed that patients who searched information on SM channels were better empowered to manage their conditions and those who shared experiences on social networking sites could cope better with their supportive care.
Introduction: Recently, fish by-products have been evaluated as a source of structurally diverse bioactive compounds. Fish mucus has a myriad of pharmacological activities including antimicrobial, anti-inflammatory, wound healing and cell proliferation properties. Objectives: The present study describes the potential activity of Channa striatus epidermal mucus for in vitro antioxidant, antibacterial, wound healing, cell proliferation and ex vivo Rat aortic assays. Methods: The free radical scavenging activity was studies in vitro by measuring 2,2-diphenyl-1-picrylhydrazyl (DPPH). Antibacterial activities were evaluated against six microorganisms using agar well diffusion method. The cell viability and proliferation of human umbilical vein endothelial cells (HUVEC) and retinal ganglion cells (RGC-5) were evaluated using MTT assay. An in vitro assay of scratch wound healing onto monolayer of HUVEC cells was used to assess the effect of fish mucous on cell migration into a wound space. Rat aortic assay was employed to evaluate proliferation of blood vessel formation. Results: Experimental results have shown that fish mucous exert proangiogenic effects by stimulating the growth of new blood vessels in rat aorta. HUVEC and RGC-5 cell proliferation increased significantly compared to the negative control. HUVEC cells migration was significantly enhanced, the extract after 12 h enhanced the wound healing in scratch model assay. In addition, fish mucus exhibited strong antioxidant and antibacterial activity. Among the selected bacterial cultures, the highest activity was recorded against Pseudomonas aeruginosa. These potent activities might be due to it high antioxidant property, IC50 =2.83ug/ml. Conclusions: The present investigation has provided preliminary information for a better understanding of epidermal fish mucus role and its pharmacological activities.
MASCC-0644 Place of death of patients in a newly established home palliative care service in greece S. Katsaragakis1, A. Tserkezoglou1, S. Amoiridou1, E. Avgetidou1, I. Liakopoulos 1 , O. Mpagiaou 1 , H. Oikonomou 1 , E. Petta 1 , H. Raimondou1, S. Tsotakos1, A. Hamou1, E. Patiraki1 1 Holy Metropolis of Mesogaia & Lavriotiki, Palliative Care Unit Galilee, Athens, Greece
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Introduction: ‘Galilee’ palliative care service has been providing home care for adult cancer patients, in a large suburban area of Athens since 2010. Objectives: Explore factors associated with the patients’ place of death and length of care. Methods: Sample consisted of 162 cancer patients receiving home palliative care. Retrospective data collection included: demographic and clinical characteristics, patients’ ESAS-r (Edmond Symptom Assessment System Revised) evaluation of symptoms (Likert type 1–10 scale) at the time of referral to the service (T0), 1 (T1) and 2 months later (T2). Results: Most patients were female (53.1 %), with a mean age 67.1 years and ECOG performance status 2.7. The husband/wife (34.6 %) was the most frequent primary caregiver. The prevalent diagnosis was lung cancer (18.5 %) and 54.1 % of patients received antineoplasmatic treatment during care. Patients’ median length of care was 54.5 days and 47.8 % were hospitalized during care. The majority of patients (70.8 %) died and 36.8 % and 20.2 % of them within the first and the second month respectively after referral to the service. Most of the patients (62.6 %) chose and were supported to die at home. A family member primary caregiver (x2(12) = 36.1, p = 0.003) and the lack of any antineoplasmatic treatment (x2(10) = 18.6, p = 0.046) were associated with patients’ death at home. High performance status (rho = −0.55, p < 0,001) and female sex (z = −2.1, p = 0,034) was associated with longer length of home palliative care. Conclusions: Study results highlight that regardless of late referral of patients to the service, a great number of patients were supported to die at home.
MASCC-0645 Personalized care program (PCP) to breast cancer patients improves the patient satisfaction L. vanlemmens 1 , S. giscard 2 , L. rotsaert 3 , B. noirot 3 , A. mailliez 1, F. aitkaci 4, C. claret3, T. loridan5, N. dereumaux6, M.H. loucheux7, M. lefebvre1, M. cucchi8, I. sakli9, J.L. cazin9, J. bonneterre1 1 Breast Cancer, Centre Oscar Lambret, Lille, France, 2Quality, Centre Oscar Lambret, Lille, France, 3Supportive Care, Centre Oscar Lambret, Lille, France, 4Psycho-Oncology, Centre Oscar Lambret, Lille, France 5 Association “Vivre Comme Avant”, Association “Vivre Comme Avant”, Lille, France, 6Day Hospital, Centre Oscar Lambret, Lille, France, 7Comité du Nord de la Ligue Contre le Cancer, Comité du Nord de la Ligue Contre le Cancer, Lille, France, 8Medical Information, Centre Oscar Lambret, Lille, France, 9Pharmacy, Centre Oscar Lambret, Lille, France Introduction: Overall care requires evaluation, analysis of best professional practice, constantly improving information. Objectives: We wanted to optimize written support for breast cancer patients (pts) who require neoadjuvant or adjuvant medical treatment. Then, we evaluated the impact on pts satisfaction. Methods: After assessing pts satisfaction in comprehensive care with a questionnaire, we created a PCP, validated by pts. After given it, we assessed pts satisfaction with the same questionnaire. Then we compared results before (n=310) and after PCP (n=177).
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We selected the Excellence Score (ES) by taking into account only ‘very satisfied’ and excluding ‘satisfied’ scores and the Dissatisfaction Score (DS) by combining ‘not very satisfied’ and ‘very dissatisfied’. Results: As regards the explanation of treatment justification, ES rose from 67 to 74 % (p NS). Concerning procedure and adverse effects information, ES rose from 63 to 79 % (p 0,001) and 52 to 62 % (p 0,043). When we focus on information related to disease and treatment, ES of written information rose respectively from 36 to 56 % and 39 to 62 % (p<0,001), DS decreased from 21 to 3 % (p 0,001) and 20 to 1 % (p<0,001). ES of oral information of 49 and 48 % increased to 65 and 72 % (p < 0,001). The satisfaction about possibility to ask questions and to have response rose respectively from 68 to 99 % (p 0,021) and 61 to 97 % (p 0,017). Conclusions: This study confirms the importance of good written documentation with positive impact not only on written records but also on the face to face physician-patient relationship.
MASCC-0646 Risk factors for severe outcome in neutropenic enterocolitis in oncology patients; a systematic review L. Naeije1, L.C.M. Kremer1, E. Leclercq1, M.D. van de Wetering1 Paediatrics Oncology, Academic Medical Center, Amsterdam, Netherlands 1
Introduction: Neutropenic enterocolitis (NEC) is a potential life threatening complication of the treatment of malignancies. NEC is characterized by a triad of symptoms: neutropenia, fever and abdominal pain and the aetiology is not well understood. The outcome can be very unpredictable with a reported mortality rate of more than 50 %. Objectives: The aim of this systematic review was to evaluate the evidence of risk factors for severe outcome of NEC in oncology patients. Methods: MEDLINE and EMBASE were searched. All studies describing risk factors for mortality or ICU admittance were included. Information about study characteristics, prevalence and risk factors were abstracted and the quality of the studies with prognostic factors was assessed. Results: The search identified 1,613 studies. 16 studies reported on risk factors for outcome of NEC. The prevalence of NEC in oncology patients was 0.34–16 %, the mortality rate varied between 2.1 % and 66 %. All studies had severe methodological limitations and various definitions of NEC were used. In total 16 risk factors were suggested, potentially useful in the risk assessment of NEC. Only two studies used multi-variate analysis for risk factors.
Author (year)
Risk factor
P value
95 % CI
Rizzatti (2010)
Use of Cytarabine
0.0195
1.21–8.6
>4 No. of abdominal symptoms Abdominal distention
0.0255
0.47–6.07
0.0118
1.30–7.98
CRP>150 mg/L
0.023
0.92–45.1
IL-8>1000 pg/ml
0.001
1.6–77.9
Van de Wetering (2003)
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Conclusions: There is limited evidence to predict the course and outcome of NEC. Literature suggests a high mortality rate and
more investigation is necessary to validate risk factors for a severe outcome.
Author (year)
Type of study
Number NEC patients
Age (years)
Prognostic factors
Baerg (1999)
Retrospective chart review
33
1–16
Diffuse abdominal pain, T>38.5 °C, multiple bacteria in blood culture.
Cardona Zorilla (2006)
Literature search
275
adults
Bacteraemia, bowel wall thickening, mucositis, use of antifungal agents
Cartoni (2001)
Retrospective
88
6–63
Bacteraemia, bowel wall thickening
Dietrich (2006)
Prospective
14
17–66
Bowel wall thickening, CRP>150 mg/L
Gomez (1998)
Retrospective
17
Adults
Positive imaging (unspecified)
Gorschlüter (2002)
Prospective
4
21–78
Bowel wall thickening
Jain (1999)
Retrospective
11
4–12
Prolonged neutropenia
Kies (1978)
Retrospective
2
16–20
Prolonged neutropenia
Kunkel (1986)
Retrospective
3
10–60
Prolonged neutropenia
McCarville (2005)
Retrospective
92
1–22
Age >16 years, diffuse abdominal pain, T >38.5 °C, prolonged neutropenia
Mower (1986)
Retrospective
13
15–76
Bacteraemia
Pastore (2002)
Prospective
7
18–60
Bowel wall thickening, diffuse abdominal pain
Rizzatti (2010)
Retrospective
188
0–24
Use of cytarabine, abdominal distention, ? 4 symptoms (abdominal pain/fever/vomiting/diarrhea/intestinal obstipation/distention/gastrointestinal bleeding)
Sloas (1993)
Retrospective
24
2–20
Early onset of symptoms after neutropenia (<2 days)
Van de Wetering (2004)
Prospective
24
1–17
CRP>150 mg/L, IL-8>1000 pg/ml
Wade (1992)
Retrospective
22
5–66
Prolonged neutropenia
References: Rizzatti MB. Pediatric Hematology and Oncology. 2010;27:462–470. Van de Wetering et al. Eur J Cancer. 2004;40:571–578.
MASCC-0647 A prospective multicenter, single blind, randomized phase iii trial to compare ramosetron, aprepitant and dexamethasone with ondansetron, aprepitant and dexamethasone for preventing CINV: KCSG PC10-21. H.J. Kim1, E.K. Song2, J.S. Kim3, J.S. Ahn4, H.J. Yun5, Y.H. Cho6, K.U. Park7, S.Y. Kim8, J.S. Jang9, S.W. Kim10, H.W. Lee11, S.R. Lee12, Y.S. Kim13, S.N. Lee14, Y.H. Ko15, H.J. Kim16, J.H. Kang17, S.W. Shin18 1 Internal Medicine, Hallym University Sacred Heart Hospital, Anyang, Korea, 2Internal Medicine, Chonbuk National University Medical School, Jeonju, Korea, 3Internal Medicine, Korea University Guro Hospital, Seoul, Korea, 4Internal Medicine, Samsung Medical Center Sungkyunkwan University School of Medicine, Seoul, Korea, 5Internal Medicine, Chungnam National University Hospital, Daejeon, Korea, 6Internal Medicine, Konkuk University Medical Center, Seoul, Korea, 7Internal Medicine, Dongsan Medical Center Keimyung University, Daegu, Korea, 8Internal Medicine, Kyunghee University Hospital, Seoul, Korea, 9Internal Medicine, Chung-Ang University Hospital, Seoul, Korea, 10Internal Medicine, Asan Medical Center University of Ulsan College of Medicine, Seoul, Korea, 11Internal Medicine, Ajou University School of Medicine, Suwon, Korea, 12Internal Medicine, Korea University Ansan Hospital, Ansan, Korea, 13Internal Medicine, Kosin University Gospel Hospital, Busan, Korea, 14Internal Medicine, Ewha Womans University, Seoul, Korea, 15I4nternal Medicine, Uijeongbu St. Mary’s hospital, Uijeongbu, Korea, 16 Clinical
Epidemiology and Biostatistics, University of Ulsan College of Medicine Asan Medical Center, Seoul, Korea, 17Internal Medicine, Seoul St. Mary’s Hospital The Catholic University of Korea, Seoul, Korea, 18Internal Medicine, Korea University College of Medicine, Seoul, Korea Introduction: The combination regimen of aprepitant, 5-HT3receptor antagonist, and dexamethasone has been widely accepted as the standard treatment for preventing highly emetogenic chemotherapy induced nausea/vomiting (CINV). Until now, there has been no clinical data whether ramosetron is as effective as other 5-HT3receptor antagonists for the regimen. Objectives: We conducted a prospective randomized phase III clinical trial to compare ramosetron, aprepitant, and dexamethasone (RAD) with ondansetron, aprepitant, and dexamethasone (OAD) to prove the non-inferiority of RAD in controlling highly emetogenic CINV. Methods: Aprepitant (125 mg, day1; 80 mg, day2, 3) and dexamethasone (12 mg day1; 8 mg day2–4) were administered for both groups. Ramosetron (0.3 mg, day1) and ondansetron (16 mg, day1) were intravenously given to each group. The primary end point was CR rate (no vomiting without rescue medication) during the acute period (day1). Results: Two hundred ninety-nine patients (RAD 143 vs. OAD 156) were eligible for the efficacy analyses. Median age and sex ratio (M:F) in RAD and OAD were 60 and 61, and 90:66 and 114:29, respectively (p=0.54 and p<0.0001). The CR rates of RAD vs. OAD were 84.6 % vs. 77.6 % (95 % C.I. −0.4~14.5 %) during acute period, 69.5 % vs. 62.6 % (−2.1~16.0 %) during delayed period (days 2–5), and 66.7 % vs. 58.1 % (−0.6~17.8 %) during overall period. Median nausea score during acute period were 4 (IQR 2~5) and 3 (2~5, p=0.14) in RAD and OAD, respectively. There were no grade 3 or 4 toxicities.
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Conclusions: RAD regimen is as effective and tolerable as OAD combination for the prevention of CINV in the cancer patients receiving highly emetogenic chemotherapy.
MASCC-0648 Cost-effectiveness of aprepitant in combination with ondansetron and dexamethasone for prevention of chemotherapy-induced nausea and vomiting (CINV) among patients with breast cancer in the UK S. Humphreys1, J. Pellissier2, A. Jones3 1 Market Access, Merck Sharp & Dohme Ltd, Hoddesdon, United Kingdom, 2Health Economic Statistics, Merck Research Laboratories, Upper Gwynedd, USA, 3Medical Oncology, University College Hospital, London, United Kingdom Introduction: Prevention of chemotherapy-induced nausea and vomiting (CINV) remains an important goal for patients receiving chemotherapy, however antiemetic regimens recommended in clinical guidelines are not always administered in UK routine practice. Objectives: To define, from the UK payer perspective, the costeffectiveness of an antiemetic regimen using aprepitant, a selective neurokinin-1 receptor antagonist, for patients receiving chemotherapy for breast cancer. Methods: A decision-analytic model was developed to compare an aprepitant regimen (aprepitant, ondansetron, and dexamethasone) with a standard UK antiemetic regimen (ondansetron, dexamethasone, and metoclopramide) for expected costs and health outcomes after singleday adjuvant chemotherapy for breast cancer. The model was populated with results from patients with breast cancer participating in a randomized clinical trial of CINV preventative therapy for cycle 1 of single-day chemotherapy. Results: During 5 days after chemotherapy, 64 % of patients receiving the aprepitant regimen and 47 % of those receiving the UK comparator regimen had a complete response to antiemetic therapy (no emesis and no rescue antiemetic therapy). A mean of £37.11 (78 %) of the additional costs of the aprepitant regimen were offset by reduced health-care resource utilization costs. The predicted gain in qualityadjusted life-years (QALYs) with the aprepitant regimen was 0.0048. The incremental cost effectiveness ratio (ICER) with aprepitant, relative to the UK comparator, was £10,847/QALY, which is well below the threshold commonly accepted in the UK of £20,000– £30,000/QALY. Conclusions: The results of this study suggest that aprepitant is costeffective for preventing CINV associated with chemotherapy for patients with breast cancer in the UK health-care setting.
MASCC-0649 Impact of paracentesis on health-related quality-of-life (HRQOL) in cancer patients with malignant ascites B. Ehlken1, C. C Schimanski2, K. Berger1, F. Lordick3 1 Health Economics & Outcomes Research, IMS Health, Munich, Germany, 2Clinic Internal Medicine, Marien-Hospital, Darmstadt, Germany, 3University Cancer Center, University Cancer Center Leipzig, Leipzig, Germany Introduction: Malignant ascites (MA) is an accumulation of fluid in the abdominal cavity due to uncontrolled tumor growth on the peritoneal surface. MA leads to a significantly impaired general health status and to poor quality-of-life. Paracentesis is the most common treatment for MA. Objectives: This study was designed to evaluate the impact of paracentesis on HRQoL in cancer patients with MA.
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Methods: The study was conducted as a prospective, observational, multicentre study in Germany. The impact was measured by using EQ5D before and within 1 day after paracentesis. Results were compared with EQ-5D utility scores of other health conditions reported in the literature. Results: In total, 29 patients were enrolled between 07/2007–08/2009; 45 paracenteses in 28 patients were available for QoL analysis. Mean EQ-5D scores before (0.48±0.26) and after (0.56±0.30) paracentesis revealed a mean increase of 0.08±0.25 indicating a 17 % improvement. QoL improved after 44.4 % of paracenteses, remained unchanged after 26.7 % and even deteriorated after 28.9 %. Literature search for other conditions revealed 0.56 mean score for hemodialysis patients (1) and 0.48 mean score for patients with chemotherapyinduced-anaemia (2). Conclusions: In over 50 % of patients undergoing paracentesis for MA, no benefit in terms of HRQoL was detected. Before paracentesis, MA patients reported HRQoL equivalent to patients with chemotherapyinduced-anaemia. Even after an improvement with paracentesis, patients’ HRQoL improved only to a mean level of hemodialysis patients. Study results confirmed poor HRQoL in patients with MA even after paracentesis. References: (1) Liem YS et al. Value Health 2008;11(4):733-41 (2) Ossa DF et al. Pharmacoeconomics 2007;25(3):223-37
MASCC-0651 Supportive care and symptoms management in Pisa medical oncology A. Antonuzzo1, L. Ginocchi1, E. Vasile1, M. Lucchesi1, I. Brunetti1, L. Galli1, S. Ricci1, A. Falcone1 1 Polo Oncologico, Azienda Ospedaliero-Universitaria Pisana. Istituto Toscano Tumori, pisa, Italy Introduction: Oncologic patients often need supportive care for cancer treatment related toxicities and their comorbidities. Objectives: To present the supportive care model of Pisa medical oncology. Methods: Symptoms management and supportive care in cancer patients undergoing anticancer therapies during late 2012. Results: We applied a model of integrated and early supportive care activity for cancer patients. The day hospital outpatients care was improved with a new visit room; this activity, held by two physicians (faculty and post-doctoral) and one dedicated nurse is provided to manage chemotherapy and targeted therapy toxicities (‘classical’ adverse events and ‘new’ as cutaneous rash, hypertension, etc.). Mainly patients with relevant unplanned clinical problems can contact the supportive care team calling the medical oncology reception or the emergency mobile phone number. When feasible, toxicities, comorbidities and others symptoms (e.g. pain) are handled directly by phone; if it is necessary, the patient can directly access to the supportive care room for visiting, collection of blood samples, intravenous administration of fluids and drugs. There are institutional linked activities with other specialists to solve clinical acute problems (e.g. anesthesiologist for severe drug-related adverse event like allergy). In addiction, psychologist and chaplain give their service daily inside the day hospital for all patients that need. Conclusions: This is a global care offer for all patients during active oncological treatments and make the possibilities to reduce their hospital admissions. Regarding that, we started a prospective database to better describe the reasons of unplanned visits to medical oncology and to improve early supportive care integrated with anticancer therapies.
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MASCC-0652 Supportive care in cancer unit (SCCU) at the national cancer institute (NCI) of Milan C. ripamonti1, P. Rondelli1, M.A. Pessi1 1 Supportive Care in Cancer, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy Introduction: “Supportive care” is the prevention and treatment of the oncological therapy-related complications as well as the maintenance of physical, psychosocial, spiritual well being of the patients thus to improve their adherence to treatment protocols in terms of doseintensity and interval of administration. Objectives: The aims of the SCCU of the NCI of Milan (born on June 2009) are mainly four: to collaborate with the individual specialists of NCI through integrated and ancillary activities by means of specific pharmacological interventions; to assess all patients’ needs through Italian vali-
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dated tools (physical and emotional symptoms, hope, existential/search of meaning/religious and communication needs) in order to ensure early care of the patient in a holistic approach; to support family members, survivors and healthcare professionals; and to promote research (pharmacological and not) and educational programs. Methods: Pharmacological intravenous therapies consists of: blood product transfusions, infusion of immunoglobulins, human albumin, human plasmatic protein, antibiotics, antifungals and antivirals, iron, analgesics, diuretics, steroids, octreotide, H2-antagonist, glutathione, antiemetics, antihistamines, bisphosphonates (with prevention and treatment of ONJ), hydration post high-dose chemotherapy, for acute and chronic renal failure, electrolyte supply, and/or multivitamin, protein, lipid supply, in patients with compromised ability to eat and drink properly, or with toxicity due to radiotherapy or chemotherapy (i.e., diarrhea, nausea, vomiting and oropharyngeal high-grade mucositis). Results:
Figure 1 shows the trend of activity from June 2009 till December 2012 at the SCCU Conclusions: Supportive Care Units are necessary in each Oncological Center.
MASCC-0653 Prevalence of pain in elderly cancer patients V. Zafferri1, A. Brunello1, A. Roma1, S. Lonardi1, U. Basso1, F. Bergamo1, P. Fiduccia1, M. Corrias2, E. Capovilla2, L. Trentin3, V. Zagonel1 1 Division of Medical Oncology 1, Istituto Oncologico Veneto-IOV IRCCS, Padova, Italy, 2Psycho-Oncology Service, Istituto Oncologico Veneto-IOV IRCCS, Padova, Italy, 3Palliative Care Unit, Istituto Oncologico Veneto-IOV IRCCS, Padova, Italy
Introduction: Information among prevalence of pain in elderly cancer patients (ECP) are limited. Objectives: To evaluate, in ECP, prevalence of pain, intensity, correlation between pain and stage of cancer, correspondence between patients’ self-reported pain and oncologist assessment. Methods: Consecutive ECP referred to our Oncology Unit from January 2011 to January 2013 were enrolled. Pain was assessed through a semi-structured interview, McGill Pain Questionnaire, Brief Pain Inventory; pain was also assessed through numerical rating scale (NRS) by the physician. Results: Enrolled ECP are 531, median age 76 years (range 70–92); 43.9 % males. Main tumor types are: gastrointestinal (42 %), breast (27 %), urological (13.8 %), other sites (17.2 %).
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ECP with early stage disease experience lower interference (Mean ± SD: 2.94±2.32), compared to those with advanced cancer (Mean ± SD: 3.82±2.24, p=0.008). Self-reported pain is stated by 212 ECP (39.9 %), whereas oncologists’ reporting of pain is present for 118 ECP (55.6 %) and in 63 (53.4 %) pain is related to cancer. For patients with both evaluations (n=100) a significant difference in NRS intensity is observed between ECP selfreported pain (median: 5, range 0–10) and oncologists’ assessment (median: 3, range 1–10, p<0.001. Conclusions: Almost 40 % of ECP reported pain, but oncologists’ assessment was present in only about half of the cases (22.3 %). When present, pain was cancer-related in about half of cases. Overall, pain was of low-intermediate intensity. Our data show that there is underestimation of prevalence and intensity of pain in ECP by physicians. References: Jackson M. (2002) Pain: the fifth vital sign. New York: Crown.
MASCC-0654 Burnout in medical oncology fellows is high even before the program starts D. Cubero1, R.R.L. Fumis1, F.M. Cruz1, P.X. Santi1, T.H. Sa2, A.A. Dettino3, F.O. Costa4, F.M. Peria5, B.M.V. Eyll6, C.A.M. Beato7, J. Altino8, S.J. Azevedo9, D.R. Filho10, A.A. Mota11, A.E.R. Lessa12, M. Moreira12, A.E.R. Del Giglio13 1 Oncology and Hematology Department/CEPHO, ABC Foundation School of Medicine, Santo André, Brazil, 2School of Public Health, University of Sao Paulo, Sao Paulo, Brazil, 3Oncology Department, Hospital A. C. Camargo, Sao Paulo, Brazil, 4Oncology Department, Unicamp, Campinas, Brazil, 5School of Medicine of Ribeirao Preto, University of São Paulo, Ribeirao Preto, Brazil, 6Oncology Department, Instituto Arnaldo Vieira de Carvalho, Sao Paulo, Brazil, 7Hospital Amaral Carvalho, Hospital Amaral Carvalho, Jaú, Brazil, 8 Faculdade de Medicina de São José do Rio Preto, Faculdade de Medicina de São José do Rio Preto, São José do Rio Preto, Brazil, 9 Oncology Department, Hospital das Clinicas de Porto Alegre, Porto Alegre, Brazil, 10Oncology Department, Instituto do Cancer do Ceara, Fortaleza, Brazil, 11Oncology Department, Hospital São Rafael, Salvador, Brazil, 12Oncology Department, Hospital Santa Isabel, Salvador, Brazil, 13Oncology and Hematology Department/CEPHO, ABC Foundation School of Medicine, Santo Andre, Brazil Introduction: Burnout is high among practicing oncologists. Medical oncology fellows (MOFs) are exposed to similar risk factors for burnout, however few data are available in this population. Objectives: To evaluate prevalence of burnout in Brazilian MOFs during their first year of fellowship. Methods: This is a prospective cohort study of Brazilian MOFs in 2010 and 2011. We evaluated burnout, stress and depression prevalence at the start, 6 and 12 months after the beginning of medical oncology program. We applied Maslach Burnout Inventory, Lipp Inventory and Beck Depression Inventory. Results: We included 53 MOFs from 11 institutions. The mean age was 29 (95 % CI 28.2–29.7 years old), 53.7 % were men, 80.8 % were single and 67.3 % had family support. The majority of them hadn’t had psychiatric or psychotherapeutic treatment (90.4 % and 73.1 %, respectively). At the beginning of the medical oncology program, the majority of fellows already presented severe burnout (emotional exhaustion score ≥ 27 in 49 %; depersonalization score≥10 in 64.7 % and lack of personal accomplishment score≤33 in 17.7 %). At this same point, 36.7 % of fellows were stressed and 34 % had depression. During the first year of medical oncology fellowship, severe burnout prevalence increased significantly, mainly for Maslach EE (p=0.0032) and Maslach DP (p=0.0088).
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Conclusions: Burnout is already high at the beginning of medical oncology fellowship. Previous intensive internal medicine residency activities may have contributed to this finding and the medical oncology fellowship experience may intensify pre-existing burnout even more.
MASCC-0655 Effects of exercises on fatigue in patients underwent hematopoietic stem cell transplantation V.D.S. Carlucci1, R.C.C.P. Silveira1, F.T.M.M. Braga1, L.M. Garbin1, P.E.D. Reis2 1 General and Specialized Nursing, University of São Paulo at Ribeirão Preto College of Nursing, Ribeirão Preto, Brazil, 2Nursing, University of Brasília, Brasília, Brazil Introduction: Patients who underwent hematopoietic stem cell transplantation (HSCT) have several side effects. The fatigue is shown by physical, mental and emotional symptoms and decrease of the patient’s functional condition ability. This effects and symptoms are revealed by sleep disturbance, anxiety, physical exhaustion and disorder nutritional condition. Under this context, physical exercises can improve healthy and quality of life. Objectives: To identify recent reports related to physical exercises in patients underwent to chemotherapy followed by HSCT. Methods: A literature narrative review was conducted in the Pubmed, Cinahl, Lilacs and Cochrane Library databases. Results: Seven controlled and randomized clinical trials were identified, in which was raised the relation between the physical exercises and the improvement of effects and symptoms of fatigue. Among some physical exercises performed by low impact were: stretch in the bed with elastic string, breathing relax, multimodal activity with progressive relaxing associated to psychologist education that consisted on behavior therapy and cognitive techniques; and prescribed in accordance with the ability of the analyzed patients. The impact of these activities was analyzed by laboratorial exams, anxiety, depression and fatigue level identification. The measurement of such variables occurred in three different periods of time: before the exercises beginning, during the transplantation and up to 6 months after HSCT. The results identified the well being and quality of life improvement, decrease of anxiety and depression levels and functional ability improvement. Conclusions: Physical exercises is a relevant intervention to fatigue and can be adopted during the patient daily care.
MASCC-0656 Effects of a psycho-educational intervention on mood in colorectalcancer and anal cancer patients and their next-of-kin: a randomized controlled trial M. Andersson1, B. Andershed2, U. Nilsson3, E. Ohlsson-Nevo3 1 Department of Surgery, Örebro University Hospital, Örebro, Sweden, 2 Department of Nursing, Gjøvik University College Gjøvik, Gjøvik, Norway, 3School of Health and Medical Sciences, Örebro University Örebro, Örebro, Sweden Introduction: Colorectal-cancer is common in both men and women with an estimated incidence of 1.2 million new cases per year. The disease can affect the physical and psychological wellbeing of both the patients and the next-of-kin. Psycho-social interventions are known to reduce the impact of the disease, reduce distress and increase abilities to cope for both the patients and the next-of-kin.
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Objectives: The aim of this study was to test if a psycho- educational program had an effect on mental wellbeing in persons treated for colorectal or anal cancer and their next-of-kin. A randomized controlled trial in a surgical clinic at a university hospital in the middle of Sweden. 99 colorectal-cancer patients and 71 next-of-kin particpated in the study. Methods: The psycho-educational program included 7 meetings with 60 min professional lectures followed by 60 min of separate reflections with others patients/next-of-kin led by one registered nurse in each group. The overall mood was measured with the Mood Adjective Check List (MACL) including three dimensions; activation, pleasantness and calmness. MACL was measured 1 month after the discharge from the hospital and 1 month, 6 and 12 months after the end of psycho-educational program. Results: The psycho-educational program increased the patient’s overall mood, calmness and pleasantness 1 month after the end of the psycho-educational program However, the program did not the overall mood or activation, pleasantness and calmness among the next-of-kin. Conclusions: The psycho-educational program has an effect on the patients overall mood but not in next-of-kin. Further studies are needed to confirm the results.
MASCC-0657 Single brain metastases: radiotherapy alone or combined with neurosurgery? D. Ivanova1, S. Georgieva1, A. Dimov1 1 Radiation Oncology, Tokuda Hospital Sofia, Sofia, Bulgaria Introduction: Most patients with single brain metastases die from progression of extracranial tumor activity, which makes it uncertain what is the best combination of treatment for this cranial disease. Objectives: The objective is to determine if the addition of surgical extirpation prior to whole brain radiotherapy (WBRT) increases survival, neurological function, and quality of life compared with radiotherapy alone in patients with single brain metastases. Methods: We conducted aretrospective study of 53 patients who received WBRT from November2009 to December 2012. Mean age was 60.8 years (31–82). Pathology ofprimary tumor included lung (29), breast (13), melanoma (5) and others (6). The patients were divided in twogroups: neurosurgery plus WBRT (28 patients) vs. WBRT alone (25patients). In both groups radiotherapy was given to the whole brainin 3 Gy fractions per day for a total dose of 30Gy in 2 weeks. Results: The combined treatment led to an increased overall survival (15 vs. 10 months). This was mostly pronounced in patients with stable extracranial disease (median survival 17 vs. 13 months). Patients with progressive extracranial disease had a median overall survival of 7 months irrespective of received treatment. Improvement in neurological functional status occurred more rapidly and for longer periods of time in patients after neurosurgical excision and radiotherapy than after radiotherapy alone. Conclusions: Patients with single brain metastases and controlled or absent extracranial tumor activity show benefit both in overall survival and neurologic status from the addition of neurosurgery prior to WBRT, while for patients with active extracranial disease radiotherapy alone appears to be sufficient.
MASCC-0658 Multicentre, prospective observational study of pegfilgrastim primary prophylaxis (PP) in patients at high risk of febrile neutropenia (FN) in Poland W. Jurczak 1 , E. Kalinka-Warzocha 2 , E. Chmielowska 3 , R. Duchnowska4, E. Wojciechowska-Lampka5, K. Wieruszewska6
Support Care Cancer (2013) 21 (Suppl 1):S1–S301 1 Dept of Hematology, Jagiellonian University, Krakow, Poland, 2Dept of Oncology, Regional Oncology Center, Lodz, Poland, 3Oncology Clinic, Oncology Centre, Bydgoszcz, Poland, 4Dept of Oncology, Military Institute of Medicine, Warsaw, Poland, 5Department of Lymphoproliferative Diseases, The Maria Sklodowska-Curie Memorial Cancer Centre and Institute, Warsaw, Poland, 6Medical Development, Amgen Biotechnologia Sp z oo, Warsaw, Poland
Introduction: Pegfilgrastim is a once-per-cycle granulocyte-colony stimulating factor (G-CSF) registered for PP of FN in patients receiving myelosuppressive chemotherapy. Guidelines recommend it in all patients with high (≥20 %) overall FN-risk. Objectives: Primary objective was to determine the most important reasons contributing to physicians’ decision to use pegfilgrastim PP in patients with high overall FN-risk; secondary objectives included estimating FN incidence and monitoring PP safety. Methods: Patients with lymphoma or breast, lung, or ovarian cancer and an investigator-assessed high overall FN-risk were eligible. All patients received pegfilgrastim prophylaxis from the first chemotherapy cycle. Results: One thousand six eligible patients were enrolled from 03/2009– 03/2011 (431 breast, 110 ovarian, 108 lung, 263 NHL, 94 Hodgkin lymphoma). Median age was 55 years (range 18–86), 74 % of patients were female, 76 % had advanced (stage III/IV) disease. Most patients received chemotherapy with intent to cure (66 %) or prolong life (29 %), with 5 % palliative. Investigator-assessed chemotherapy FN-risk was high in 69 %, intermediate in 18 %, and low in 3 % of patients (10 % missing). The most commonly selected first important reason for pegfilgrastim prophylaxis in cycle 1 was high FN-risk chemotherapy (72 %); the most commonly selected second important reason was advanced disease (28 %). Overall FN incidence was 4 %; most events occurred in NHL patients (26/44). Bone and muscle/joint pain were the most common adverse drug events (both 6 %), with none serious. Conclusions: The most important reasons for pegfilgrastim PP were high-risk chemotherapy and advanced disease. FN rates were relatively low in patients at high overall FN-risk with pegfilgrastim PP.
MASCC-0659 Community acquired pneumonia: our centers experience in oncologic patients C. Ribeiro1, F. Gomes1, R. Pereira2, S. Oliveira1, P. Barata1, A.C. Trindade1, R. daLuz1, A. Castro2, L. Batarda1 1 Medical Oncology, Centro Hospitalar Lisboa Central, Lisboa, Portugal, 2 Internal Medicine, Centro Hospitalar Lisboa Central, Lisboa, Portugal Introduction: Community Acquired Pneumonia (CAP) is an important cause of morbidity and morbility and hospital admissions for CAP have markedly increased over the last decade, particularly in elderly patients. Objectives: With this study, our aim was to compare the severity and outcome of respiratory infections in patients with previous diagnosis of neoplasms with the ones without, in our hospital. Methods: We reviewed of all cases of “Pneumonia” in hospitalized patients between January 1st and December 31st of 2010. Results: A total of 320 patients (80 oncologic) were admitted with CAP in 2010. There were no significant differences regarding age between both groups (68 versus 71 years, p=0.133). Oncologic patients had a higher mortality rate (14.7 % versus 28.8 %, p=0.003) and more severe disease (SOFA score)(p=0.021). Among patients with oncologic disease, 40 had active disease in the past year, but we only found a tendency for lower survival when comparing these patients with the ones with disease not considered active (343 versus 193 days, p=0.054). Of our patients, 23 had been treated with chemotherapy on the previous 3 months, in a median of 19 days before the admission
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with CAP. Only 11 patients did chemotherapy after the CAP admission, in a median of 32 days. Conclusions: Despite all the limitations of being a small, retrospective study, with this report we hope to alert for how important it is to better understand respiratory infections in oncologic patients in order to improve treatment and prognosis. References: British thoracic Society guidelines for the management of CAP.
MASCC-0660 Bereavement care after patients’ immediate death and postmortem care in Japan
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Results: The urinary catheter was associated with restrictions in mobility and some discomfort and pain. Men attributed their discomfort to constipation, bladder spasms, movement of the catheter tube and leakage of urine around the catheter. Men were embarrassed when leakage of urine occurred. Men described the overwhelming feelings of relief when the catheter was removed. In the longer term men made a strong link between the penis being a key focus of male sexuality and the ability to engage in penetrative sexual activity being a fundamental constituent part of male gender identity. Participants spoke at length in relation to their very real need for information and the need for peer, family and healthcare professional support. Conclusions: This type of information is vital in order to tailor healthcare services to meet the unique needs of each patient.
S. Jahana1, M. Kamizato1 1 Adult Nursing, Okinawa Prefectural College of Nursing, Naha, Japan Introduction: Postmortem care has been reconsidered as a care for the bereaved family in Japan. However, there are few studies about postmortem care as bereavement care. Objectives: To clarify how bereavement care is provided for the family by nurses after patient’s death until the discharge and to examine the interaction between the bereaved family members and nurses. Methods: This study was an exploratory study to collect data primarily through ethnographic observations and interviews. Participants were 49 bereaved family members of 19 terminally ill cancer patients and 19 nurses in Japan. Study period was 7 months in 2010. A researcher participated patients’ death and postmortem care with the nurses and observed attitudes and responses of the family and the nurses. Data analysis was conducted by using a qualitative descriptive method. After an ethics review by the College and hospitals, the research was conducted. Results: After the patients’ breathing stopped, the nurses provided the bereaved family members time with the patients for about an hour as grief care before death pronounced by the doctor. During the period of Postmortem Care, the nurses not only gave showers, got dressed on and put makeup on the deceased patients with the bereaved family members, but also the nurses listened to the family members about good memories of patients. Inaddition, the nurses helped the family to find the meaning about what they did for the patients. Conclusions: The nurses provided grief care to the bereaved family members during the period immediately, following the patients’ death and postmortem care.
MASCC-0661 Experiences of having a urinary catheter post radical prostatectomy for prostate cancer J. Hegarty1, S. Curran1 School of Nursing and Midwifery, University College Cork, Cork, Ireland 1
Introduction: Continued investigation into the health concerns of men post treatments for prostate cancer is required. Interestingly, the experience of men with urethral catheters has received little attention in the research literature. Leakage of urine around a catheter is not uncommon in patients. Aetiological factors for leakage of urine around a catheter include partial blockage of catheter, bladder spasms, constipation, urinary infections, and inappropriate catheter/balloon size. Objectives: To provide a retrospective picture of men’s experiences of having a urethral catheter post prostatectomy. Methods: A qualitative, descriptive design was employed. Ethical approval was obtained. A volunteer sample (n=20) of men post radical prostatectomy were interviewed. Data was analysed using qualitative thematic content analysis.
MASCC-0662 Reflexology in breast cancer patients receiving chemotherapy: results from a single center pilot study E. Cappai1, S.M. Magno1 Breast Center, Catholic University of the Sacred Heart, Rome, Italy
1
Introduction: A pilot study was conducted on a small series of breast cancer patients receiving chemotherapy between March 2011 and August 2012 at the Breast Center of the Catholic University of Rome. Objectives: To evaluate the effectiveness of reflexology in reducing side effects of chemotherapy. Methods: Thirteen women with a histologically proven diagnosis of breast cancer, undergoing weekly cycles of a Taxan-based chemotherapy regimen (80 mg/m2) were recruited in the study. Weekly questionnaires were submitted to assess the presence and intensity of chemotherapy side effects. Patients were randomly assigned to receive 45 min weekly courses of foot reflexology (seven patients), or to be included in the control group (four patients). Adherence to chemotherapy plan and granulocyte stimulating factors prescription were monitored for each patient. Results: A decreased incidence and/or reduced intensity of hot flushes and insomnia was observed in the reflexology group, together with a reduced consumption of drugs for nausea and pain and better adherence to weekly chemotherapy cycles. Conclusions: Despite the small size of the sample tested, the present study homogeneity in patient’s recruitment standards (age, pathology, chemotherapic schedule, treatment Center, and reflexology therapist) contribute to endorse reflexology as a promising therapeutic option both for its safety and effectiveness in breast cancer patients treated with chemotherapy. The promising trends shown in this pilot study are to be confirmed in a larger trial.
MASCC-0663 Clinical standards of care on diagnosis, prevention and treatment of (CHEMO)radiation-induced dysphagia in head and neck cancer patients: a MASCC/ISOO survey results P. Bossi1, B. Murphy2, E. Russi3, R.J. Bensadoun4, A. Merlotti5, I.M. Verdonck-de Leeuw6, L. van-der Molen7, J. Raber-Durlacher8, A. Barasch9 1 Head and Neck Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy, 2Medical Oncology, VanderbiltIngram Cancer Center, Nashville, USA, 3Radiation Oncology, General Hospital S Croce e Carle, Cuneo, Italy, 4Radiation Oncology, CHU de Poitiers, Poitiers, France, 5Radiation Oncology, Azienda Ospedaliera Busto Arsizio, Busto Arsizio, Italy, 6Otolaryngology/Head & Neck Surgery, VU University Medical Cancer Center, Amsterdam, Netherlands, 7Head and Neck Oncology and Surgery, The Netherlands Cancer
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Institute, Amsterdam, Netherlands, 8Department of Oral and Maxillofacial Surgery, Academic Medical Center, Amsterdam, Netherlands, 9Dental Medicine, Winthrop University Hospital, Mineola, USA Introduction: Although dysphagia is a common side effect in head and neck cancer (HNC) patients, standards for assessment, prevention and treatment are lacking. Objectives: To assemble information regarding patterns of care related to dysphagia in HNC patients. Methods: MASCC/ISOO members and HNC specialists were asked to complete an electronic survey querying patterns of dysphagia care at their institution. Results: One hundred thirty surveys, mainly from Europe and North America, were returned. Supportive care issues were considered at HNC tumor board in 80 % of institutions. Pre-treatment dysphagia and weight loss were often/always discussed in 61 % and 71 % of teams, respectively. A dedicated speech pathologist (SLP) and a dietician were present in 45 % and 55 % of the institutions, respectively. Instrumental evaluation was mainly performed by flexible endoscopy (58 %), usually after development of dysphagia or aspiration signs/symptoms. Among signs and symptoms that should trigger referral for assessment by an SLP, weight loss was included by 47 % of responders. A feeding tube was placed prophylactically in 31 % of patients, usually due to pre-existing weight loss and/or swallowing disorders. 66 % of responders did not use patient reported outcome (PRO) measures routinely. Dysphagia care and nutritional support were deemed satisfactory by 51 % and 71 % of the responders, respectively. The main problem with dysphagia care was lack of SLP availability. Conclusions: Dysphagia care is inadequate at many institutions treating HNC. Dedicated SLP services and PRO measures should be made available in order to improve the patient’s support. Standards for assessment, prevention and treatment of dysphagia in HNC are needed.
MASCC-0664 Clinical and molecular predictors of late patient-reported dysphagia in oropharyngeal cancer treated with intensity modulated radiotherapy concurrently with chemotherapy P. Bossi1, A. Mirabile1, R. Miceli2, E. Orlandi3, E. Iannacone3, N. Denaro4, A. Schindler5, N. Pizzorni5, L. Gianello6, E. Russi6, L. Licitra1 1 Head and Neck Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy, 2 Statistics and Biometry, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy, 3Radiation Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy, 4Medical Oncology, General Hospital S Croce e Carle, Cuneo, Italy, 5Otolaryngology, University of Milan, Milano, Italy, 6 Radiation Oncology, General Hospital S Croce e Carle, Cuneo, Italy Introduction: The impact of late dysphagia in patients treated with chemoradiation for head and neck cancer is generally underreported, with limited data about clinical and molecular predictive factors. Objectives: To evaluate late patient-reported dysphagia. Methods: Stage III-IV oropharyngeal cancer without evidence of disease, treated since more than 6 months with IMRT and concurrent chemotherapy, with/without induction chemotherapy (IC) were selected. Clinical data were collected together with p16 tumoral status as marker of HPV positivity. We analyzed the MDADI and FACT total scores administered in a cross sectional study. Results: In 3 months we selected 83 pts, having the characteristics in Table 1. In multivariable analysis, lower MDADI total score was significantly related to high risk group (p16 negative tumors), higher xerostomia and short time from treatment end; similarly, FACT-HN global score showed a significant association with xerostomia and time from treatment end.
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Table 1: Age, Sex
Mean 60 year (43–78), M 82 %, F 18 %
Stage
T3-4 51 %; N2-3 81 %
Induction chemotherapy
Yes 31 %, No 69 %
p16
Pos 75 %, Neg 25 %
Risk
High (p16 negative) 21 %, intermediate 43 %, low 36 %
Late xerostomia
G0 41 %, G1 35 %, G2 24 %
Time from treatment end
≤ 24 months 47 %; > 24 months 53 %
Mean RT dose
70 Gy
MDADI global score
Mean 75 (40–100)
FACT-HN global score
Mean 108 (56–148)
Conclusions: Globally, treatment with IMRT and chemotherapy has a reduced burden of patient-reported dysphagia, with further improvements after 24 months of follow up. HPV status and late xerostomia are the main predictors of perceived late dysphagia symptoms.
MASCC-0665 The experience of being diagnosed with prostate cancer and having a radical prostatectomy J. Hegarty1, S. Curran1 1 School of Nursing and Midwifery, University College Cork, Cork, Ireland Introduction: Radical prostatectomy remains the first choice of treatment for many men. Thus, continued investigation into the health concerns of men prior to and post treatments for prostate cancer is required. Objectives: The objective of this study was to provide a retrospective picture of men’s experiences of surgery for prostate cancer from initial diagnosis, through their surgery and 2 weeks beyond. Methods: A qualitative, descriptive design was employed. Ethical approval was obtained. A volunteer sample (n=10) of men 2 weeks post radical prostatectomy were interviewed. Data was analysed using qualitative thematic latent content analysis. Results: Men identified a number of themes related to their prostate cancer journey. These included: the process of being diagnosed (the existential meaning attributed to the word cancer), experience of having surgery, side-effects of treatments (pain, feeling sick, bit wobbly, constipation), the emotional challenges on the cancer journey, difficulties with the urinary catheter and the need for information and support. The word “cancer” engenders fear in individuals and does not reflect the knowledge of the 21st century but alternatively reflects fears, uncertainties and a perceived certainty that death is somehow accelerated by the fact of the diagnosis. Words really do matter because they influence out thoughts and behaviours. Conclusions: In a healthcare system which increasingly values the ‘patients view’ this type of information is vital in order to tailor healthcare interventions to meet the unique needs of each patient.
MASCC-0666 Development of a simple assessment tool for the elderly cancer patients based on relationships between comprehensive geriatric assessment items and performance status S. JUN1, J.Y. Kim2, K.U. Park2 1 Collegle of Nursing, Keimyung University, Daegu, Korea, 2Department of Hematology/Oncology, Keimyung University Dongsan Hospital, Daegu, Korea
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Introduction: The Comprehensive Geriatric Assessment (CGA) is the multidisciplinary evaluation of older patients. Recent studies have reported its efficacy to predict morbidity and mortality in elderly cancer patients, but it requires resources and relatively long time to complete it. The Eastern Cooperative Oncology Group Performance Status (ECOG-PS) has been widely used to predict response to systematic treatments or overall survival in various cancer patients, but provides very limited information. Objectives: To explore what items of CGA are highly correlated with ECOG-PS and represent 5 domains of CGA in Korean elderly cancer patients. Methods: Patients aged ≥65 years with cancer (n=153) were evaluated by ECOG-PS and a set of 5 CGA scales: Instrumental Activities Daily Living (IADL), Mini Nutritional Assessment (MNA), Hospital Anxiety and Depression Scale (HADS), Charlson's Comorbid Index (CCI), Mini-Mental State Examination (MMSE). The Functional Assessment Cancer Therapy-General (FACT-G) was used a reference test. Results: Demographic and CGA characteristics of the patients were described in Table 1. Age, educational years, IADL, HADS, MNA and MMSE were significantly correlated with ECOG-PS (p values, 0.01 to <0.001). The FACT-G showed similar patterns with ECOG-PS in the correlation tests. Ten items were selected from the CGA based on their correlations with ECOG-PS (3 items from IADL, 3 items from HADS, 3 items from MNA and 1 item from MMSE; p-values, 0.01 to <0.001). 1. Demographic and CGA Characteristics of the Patients Characteristics
Number of patients, n (%) (n=153)
Age, range
Values 65–89
65–69
41 (26.8)
≥ 70
112 (73.2)
Sex Male
99 (64.7)
Female
54 (35.3)
ECOG* 0-1
109 (71.2)
≥2
41 (26.8)
Years of education* ≤6
43 (28.1)
>6
109 (71.2)
Marital status Partnered
114 (74.5)
Non-partnered
39 (25.5)
Cancer type* Lung
23 (15.0)
GI
70 (45.8)
Hepatobiliary
27 (17.6)
Hematologic
12 (7.8)
Breast
6 (3.9)
Others
14 (9.2)
FACT-G
2
36 (23.5)
3-5
46 (30.1)
≥6
69 (45.1)
MMSE Definite normal
108 (70.6)
Questionable dementia
32 (20.6)
Definite dementia
13 (8.5)
*
missing values in the data
Conclusions: This result indicates that the 10 items of CGA may play a role as a short version of CGA in this population.
MASCC-0667 Pro-angiogenic and wound healing potency of virgin coconut oil A. Ibrahim1, S. Al-Rawi2, S. Abdul Majid3, O. Al-Habib1, A. Abdul Majid2 1 Biology, University of Zakho Faculty of Sciences., Zakho Kurdstan Rigion., Iraq, 2Pharmacology, Universiti Sains Malaysia School of Pharmaceutical Sciences, Pinang, Malaysia, 3Integrative Medicine, Universiti Sains Malaysia Advanced Medical and Dental Institute, Pinang, Malaysia Introduction: Angiogenesis, the formation of new blood vessels is crucial in the initial development of embryonic growth, wound healing, tissue development and in many diseases including stroke. Wound healing occurs as a cellular response to injury and involves activation of keratinocytes, fibroblasts, endothelial cells, macrophages and platelets. Virgin Coconut Oil (VCO) an edible form of coconut oil, widely utilized in South Asian region for various applications including food, medicine and industry application. Fermented form of VCO (FVCO) meticulously extracted through bacterial fermentation process. Objectives: This study evaluates the potency of FVCO in angiogenesis and wound healing. Methods: Rat aortic assay was employed to evaluate proliferation of blood vessel formation using six different concentrations. Wound healing was evaluated using in vivo wound excision model in Sprague Dawley rats, supported by in vitro assays using human umbilical vein endothelial cells (HUVEC), human fibroblast cells (CCD-18) and retinal ganglion cells (RGC-5). The proliferation, migration and morphological changes of these cell lines using Hoechst fluorescent dye were also investigated. Results: FVCO significantly stimulated the growth of new blood vessel at different concentrations as compared with negative control. The excision wound model shows that VCO demonstrated higher percentage of wound contraction compared to the control group. Shorter closure time and epithelialisation (16 days) was observed using FVCO compared to 20 days for the control group indicating better wound healing activity. FVCO was significantly active on wound healing, CCD18 and RGC-5 cell proliferation at concentrations of 12–25 μg/mL respectively. Conclusions: These findings suggest that FVCO might be a good proangiogenic agent.
70.37 (16.78)
Comprehensive Geriatric Assessment IADL, mean (sd)
15.85 (5.29)
MNA, mean (sd)
21.3 (4.28)
HADS-A, mean (sd)
4.18 (4.33)
HADS-D, mean (sd)
7.17 (5.28)
CCI 1
2 (1.3)
MASCC-0668 Mucositis prevention and treatment in head and neck cancer patients treated with (CHEMO)radiation: report of an Italian survey E. Russi1, P. Bossi2, G. Numico3, M. Mazzer4, G. Saibene4 1 Radiation Oncology, General Hospital S Croce e Carle, Cuneo, Italy, 2 Head and Neck Medical Oncology, Fondazione IRCCS Istituto
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Nazionale dei Tumori, Milano, Italy, 3Medical Oncology, Azienda USL Valle d’Aosta, Aosta, Italy, 4Pharmacy, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy
centers. One should consider Adjuvant analgesics therapy as well as behavioral & physical Methods at all stages of pain control.
Introduction: There is a limited number of therapies reaching an high level of recommendation for mucositis, while several strategies are employed with a limited evidence for efficacy. Objectives: To assess standard of care of Italian Centers in prevention and treatment of chemoradiation induced mucositis in head and neck cancer patients. Methods: We conducted a 21 items electronic survey among Italian radiation and medical oncologist, aimed to assess preventive and therapeutic strategies regarding mucositis in HNC, involving also nutritional aspects and pain treatment employed. Results: We collected 111 answers (51 % medical and 49 % radiation oncologists). CTCAE scale is employed by 55 % of the physicians in assessing mucosal toxicity. The highest predictive factors for mucositis development are considered active exposure to oral stressors (smoke, alcohol), planned radiotherapy on oral cavity and oropharyngeal mucosa, concurrent use of radiosensitizing chemotherapy. Gastrostomy is prophylactically placed in less than 10 % of the patients, mainly due to weight loss before treatment. Preventive antibiotic or antibiotic are prescribed by 46 % of the responders (mainly local or systemic antimicotic drugs). Alkalinizing mouthwashes or coating agents are frequently adopted (70 % of the cases). Among therapeutic intervention, systemic fluconazole is administered by 80 % of the physicians, while the antibiotics chosen are penicillins, cephalosporins or fluoroquinolones (20 % each). Mucositis induced pain is mainly treated by weak followed by strong opioids. Pain during swallowing is considered as breaktrough pain by 69 % of the responders. Conclusions: Pattern of mucositis prevention and treatment varies among Italian Centers, with some uniform conducts in nutrition, use of antimicotic and painkillers.
MASCC-0670 Palliative care perspectives on QOL assessment tools
MASCC-0669 Pain in children with cancer E.R.K. Abdel Khalek1 1 Pediatric Oncology Unit, Faculty of Medicine - Zagazig University, Cairo, Egypt Introduction: Most of children with cancer suffer some pain during the course of their illness. Despite there has been large number of studies in adult, little has been written in children with cancer. Objectives: This work is directed to study the causes and scoring of pain in children with cancer, as well as to determine the response of pain treatment to analgesics and Non Pharmacological Methods. Methods: The characteristics of pain, was recorded on 120 children with proved cancers, using behavioral, pulse and Ouhart techniques. The response of the pain to analgesic drugs and non—pharmacological Methods was recorded in each case after 4 hours. Results: It was found that, the diagnostic procedures constituted the main causes of pain (60 %), followed by pain due to therapy(52.5 %) which included painful mucositis, post-operative pain and post-lumbar puncture headache. Whereas, the disease itself was responsible for 27.5 % cases. Concerning the scoring of pain, it was found that the majority of pain was moderate (90 %), mild pain were 30 %, while a minority was complaining from a severe form of pain (20 %). Response to management was recorded for all children. Conclusions: Pain in children with cancer is often underestimated and one that is inadequately evaluated and treated in many cancerous
B. Alt-Epping1, M. Jansky1, F. Nauck1 Palliative Medicine, University Medicine Göttingen, Göttingen, Germany 1
Introduction: Although restoring or maintaining best possible quality of life (QoL) is one of the most important goals in palliative care, structured assessment of QoL by using validated tools is still uncommon, unlike in oncology (study) settings and supportive care. Objectives Methods: Review of relevant literature and conceptual considerations from a palliative care perspective. Results: Several reasons were identified that might impede palliative care institutions to use QoL assessment tools: 1) a tradition in palliative and hospice care that focuses on personal relationship, verbal communication and listening, 2) a high number of disoriented or confused patients, not being able to follow complex questionnaires, 3) a relevant burden for palliative care patients in filling out multiple item QoL questionnaires, with consecutive research on single item tools, and 4) a reasoning about the general nature of the term ‘quality of life’, its dimensions beyond symptoms and functioning like its psychosocial context and existential grounds. On the other hand, there is increasing awareness that for determining structural traits of palliative care, for reimbursement of services, or for palliative care research, structured QoL assessment seems to be imperative. This becomes even more true in the advent of “early integration” of palliative care into oncology. Conclusions: Review of relevant literature and conceptual considerations from a palliative care perspectiveThe use of QoL assessment tools in palliative care may be considered ambivalent, with clear arguments for and against operationalized recording of a feature that becomes more and more complex at the end of life. With respect to “early integration” concepts, Methods of QoL assessment that are already well validated in supportive care will have to be considered.
MASCC-0671 What can specialized palliative care provide for supportive care in cancer? B. Alt-Epping1, F. Nauck1 1 Palliative Medicine, University Medicine Göttingen, Göttingen, Germany Introduction: The early integration of palliative care into ‘active’ oncology concepts, as validated by Temel 2010 and demanded in national and international guidelines, and the developments in modern medical oncology, will lead to an increase in the number of patients that will both receive specialist palliative care support as well as active anticancer treatment. Symptoms and needs early in the course of an incurable disease will not necessarily be distinguishable as disease related or treatment related problems. Therefore, it has to be asked, besides others, - to what extend specialized palliative care services with its 24 h availability and home care offers would have to address also treatment related needs that has been traditionally considered as a supportive care domain - what particular offers in specialized palliative care might prove helpful for patients under active anticancer therapy
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- what expertise in supportive care would be necessary to learn by palliative care providers (and vice versa), in order to treat symptomatic cancer patients receiving anticancer therapy adaequately, - to what extend early palliative care could also be a task provided by supportive care facilities, also with respect to the high number of patients recently diagnosed as having incurable cancer, and the comparably low number of specialised palliative care providers. This congress contribution will try to provide a balanced view on palliative care and supportive care interactions, based on the altered viewpoint of early palliative care and on the conceptual and pharmaceutical developments in oncology and supportive care Objectives Methods Results Conclusions
MASCC-0672 Haemoglobin outcomes in the management of chemotherapyinduced anaemia in cancer patients with biosimilar epoetin alfa (Binocrit®): first results from the French oncobos observational study J. Fayette1, C. Aubron-Olivier2, R.F. Soumoudronga2, B. Narciso3 1 Medical Oncology, Centre Léon Bérard, Lyon, France, 2Biotech-Hospital Division, Sandoz Biopharmaceuticals, Paris, France, 3Oncology, Hôpital Bretonneau, Tours, France Introduction: OnCoBOS is an ongoing, prospective, multicentre, observational study of the use of Binocrit® (biosimilar epoetin alfa) for the treatment of chemotherapy-induced anaemia (CIA). Here we present first data from 444/2000 patients treated in France. Objectives: To evaluate evolution in haemoglobin (Hb) outcomes in cancer patients with CIA treated with Binocrit®. Methods: We analysed 444 cancer patients with CIA treated with Binocrit® in 75 centres in France. Data were collected at treatment start and 3–4 weeks (W3-4) and 12 weeks (W12) later. Results: Median age was 67y; 59.3 % were male; mean ± SD Karnofsky score was 77.9±13.2. 77.5 % of patients had solid tumours, including lung (22.1 %), breast (13.4 %), and colorectal cancer (12.8 %), mainly stage 3 or 4 (59.3 %); 22.5 % had haematological malignancies including 55.0 % with non-Hodgkins lymphoma and 24.0 % with multiple myeloma, mainly stage 3 or 4 (77.7 %). Mean ± SD Hb at Binocrit® initiation was 9.6±0.9 g/dL. Mean ± SD Binocrit® starting dose was 32793± 5147 IU/week; the dose at W12 was 32605±6359 IU/week. At W3-4 11.9 % of patients received I.V. iron. Mean ± SD Hb increased to 10.6± 1.4 g/dL at W3-4 and 11.2±1.5 g/dL at W12 (p<0.001). Also at W12, 65 % of patients had Hb increase ≥1 g/dl. 81.3 % of patients were able to continue their chemotherapy without delays or dose reduction. Only three patients experienced an adverse drug reaction (none serious). Conclusions: This analysis indicates the real-world clinical effectiveness and safety of managing CIA with Binocrit®. The results reflect the ability to safely correct anaemia and maintain Hb, in line with current recommendations, using a weekly dose regimen.
MASCC-0673 Chamomilla recutita mouthwash development for buccal mucositis treatment F.T.M.M. Braga1, R.C.C.P. Silveira1, E.C. Carvalho1 1 General and Specialized Nursing, University of São Paulo at Ribeirão Preto College of Nursing, Ribeirão Preto, Brazil
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Introduction: Chamomilla recutita has flavonoid (powerful antiinflammatory) and may contribute to the mucositis treatment which physiopathology involves a bunch of steps interceded by cytokine proinflammatory Objectives: To develop a mouthwash containing Chamomilla, performing an organoleptical analysis and identifying the possible side effects. Methods: The mouthwash was developed with Chamomilla fluid extract in a water-based formula in three different dosages (0,5; 1 and 2 %). Physical-chemical and microbiological analysis and apigenin-7-glycoside dosage (flavonoid species marker) were done. 30 patients in hematopoietic stem cell transplantation were randomly allocated into three groups, according to the offered doses; they performed the mouthwash organoleptical assessment (flavor, scent, refresh), after rinsing the mouth with one of the formulas during 1 min, twice a day. Results: The physical-chemical and microbiological analysis evidenced the quality (density 1,003; pH 5,24 to 5,70; total bacteria and fungi <10 UFC/g) and the active ingredient integrity (apigenin-7-glycoside percentage: dose 0,5 %—0,054 mg/mL; 1 %—0,108 mg/mL and 2 %—0,216 mg/mL). Most of them classified the flavor as very pleasant or pleasant and sweet and refreshing, apart of the group. The scent was considered unpleasant for one patient (dose 2 %) and very unpleasant for the other (dose 0,5 %). Four patients had side effects: seldom nauseas (n= 3), mouth burning low frequency (n=2) and frequent vomit (n=1). Conclusions: The physical-chemical profile analysis evidenced the mouthwash quality, also well evaluated by the patients and considered as a safe product since no moderate or severe adverse effect was identified.
MASCC-0674 Location and prevelance of pain in a cohort of women up to 4 years after treatment for breast cancer M. Cooney1, R. Galvin2, E. Connolly3, E. Stokes1 Physiotherapy, Trinity College Dublin, Dublin, Ireland, 2HRB Centre for Primary Care Research, Royal College of Surgeons in Ireland, Dublin, Ireland, 3Breast Care Department, St. James’s Hospital, Dublin, Ireland 1
Introduction: More than 75 publications address pain following treatment for breast cancer yet the incidence remains unknownand little is known about where pain is experienced by women treated for the condition. This study was part of a broader study to validate the ICF Core Set for breast cancer (WHO,2001) Objectives: The aim was to determine prevelance and anatomical location of pain experinced by women treated for breast cancer. Methods: A self-report postal survey was sent to women with primary breast cancer who were >6 months and <4 years after surgery, fluent in English, >18 years (n=441). All treatment types were included and the sample were screened for comorbid conditions affecting function. Results: A response rate of 67 % was achieved (n=296). Average age was 57 (±12.6 years), time since surgery was 23.4 months. Surgery types: mastectomy 40 %, bilateral mastectomy 3 %, lumpectomy 46 %, no answer 11 %, radiation83%, chemotherapy 66 % and hormonal therapy 66 % (31 % currently). Since surgery 86 % had experienced pain and 71 % reported on-going pain. Joint pain was experienced by 53 %, followed by arm/shoulder pain 48 %, back 46 %, Chest trunk 41 % and lower limbs 32 %. Twenty seven per cent of respondents had pain in two locations and 40 % had pain in three or more locations. Findings suggest that pain is not being adequately managed. Prospective surveillance and active intervention is required. Widespread pain
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(>3 locations) has been associated with a twofold increase in mortality in the cancer population (Mc Beth et al.,2003). Conclusions: Knowledge of the locations where pain is experienced can be used to both assess for presence and evaluate intervention.
MASCC-0675 Use of Chamomilla recutita in the prevention and treatment of oral mucositis in patients undergoing hematopoietic stem cells transplantation: phase II randomized controlled clinical trial F. Titareli Merizio Martins Braga1, R.C.C.P. Silveira1, A.C.F. Santos2, E.C. Carvalho3 1 General and Specialized Nursing Department, University of São Paulo at Ribeirão Preto College of Nursing, Ribeirão Preto, Brazil, 2Bone Marrow Transplantation, Hospital Amaral Carvalho, Jaú, Brazil, 3General and Specialized Nursing Departament, University of São Paulo at Ribeirão Preto College of Nursing, Ribeirão Preto, Brazil Introduction: Oral mucositis is a common inflammatory complication manifested by patients undergoing hematopoietic stem cell transplantation (HSCT). The Chamomilla recutita is rich in flavonoids, especially apigenin 7-glucoside which has excellent anti-inflammatory activity. Objectives: To identify the dose of fluid extract of this plant in mouthwash to reduce the incidence and severity of oral mucositis in adult patients undergoing allogeneic HSCT. Methods: This is a phase II randomized controlled clinical trial. 40 patients were included from January to August 2011, undergoing allogeneic HSCT, aged ≥18 years. The mouthwash was standardized to apigenin 7-glucoside; were submitted to physical-chemical and microbiological analysis that showed its quality. Eligible patients were randomized to receive the mouthwash (doses of 0.5, 1 or 2 %; respectively 0.054 mg/ml, 0.108 mg/ml and 0.216 mg/ml of apigenin 7-glucoside) or for the control group (care routine). The daily evaluation of the buccal cavity was performed by WHO scale. The statistical analysis compared each dose mouthwash group with the control group. Results: Patients who received the 1 % mouthwash solution had a lower incidence (p=0.01), intensity (p=0.01) and duration of oral mucositis (p=0.01) when compared to control group. The formulation was well tolerated by the patients and it was not identified any moderate or severe adverse effect. Conclusions: The results suggest that mouthwash containing Chamomilla, at a dose of 1 %, acts in reducing the incidence, intensity and duration of days of mucositis in patients undergoing allogeneic HSCT. These findings provide subsidies for the execution of a phase III clinical trial.
MASCC-0676 Screening of venous thrombosis in advanced cancer patients: does D-dimer has role? S. Oh1, S.J. Park1, S.J. Cho2 1 Internal Medicine, Seoul Medical Center, Seoul, Korea, 2Hospice Team, Seoul Medical Center, Seoul, Korea Introduction: The incidence of venous thromboembolism (VTE) in advanced cancer patients is reported up to 30–40 %. D-dimer is used as screening test for VTE because it is cheap and highly sensitive. But, it is frequently elevated by other cause like infection or malignancy.
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Objectives: To assess role of d-dimer in advanced cancer patients to screen VTE. Methods: Patients with incurable cancer and swollen leg or other factors (according to Well’s clinical DVT model) undergo d-dimer test at admission according to policy of our hospice team. This report is retrospective analysis of patients who admitted in Hospice & palliative care ward from July to December 2012. Results: Among 125 incurable cancer patients, 103 patients were Well’s score ≥2 at admission. Among 103 patients, only 5 patients had normal d-dimer (<0.5 μg/mL) and majority (n=79, 76.7 %) was above 2.0 μg/mL. Basically, patients with d-dimer level ≥2.0 μg/mL should be recommended for Doppler ultrasonography or contrast-enhanced CT angiography. However, such radiologic workups were done at only 11 patients, because diagnosis of VTE could rarely beneficial to patients. Seven patients (63.6 %) had VTE in radiologic workup among 11 patients. Mean d-dimer level of VTE patients was 4.9± 3.2 μg/mL and in 11.6 ±7.9 μg/mL patients without VTE (p=0.070). All of the patients with VTE had d-dimer level of >2.0 μg/mL. Conclusions: In advanced cancer patients, d-dimer may lack its screening value for VTE. Patients without VTE also have high level of d-dimer. A novel cost effective tool is necessary for screening of VTE References: Cancer-associated thrombosis: updates and controversies. Am Soc Hematol Educ Program. 2012:626
MASCC-0677 Development of a walker 256-TC tumour-bearing rat model to study lapatinib-induced mucosal injury W.N.I. Wan Mohamad Zain1, J. Bowen2, E. Bateman1, D. Keefe1 1 School of Medicine, University of Adelaide, Adelaide, Australia, 2 School of Medical Sciences, University of Adelaide, Adelaide, Australia Introduction: Development of tumour-bearing animal models is important to investigate toxicity of cancer treatments. In this study, the effects of lapatinib, a small molecule agent which targets EGFR and ErbB2 and is known to cause mucosal injury were investigated on a Walker 256-TC cell line. Objectives: To test lapatinib activity against EGFR and ErbB2 in Walker 256-TC cells in order to develop an animal model to investigate mechanisms of lapatinib-induced mucosal injury. Methods: Cytotoxic effects of lapatinib on Walker 256-TC cells were determined using the XTT assay. Results were confirmed via trypan blue exclusion method. EGFR and ErbB2 expression were examined using real-time PCR. Walker 256-TC cells were then injected into the right flanks of female albino Wistar rats and grown over 3 weeks. This correlates with the peak of lapatinib-induced diarrhoea in Wistar rats [1]. Results: Lapatinib was shown to inhibit Walker 256-TC cell growth, with an IC50 value of 8.2 μM±0.26. Real time-PCR data showed increased mRNA expression levels of EGFR and ErbB2 in Walker 256-TC cells. A concentration of 1×107 cells/mL resulted in consistent tumour growth. Tumours were measurable by day 4 and reached 10 % of body weight 25 days post-inoculation, without metastasis to distant sites. Conclusions: Increased expression of EGFR and ErbB2 in the Walker 256-TC cell line might contribute to the cytotoxic effect of lapatinib on these cells. The animal model now provides a framework which will enable the study of lapatinib-induced diarrhoea in tumour-bearing animals. References: [1] Cancer Biol Ther, 2012, 13 (13): 1269–75
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MASCC-0678 Pinnacle study: epidemiology and characteristics of febrile neutropenia, FN, in oncological patients in Spain A. Casas Fernandez de Tejerina1, C. Font2, E. Aranda Aguilar3, J.J. Cruz4, L. Calera5, B. Masutti Sureda6, C. Camps7, R. López López8, N. Calvo9, F.J. Rebollo Laserna10, J. de Castro Carpeño11 1 Oncology dpt, H. Virgen del Rocio, Sevilla, Spain, 2Oncology dpt, H. Clinic i Provincial, Barcelona, Spain, 3Oncology dpt, H. Reina Sofía de Córdoba, Córdoba, Spain, 4Oncology dpt, H. Clinico Universitario de Salamanca, Salamanca, Spain, 5Oncology dpt, H. Miguel Servet, Zaragoza, Spain, 6Oncology dpt, H. General de Alicante, Alicante, Spain, 7 Oncology dpt, H. General de Valencia, Valencia, Spain, 8Oncology dpt, H. Clinico Universitario de Santiago de Compostela, Santiago de Compostela, Spain, 9Oncology dpt, Hospital de Sant Pau, Barcelona, Spain, 10Medical dpt, Sandoz Farmaceutica, Madrid, Spain, 11Oncology dpt, H la Paz, Madrid, Spain Introduction: Chemotherapy-induced FN is one of the most important causes of morbidity and mortality in patients receiving chemotherapy. The study aims to updated data about this event in Spain that will help define the real burden of FN in cancer patients. Objectives: Depict incidence of hospital admissions for FN and the clinical characteristics, treatment of events and their evolution in these patients. Methods: Epidemiological, retrospective, descriptive, multicentric study. 10 sites included an average of 12 cancer patients admitted for FN recruited in retrospective chronological order. Additionally centres recovered the number of FN events in patients treated with chemotherapy in the last 3 months. Results: One hundred nineteen patients with FN were included in the study with an average age of 59 years. The most frequent type of tumours were lung (28,5 %), breast (21,8 %) and colorectal (11,7 %) and 21 % of these patients were treated prophylactically with CSFs. The incidence of FN was 4.10 % and drove to a reduction and delay of treatment in 11,8 % and 40 % of those patients respectively. Regarding related adverse events, the incidence of anaemia, transfusion use and mucositis were 42.3 %, 16.9 % and 19.5 % respectively. Mean length of hospitalization was 8.7 days with a trend of longer length of hospitalization (p= 0.052) in patients who did not receive G-CSF prophylaxis, 9.3 days. Eight patients with FN died (6,7 %), out of them 2 due to FN. Conclusions: FN still remains an important problem in the management of oncology patients. There is a trend of higher hospitalization stay in patients who did not receive G-CSF prophylaxis
MASCC-0679 Effect of adjusting the PH by mixing steroid for venous pain in CRC patients receiving oxaliplatin through peripheral vein. Randomized phase II study (Apollo) A. Toyokawa1, T. Hata2, M. Kobayashi3, M. Tsuda4, Y. Tokunaga5, K. Takase6, M. Miyake7, S. Morita8, J. Sakamoto9, H. Mishima10 1 Surgery, Yodogawa Christian Hospital, Osaka, Japan, 2Gastroenterological Surgery, Osaka University, Suita, Japan, 3Cancer Treatment Center, Kochi University, Kochi, Japan, 4Gastroenterology and Hepatology, Hyogo Cancer Center, Akashi, Japan, 5Surgery, Kyoto Teishin Hospital, Kyoto, Japan, 6Surgery, Kobe Rosai Hospital, Kobe, Japan, 7Surgery, Toyonaka Municipal Hospital, Toyonaka, Japan, 8Biostatistics and Epidemiology, Yokohama City University Medical Center, Yokohama, Japan, 9Director, Tokai Central Hospital, Hihgashijima, Japan, 10Cancer Center, Aichi Medical University, Nagakute, Japan Introduction: Administration of oxaliplatin through peripheral vein can cause venous pain. One of possible reasons is pH. The pH level of
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oxaliplatin solution is about 4.8 and that of buffered by steroid is around 7.0. Objectives: To investigate the hypothesis that adjusting the pH of oxaliplatin solution by mixing steroid can reduce venous pain, we have conducted the randomized control study to compare pH adjusted oxaliplatin solution with unadjusted xaliplatin solution. Methods: Colorectal cancer patients receiving oxaliplatin through peripheral vein were randomly assigned to arm A (oxaliplatin 130 mg/m2 with dexamethasone 1.65 mg) or arm B (the same, without dexamethasone). Venous pain was evaluated by CTCAE (ver. 4.0) and the verbal rating scale (VRS). Assessments were conducted every 3 weeks until cycle 4. Results: A total of 53 patients were enrolled. Of these, 48 evaluable patients were randomized to either arm A (n=24) or arm B (n=24). Incidence of venous pain (grade≥2) was 33.3 % in arm A and 58.3 % in arm B (relative risk 0.57). Incidence of venous pain (VRS score≥3) was 12.5 % in arm A and 37.5 % in arm B (relative risk 0.33). No difference was observed in efficacy and safety. Conclusions: Adjusting the pH of oxaliplatin solution by adding low doses of dexamethasone reduced severe venous pain without influence on efficacy and safety.
MASCC-0680 A multicenter clinical trial on skin reactions and translational research in patients with locally advanced head and neck cancer undergoing definitive radioimmunotherapy: the HICARE trial K. Potthoff1, G. Habl2, M. Haefner2, A. Abdollahi3, J. Hassel4, J. Debus2 1 Medical Oncology, National Center for Tumor Diseases, Heidelberg, Germany, 2Radiation Oncology, University of Heidelberg Medical Center, Heidelberg, Germany, 3Molecular and Translational Radiation Oncology, University of Heidelberg Medical Center, Heidelberg, Germany, 4 Dermatology, University of Heidelberg Medical Center, Heidelberg, Germany Introduction: The most frequent side effects of radioimmunotherapy are skin reaktions, i.e. radiation dermatitis and cetuximab-induced acneiform rash. Incidence and severity of these frequent, often overlapping and sometimes limiting skin reactions, however, are not well explored and molecular analyses in correlation with clinics and outcome have never been analyzed prospectively before. Objectives: The objectives of the HICARE trial are to differentiate skin reactions caused by radiation from those caused by the monoclonal antibody cetuximab, to evaluate the incidence and severity of these skin reactions and to correlate them with outcome parameters. Besides, the translational research program will help to identify and confirm novel peripheral blood based molecular predictors and surrogates for treatment response and resistance. Methods: The HICARE study is a national, multicenter, prospective phase IV study. 500 patients with locally advanced head and neck cancer will be enrolled in 40 participating sites in Germany. Radioimmunotherapy will be applied according to SmPC. For translational research HPV status of the tumor samples and genomic and proteomic analyses of blood samples will be carried out at several time points. Results: As of January 2013, 70 patients were recruited and evaluable for safety analysis. Application of cetuximab and radiation therapy was well tolerated. 2 patients died due to severe comorbidities. QoL was maintained in all patients alive Results of an interim analysis will be presented Conclusions: The radioimmunotherapy with cetuximab is feasible, safe and effective. Skin reactions can be differentiated and adequately treated. Due to promising initial results active accrual will be continued.
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MASCC-0681 Experiences and support needs of adolescent patients with cancer form the perspectives of nurses in Taiwan W. Wu1, S. Cheng1, J. Lee1 1 Department of Nursing, National Taipei University of Nursing & Health Sciences, Taipei, Taiwan Introduction: Cancer treatment have a dramatic improvement resulting in a decreased mortality rate in pediatric patients. However, the unique experiences and support needs of adolescent patients with cancer (APC) seem to be overlooked. Nurse among health care professionals is the most closed one with APC and therefore would be appropriate to declare adolescent patients’ illness experiences and support needs. Objectives: The objective was to understand the experiences and support needs of APC from the perspectives of nurses. Methods: Ten nurses who were head nurses or leaders in pediatric hematology/oncology wards in teaching hospitals in Taiwan have been recruited and interviewed with semi-structured questions. They were experienced nurses and worked in pediatric hematology/oncology wards at least 5 years. Data were analyzed by Colaizzi method and Nvivo 8.0 qualitative software. Results: Results indicated that adolescents experienced greater symptom occurrence and severity. They depended on parents’ care in their physical symptoms; however, they seldom talked their psychological concerns with parents. Friends/peers would be the ones they would like to share life experiences with via social networks, such as Facebook. They also have cancer-related knowledge’s needs. They were used to searching health-related information via the Internet. Conclusions: Cancer significantly affect the physical and psychosocial well-being. APC have information needs in self care. The Internet would be an appropriate media to perform the mission. Social network provides the efficient and convenient way for them to reconnect with friends and peers and would be a feasible way to fulfill their social and support needs.
MASCC-0682 Patient-oncologist communication in office-based practices in Germany C. Riese1, W. Baumann1 health services research/quality improvement, WINHO - Scientific Institute of the Office-Based Hematologists and Oncologists, Cologne, Germany 1
Introduction: Taking the special needs of patients into account, good communication between cancer patients and physicians is a key factor for good cancer care. Objectives: The aim of the study was to measure how oncologists meet patients’ expectations in the different fields of communication. Furthermore, the study focused on the physician-patient relationship in reference to the socio-economic status of patients. Methods: This survey was based on the KOVA questionnaire by Farin, Gramm & Koziol (2009). The instrument distinguishes between four different fields: patient-participation and patient-orientation, effective and open communication, emotional-supportive communication and communication about personal issues. The KOVA includes 32 items. Additionally, patients were asked to evaluate the general satisfaction with the delivery of care. Psycho-social characteristics were raised as well. The in-house survey was conducted in 109 practices including 267 doctors (16,020 paper-based questionnaires) in total. The data was analysed with SPSS. Results: In total, we received 12,778 questionnaires (RR 79.76 %). The results indicate an appropriate physician-patient communication in cancer care in most practices. Significant differences were especially
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noticed in the correlation between the patients’ level of stress and the doctors’ communication behavior. With regard to the socialdemographic characteristics of the patients, only few significant differences in the communication relationship can be shown. Conclusions: The results show a broad range of communication relationships in outpatient oncology care. Most oncologists meet patient communication needs properly. The survey allows us to benchmark practices and to identify settings where oncologists bear stronger challenges in communicating with patients. References: References can be requested by the author.
MASCC-0683 The relation among socio-economic status, health behaviors, and quality of life in cancer survivors J. Sim1, Y.H. Yun1 College of Medicine, Seoul National University, Seoul, Korea
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Introduction: Recently, the ‘socio-economic status(SES)’ has been widely studied in health research. However, there are some limitations that the relationship between SES, health behaviors and quality life among cancer survivors does not much studied yet. Objectives: This study investigates the direct and/or indirect pathway among socio-economic status (SES), the 10 health behavior factors and the quality of lives (QOL) of Korean cancer survivors. Furthermore, this study also aims to examine the degree of socio-economic status affect the 10 health behavior factors and health related quality of life. Methods: In this cross-sectional study,r. the 668 cancer patients ecruited from 6 large hospitals in Korea were given quesionnaire to estimate the significance of the 10 health behaviors on the QOL. The variables of socioeconomic factors in this study are education, income level, and of the patients and the estimation of the quality of life was based on the selfreported information of the short form 36-item questionnaires. Results: The socio economic status was not the ultimate determinant of quality of cancer survivors’ lives. Rather, the ten Health behaviors such as regular exercise, proactive living, regular check-ups, living with people who you love have higher significance in determining the quality of the lives of cancer survivors. Conclusions: The level of health behaviors has higher significance in determining the quality of lives of cancer survivors than that of the level of income and education. References: Paula M et al., Socioeconomic Factors, Health Behaviors, and Mortality. JAMA, 1998; 279:1703–1708:
MASCC-0684 Cancer survivorship in old age: which quality of life? B. Muzzatti 1 , A. Surbone 2 , L. Giovannini 1 , C. Flaiban 1 , M. Annunziata1 1 Unit of Oncological Psychology, Centro di Riferimento Oncologico National Cancer Institute, Aviano (PN), Italy, 2Oncology, New York University, New York, USA Introduction: In this last decade great effort has been made to describe quality of life and functioning of people surviving cancer. However, scarce data are still available on elderly cancer survivors. Since ageing itself modifies persons’ quality of life and functioning, investigation tailored to older survivors is relevant both to clinical care and research. Objectives: In this study the quality of life of elderly Italians, who had been free from cancer and its treatments for at 5 years, has been analyzed. Methods: Seventy-eight elderly (age range: 65–80 years) long-term cancer survivors (survival length range: 5–31 years) compiled the Short Form 12 Health Survey Questionnaire, the State-Trait Anxiety Inventory, and the Zung Self-rating Depression Scale.
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Results: 28.8 % and 19.7 % of the sample showed respectively a moderate and severe reduction in physical health status, whereas 22.7 % and 9.1 % displayed a moderate or severe reduction in mental health status. In addition, 11.9 % and 17.9 % of the sample were possible and probable cases of anxiety, whereas 13.0 %, 15.6 % and 7.8 % displayed, respectively, mild, moderate and severe depression. Physical health status was associated with marital status (p<0.001) and state anxiety was associated with gender (p<0.05). Conversely, no associations between the four tested variables and education, cancer type, other health issues, survival length were found. Conclusions: Despite its limitations, this study supports the multidisciplinary approach to cancer survivorship in old age too and encourages further research, aimed to extend the study to other relevant dimensions (e.g. pain, fatigue, cognitive functioning, fear of relapse).
MASCC-0685 Development of a prognostic index to predict survival of Egyptian palliative care patients with advanced cancer G.A. Abdel Salam1, Y.S. Abdel Kader2, M.E. Ramadan1, S.A. Alsirafy3 1 Clinical Oncology Department, Faculty of Medicine - Beni-Suef Universty, Beni-Suef, Egypt, 2Clinical Oncology Department - Kasr AlAiny Center of Clinical Oncology & Nuclear Medicine (NEMROCK), Kasr Al-Ainy School of Medicine - Cairo University, Cairo, Egypt, 3 Palliative Medicine Unit - Kasr Al-Ainy Center of Clinical Oncology & Nuclear Medicine (NEMROCK), Kasr Al-Ainy School of Medicine Cairo University, Cairo, Egypt Introduction: Prediction of survival is important for improving endof-life care for patients with advanced cancer. Some clinical, biological and disease-related parameters were found to be of prognostic significance in patients with advanced cancer. Objectives: To develop a survival prediction tool for Egyptian patients with advanced cancer using clinical parameters. Methods: We prospectively assessed the predictive value of 14 clinical variables in 170 Egyptian patients with advanced solid tumors managed in a cancer center-based palliative medicine unit. Multivariate analysis was performed to identify independent predictive variables to develop a prognostic score. Results: Four variables predicted shorter survival independently, Eastern Cooperative Oncology Group (ECOG) performance score 3–4 (p< 0.014), presence of delirium (p<0.011), moderate to severe dyspnea at rest (p<0.001) and clinical prediction of survival <24 weeks (p<0.002). Using these four variables a prognostic index was developed with a total score ranging from 0 to 7. Patients were divided into three groups: Group 1 (score ≤3), Group 2 (score 3 to ≤5) and Group 3 (score>5). The median survival differed significantly between the three groups and was 155 days for Group 1, 70 days for Group 2, only 14 days for Group 3 (p<0.001). Conclusions: The presence of delirium, dyspnea at rest, ECOG performance score 3–4, and clinical prediction of survival <24 weeks independently predict shorter survival among Egyptian patients with advanced solid tumors. The newly developed prognostic scoring system based on these four clinical parameters needs further validation in a different set of patients.
MASCC-0686 Randomized, controlled intervention trial to evaluate the effects of supervised progressive exercise training in breast cancer patients during adjuvant radiotherapy: the best trial K. Potthoff1, M. Schmidt2, J. Wiskemann3, O. Klassen3, J. Oelmann4, S. Wessels4, H. Hof4, A. Koffka4, H. Hauswald4, C. Ulrich3, J. Debus4, K. Steindorf2
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Medical Oncology and Radiation Oncology, National Center for Tumor Diseases and University of Heidelberg Medical Center, Heidelberg, Germany, 2Unit of Physical Activity and Cancer, German Cancer Research Center, Heidelberg, Germany, 3Department of Preventive Oncology, National Center for Tumor Diseases, Heidelberg, Germany, 4 Department of Radiation Oncology, University of Heidelberg Medical Center, Heidelberg, Germany Introduction: Fatigue is one of the most distressing and most frequent complication in breast cancer patients during and after radiotherapy. It often is associated with a significant impact on quality of life. Physiological and immunological mechanisms induced by training might be relevant for prognosis but they are largely unknown. First hints on positive effects of resistance training have already been published. Results of randomized controlled trials, however, are still missing. Objectives: The objective of the BEST trial is to evaluate the effects of a 12-week high intensity and supervised progressive resistance training versus a group-based progressive muscle relaxation training. Primary endpoint is cancer-related fatigue. Secondary objectives are to assess the effects of the different training Methods on fatigue, quality of life and outcome as well as on molecular, immunological and inflammatory biomarkers. Methods: The BEST study is a prospective, randomized, controlled intervention trial for tertiary prevention of breast cancer. 160 patients with breast cancer undergoing adjuvant radiotherapy will be recruited and randomized 1:1 for a 12-week high intensity and supervised progressive resistance training or a group-based progressive muscle relaxation training. Recruitment started in February 2011. Results: As of February 14th, 2013, 147 patients. The interventions in both arms were safe and feasible. Relevant side effects did not occur. There was a very good adherence to the intervention in patients undergoing adjuvant radiotherapy Conclusions: The BEST study is the first randomized, controlled trial comparing progressive resistance training with muscle relaxation training in breast cancer patients during radiotherapy. Due to promising interim results accrual will continue.
MASCC-0687 Managing psychological distress in oncology: a brief intervention M. Annunziata1, B. Muzzatti1, L. Giovannini1, S. Mella1, F. Bomben1, C. Flaiban1, A. Surbone2 1 Unit of Oncological Psychology, Centro di Riferimento Oncologico National Cancer Institute, Aviano (PN), Italy, 2Oncology, New York University, New York, USA Introduction: Due to its prevalence, pervasiveness, and negative effects on quality of life, constant monitoring and management of psychological distress are widely recommended. Objectives: To describe a routine clinical activity performed in accordance to the international guidelines, in order to inform oncological patients of the importance of taking care of their emotions (as well as of their diseased bodies), and to alert them to the presence of a psychology service in our cancer center to facilitate holistic self-care. Methods: The intervention consisted of three consecutive steps: psychological distress screening; clinical interview, which is conducted according to Rogers’ client-centered model; collection of data regarding appreciation of the initiative and codification of interview contents. Results: The intervention was administered to 484 consecutive new inpatients. Amongst them, the prevalence of psychological distress and its components of anxiety and depression were comparable to those found in the literature. The low percentage of participants who refused the screening (15.4 %) and of those who do not wish to have the results returned to them (3.1 %), together with the high scores regarding the usefulness and
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effectiveness given to the intervention (all>80/100), indicated a highly positive reception of this activity. Lastly, the analysis of the contents of the exit interview showed a wide range of themes, multifaceted and heterogeneous, which go beyond anxiety and/or depression symptoms. Conclusions: Even though this was a clinical and not a research activity, it still offers important descriptive data.
MASCC-0688 Trajectories of distress in women diagnosed with breast cancer P. Bidstrup1, J. Christensen2, B.G. Mertz3, S.O. Dalton1, N. Kroman3, C. Johansen1 1 Survivorship, Danish Cancer Society Research Center, Copenhagen, Denmark, 2Statistics Bioinformatics and Registry, Danish Cancer Society Research Center, Copenhagen, Denmark, 3Breast Surgery Clinic, Rigshospitalet, Copenhagen, Denmark Introduction: Psychological distress among women diagnosed with breast cancer are often reported to decline within the first year. Still, little is known on whether subgroups of women have different patterns of change in distress over time. Objectives: In this study, we aim at identifying distinct patterns of distress in women diagnosed with breast cancer. Methods: In 2008–2009, 357 women with newly diagnosed primary breast cancer participated (84 %) in a study at a breast surgery clinic at a university hospital in Denmark. Questionnaire data was obtained before operation, after 4 and 8 months (N=322) and distress was measured using the distress thermometer. Data analyses are in progress. The distress trajectories are explored visually and the TRAJ finite mixture model procedure applied. The final number of trajectories are selected based on the Bayesian information criterion and Akaike information criterion. Factors associated with distinct distress trajectories will be examined in a logistic regression model. Results: Preliminary results show four distinct groups of distress trajectories. 8 % of the women had a high level of distress at baseline which decreased to a moderate level after four months. 53 % had a continuously moderate level of distress. 29 % had a moderate level of distress at baseline which decreased to a low level after 4 months. 9 % had a continuously low level of distress. Conclusions: We identified four distinct trajectories of distress which provide important knowledge about the timing of distress in the first 8 months after breast cancer diagnosis. We plan to identify factors that are associated with belonging to the high distress trajectory.
MASCC-0689 Cancer in the context of social political and economic upheavals in Sub-Saharan Africa D. Kinyanjui1, L. Gichini1 1 Cancer Program, Aga Khan University Hospital Nairobi, Nairobi, Kenya Introduction: Caring for patients and families facing a diagnosis of cancer in Africa presents unique challenges. Economic and physical, access to specialist healthcare for cancer patients compounded by cultural and political barriers present major threat to patient’s sense of security and ability to cope with a cancer diagnosis. Objectives: Describe the psycho-social impact of a cancer diagnosis in politically and economically unstable environments. Methods: A desk review, practice observations and interviews with key frontline caregivers on the psychosocial impact of cancer on patients and families as seen in African in the context of social, economic and political upheavals.
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Results: A diagnosis of cancer has a devastating effect on family dynamics. In Africa where the incidence is predicted to triple in the next 15 years, the cancer epidemic is happening in the context of wars, poverty and other social economic challenges. Poor people with cancer suffer disproportionate physical, emotional psychological, and social distress Conclusions: Formal and informal carers must take cognizance of the fact that cancer patients in Africa maybe facing double tragedy of being refugees, slum dwellers or an internally displaced. These factors have a major influence on the patients ability to cope and must be considered in designing psychosocial interventions. The impact of a cancer diagnosis on individuals and families cannot be looked at from a psychological or emotional perspectives alone. It should be seen in the context of how the patient interacts with his social, economic and political environment.
MASCC-0690 A dramatic case of BRONJ in maxilla- 1 year follow up K. Bektas-Kayhan1, C. Özbek1, M. Ünür1 Oral and Maxillofacial Surgery, ?stanbul University Faculty of Dentistry, Istanbul, Turkey 1
Introduction: Bisphosphonate related osteonecrosis of the jaws (BRONJ) is a growing problem in dental area. These drugs are commonly prescribed for treatment of osteoporosis, bone metastasis of cancers and multiple myeloma. The use of various forms of the drug especially intravenous forms plus prolonged use as in multiple myeloma cases increases the BRONJ risk. Objectives: This report is a focus on a prolonged use of bisphosphonates (7 years of zolendronic acid/monthly intervals) and the conservative treatment of a very severe case of maxillary necrosis. A 60 year- old female was referred to oral and maxillofacial surgery clinic with pain and discomfort in her dentures. She was edentulous for more then 10 years and she was suffering from pain in her maxilla. The clinical examination revealed BRONJ in maxilla. Methods: Therapy started with ampisilin 1 g plus metronidazole 500 mg for 2 weeks and then with doxycycline 100 mg (for 6 months). These antibiotics were supported by antimicrobial rinses and irrigation of exposed hard tissues with saline three times a day. Results: The respond of this conservative protocole was spectecular. No side effects due to prolonged use of antibiotics or alterations of in hematologic tests were observed. After 1 year sequestration was observed in all maxillary structures and premaxilla was totally reepitelizied after the loss of bony structure. Conclusions: The conservative approach to BRONJ cases seems to be related with sufficient outcomes with less discomfort when compared to surgical resections. The need of further studies that support the role of conservative treatment is mandatory.
MASCC-0691 Continuous palliative sedation in terminal cancer P. Gagnon1, G. Lim2, J. Le Moignan3, F. Tardif4, O. Desilets5 1 Pharmacy, Laval University, Quebec City, Canada, 2Cancer Research Center, Laval University, Quebec City, Canada, 3Équipe de recherche Michel-Sarrazin en oncologie psychosocial et soins palliatifs, CHU de Québec, Quebec City, Canada, 4Psycho-oncology and Palliative care, CHU de Québec, Quebec City, Canada, 5Medicine, Maison MichelSarrazin, Quebec City, Canada Introduction: Continuous palliative sedation (CPS) is used for refractory symptoms at the end of life. However, it is sometimes seen as a
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controversial option and more empirical data are needed on its use in naturalistic studies. Objectives: To describe the use of CPS in terminal cancer. Methods: The charts of 1764 patients admitted to a terminal cancer care hospice over 7 years were reviewed to retrieve CPS cases. Benzodiazepines, opioids, and antipsychotics doses were converted into equivalent units (oral lorazepam, morphine, and haloperidol). Results: 5 % (n=91) of patients received a CPS, which lasted on average 43 h. The administration of CPS was always approved by a multidisciplinary treating team. The mean age of patients who received CPS was 62.7 years and 43.5 % of those had lung cancer. No significant differences were observed in the length of stay between patients who received CPS and those who did not (22 days vs. 21 days). Indications for the administration of CPS were respiratory problems (67 %), delirium (43 %), psychological distress (34 %), and pain (34 %), with 84 % having 2 indications or more. 44 % of patients who received CPS needed a dose adjustment because of agitation, while 89 % showed no sign of agitation at the time of death. On average, the doses administrated during sedation were 177 mg/24 h of morphine equivalent, 17.7 mg/24 h of lorazepam equivalent, 4.7 mg/24 h of haloperidol equivalent, and 3.7 mg/24 h of scopolamine. Conclusions: CPS was used in 5 % of terminal cancer deaths over a 7 year period. The main indications were respiratory problems and delirium.
MASCC-0692 Palliative surgery for advanced gastric cancer D. Simlesa1, J. Cosic1, G. Santak1, L.J. Begic1, Z. Glavic1 1 Digestive Surgery, General Hospital Pozega, Pozega, Croatia Introduction: Effective palliative surgery is often the only option for advanced gastric cancer. Objectives: Comparing the results of gastric resection and gastrectomy with less aggressive surgical procedures in patients with advanced gastric cancer. Methods: Between 2000. and 2010. 159 patients with gastric cancer underwent surgery at the Department of Digestive Surgery, General Hospital Pozega. Patients who had had palliative surgery were identified. Results: Fifty-nine patients underwent palliative surgery which makes 37 % treated for stomach cancer. There were 39 men (66 %) and 20 (34 %) women with average age of 68,1 years. In the majority of patients (31 or 52 %) cancer was localized in the lower third oh the stomach. Incidence of postoperative complications, mortality and survival of the two groups of patients were compared; those who underwent palliative gastrectomy or resection (24 or 40,7 %) with those who only underwent gastroenterostomy, gastrostomy or just exploration (35 or 59,3 %). In the first group there were 7 (29,2 %) patients with postoperative complications and postoperative mortality equaled 2 (8,2 %). In the second group postoperative complications occurred in 6 (17,1 %) patients, and postoperative mortality rate was 5 (14,5 %). Patients who underwent resection or gastrectomy had longer average survival of 10,8 months, compared to the patients in the second group who survived an average 5,3 months. Conclusions: In patients with advanced gastric cancer, in a case of a good general condition, palliative resection could be the method of choice and can provide better survival apart from less radical surgery.
MASCC-0693 Risk assessment of pressure ulcers by Braden skin score in acute care palliative medicine S. Thomas1, D. Walsh1, S. Shrotiya1, A. Fitz1 1 Palliative Medicine, Cleveland Clinic, Cleveland, USA
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Introduction: Pressure ulcers amplify morbidity; affect health care cost. Prevention is the key and high nursing care priority. Braden Skin Score (BSS) is a validated tool to assess predictability of pressure ulcer risk. Objectives To assess impact of hospital admission on BSS in palliative inpatients. We compared BSS at admission and discharge. Methods Retrospective chart review of 50 patients admitted and discharged from acute palliative unit. Data entered into REDCap (secure web application for data capture; REDCap Software Version 5.1.3 - © 2013 Vanderbilt University) and analyzed. Results: N=50 (Cancer diagnosis=38) Median age (25th, 75th quartiles)=73 (62–80) years Median length of stay (25th, 75th quartiles)=10 (6–17) days BSS: (i) Admission=32 no risk, 7 high risk, 6 low risk,5 moderate risk; Mean Score 17 (low risk) (ii) Discharge=19 no risk, 16 high risks, 7 low risks, 5 moderate risks; Mean score 14 (high risk) BSS sub-scores analysis: Number of patients at risk increased in each of the four areas from admission to discharge: (i) Sensory Perception (ii) Activity (iii) Poor Nutrition (iv) Friction and Shear Conclusions: 1. BSS increased between admission and discharge. 2. All BSS sub-scores deteriorated during hospital admission. 3. Negative factors were multifactorial (e.g.: cachexia, immobility due to patient preference, disease progression, symptom issues). 4. Prevention of pressure ulcers can be a challenge in palliative population despite interventions.
MASCC-0694 Immunogenicity of lipegfilgrastim and pegfilgrastim in breast cancer patients: analysis from phase II/III trials A. Abdolzade-Bavil1, L. Zou2, C. Sadhu3, A. Buchner4, P. Liu5 1 Bioanalytical Development, BioGeneriX GmbH, Ulm, Germany, 2 Global Bioassay and Technology, Teva Pharmaceuticals, Rockville, USA, 3 Biotechnology, Teva Biopharmaceuticals, Washington D.C., USA, 4 Biosimilars, Teva ratiopharm, Ulm, Germany, 5 Bioanalytical Sciences and Technologies, Teva Pharmaceuticals, Rockville, USA Introduction: Lipegfilgrastim is a novel glycoPEGylated granulocytecolony stimulating factor (G-CSF) under review for the prevention of neutropenia in patients receiving chemotherapy. Like any biological product, lipegfilgrastim could potentially elicit an anti-drug antibody (ADA) response, which could cause adverse events (AEs) or lack of efficacy. Objectives: To assess the immunogenicity of lipegfilgrastim compared with pegfilgrastim from a Phase II and III study in patients receiving chemotherapy for breast cancer and correlate laboratory results with clinical events. Methods: Serum samples from patients with breast cancer receiving a subcutaneous injection of lipegfilgrastim or pegfilgrastim on Day 2 of each of four doxorubicin/docetaxel chemotherapy cycles were taken before each cycle, at the end of the study (Day 85), and twice during the follow-up period. Samples were analyzed using multi-tiered ADA assays based on Mesoscale Discovery (MSD) technology. Screening reactive samples were confirmed by immunocompetition. All confirmed ADA-positive (ADA+) study samples were further characterized and subsequently analyzed for neutralizing activity using NFS-60 cell proliferation assay.
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Results: The incidence of ADAs is summarized in the table below. Drug/study
Confirmed ADA+ samples (number of patients) Phase II (n/N)
Phase III (n/N)
Lipegfilgrastim
1.3 % (2/154)
1 % (1/100)
Pegfilgrastim
1.85 % (1/54)
1 % (1/101)
ADA+ samples did not exhibit neutralizing activity against lipegfilgrastim, pegfilgrastim, or endogenous G-CSF. Unexpected AEs or lack of efficacy was not observed for patients with confirmed positive ADA Conclusions: Immune response following lipegfilgrastim administration was comparable to pegfilgrastim and not considered clinically relevant. Serum ADA status did not appear to impact the clinical safety and efficacy of lipegfilgrastim.
MASCC-0695 Feasibility and benefits of a physical activity (PA) program for cancer survivors in an underprivileged community L. Zelek1, A. Festa2, E. Barbeau2, J.M. Descotes3, T. Bouillet3 1 Oncology, Hopital Avicenne, Bobigny, France, 2Supportive Care, Oncologie 93, Bobigny, France, 3Physical Activity, Cancer Arts Martiaux et Information, Bobigny, France Introduction: Benefits of PA have been reported in several studies and it is widely admitted that PA should be part of a cancer survivorship plan. However, numerous barriers impede the practice of PA. Objectives: To evaluate the feasibility of PA in an area faced with poverty and deprivation (two thirds of the population), in which cancer is a leading cause of premature mortality. Methods: Over an 8 months period, among 152 cancer patients, 20 were enrolled in a tailored PA program. Twelve had early stage cancers (breast: 11 pts, lung: 1 pt) and underwent semi-structured interviews. Vulnerability was evaluated using an 11-item standardized score *. Results: A majority of patients (7/12) did not practice PA on a regular basis before enrolment. Only 1 pt was included in the program by his oncologist and 11 pts were included by caregivers. Six pts had an elevated vulnerability score; surprisingly, they were more attentive toward PA and planned to continue the program beyond the initial 6 months. Main benefits were not only improvement of psychological and physical wellbeing, but also, in the same extent, restoration of relationships with other people. For all patients, accessibility with public transportation was regarded as essential. Conclusions: We showed that, in an underprivileged community, PA programs are feasible in selected cancer survivors (mainly breast cancer pts). Besides benefits previously reported, an effect on social functioning was observed in these pts. Raising physicians’ awareness and making PA more accessible for vulnerable cancer survivors are critical issues. References: * Sass C et al. Santé Publique 2006.
MASCC-0696 Are validated symptom assessment instruments comprehensive? “orphan” and “champion” symptoms S. Thomas1, D. Walsh1, A. Aktas1 1 Palliative Medicine, Cleveland Clinic, Cleveland, USA Introduction: Cancer patients experience multiple symptoms which vary in prevalence, severity, distress and negative impact on life. Comprehensive assessment is essential. Many validated assessment
instruments are used. They have limitations; varied content, clinical utility, completion rates, and acceptability. Objectives: 1. Compare common cancer multisymptom assessment instruments to a comprehensive checklist 2. Identify commonly assessed (“champions”) and frequently neglected (“orphans”) symptoms 3. Examine the clinical importance of “orphan” symptoms Methods: A 46-symptom checklist was developed from available evidence. This was compared against the content of 6 commonly used, validated, multisymptom instruments. Those with ≤2 symptoms, cancer site-specific, and tumor response instruments were excluded. Results: Symptom numbers varied in the 6 instruments; median (range) 19 (3–32). Of the 46 checklist symptoms, only 28 were present in ≥1 of the instruments. “Orphans”: 18 of the 46 were not evaluated in any of the 6 (e.g. confusion, agitation, early satiety, indigestion, tremors). 12 of the18 had prevalence rates >10 %. These symptoms are also often rated moderate/severe (≥ 30 %) and distressful (≥ 30 %). “Champions”: Only 4 checklist symptoms (pain, fatigue, dyspnea, anorexia) were present in all 6 instruments. Conclusions: 1. Eighteen “orphan” symptoms (severe/distressing) not captured. 2. Four “champion” symptoms were present in all six validated instruments. 3. Unreported symptoms bias our view of the cancer symptom experience. 4. This challenges the validity and reliability of current symptom assessment instruments in clinical research.
MASCC-0697 Neuromuscular complications after haematopoietic stem cell transplantation S. Koeppen1, A.T. Thirugnanasambanthan1, M.K. Koldehoff1 1 Neurology, Universitätsklinikum Essen, Essen, Germany Introduction: Early or delayed neurological complications usually associated with graft-versus-host disease (GvHD) occur in 50–60 % of allogeneic haematopoietic stem cell transplantation (HSCT) recipients. The most commonly recognized manifestations include polyneuropathy (PNP), followed by myopathy and myasthenia gravis. Improved survival of patients undergoing allogeneic HSCT shifts the focus of neurologic involvement towards long-term complication. Objectives: To analyze the occurrence of neuromuscular symptoms in 20 recipients of allogeneic HSCT for treatment of malignant haematopoietic disease. Methods: During follow-up visits clinical and electrophysiological findings were correlated to the presence of auto-/alloantibodies in blood samples. Results: Five patients (25 %) were identified with PNP, 10 patients (50 %) with combined PNP and myopathy, 4 patients (20 %) with myopathy or polymyositis (PM) and one patient (5 %) with myasthenia gravis. Immune mediated sensorimotor PNP after HSCT is characterized by a predominantly axonal lesion. The latency between HSCT and development of PM varied between 60 days and 60 months. PM occurs parallel to a GvHD after tapering of immunosuppressive medication. Typical clinical features are proximal bilateral limb weakness with muscle atrophy. Autoantibodies were detected in 14 patients, myositis-specific antibodies only in one patient. In patients with progressive neurological symptoms, an increase in the CD4/CD8 ratio was observed. Conclusions: GvHD-related myositis appeared similar to idiopathic myositis regarding clinical and electromyographical findings. As outcome measure sequential analysis of lymphocyte subpopulations in peripheral blood seems to be more suitable than autoantibody
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measurements. Whereas peripheral neuropathies are commonly observed in the early phase after HSCT, myasthenia gravis is a rare complication in the post-HSCT phase.
MASCC-0698 Post-mastectomy pain syndrome treated with the capsaicin 8 % patch: a case report J. López-Millán1, C. Sánchez Blanco1, D. Díaz Rodríguez1, E. Peralta1, M.L. Berraquero1 1 Anesthesiology Critical Care and Pain Unit, Virgen Macarena University Hospital, Seville, Spain Introduction: Post-mastectomy pain syndrome (PMPS) can affect women who have received mastectomies due to breast cancer. PMPS can be difficult to treat and prolonged; however, the capsaicin 8 % patch, EU-approved for treatment of peripheral neuropathic pain in non-diabetic adults, offers a therapeutic option. Objectives: We present a case study of a PMPS patient, successfully treated with the capsaicin patch. Methods: Assessments were made using the Visual Analogue Scale (VAS), douleur neuropathique 4 (DN4) questionnaire, Lattinen Index (LI) and Patients’ Global Impression of Change (PGIC). Results: Following a total mastectomy (2008) and reconstructive surgery (2011), the 55-year-old female experienced symptoms in the left upper limb that included reduced shoulder mobility, pins and needles, and allodynia. Her pain medications—amitriptyline, pregabalin and oxycodone—were associated with systemic side effects and low efficacy; she had VAS and DN4 scores of 10/10 and 6/10, respectively, and LI of 16. She was diagnosed with intercostobrachial syndrome and received four capsaicin patch treatments to the left upper limb over 1 year. Post-treatment, 50 % reductions in VAS (5/10) and DN4 (3/10) were reported, as was an LI decrease (14). The patient experienced increased shoulder mobility, reduced allodynia area and rescue medication intake, and improved mood. However, she rated 5 on the PGIC, indicating partial treatment satisfaction. Conclusions: In this patient, the capsaicin patch was used successfully to treat PMPS, reducing pain intensity and allodynia area. Despite a favourable response, the partial satisfaction perceived by the patient suggests a need to manage expectations in addition to pain itself.
MASCC-0699 International classification of functioning (ICF) core set for breast cancer—can it serve as a surveillance tool to identify rehabillitation needs? M. Cooney1, E. Stokes1, E. Connolly2, R. Galvin3 1 Physiotherapy, Trinity College Dublin, Dublin, Ireland, 2Breast Care Department, St. James Hospital, Dublin, Ireland, 3HRB Centre for Primary Care, Royal College of Surgeons, Dublin, Ireland Introduction: The rehabillitation needs of the breast cancer population are currently not being met (Schmitz et al., 2012). Many instruments exist that measure aspects of health of this population but none assesses the total range of health affected. The ICF Core Set for breast cancer was designed to do just that. Eighty categories of health describe alterations in function, structure, activities and participation and envronmental factors. Objectives: The aim was to test the content validity of the Core Set from the perspective of women with the condition. Methods: A mixed methodology study involving focus groups, followed by a postal questionnaire (sent to 441 women) was
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undertaken. Inclusion criiteria: women with primary breast cancer >6 months <4 years after surgery, fluent in English >18 years. All treatment types were included, the sample was screened for comorbid conditions affecting function. Results: The 7 focus groups (N=34) confirmed most of the 80 categories and identified 30 additional categories that warranted consideration, these were included in the questionnaire. Response rate was 68 % (n=296). Women confirmed all the categories of the Core Set plus the additional categories. The information generated identified several categories of health that remained altered but are amenable to rehabillitation and it identified areas of information needs that are currently unmet. Conclusions: The range of categories confirmed by women in this study can be used as a patient-administered surveillance tool to identify rehabillitation needs. References: Schmitz K.H. et al.,(2012). Prevalence of breast cancer treatment sequelae over 6 years follow-up : the Pulling Through Study. Cancer,118(8 Suppl), 2217–2225.
MASCC-0700 The capsaicin 8 % patch as a treatment for chemotherapy-induced neuropathy A. Bhaskar1, G. Beirne2 Critical Care Directorate, The Christie NHS Foundation Trust, Manchester, United Kingdom, 2Pain Medicine, The Christie NHS Foundation Trust, Manchester, United Kingdom 1
Introduction: Chemotherapy-induced neuropathy (CIN) is a side effect of many chemotherapeutic agents, which is often debilitating, difficult to manage and can result in dose limitation or even discontinuation of both curative and palliative chemotherapy. The capsaicin 8 % patch, EUapproved for peripheral neuropathic pain treatment in non-diabetic adults, provides an effective treatment option for patients with CIN. Objectives: We present a representative case study of successful CIN treatment with the capsaicin patch. Methods: The capsaicin patch was applied to both feet (sole, heels, dorsum, digits) for 30 min. Results: The 21-year-old male, diagnosed with acute lymphoblastic leukaemia (ALL) in October 2010, developed painful small-fibre neuropathy after receiving vincristine chemotherapy on the UKALL 2003 trial. The patient’s pain was severe (8–9 on an 11-point scale) and difficult to control despite receiving pregabalin, oxycodone, amitriptyline and morphine. Owing to his CIN, chemotherapy was deferred in November 2010. In February 2011, the patient received a single capsaicin patch treatment. After 4 weeks, good analgesia was achieved in both feet, resulting in the patient re-starting vincristine chemotherapy in May 2011. Intake of opioids and systemic neuropathic agents was also reduced. Six months post-treatment, the patient remained in an improved state. This patient is representative of a population with CIN who received capsaicin patch treatment at The Christie Hospital (n=42), where 80 % of patients achieved ≥50 % reduction in pain post-treatment. Conclusions: Successful capsaicin patch treatment enabled this patient with previously poorly managed CIN to recommence life-saving chemotherapy, which had been deferred due to painful neuropathy.
MASCC-0701 Observational study of ferric carboxymaltose (FCM) in France (Oncofer study; interim analysis) A. Toledano1, E. Luporsi2, J.F. Morere3, F. Scotté4, L. Zakin5, L. Mahi5, R. Bugat6 1 Oncology, American Hospital of Paris, Neuilly-sur-Seine, France, 2 Oncology, Centre Alexis Vautrin, Vandoeuvre-Les-Nancy, France,
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3 Oncology, Hôpital Avicenne, Bobigny, France, 4Oncology, Hôpital Européen Georges Pompidou, Paris, France, 5 Medical, Vifor Pharma, Neuilly-sur-Seine, France, 6Oncology, Institut Claudius Regaud, Toulouse, France
References: • Crighton, M., 2004. Dimensions of neutropenia in adult cancer patients: Expanding conceptualizations beyond the numerical value of the absolute neutrophil count. CancerNursing, 27(4), 275–284.
Introduction: Iron deficiency with anemia is a frequent complication in cancer patients. Objectives: This French multicenter observational study aims to describe Ferric carboxymaltose use in patients with hematological malignancies or solid tumors. Methods: Two cohorts of patients (1:1) are enrolled. Cohort 1 (retrospective): patients treated in 2010 with any intravenous iron (IV) or red blood cell transfusion if no IV iron; Cohort 2 (prospective): patients treated with FCM after July 1st 2011. Patient characteristics were collected for a period of 3 months pre and post intervention. Outcomes of the first 100 patients are described below. Results: Fifty patients were analyzed in each cohort (mean age, 62 and 66; solid tumors, 84 % and 100 %; metastatic, 61 % and 63 % for Cohorts 1 and 2, respectively). In Cohort 1, 16 patients received intravenous iron (iron sucrose (IS)) and 34 were transfused. The mean total iron dose was 706 for IS and 959 mg for FCM; the mean number of infusions was 3.8 and 1.8 for IS and FCM respectively. In cohort 2, 69 % of the administrations were done at home. In patients receiving FCM without erythropoietin stimulating agents (ESA), mean Hb (g/dL) increased from 10.9 to 12.1, from baseline to Month 3. ESA use was 44 % in cohort 1 vs 22 % in cohort 2 during observational period. No serious adverse events related to IS or FCM were observed. Conclusions: Preliminary results showed that FCM was well tolerated and seemed effective in treating iron deficiency anemia but this need to be confirmed by the final analysis.
MASCC-0703 Receipt of care for depression and perceived barriers to psychological treatment in community radiotherapy departments: results from RTOG 0841
MASCC-0702 Quality of life among adult haematological cancer survivors A.S. immanuel1, J.A.N.E. Hunt2, E. van Teijlingen3 1 Haematology, Royal Bournemouth Hospital, Bournemouth, United Kingdom, 2School of Health and Social Care, Bournemouth University, Bournemouth, United Kingdom, 3Centre for Midwifery Maternal & Perinatal Health, Bournemouth University, Bournemouth, United Kingdom Introduction: Cancer is a devastating disease that can negatively affect a person’s health-related quality of life (HR-QoL) (Padilla & Ropka, 2005; Fortner et al., 2004; Crighton, 2004). This research focuses on patients who have completed all treatment for a lymphoid malignancy. Those who do survive the side-effects of treatment and who go on to experience prolonged remissions following treatment, must often continue to live with decreased functioning and decreased HRQoL over time. Objectives: · To identify factors influencing the quality of life among survivors of haematological cancer · To assess the impact of demographic variables on the quality of life among haematological cancer survivors · To compare the quality of life in patients treated with a curative or a non-curative intent Methods: This study comprises two distinct phases. The first quantitative phase, will use validated questionnaires to explore health related quality of life in the sampled population (QLQ-C30). The target population in this study are adults who have been diagnosed with a lymphoid malignancy which are a type of blood cancer and have completed treatment 1– 5 years prior to the commencement of this study.In depth semi-structured interviews will be conducted for the second part of the study. Qualitative data will be collected until data saturation is achieved. Results: Awaiting. Conclusions: Awaited.
D. Bruner1, S.P. Pugh2, W.J.S. Small3, J.K. Kirshner4, K.S. Sidhu5, M.B.J. Bury6, A.S.D. DeNittis7, T.E.A. Alpert8, B.T. Tran9, B.F.B. Bloom10, J.M. Mai11, L.I.W. Wagner12 1 School of Nursing, Emory University, Atlanta, USA, 2Statistician, R T O G, Philadelphia, USA, 3Co-Chair, GYN, Chicago, USA, 4Co-Chair, C C O P, East Syracuse, USA, 5SE Cancer Control Consortium, C C O P, Winston Salem, USA, 6Oncology, Grand Rapids Clinical Oncology Program, Grand Rapids, USA, 7Radiation Oncology, Main Line C C O P, Philadelphia, USA, 8Hematology Oncology, Hematology Oncology Associates of CNY C C O P, East Syracuse, USA, 9Oncology, Northern Indiana Cancer Research Consortium C C O P, South Bend, USA, 10 Oncology, North Shore Universit Hospital C C O P, Manhasset, USA, 11 Radiation Oncology, Mercy Hospital, St. Louis, USA, 12Study Chair, Northwestern University, Chicago, USA Introduction: Primary results of RTOG 0841 of 454 patients (mostly women [66 %] with breast cancer [45 %]) undergoing definitive or palliative radiotherapy (RT) for first diagnosis of cancer showed 16 % self-reported depressive symptoms and 3 % met diagnostic criteria for major depression. Objectives: Report receipt of care for depression and perceived barriers to psychological treatment among subset interviewed. Methods: Patients exceeding cutoff scores on Hopkins Symptom Checklist (HSCL-25), Patient Health Questionnaire (PHQ-9), and a sample who screened negative, completed telephone interviews of Structured Clinical Interview for DSM-IV (SCID) Mood Disorder and questions regarding depression care. Results: Sixty-eight percent of 35 community/2 academic RT sites had mental health services on site and reported providing distressed patients on-site support (48 %), outside referrals (21 %), or oncology team notified (31 %). 70 patients were interviewed: 37 who screened positive, 33 who screened negative on HSCL-25/PHQ. Among those who screened positive or negative, 14 (38 %) and 1 (1.4 %) respectively, met SCID criteria for major depression. 70 % of patients who received psychological help in the past were currently receiving help. Patients sought help from nurse/oncologist (34 %), psychiatrist/psychologist/counselor (29 %), family physician (16 %), or other. Moderate/extreme barriers to seeking help included logistical concerns: daily responsibilities (28 %), getting off work (6 %), pain/fatigue (18 %); and emotional concerns: believing problems not severe enough for counseling (20 %), discomfort with being seen as emotional (20 %), discomfort/concern about counseling (55 %). Conclusions: Patients with depression treated at community RT sites participating in clinical trials receive moderate to high levels of psychological care, a third provided by the oncology team.
MASCC-0704 Functional status and quality of life of disease free cervical cancer survivors in India S. Veeraiah1, V. Elangovan1, S. Ganesan2 1 Psycho-oncology, Cancer Institute (WIA), Chennai, India, 2Radiationoncology, Cancer Institute (WIA), Chennai, India Introduction: Cervix cancer is one of the comenest cancer in India. However the quality of life of these patients during their survival are under reported in India.
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Objectives: To determine the functional status and quality of life of cervical cancer survivors in India Methods: Three year or more DFS Cervical cancer survivors (N=103) from January 2011 (average years of survival=3.85, age range=27 to 70 years, Mean age=49.68 years) were administered Cancer Institute Quality of Life Questionnaire (CI-QOL), EORTC QLQ CX24 and Distress Thermometer with their consent. Disease stage (Stage I & II N=77, and stage III N=26), type of treatment and year of survival were considered for analysis. Results: Analysis revealed that the level of distress was found to be less (M=3.88) which ranged from 0 to 10 (0–4(52.4 %); 5–7(38.9 %) and 8–10(8.7 %). Similarly QOL reported to be better among 33.9 %. While 66.1 % reported poor QOL, factors contributed to poor QOL were not attributable to disease or treatment. Further, majority (79.6 %) of them found to have better body image, no peripheral neuropathy (81.6) and no menopausal symptoms (96.1 %). The disease stage (t=.303; p<.762) and treatment (t=.551; p<.583) did not differ significantly on the QOL during their survival. Similarly these patients did not differ significantly in body image, symptom experience scale and sexual/vaginal functioning. These findings further support that the physical symptoms, disease or treatment did not influence QOL. Conclusions: The cervical cancer survivors experience better quality of life and free from distress.
MASCC-0705 Treatment of a patient with chemotherapy-induced neuropathy using the capsaicin 8 % patch A. Bhaskar1, G. Beirne2 1 Critical Care Directorate, The Christie NHS Foundation Trust, Manchester, United Kingdom, 2Pain Medicine, The Christie NHS Foundation Trust, Manchester, United Kingdom Introduction: Chemotherapy-induced neuropathy (CIN) is a side effect of many chemotherapeutic agents and can disrupt lifesaving treatment. The capsaicin 8 % patch, EU-approved for peripheral neuropathic pain in non-diabetic adults, provides a treatment option. Objectives: A representative case study of a patient with CIN who received capsaicin patch treatment is presented. Methods: The capsaicin 8 % patch was applied to both feet for 30 min. Results: The 54-year-old female was diagnosed with breast cancer and received eight cycles of oxaliplatin and trastuzumab. She began experiencing CIN after her fourth oxaliplatin cycle, 20 months before pain clinic referral. On presentation, she reported tingling in both feet, allodynia, poor mobility, and inability to wear shoes. Her only pain medications were codeine and paracetamol, following poor tolerance to anticonvulsants, opioids and amitriptyline. The patient received a single capsaicin patch treatment, which was well tolerated during application. However, delayed treatment-associated discomfort occurred with the onset of a burning sensation in the feet 6 h post-treatment, which persisted for 3 days. After 4 weeks, the patient reported no pain, could wear shoes and had sleep improvement. The pain remained resolved at 12 weeks, with improved mobility, despite some numbness. Efficacy was, however, not fully appreciated due to a focus on the treatment-associated discomfort. Conclusions: At 12 weeks following capsaicin patch treatment, this patient with CIN reported no pain and experienced improved mobility. However, her perception of capsaicin patch treatment efficacy was influenced by treatment-associated discomfort, indicating the importance of providing patients with realistic expectations and management techniques.
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MASCC-0706 The Edmonton symptom assessment system (ESAS) as a screening tool for depression and anxiety in non-advanced patients with solid or haematological malignancies on cure or follow-up C. Ripamonti1, E. Bandieri2, M.A. Pessi1, A. Maruelli3, L. Buonaccorso4, P. Rondelli1, G. Miccinesi5 1 Supportive Care in Cancer, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy, 2Oncological Unit, Azienda Usl Modena (CeVEAS), Modena, Italy, 3Psychology Unit, LILT and Center for Oncological Rehabilitation-Psychology Unit LILT and Center for Oncological Rehabilitation-CERION of Florence, Florence, Italy, 4Psychology Unit, AMO Association of Oncological Patients from nine towns and villages located in the Northern area of Modena, Modena, Italy, 5Clinical Epidemiology Unit, ISPO-Institute for the Study and Prevention of Cancer, Florence, Italy Introduction: Symptoms’ assessment should be considered a routine clinical practice in all stages of cancer. Objectives: The main objective of the study was to assess the performance of Edmonton Symptoms Assessment System (ESAS) items on anxiety, depression and not well being in detecting Hospital Anxiety Depression Scale (HADS) ‘cases’. Methods: Cross-sectional study carried out on 194 non advanced patients with solid (108) or hematologic (86) malignancies on cure or follow up, with Karnofsky Performance Status ≥70 and life expectancy >6 months. Patients were assessed by means of ESAS and by HADS. ROC analysis of ESAS anxiety, depression and not wellbeing items versus cases of moderate (cutoff 8) or severe (cutoff 11) anxiety and depression according to HADS specific subscales was performed. Results: Depression and anxiety ESAS items correlated strongly each other (.707, Spearman); not well-being item correlated more than anxiety and depression with all the other six ESAS items. Area under the curve ranged between 0.78 and 0.84 for the three ESAS items when detecting moderate anxiety or depression according to HADS subscale (cutoff=8). When detecting severe anxiety or depression HADS cases (cutoff=11) it ranged .84–.96 for anxiety and depression items, but 77-.81 only for not well being. Moderate ESAS anxiety or depression (cutooff =4) detected quite well the severe depression HADS cases (Sensibility=75Specificity=84, Sensibility=87-Specificity=90, respectively).
Conclusions: Moderate anxiety or depression reported through the corresponding ESAS items (cutoff=4) can be considered an useful screening tool for anxiety and depression in non-advanced patients with solid or haematological malignancies.
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MASCC-0707 Patient-centred management of chemotherapy-related nausea and vomiting (CINV): survey and patient charter A. Young1, P. Dielenseger2, P. Fernandez Ortega3, D. Fernandez Perez 4 , P. Jones 5 , E. Lennan 6 , E. O’Donovan 7 , S. Sharp 8 , A. Whiteford9, L. Wiles10 1 Warwick Medical School, University of Warwick, Coventry, United Kingdom, 2Clinical Research and Early Clinical Trials Unit, Institut GustaveRoussy, Paris, France, 3Institut Catala d’Oncologia, L’Hospitalet de Llobregat, Barcelona, Spain, 4Complejo Hospitalario de Ourense, Ourense, Spain, 5Greater Midlands Cancer Network, Wolverhampton, United Kingdom, 6University Hospital Southampton, Southampton, United Kingdom, 7 Irish Cancer Society, Dublin, Ireland, 8Worcestershire Acute Hospitals NHS Trust, Worcester, United Kingdom, 9Macmillan Cancer Support,, United Kingdom, 10Beating Bowel Cancer,, United Kingdom Introduction: Patients scheduled for chemotherapy frequently cite CINV as one of their greatest fears,1 yet its prevalence is underestimated by healthcare professionals.2 Objectives: A group of specialist cancer nurses, some from patient advocacy groups, reached consensus on optimal CINV management, and how to empower patients to request guidelines-based care.3 Methods: Telephone/web-based meetings were convened. Subsequently, patients’ views on CINV were investigated via an internet questionnaire. Results: The nurses agreed that although evidence-based guidelines are available on CINV prophylaxis,3 patient care is this setting is often suboptimal.1 They compiled a series of questions on CINV that patients may wish to ask their nurse or doctor, e.g. who can I contact if I develop CINV outside of clinic hours? The survey was then completed by 369 patients in France, Germany, Italy, Spain and the UK, all of whom had experienced CINV. It showed that the top three concerns prior to chemotherapy were hair loss, vomiting and nausea. CINV was cited at the number one concern by 15 %. Conclusions: The question list has been compiled into a CINV Patient Charter, which is to be translated (from English) into several European languages and circulated via patient and professional groups, with a view to empowering chemotherapy recipients in their discussions of potential CINV. References: 1. Young A et al. Ecancermedicalscience 2013, in press. 2. Salsman JM et al. J Natl Compr Canc Netw 2012; 10, 149–57. 3. MASCC (2011) MASCC/ESMO antiemetic guideline 2011 (Hillerød: Multinational Association of Supportive Care in Cancer).
MASCC-0708 Management of gastrointestinal adverse events associated with afatinib, an oral erbb family blocker J. Köhler1, J.C.H. Yang2, N. Reguart3, J. Barinoff4, M. UttenreutherFischer5, U. Stammberger6, D. O’Brien7, J. Wolf8, E.E.W. Cohen9 1 Medical Oncology, West German Cancer Center University Hospital Essen, Essen, Germany, 2Medical Oncology, National Taiwan University Hospital, Taipei, Taiwan, 3Medical Oncology, ICMHO Hospital Clinic Barcelona, Barcelona, Spain, 4Department of Gynecology and Gynecological Oncology, Klinikum Essen-Mitte, Essen, Germany, 5 Therapeutic Area Oncology, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany, 6Clinical Development & Medical Affairs, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany, 7Global Safety Evaluations, Boehringer Ingelheim Pharmaceuticals, Ridgefield, USA, 8Department of Internal Medicine, Center for Integrated Oncology University Hospital Köln, Köln, Germany, 9 Medicine, University of Chicago Medical Center, Chicago, USA Introduction: Afatinib, an irreversible ErbB Family Blocker, inhibits signalling from EGFR (ErbB1), HER2 (ErbB2), ErbB3 and ErbB4, and is
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in Phase III investigation in NSCLC, breast and head and neck cancers. Similar to reversible EGFR TKIs, diarrhoea is common with afatinib. Objectives: To provide management strategies for afatinib-associated diarrhoea. Methods: Pooling all unblinded Phase II/III afatinib monotherapy trials in patients with solid tumours provided a large (n=2281) dataset (cut-off September 2011). This annual snapshot generated a dataset of individuals with a similar duration of drug exposure, irrespective of selection criteria. An advisory board of medical oncologists reviewed diarrhoea AEs of afatinib and proposed management algorithms. Results: Incidences will be presented. Expert algorithms included for evaluation: history of diarrhoea, stool number/characteristics, assessing serious AE risk, diet and previous anti-diarrhoeal treatment compliance. Recommendations were given for Grade 1–2 diarrhoea, Grade 2 diarrhoea >48 h despite loperamide, and Grade 3–4 diarrhoea. Alongside early identification and proactive management, treatment included loperamide, prevention of dehydration and other symptomatic treatment of diarrhoea. For Grade 1–2 diarrhoea, continue afatinib at the same dose; for Grade 2 diarrhoea >48 h despite loperamide, or Grade 3–4 diarrhoea, interrupt afatinib until resolution to Grade ≤1, then restart afatinib at a 10 mg reduced dose (20 mg minimum). Conclusions: Awareness, early identification, timely management and ongoing assessment will help prevent aggravation of diarrhoea, afatinib dose reductions or discontinuation, allowing patients to obtain the maximum benefit from afatinib.
MASCC-0709 Management of dermatological adverse events associated with afatinib, an oral erbb family blocker D. Schadendorf1, M.E. Lacouture2, C.Y. Chu3, M. UttenreutherFischer4, U. Stammberger5, D. O’Brien6, A. Hauschild7 1 Dermatology, Universitätsklinikum Essen, Essen, Germany, 2Dermatology, Memorial-Sloan Kettering Cancer Center, New York, USA, 3 Department of Dermatology, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan, 4 Therapeutic Area Oncology, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany, 5Clinical Development & Medical Affairs, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany, 6Global Safety Evaluations, Boehringer Ingelheim Pharmaceuticals, Ridgefield, USA, 7Department of Dermatology, University Hospital Schleswig-Holstein Campus Kiel, Kiel, Germany Introduction: Afatinib, an irreversible ErbB Family Blocker, inhibits signalling from EGFR (ErbB1), HER2 (ErbB2), ErbB3 and ErbB4, and is in Phase III investigation in NSCLC, breast and head and neck cancers. Similar to reversible EGFR TKIs, dermatological AEs are common with afatinib. Objectives: To provide management strategies for afatinib-associated dermatological AEs. Methods: Pooling all unblinded Phase II/III afatinib monotherapy trials in patients with solid tumours provided a large (n=2281) dataset (cut-off September 2011). This annual snapshot generated a dataset of individuals with a similar duration of drug exposure, irrespective of selection criteria. An advisory board of afatinib-experienced dermatologists reviewed dermatological AEs and created management algorithms. Results: Incidences will be presented. The following treatment options were recommended: For papulopustular (acneiform) rash, topical and oral steroids or antibiotics; for paronychia, topical antibiotics or antiseptics and silver nitrate applications; for pruritus, topical oral agents (steroids, antihistamines or GABA agonists); for xerosis, topical steroids, ammonium lactate and moisturizing creams. Patients with an intolerable Grade 2/Grade ≥3 dermatological AE should be referred to a dermatologist; these patients may have afatinib treatment interruption for <28 days. Afatinib can be reintroduced at a lower dose following
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recovery to Grade ≤2 within 28 days after interruption. Afatinib should be permanently discontinued if a Grade ≥3 dermatological AE persists, despite intervention and afatinib interruption. Conclusions: Patient education, with early, timely and proactive management of afatinib-associated dermatological AEs, may facilitate continuous treatment and help maximize clinical benefit from afatinib. MASCC-0710 Impact of bone metastases (BM) on patients with castrationresistant prostate cancer (CRPC) G. Hechmati1, J. Arellano2, I. Haynes3, A. Rider4, A. Worsfold4 1 Health Economics, Amgen (Europe) GmbH, Zug, Switzerland, 2 Health Economics, Amgen Inc., Thousand Oaks, USA, 3International Research and Development, Amgen Ltd., Uxbridge, United Kingdom, 4 Real World Research & Disease Programmes, Adelphi Real World, Macclesfield, United Kingdom Introduction: Prostate cancer is the most prevalent form of cancer in men and in the majority of cases, will become castration-resistant; a progressive state whereby most patients develop BM. BM are associated with pain, increased risk of skeletal complications (e.g. fracture, need for radiation) and impact on quality of life. Objectives: To evaluate the impact of BM on performance status and pain as well as the use of pain relief medication in patients with ‘high risk’ CRPC. Methods: Data were extracted from the Adelphi Prostate Cancer DiseaseSpecific Programme© (DSP), a cross-sectional survey of 348 urologists/oncologists and their prostate cancer patients, conducted December 2009–May 2010 in France, Germany, Italy, Spain and the UK. Each physician reported on 10 patients receiving treatment for prostate cancer. Results: A total of 1,180 patients with CRPC were included: median time since prostate cancer diagnosis was 35.8 months; 146 (12 %) patients were ‘high-risk’ for developing BM (defined as PSA doubling time ≤6 months, or most recent PSA of ≥8 ng/mL, or Gleason score ≥8, or having received local therapy in addition to systemic medication); 680 (58 %) patients had BM.
Age (median) Mean Karnofsky status (0–100) Current bone reported, n (%) Analgesic use (including Over The Counter), n (%)
High risk patients (n=146) 72.0
BM patients (n=680)
p-value
72.0
–
85.1
72.7
<0.0001
11 (8 %)
400 (59 %)
<0.0001
26 (18 %)
347 (51 %)
<0.0001
Conclusions: BM are associated with a significant reduction in performance status and increased pain burden for the patient including the need for more analgesic use. There is a need for treatments to prevent or delay the onset of BM, thereby delaying their associated pain burden and impact on quality of life. MASCC-0711 Burden of bone metastases (BM) in patients with castrationresistant prostate cancer (CRPC): findings from a prospective routine practice study in 13 medium-sized european countries G. Hechmati1, P. Vrouchou1, J. Arellano2, J. Cristino1, I. Haynes3, A. Liede2, A. Rider4, A. Worsfold4, V. Crossland4 1 Health Economics, Amgen (Europe) GmbH, Zug, Switzerland, 2Health Economics, Amgen Inc., Thousand Oaks, USA, 3Research and Development, Amgen Ltd., Uxbridge, United Kingdom, 4Real World Research & Disease Programmes, Adelphi Real World, Cheshire, United Kingdom
Introduction: Patient and physician burden of BM has not been widely reported Objectives: To evaluate the patient and physician burden of BM in CRPC Methods: Oncology and urology specialists completed a 5-day workload form, an interview and an average of 7 patient records forms (PRFs; October 2012-ongoing as of February 2013). Preliminary interview and PRF data are reported. Results: Eight hundred fifty-two PRFs were included in this analysis; 393 patients had non-metastatic CRPC at ‘high risk’ of developing BM per the treating physician (92 % had a PSA doubling time (PSADT) ≤6 months); 366 patients had CRPC with BM alone; 93 patients had CRPC with bone and visceral metastases. Patients with BM only had a worse Eastern Cooperative Oncology Group (ECOG) performance status than those at ‘high risk’ of developing BM (p<0.0001). Those with bone and visceral metastases also had a poorer ECOG status versus those at ‘high risk’ (p=0.0002). Physician interviews (completed by 84 oncologists, 60 urologists) showed that 92 %, 63 % and 62 % of the physicians believed the greatest patient impact of BM are spine pain, fractures and reduced ability to perform daily activities (from a predetermined list), respectively. The biggest impact of BM on treating physicians was seeing patient deterioration (73 %), inability to propose effective treatment (55 %), managing complex regimens (28 %) and transferring patients for respite/hospice care (24 %) Conclusions: Preliminary results highlight the burden of BM in patients with CRPC and the perceived impact on physicians treating this population. There is an unmet need for treatments to delay BM and their associated burden.
MASCC-0712 Lipegfilgrastim—a long-acting, once-per-cycle, glycopegylated recombinant human filgrastim C. Scheckermann1, K. Schmidt2, A. Abdolzade-Bavil3, H. Allgaier4, U. Mueller5, W. Shen6, P. Liu7 1 CMC Project Leader - Downstream Processing, BioGeneriX GmbH, Ulm, Germany, 2CMO-Management, BioGeneriX GmbH, Ulm, Germany, 3 Bioanalytical Development gB&T, BioGeneriX GmbH, Ulm, Germany, 4 Biopharmaceutical Ops Network, BioGeneriX GmbH, Ulm, Germany, 5 Global Medical Affairs, Teva Pharmaceuticals, Ulm, Germany, 6 Biologics Development, Teva Pharmaceuticals, West Chester, USA, 7Bioassays, Teva Pharmaceuticals, West Chester, USA Introduction: Lipegfilgrastim is a once-per-cycle fixed-dose glycoPEGylated granulocyte-colony stimulating factor (G-CSF) under development for the prevention of severe neutropenia in cancer patients receiving chemotherapy (CTx). Covalent attachment of polyethylene glycol (PEG) has been shown to prolong the half-life of therapeutic proteins, allowing for less frequent dosing, improved patient compliance, and potentially lower production costs. However, traditional PEGylation Methods rely on chemical conjugation through amino acid reactive groups, which may reduce protein activity and result in non-uniform chemical and pharmaceutical properties. Objectives: To describe a highly site-specific glycoPEGylation technology for site-directed PEGylation and summarize preclinical findings of lipegfilgrastim versus pegfilgrastim (Neulasta®). Methods: Glycosylation sequon scanning was used to identify the glycoPEGylation site with the least impact on protein activity. Escherichia coli-expressed G-CSF was selectively glycosylated at the natural O-glycosylation site (Threonine 134) and a PEG sialic acid derivative attached using a sialyltransferase (glycoPEGylation technology). Biologic activity of lipegfilgrastim was assessed in an NFS-60 cell line proliferation assay versus filgrastim and pegfilgrastim. Pharmacokinetic (PK) and pharmacodynamic properties were studied in healthy and neutropenic animal models.
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Results: GlycoPEGylation produces long-acting G-CSF with improved PK profiles. In vitro, lipegfilgrastim had binding affinity and specific activity comparable to pegfilgrastim. Similar increases in leukocytes, neutrophilic granulocytes, and monocytes were seen with lipegfilgrastim and pegfilgrastim in rats and monkeys and were consistent with the effects expected for a long-acting G-CSF. Conclusions: GlycoPEGylation technology platform is used to produce lipegfilgrastim–a novel, biologically active G-CSF with greater structural homogeneity and comparable pharmacologic properties to conventionally PEGylated G-CSFs
MASCC-0713 Epidemiology of castration-resistant prostate cancer (CRPC) in 13 medium-sized European countries: data from a prospective routine practice study G. Hechmati1, P. Vrouchou1, J. Arellano2, A. Liede2, J. Cristino1, I. Haynes3, A. Rider4, A. Worsfold4, V. Crossland4
On average, patients with prostate cancer account for 19 % of a physician’s daily workload, with more patients seen by urologists (24 % vs 16 % seen by oncologists). 46 % of the patients had CRPC and the majority of them were treated by oncologists (65 % treated by oncologists, 27 % treated by urologists). Among the CRPC population, 53 % had bone metastases only (BM); 22 % had BM and visceral metastases; and 5 % had visceral metastases only Conclusions: Although urologists treat more patients with prostate cancer than oncologists, as disease progresses to CRPC, patients are generally treated by oncologists. CRPC most commonly metastasises
Support Care Cancer (2013) 21 (Suppl 1):S1–S301 1 Health Economics, Amgen (Europe) GmbH, Zug, Switzerland, 2Health Economics, Amgen Inc., Thousand Oaks, USA, 3Research and Development, Amgen Ltd., Uxbridge, United Kingdom, 4Real World Research & Disease Programmes, Adelphi Real World, Cheshire, United Kingdom
Introduction: Epidemiology of CRPC represents a growing public health concern that has not been adequately quantified, particularly in medium-sized European countries. Objectives: The aim of this study was to characterise the epidemiology of CRPC in these countries using real-world data as provided by treating physicians. Methods: A prospective routine practice study involving oncology and urology specialists across 13 medium-sized European countries with a focus on CRPC patients was initiated in October 2012 (ongoing as of February 2013). Each specialist completed an interview, a 5-day workload form and an average of 7 CPRC patient records forms. Preliminary workload data are reported here. Results: Figure 1 provides a breakdown of the CRPC population groups seen by 74 oncologists and 44 urologists that completed the workload in routine clinical practice.
to bone and given the high incidence, there is a need for novel therapies that could prevent their occurrence.
MASCC-0715 International prevalence of non-metastatic (M0) castrationresistant prostate cancer (CRPC) A. Liede1, J. Arellano2, G. Hechmati3, B. Bennett4, S. Wong4 1 Center for Observational Research, Amgen Inc., San Francisco, USA, 2Health Economics, Amgen Inc., Thousand Oaks, USA,
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Health Economics, Amgen (Europe) GmbH, Zug, Switzerland, Health Economics, Plan A Inc, Mountain View, USA
4
Introduction: CRPC represents a growing public health concern that has not been adequately quantified. In the absence of metastases, CRPC represents a transitional disease state defined by increases in serum prostate-specific antigen (PSA) despite castration levels of androgens during androgen-deprivation therapy (ADT) Objectives: We developed a model to estimate M0 CRPC prevalence in selected countries Methods: A patient-flow model was developed to estimate 5-year limited-duration prevalence of prostate cancer (PC) and M0-PC in each country, each year (2008 to 2028) using age-specific incidence and survival data from population cancer registries from 28 countries in North (US, Canada, Mexico) and South (Brazil) America, Europe (18 countries), Asia (5 countries), and Australia. The proportion of men with M0-PC treated with ADT was based on literature and survey research with PC-treating physicians. PSA relapse rates from literature were used to estimate CRPC among ADT treated men. Results: PC prevalence is driven by size and aging of populations, with notable increases predicted within 15 years in regions other than US, Canada, EU5 (table). The prevalence model, which utilized country-level data, indicates that M0-CRPC represents a relatively small proportion (2–7 %) of the total PC population. Nonetheless, widespread screening and demographic changes dictate that prevalence of CRPC will increase over the next 15 years, assuming current ADT rates. Conclusions: PC incidence trends are dependent on PSA screening, which is projected to lead to an increase in M0-PC and PC prevalence in most regions. The number of men treated with ADT and who ultimately develop CRPC will increase accordingly, as demonstrated in the model.
MASCC-0716 Postoperative rehabilitation in operations for lung cancer—a randomised clinical trial with blinded effect evaluation: rationale and design (PROLUCA) M. S. Sommer1, K. Trier1, M. Missel2, K. Richter3, J. Vibe-Petersen4, J. H. Pedersen2, H. Langberg5 1 Research Unit, Copenhagen Centre for Cancer and Health, Copenhagen, Denmark, 2Thoracic Surgery RT, Rigshospitalet, Copenhagen, Denmark, 3 Pulmonary Department L, Bispebjerg Hospital, Copenhagen, Denmark, 4 Head of Center, Copenhagen Center for Cancer and Health, Copenhagen, Denmark, 5Faculty of Health Science and Municipality of Copenhagen, University of Copenhagen, Copenhagen, Denmark Introduction: The rationale of Postoperative Rehabilitation in Operations for LUng CAncer (PROLUCA) is to identify the optimal postoperative rehabilitation in patients with non-small cell lung cancer (NSCLC). Objectives: The purpose is, in a non-hospital setting, to investigate the efficacy of early postoperative rehabilitation in patients with operable lung cancer—with focus on exercise. Methods: We are planning a trial of a continuous response variable (VO2peak) from independent experimental and control participants (1:1). One hundred and seventy participants (85 in each group) with histological evidence of NSCLC at disease stage I-IIIa, referred for surgical resection at Department of Cardiothoracic surgery RT, Rigshospitalet, will be randomly assigned to postoperative rehabilitation initiated either (1) 2 weeks after surgery or (2) 14 weeks after surgery. The rehabilitation program consists of a supervised group exercise program comprising resistance and cardiovascular training 2 h weekly for 12 weeks (intensity at 60–90 % of VO2peak and
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60–80 % of 1RM) and individual counseling. The primary endpoint is VO2peak (direct measurement). Secondary endpoints include: Perioperative complications, 6 MWT, 1 RM, patient-reported outcomes (e.g., quality of life, fatigue, depression, lifestyle), hospitalization time, sick leave, work status, and survival. All endpoints will be assessed (1) baseline (the day before surgery), (2) 2 weeks (only 6MWD), (3) 14 weeks, (4) 26 weeks and (5) 52 weeks postoperatively. Results: The results of PROLUCA will identify the optimal postoperative rehabilitation for NSCLC patients with focus on exercise initiated as early as 14 days post surgery. Conclusions: This study will contribute to establish rehabilitation guidelines for operable NSCLC patients.
MASCC-0717 Antihypertensive drugs with the potential to prolong the QT interval L. Lemos1, S. Morgado2, M. Morgado2 1 Health Sciences Faculty, University of Beira Interior, Covilhã, Portugal, 2 Pharmaceutical Services, Hospital Centre of Cova da Beira, Covilhã, Portugal Introduction: Regulation No. 173/CD/8.1.7. from the Portuguese Authority of Medicines and Health Products (INFARMED), dated 02/08/2012 and titled “Ondansetron—dose constraint for injectable drugs”, recommends that “care must be taken when administering this antiemetic associated with other drugs that prolong the QT interval”. Antihypertensive drugs are an example of drugs that may prolong the QT interval due to its potential to cause hypokalemia. To effectively implement this recommendation, it was thought advisable to point out, in the computerized hospital drug database, all antihypertensive drugs that prolong the QT interval. Objectives: To review all antihypertensive drugs available in the Portuguese pharmaceutical market to identify those with the potential to prolong the QT interval, in order to allow hospital pharmacists to quickly and efficiently implement the above-mentioned recommendation Methods: Literature review based upon all Summary of Product Characteristics (SPC) of antihypertensive drugs available in Portugal and 35 literature sources from the PubMed, found by intersecting the terms “antihypertensive-induced prolongation of the QT interval” and using the limit time interval from January/2003 to September/2012. Results: A total of 63 antihypertensive agents currently available in Portugal were analyzed. Agents with the potential to prolong the QT interval are: furosemide, indapamide, hydrochlorothiazide, nebivolol e lacidipine. Substantial evidence supports the conclusion that indapamide, isradipine and nicardipine have a possible risk of torsades de pointes (TdP) when used as directed in SPC. Conclusions: The produced database is a valuable tool to Portuguese hospital pharmacists that dispense antihypertensive drugs, contributing to implement one of the recommendations of the above-mentioned regulation.
MASCC-0718 Program of physical activity after a localized breast cancer : patient’s compliance to a free physical reconditioning L. copel1, C. hiegel2, B. boistard1, C. boiron1, S. dolbeault1 1 Disspo, Curie, Paris, France, 2Siel Bleu, Groupe Associatif, Paris, France Introduction: A regular and dynamic physical activity (PA) reduced the risk of recurrence for localized breast cancer (LBC) and has also shown its effectiveness in terms of improving quality of life in the post
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cancer period. Courneya made recommendations on the level of PA needed. Objectives: To help women behavior of living adequate recommendations, we make a systematic proposal to each patient to join the “Program Activ” 'This one is free and involves an initial assessment on the individual PA with recommendations that can be broken into3 proposals : autonomy (patient sufficiently active),12 collectiv lessons or 14 individual lessons. Methods: During this proposal, a questionnaire on the PA level of patients is distributed. Results: Three hundred ninety-five patients received the proposal. Among them 80, called to make an appointment(groupA) and 315 did not express(groupB). In groupA: only 12,5 % of patients reported a PA>Courneya’s recommendations while in groupB they represented 27 %. Parallely 69,5 % of patients in groupA had a PA lower than recommendations against 55 % in groupB (18 % of patients in each group were unassessable). Group A’s patients were younger, from a higher-level social bracket and followed by an motivated oncologist. Among patients who made the initial assessment, 60 % have integrated a course of training. Six months after the end of training, 83 % continued PA (53 % with an activity equal or superior to recommendations). Conclusions: Despite the potential for significant outcomes, patients had difficulty entering a free program of physical reconditioning.
MASCC-0719 Efficacy and safety of balugrastim in chemotherapy-induced neutropenia: integrated analysis of two randomized phase III studies O. Gladkov1, C. Volovat2, S. Barash3, A. Buchner4, N. Avisar5, P. Bias4, U. Mueller4 1 Clinical Oncology, Chelyabinsk Regional Clinical Oncology Dispensary, Chelyabinsk, Russia, 2Oncology, Centrul de Oncologie Medicala, Iasi, Romania, 3Biopharmaceuticals, Teva Biopharmaceuticals USA, Rockville, USA, 4Biosimilars, Teva ratiopharm, Ulm, Germany, 5 Clinical Pharmacology & Experimental Medicine, Teva Pharmaceuticals, Netanya, Israel Introduction: Balugrastim is a recombinant fusion protein composed of human serum albumin and human granulocyte-colony stimulating factor, which allows for once-per-chemotherapy cycle, fixed dose administration. Objectives: To present the results of a combined analysis of two randomized Phase III studies comparing the efficacy and safety of balugrastim versus pegfilgrastim in breast cancer patients receiving myelosuppressive chemotherapy (CTx). Methods: All patients were treated with i.v. doxorubicin 60 mg/m2 followed by docetaxel 75 mg/m2 on Day 1 of a 21-day cycle for up to four cycles. For each cycle, patients received a single s.c. injection of balugrastim approximately 24 h after the administration of CTx. The primary endpoint was duration of severe neutropenia (DSN) in Cycle 1. Safety of balugrastim was assessed by type, frequency, and severity of adverse events (AEs); changes in laboratory parameters and vital signs; and immunogenicity over time. Analyses were performed in the per-protocol population. Results: Balugrastim demonstrated non-inferiority versus pegfilgrastim for reduction in DSN. Mean DSN in Cycle 1 was 1.1± 1.11 days in balugrastim patients (n = 236) and 1.0 ± 1.14 days in pegfilgrastim patients (n=234). Patients treated with balugrastim had a significantly shorter time to ANC recovery in Cycle 1 versus pegfilgrastim. No other significant differences in treatment effects were observed between groups. The safety profile was similar for both drugs, with the most frequent AEs consistent with the underlying medical condition and administration of myelosuppressive CTx.
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Conclusions: Balugrastim is a non-inferior, safe and effective alternative to long-acting pegfilgrastim for reducing DSN in breast cancer patients receiving myelosuppressive chemotherapy.
MASCC-0720 Experiences of uncertainty and disruption to continuity of care in cancer of unknown primary R. Foster1, R. Wagland2, J. Symons3, C. Davis4, L. Boyland5, C. Foster1, J. Addington-Hall2, A. Richardson6 1 Macmillan Survivorship Research Group, University of Southampton, Southampton, United Kingdom, 2Cancer Palliative and End of Life Care Research Group, University of Southampton, Southampton, United Kingdom, 3Jo’s Friends, Cancer of Unknown Primary Foundation, Newbury, United Kingdom, 4Southampton General Hospital, University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom, 5 Oakhaven Hospice, Oakhaven Hospice Trust, Lymington, United Kingdom, 6 Cancer Palliative and End of Life Care Research Group, University of Southampton & University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom Introduction: In 2010, Cancer of Unknown Primary (CUP) was the fifth most common cause of cancer death in the UK. Despite this, it is a neglected and poorly understood disease. There is little evidence about the experiences of living with CUP or caring for CUP patients. Objectives: To investigate experiences of living with CUP from the perspectives of patients, informal carers and health professionals. Methods: Case study methodology was employed. In-depth interviews with patients, their informal carers and their health professionals were conducted in 2011 and 2012. NHS patients’ medical records provided additional data. Patients were recruited from three NHS Trusts and via the CUP Foundation. Other interviewees were nominated by patients. Results: Forty-four interviews with 17 CUP patients, 14 informal carers and 13 health professionals were carried out. Uncertainty was a prominent feature of patients’ and informal carers’ experiences, often leading to anxiety regarding diagnosis, prognosis, treatment and possible recurrence. Health professionals reported concerns about the impact of uncertainty on CUP patients and some described experiencing a “test or treat” dilemma. Disruption in continuity of care was described by some interviewees and there was evidence of “MDT tennis”, where patients were “bounced” between MDTs. Conclusions: Uncertainty in CUP has negative consequences for patients, informal carers and health professionals. It contributes to the poor outcomes of this patient group. Disruption in continuity of care was linked to uncertainty. Reducing uncertainty by minimising disruption in continuity of care and improving information could lead to better experiences for patients and families.
MASCC-0721 Post-operative pain management after single port laparoscopic oncologic surgery S.W. Byun1, K. Lee1, J.S. Park1 1 OBGYn, Catholic University of Korea, Seoul, Korea Introduction: As a minimally invasive surgery, single port laparoscopic surgeries were introduced in many of oncologic surgery. Post-operative pain would be reduced by means of single port surgery but compared to single port laparoscopic benign surgery, property of post-operative pain management was not accessed in single port laparoscopic oncologic surgery. Objectives: We are aim to show the post-operative pain management after single port laparoscopic oncologic surgeries.
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Introduction: Breast cancer survivors are faced with multiple physical and psychological sequelae of cancer diagnosis and treatment.[1–5] Sur-
vivorship care can be fragmented and inefficient. The Institute of Medicine recommends new models of care that address physical and psychological concerns and provide each cancer survivor with an individualized ‘Survivorship Plan of Care’ (SPOC).[6] Objectives: To assess the feasibility and benefits of a breast cancer survivorship care model inclusive of the above components. Methods: We designed a pilot study of 16 breast cancer survivors within 6 months from ‘active’ treatment completion. See Fig 1 for study description. The ‘Survivorship Visit’ included: · assessment of physical and psychological sequelae and referral as needed · development of an individualized SPOC (summary of cancer type, treatment, potential treatment sequelae, follow-up and wellness recommendations) · optional wellness-oriented appointments in physical therapy, acupuncture, massage, wellness coaching, stress management class Outcomes: · feasibility · pre- and post-intervention knowledge survey · post-intervention satisfaction survey
Results: To recruit the 16 patients, we approached 22. Currently, 14 participants have completed the survivorship visit and are undergoing the optional appointments.
The following number of patients signed up for the optional wellness appointments: acupuncture-12, massage-14, physical therapy-14, wellness-13, stress management-11.
Methods: Eight cases of single port laparoscopic oncologic surgery including borderline tumor were reviewed in term of postoperative pain control and prescription patterns of pain-killer in oncologic surgeries were compared to that in benign surgeries. Results: Eight cases of. Conclusions: Post-operative pain control after single port laparoscopic oncologic surgeries were varied and were not adequately transferred to the patients compared to that for benign disease. Considering the operative field in oncologic surgery, prescription patterns of pain killers should be modified to relief the post-operative pain.
MASCC-0722 Pilot study of a new model of breast cancer survivorship care D. Stan1, S. Pruthi1, D. Wahner-Roedler1, M. Destro-Borgen1, K. Ghosh1 1 Internal Medicine, Mayo Clinic, Rochester, USA
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Completion of SPOC took in average 30 min. The survey results will be available in March 2013. Conclusions: Breast cancer survivors are interested in participating in a comprehensive model of breast cancer survivorship care that includes components of both traditional and alternative medicine. The model of care is feasible, although resource intensive. References: 1. Cheville, A.L. and J. Tchou, Barriers to rehabiliation following surgery for primary breast cancer. Journal of surgical oncology, 2007. 95(5): p. 409–18. 2. Denmark-Wahnefried, W., et al., Changes in weight, body composition, and factors influencing energy balance among premenopausal breast cancer patients receiving adjuvant chemotherapy. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2001. 19(9): p. 2381–9. 3. Karki, A., et al., Impairments, activity limitations and participation restrictions 6 and 12 months after breast cancer operation. Journal of rehabilitation medicine : official journal of the UEMS European Board of Physical and Rehabilitation medicine, 2005. 37(3): p.180–8. 4. Przezdziecki, A., et al., My changed body: breast cancer, body image, distress and self-compassion. Psycho-oncology, 2012. 5. Rotonda, C., et al., Factors Associated With Fatigue After Surgery in Women With Early-Stage Invasive Breast Cancer. The oncologist, 2013 6. Hewitt, M.G., S; Stovall, E, Committee on Cancer Survivorship: Improving Care and Quality of Life National Cancer Policy Board. From Cancer Patient to Cancer Survivor: Lost in Transition. Institute of Medicine and National Research Council of the National Academies (ed). Washington, D.C.: The National Academies Press, 2005.
MASCC-0723 Integrating pediatric palliative care in the community- a model for homa bay county P. Were1, F. Emali2, M. Liru3, J. Lynnette4, W.A. Aketch4, C.A. Kasera4 1 Nursing, Moi Teaching and Referral Hospital, Eldoret, Kenya, 2Public Health, Homa Bay District Hospital, Eldoret, Kenya, 3Pediatric, Homa Bay District Hospital, Eldoret, Kenya, 4Nursing, Homa Bay District Hospital, Eldoret, Kenya Introduction: The number of children diagnosed with life limiting condition has increased tremendously since the introduction of Burkitt’s lymphoma treatment at the Homabay District Hospital. Lack of awareness, early detection and diagnosis is one factor that makes many parents present to the health facilities with late disease leaving them with no option but Palliative care. Due to high level of poverty and unaffordable Hospital bills, most parents have no option but to keep their children at home where their care is compromised. Western Kenya has only two academic hospitals able to provide limited treatment to oncology patients. Moi Teaching and referral Hospital is situated in Eldoret, 200kms away while Jaramogi Oginga Odinga Teaching and referral Hospital is situated in Kisumu, 100kms from Homabay so access to care is limited Objectives: This papers highlights the combined activities initiated by Homabay District hospital within this region to improve pediatric Palliative care in the region. Methods: Eighty Community Health workers drawn from 3 locations have attended 2 sessions on basic skills for palliative care volunteers. Topics covered include communication with children, pain control, wound care and basic drug administration. Theory sessions have been covered and accompanied home visits to the families with children having life limiting conditions. Children visited had Kaposi Sarcoma, Down’s syndrome and other related conditions Results: Twenty households have been reached regularly. Information dissemination through community meetings.
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Conclusions: Challenges: Poor road network. Lack of essential pain control drugs. Capacity building to empower them do more. Collaborators to help support this project.
MASCC-0724 Nausea causes more discomfort in respect to vomiting during the first 3 cycles in naïve- patients treated with moderate/high emetogenic chemotherapy: preliminary data C. Ripamonti1, A. Necchi2, P. Bossi3, R. Buzzoni4, D. Raggi2, P. Giannatempo2, C. Resteghini3, N. Zilembo4, M.A. Pessi1 1 Supportive Care in Cancer Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy, 2Department of Medicine Medical Oncology 2 Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy, 3Head and Neck Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy, 4Department of Medicine Medical Oncology 1 Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy Introduction: International Guidelines (IGs) for Antiemetic Treatment of Chemotherapy (CT)-Induced Nausea and Vomiting are published. Data are lacking on the frequency/severity of nausea and vomiting during inter-cycle phases. Objectives: To assess the frequency, severity and discomfort of nausea and vomiting before and 15 days after CT. Methods: In an observational, prospective study we considered 93 consecutive CT naïve adult pts with lung, pleuric, head and neck and male genito-urinary-tract cancers. Exclusion criteria: use of strong opioids, cannabinoids, steroids, alcohol (C.A.G.E. ≥ 2). The most used CT schemes were: MVAC (9 %); PEB (34.6 %), TPF (37.2 %). Patients received antiemetics according to IGs. The Edmonton Symptom Assessment System (ESAS) was administered before the first CT infusion during the patients’ hospitalization and then by phone call (from 14th° to 16th° day) after each of the 3 consecutive cycles. Vomiting was added as tenth symptom. At the end pts were asked about which of the two symptoms had created more discomfort during all the treatment period. Results: Of 93 pts enrolled (mean age 51, 84 % male, ECOG PS 0= 93.4 %) 50 completed the study. Fifty per cent of pts self-reported nausea and vomiting of low-mild severity during inter-cycles and 72 % referred nausea as the most discomforting symptom in respect to vomiting (6 %) during all the period under investigation. Conclusions: Compared to vomiting, nausea is the most discomforting symptom. Further studies are necessary to investigate CT-induced nausea during the treatment period, because no specific IGs are available for its prevention and treatment.
MASCC-0725 An all-ireland population-based study of immediate and current physical and psychological side-effects of prostate cancer treatments F. Drummond1, H. Kinnear2, L. Sharp1, A. Gavin3 1 Research, National Cancer Registry Ireland, Cork, Ireland, 2Research, Northern Ireland Cancer Registry, Belfast, Ireland, 3Director, Northern Ireland Cancer Registry, Belfast, Ireland Introduction: Prostate cancer (PCa) is the most common male cancer in Europe. Recommendations that men be involved in treatment decision-making requires high-quality information on treatment sideeffects. However, such data is limited. Objectives: This all-Ireland study investigated physical and psychological side-effects of PCa treatments up to 15 years post-diagnosis.
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Methods: Six thousand nine hundred thirty-seven men diagnosed with primary, invasive, PCa, identified through cancer registries in Northern Ireland (NI) and Republic of Ireland (RoI), received a postal questionnaire during 2012. This asked about treatment(s) and side-effects (incontinence/impotence/sweats/hot flashes/loss of sexual desire/bowel problems/depression) and whether these were experienced (1) immediately after treatment and (2) currently. Results: Fifty-five percent of men responded. Differences in prevalence of treatments were betwen RoI and NI. Temporal changes in treatments were observed. Pre-treatment urinary symptoms were common (5 % reported depression/17 % impotence/36 % urinary incontinence). Immediate treatment side-effects were common (64 % impotence/62 % loss of sexual desire/48 % incontinence/26 % bowel problems/22 % depression and 27 % hot flashes). Prevalence varied by treatment modality (29 % of RP patients reported current urinary incontinence compared to 14 % treated by radiotherapy/ADT). Hot flushes/changes in breast tissue were more common with ADT than other treatments. Levels of regret were higher in men treated by RP/watchful waiting and who reported current incontinence. Conclusions: This large study quantifies, for the first time on population-basis short and longer-term side-effects of PCa treatments. Such information is valuable for informing men’s decision-making processes and identifies those likely to require additional support.
MASCC-0726 Real life experience with palonosetron in a two or three drug antiemetic regimen in breast cancer patients receiving (NEO)adjuvant AC chemotherapy J. Schilling1, H.J. Hindenburg2, K. Kittel3, P. Jungberg4, D. Guth5, S. Busch6, M. Konias7, I. Diel8, P. Feyer9, P. Ortner10 1 Headquarter, BNGO e.V., Schöneiche b. Berlin, Germany, 2Practice, Gynaeco-Oncology Practice, Berlin, Germany, 3Practice, Praxisklinik Krebsheilkunde, Berlin, Germany, 4Practice, Gynaeco-Oncology Practice, Chemnitz, Germany, 5Practice, Gynaeco-Oncology Practice, Plauen, Germany, 6Practice, Gynaeco-Oncology Practice, Mühlhausen, Germany, 7Practice, Gynaeco-Oncology Practice, Oranienburg, Germany, 8Practice, Gynaeco-Oncology Practice, Mannheim, Germany, 9Clinic of Radiooncology and Nuclear Medicine, Vivantes Klinikum Neukölln, Berlin, Germany, 10Headquarter, Pommemed, Munich, Germany Introduction: Anthracycline/cyclophosphamide (AC) chemotherapy for breast cancer is regarded as highly emetogenic in modern guidelines (1). They recommend a three drug combination of a 5-HT3receptor-antagonist (5HT3RA), dexamethasone (DEX) and a neurokinin1-receptorantagonist (N). Palonosetron (P) is a modern 5HT3RA that has shown high efficacy in the prevention of emesis in moderate (MEC) and high (HEC) emetogenic chemotherapy. Objectives: To evaluate the real life experience with palonosetron (P) plus dexamethasone (DEX) +/- NK1-Antagonist (N) as antiemetic prophylaxis in breast cancer (BC) patients (pts) receiving adjuvant or neoadjuvant ACchemotherapy (CT) in practices of Gyneco-Oncology in Germany. Methods: 653 BC patients who had received 4 cycles of an ACcontaining CT and an antiemetic prophylaxis with P-DEX or P- DEX-N were recorded in an online documentation system assessing severity, frequency, duration and onset of nausea (N) and vomiting (V). Efficacy criteria : complete control (CC: no V, no rescue, only mild N); complete response (CR: no V, no rescue) and rescue Results: 653 pts from 45 institutions were included, median age 55 years, in 74 % of pts the anthracycline component of the CT schedule was epirubicin. Response was evaluated after cycle 4 of CT. 251 pts. had P-Dex, 402 (P-Dex-N). Overall efficacy (5 days): P-Dex: CC: 59,0 %, CR 83,3 %; P- Dex-N: CC 74,13 %, CR 84,3 %. Delayed nausea was well controlled in both groups
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Conclusions: Antiemetic prophylaxis with the three drug combination P-DEX-N resulted in higher rate of complete control of N/V. References: Basch E J Clin Oncol. 2011 Nov 1;29(31):4189–98.
MASCC-0727 Patterns and predictors of workforce participation in cancer survivors 6 and 12-months post-diagnosis: a longitudinal study L. Sharp1, D. O’Driscoll1, K. Higney1, C. Bradley2 1 Research, National Cancer Registry Ireland, Cork, Ireland, 2Healthcare policy and research, Virginia Commonwealth University, Richmond, USA Introduction: Most cancer patients in work at diagnosis take time off for treatment and recuperation. Return to work post-cancer is important for survivors, their families, employers and society. Although evidence is accumulating on factors positively and negatively associated with post-cancer work participation, most studies have been cross-sectional. Objectives: To investigate, in a longitudinal, population-based study, patterns and predictors of survivors’ workforce participation at 6- and 12-months post-diagnosis. Methods: People with incident breast, prostate and colorectal cancer, aged 18–64 and employed/self-employed at diagnosis, were identified from the National Cancer Registry Ireland. Structured telephone interviews were conducted at 6- and 12-months post-diagnosis. Preliminary analyses involved Wilcoxon signed-rank and chi-square tests. Results: Six hundred twenty-five subjects (breast 53 %; prostate 30 %; colorectal 17 %) were recruited and completed 6-month interviews; 12month interviews will be completed end March 2013. At 6-months post-diagnosis, 38 % of survivors were working: 12 % did not stop working and 26 % had resumed working after a period of absence. Workforce participation at 6-months varied significantly by site (breast 22 %; prostate 65 %; colorectal 40 %; p<0.001) and sex (males 52 %; females 23 %; p<0.001). At 6-months, survivors worked on average 6 h/week less than pre-diagnosis (p<0.001). Few (3 %) had changed jobs since diagnosis, but for one quarter their work duties had changed. Multivariate analyses and 12-month results will also be presented. Conclusions: Better understanding of patterns of workforce participation, and the factors that affect this, could help health professionals to advise patients appropriately and patients to make treatment decisions and plan for time away from work.
MASCC-0728 Utilization of intravenous bisphosphonates (IVB)S in patients with bone metastases (BMET)S secondary to breast, lung, or prostate cancer (BC, LC, PC) M. Hagiwara1, Z. Cong2, K. Chung2, T.E. Delea1 1 Senior Research Consultant, Policy Analysis Inc. (PAI), Brookline, USA, 2Global Health Economics, Amgen Inc., Thousand Oaks, USA Introduction: Cancer patients with BMets are predisposed to skeletal complications. Bone targeted therapies such as denosumab or IVBs reduce risks of these complications. Objectives: The objective of this study was to characterize patterns of IVB use in these patients. Methods: This was a retrospective, observational study using the Thomson MedStat MarketScan® Commercial and Medicare databases (9/02 - 6/11). Subjects were all persons with ≥1 claim with a diagnosis (Dx) of BC, LC, or PC and ≥1 claim with a Dx of BMets. The date of first BMet Dx claim was the ‘index date’. Key exclusion criteria were Dx of other primary cancer, receipt of IVB pre-index, or <6 months continuous enrollment pre-index. Cumulative incidence of treatment initiation (first IVB claim, death as competing risk), interruption (gap of >60 days between IVB claims, discontinuation as competing risk), and discontinuation (last IVB claim) were analyzed.
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Results: Cumulative incidence of IVB initiation at 12 months post-index was greatest for BC followed by PC and LC (Table). IVB treatment interruption at 12 months ranged from 16 % (LC) to 31 % (PC). IVB treatment discontinuation at 12 months ranged from 46 % (BC) to 83 % (LC). Cumulative incidence of IVB initiation at 12 months declined with age in all tumor types: e.g., in BC, from 62 % at age <50 years to 47 % at age 75+ years. Conclusions: IVBs are used more frequently in patients with BMets secondary to BC than PC or LC. Many patients interrupt or discontinue IVB therapy within 12 months. of initiation, potentially impacting effectiveness.
Age, Y, Mean (SD)
BC (N=11670)
PC (N=7596)
LC (N=10982)
59 (13)
73 (11)
64 (11)
15.5 (14.4)
7.7 (8.3)
Follow-up, mos, 16.5 (15.4) Mean (SD) Cumulative Incidence, % (95 % CI)
Results: Controlling for hospital, chemotherapy, and restricting to first 10 days of chemotherapy per cycle, odds of antiemetic switch were 4.6 (95 % CI 2.76–7.71) times higher on chemotherapy days vs. nonchemotherapy days. Within cycles, each additional consecutive day of chemotherapy decreases odds of antiemetic switch 12 % (OR 0.88, P< 0.01). Odds of antiemetic switch do not differ across cycles or with additional non-chemotherapy days. With increasing age, odds of switch increase (P<0.01). Odds of antiemetic switch are not associated with insurance, sex, or patient race, though Asian and Black patients may have lower odds (P=0.06 and 0.08, respectively). Conclusions: Pediatric patients are at increased odds of antiemetic switch on chemotherapy days and as they age, and decreased odds with each successive chemotherapy day in a cycle. Odds of switch do not vary amongst cycles.
Initiation of IVB 6 months
54 (53–55)
37 (35–38)
32 (31–33)
12 months
59 (58–59)
42 (40–43)
34 (33–35)
Among patients with IVB Interruption of IVB
N=6936
N=3294
N=3654
6 months
21 (20–22)
24 (22–25)
13 (12–14)
12 months
29 (28–30)
31 (29–32)
16 (15–17)
6 month
29 (28–30)
36 (35–38)
65 (63–67)
12 month
46 (45–47)
56 (54–58)
83 (82–84)
Discontinuation of IVB
MASCC-0729 Antiemetic switch in pediatric patients with acute myeloid leukemia J.L. Freedman1, J. Faerber2, T.I. Kang3, D. Dai4, B.T. Fisher5, Y.S. Huang4, K. Torp6, Y. Li6, R. Aplenc7, C. Feudtner8 1 Pediatric Hematology/Oncology, Children’s Hospital of Philadelphia, Philadelphia, USA, 2Pediatrics, Children’s Hospital of Philadelphia, Philadelphia, USA, 3Pediatric Oncology/Palliative Care, Children’s Hospital of Philadelphia/University of Pennsylvania, Philadelphia, USA, 4Center for Pediatric Clinical Effectiveness, Children’s Hospital of Philadelphia, Philadelphia, USA, 5Pediatric Infectious Diseases/Center for Pediatric Clinical Effectiveness, Children’s Hospital of Philadelphia/University of Pennsylvania, Philadelphia, USA, 6Pediatric Oncology, Children’s Hospital of Philadelphia, Philadelphia, USA, 7Pediatric Oncology/Center for Clinical Epidemiology & Biostatistics, Children’s Hospital of Philadelphia/University of Pennsylvania, Philadelphia, USA, 8 Pediatrics/Center for Pediatric Clinical Effectiveness/Center for Clinical Epidemiology & Biostatistics, Children’s Hospital of Philadelphia/University of Pennsylvania, Philadelphia, USA Introduction: Patient demographic/sociocultural factors associated with chemotherapy-induced nausea/vomiting (CINV) are not well described in the pediatric population. Whether additional successive days/cycles of chemotherapy augment a child’s risk of CINV is also unknown. Objectives: To elucidate patient/treatment factors associated with switching 5HT3-antagonist antiemetics in children with Acute Myeloid Leukemia (AML), where antiemetic switch is a clinical surrogate for problematic CINV. Methods: Retrospective cohort study of 748 hospitalized pediatric patients with AML (mean age: 8.56y, male: 396/female: 352) from the Pediatric Health Information System database (42 hospitals, 1999– 2010). Clinically detailed administrative data analyzed for exposures: chemotherapy and antiemetics. Outcome: any observed switches in 5HT3-antagonists. Association of patient and treatment characteristics with odds of antiemetic switch assessed through logistic regression.
MASCC-0730 A prospective study about pain in breast cancer survivors V.T.K. Ferreira1, M.A.E. Prado2, E.C.O. Guirro3, A.M. Almeida2 1 Faculty of Medicine Ribeirão Preto/Department of Rehabilitation and Functional Performance, University of Sao Paulo, Ribeirão Preto, Brazil, 2 Department of Maternal-Infant and Public Health Nursing, University of São Paulo at Ribeirão Preto College of Nursing, Ribeirão Preto, Brazil, 3 Department of Rehabilitation and Functional Performance, University of São Paulo at Ribeirão Preto, Ribeirão Preto, Brazil Introduction: Pain after breast cancer treatment is common, may have several causes, this sympton is characterized by an important reduced functional and emotional. Objectives: Describe the pain in women with breat cancer, identify factors of improvement and worsening of pain in the lives of women, identify and locate the pain of women undergoing treatment for breast cancer (TBC). Methods: Thirty women undergoing TBC, attending a rehabilitation center during the period February to August of 2008, and responding to a form of the disease, treatment and pain. An image was applied to identify the location of the pain. Results: Most women were aged over 50 years. There is an equitable distribution between mastectomy and lumpectomy. The pain began after the breast surgery in 46.7 % of the women, daily frequency, and constantly, interfering with sleep and mood. Movements related to increased pain were reaching, pusching, pulling and supporting. The place mostly chosen by women to identify the pain were demonstred in Figure 1. Conclusions: To know, recognize and deal with the symptom allows therapeutic alternatives for its relief, minimizing the physical and emotional effects that the pain may cause in the relief of these women.
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References: Andersen KG, Kehlet H. Persistent pain after breast câncer treatment: a critical review of risk factors and strategies for prevention. Journal of Pain. 2011; 1–22. Lauridsen MC, Overgaard M, Overgaard J, Hessov IB, Cristiansen P. Shoulder disability and late symptoms following surgery for early breast cancer. Acta Oncologica. 2008; 47 (4): 569–575.
MASCC-0731 The lived experience of cancer in female body: adjusting to and accepting an altered self C. Laranjeira1, P. Ponce Leão2, I. Leal3 1 Higher School of Health Sciences, Piaget Institute, Viseu, Portugal, 2 University Institute of Applied Psychology, ISPA, Lisbon, Portugal, 3 University Institute of Applied Psychology, Ispa, Lisbon, Portugal Introduction: Cancer survival rates for different forms of cancer have increased substantially in recent decades. As a result, there is a growing body of research focusing on psychosocial issues faced by cancer survivors on a daily basis. Previous research has show that gynaecological cancer is connected to particular adaptation needs relating to unique sexuality, identity, reproductive and femininity demands. Through understanding women’s experiences, multidisciplinary health care strategies can be developed to meet the needs of this population. Objectives: The goal of this study is to present and discuss from a phenomenological and feminist perspective findings from a qualitative study of how Portuguese female cancer survivors experience their lived body and life world after cancer. Methods: Data was collected through in-depth interviews with ten cancer survivors who had completed pos-adjuvant treatment and were considered disease-free. The interviews were analysed using a phenomenological hermeneutical interpretation (Ricoeur, 1995). Results: The cancer survivors’ experiences of their bodies were characterised by reflective, distressing, and, in part, unintelligible changes during the onset and the process of recovery from cancer. Their experiences can be synthesised under three major themes: body action, body image and body sensation. Conclusions: Female cancer survivors experience great changes in their bodies over a long period, perhaps for the rest of their lives. Understanding the complex bodily changes that follow cancer is mandatory to help cancer survivors reintegrate and “re-own” their bodies and adjust to the implications of the changes. References: Ricoeur, P. (1995). Hermeneutics and the human sciences: Essays on language, action and interpretation. Cambridge University Press.
MASCC-0732 Efficacy and safety of amphotericin b versus micafungin as an empirical antifungal therapy for neutropenic fever in haematologically malignant patients in local hospal settings Y.H. Chan1, W.Y. Li1, K. Zhou1, S.M. Wong2, S.L. Chan3, S.Y. Leung3, Y.M. Ma3, S.C. Lee4 1 School of Pharmacy, The Chinese University of Hong Kong, Shatin, Hong Kong China, 2Medicine & Therapeutics, Prince of Wales Hospital, Shatin, Hong Kong China, 3Pharmacy, The Pamela Youde Nethersole Eastern Hospital, Chai Wan, Hong Kong China, 4Pharmacy, Prince of Wales Hospital, Shatin, Hong Kong China Introduction: Fungal infection in neutropenic patients continues to be a frequent cause of morbidity and mortality. Micafungin is often chosen over amphotericin B as the first line agent in recent years. Yet, the efficacy and safety of using micafungin in the empirical management of neutropenic fever is limited. Objectives: To evaluated the efficacy and safety of amphotericin B and micafungin as empirical antifungal treatment for neutropenic
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fever in patients with haematological malignancy in local hospitals. Methods: All patients received chemotherapy for haematological malignancy and received amphotericin B or micafungin as an empiric antifungal for neutropenic fever at the Pamela Youde Eastern Hospital and the Prince of Wales Hospitals between 2009 and 2011were included. Retrospective reivew of patient records were done. Successful outcome was defined as the fulfillment of the three-part composite endpoint. Results: Efficacy was evaluated in 167 patients. The overall treatment success rate were 51.8 % for amphotericin B and 71.4 % for micafungin group (p=0.094). More patients receiving amphotericin B had breakthrough fungal infection (14 patients [16.9 %]) than those receiving micafungin (1 patient [1.2 %]) (p=0.001) and more patients receiving micafungin (71.4 %) than amphotericin B (55.4 %) achieved resolution of fever (p=0.032). Micafungin was better tolerated than amphotericin B. Fewer patients in the micafungin group had an event associated with nephrotoxicity (22.9 % in amphotericin B vs. 1.2 % in micafungin, p<0.001), or discontinuation therapy due to drug-related events (31.1 % in amphotericin B vs. 1.2 % in micafungin, p<0.001). Table 1. Demographic Characteristics of the Patients
Characteristics Female (sex)–no. (%)
Amphotericin B (N=83) 40 (48.2)
Micafungin (N=84) 49 (57.6)
Age–yr
P value 0.189 0.772
Median
52
55
Range
71
69
≤ 17 year
1 (1.2)
0 (0)
18–40 year
23 (27.7)
18 (21.2)
41–65 year
46 (55.4)
48 (56.5)
> 65 year
13 (15.7)
18 (21.2)
48 (57.8)
64 (75.3)
0.131
8 (9.6)
1 (1.2)
0.020
3 (3.6)
5 (5.9)
0.480
19 (22.9)
4 (4.7)
0.002
6 (6)
10 (11.8)
0.317
20.17 (14.891)
18.81 (8.507)
0.499
30
100
–
10.44 (9.765)
10.54 (6.509)
0.940
7.37 (6.535)
6.57 (4.067)
0.350
23 (27.7)
24 (28.2)
0.902
34.07 (20.101)
28.69 (13.142)
0.057
Age group–no (%)
0.772
Primary diagnosis–no. (%) Acute myelogenous leukemia Acute lymphocytic leukemia Hodgkin’s lymphoma Non-Hodgkin’s lymphoma Others* Mean duration (day) of neutropenic fever (standard deviation) Median dosage (mg/day) Mean duration (day) of antifungal (standard deviation) Mean duration (day) of neutropenic fever before initiation of antifungal agent (standard deviation) Prior antifungal prophylaxis#–no. (%) Mean duration (day) of hospitalization (standard deviation)
#
Antifungal prophylaxis was allowed in the study. Fluconazole 200 mg daily and Itraconazole 200 mg daily were used. * This category included chronic myelogenous leukemia, multiple myeloma, solid tumors, and the myelodysplastic syndrome
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Table 2. Efficacy of Empirical Antifungal therapy using Amphotericin B versus Micafungin Endpoints
Amphotericin B (N=83) (%) Observed components of primary end points Resolution of fever (defined as a temperature below 38 °C for at least 48 h) during neutropenia Any breakthrough fungal infection during therapy or within 7 days after the completion of therapy Survival for 7 days after the completion of therapy Overall treatment success rate
Micafungin (N=84) (%)
P value
46 (55.4)
60 (71.4)
0.032
14 (16.9)
1 (1.2)
0.001
73 (88)
67 (79.8)
0.151
43 (51.8)
60 (71.4)
0.094
Conclusions: Micafungin is found to be as effective as and better tolerated than amphotericin B. MASCC-0733 The relationships between patients’ bowel symptom experiences and self-care strategies following sphincter-saving surgery for rectal cancer M. Landers1, E. Savage1, G. McCarthy1 1 Nursing and Midwifery, University College Cork, Cork, Ireland Introduction: Patients experience problematic bowel symptoms following sphincter-saving surgery for rectal cancer yet limited research exists on the relationship between patients’ symptom experiences and self-care strategies used postoperatively. Objectives: To investigate the relationships between bowel symptom experiences and self-care strategies used following sphincter-saving surgery for rectal cancer. Methods: The research was underpinned by the Symptom Management Theory. A quantitative correlational design with a convenience sample of 143 patients aged 30 to over 70 years was used. Data were collected using the Illness Perception Questionnaires, the Difficulties of Life Scale and a Self-care Strategy Measure. Results: Respondents experienced an average of four bowel symptoms following sphincter-saving surgery. Respondents with a higher identity score were more likely to use the self-care strategy proximity/knowing the location of a toilet at all times (OR=1.48, 95 % CI: 1.04 to 2.11). Females (OR=7.13, 95 % CI: 2.56 to 19.89), respondents with high timeline cyclical scores (OR=1.73, 95 % CI: 1.03 to 2.92) and with high physiological responses scores (OR=11.91. 95 % CI: 3.30 to 42.96) were more likely to use protective clothing. Respondents with higher identity (OR= 1.40, 95 % CI: 1.07 to 1.83) and social responses scores (OR=1.87, 95 % CI: 1.11 to 3.14) were more likely to use bowel medication. Females were more likely to use incontinence pads (OR=3.55, 95 % CI: 1.48 to 8.52). Conclusions: Supportive care for patients following sphincter-saving surgery for rectal cancer should be comprehensive and tailored to meet their individual needs. MASCC-0734 Chemotherapy medication errors: causes, errors and measures O. Aslan1 Department of Fundamentals of Nursing, Gülhane Military Medical Academy, Ankara, Turkey
1
Introduction: Chemotherapy medication errors are very important for the safety of patient, health care professionals and care environment. Objectives: To describe the causes, errors and preventive measures regarding chemotherapy administration process by using scientific literature. Methods: Articles and research studies from Medline and Pubmed databases were evaluated. Results: According to the scientific literature, causes of these errors were mostly stress, insufficient number of staff, lack of knowledge and experience, unclear orders. Errors included 3 main groups: 1)order writing, transcribing, 2)nurse or pharmacy dispensing errors, 3)nurse administration errors. These errors were administering under-overdosing, timing errors, wrong drugs, infusion-rate errors, omission of drugs/hydration, administration to wrong patients, improper drug preparation, improper drug storage, confusing medication names, memory problems, etc. Preventive measures were as follows: being familiar with look or sound like medications, establishing pop-up alerts in computer, placing eye-catching labels on storage bins, using a reliable method to confirm patient identity, establishing an error prevention system. Conclusions: Chemotherapy medication errors can be preventable if an appropriate drug administration system including an interdisciplinary approach with well-educated health care professionals is established. This initiative can eliminate medication problems which interrupt supportive care in cancer process. References: 1.Daouphers M, Magali A et al, Knowledge Assesment and Information Needs of Oncology Nurses Regarding Inpatient Medication, Clin J Oncol Nurs, 16(2), 2012,pp.182–187. 2.Schulmeister L, Look-alike, Sound-alike Oncology Medications, Clin J Oncol Nurs, 10(1), 2006, pp.35–41. 3.Griffin E, Safety Considerations and Safe Handling of Oral Chemotherapy Agents, Clin J Oncol Nurs, 7(6 Suppl), 2003, pp.25–29. MASCC-0735 Cancer survivor epiphany: a phenomenological perspective C. Laranjeira1, P. Ponce Leão2, I. Leal2 Higher School of Health Sciences, Piaget Institute, Viseu, Portugal, 2 University Institute of Applied Psychology, Ispa, Lisbon, Portugal 1
Introduction: A diagnosis of cancer can yield uncertainty in the lives of patients and family. Through the process of reflection and self-discovery, the survivor often uses spirituality as an integral component of coping. The concept of epiphany describes the developmental process through which cancer survivors can attain a sense of support and nurturance to develop a “new normal”. Spirituality may promote connectedness, an integral component of epiphany that leads to a sense of self-determination and mastery Objectives: To explore the cancer patients perceived needs for spiritual care Methods: This study is founded on a phenomenological lifeworld perspective. A purposeful sample of ten female cancer survivors was invited to participate and subsequently interviewed. Data was transcribed and reviewed to identify themes related to spiritual care. Results: Surviving cancer entails living with profound life-changes; strong relationships emerged between inner strength, knowing one’s personal spirituality and creating a “new normal” after cancer. For a majority of participants these themes support the concept of epiphany, particularly connectedness by nurturing supportive relationships with self, family, friends, and a spiritual power. Conclusions: Cancer survivors have a positive self-concept which enhances quality of life. The experience of epiphany is an effective process to examine expressed needs and concerns of cancer survivors. Application of data to this process may provide the healthcare provider with cues to nurture development of spirituality; it is also a process that can guide the choice of interventions to enhance self-determination and mastery of a “new normal” following a cancer diagnosis may improve quality of life and self-management.
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MASCC-0736 Challenges in patient recruitment during KODIAC-06, a randomized, placebo-controlled, double-blind, multicenter, phase 3 trial of naloxegol in patients with neoplasia and opioid-induced constipation (OIC) J.H. Von Roenn 1 , J. Tack 2 , P.N. Barker 3 , E.S. Lowe 3 , C. Fleischmann3, M. Sostek3 1 Department of Internal Medicine Division of Hematology-Oncology, Northwestern University, Chicago, USA, 2Translational Research Center for Gastrointestinal Disorders (TARGID), University of Leuven, Leuven, Belgium, 3Research and Development, AstraZeneca Pharmaceuticals, Wilmington, USA Introduction: KODIAC-06 (NCT01384292) aimed to evaluate the efficacy and safety of naloxegol, an oral, peripherally-acting, μopioid receptor antagonist for treatment of OIC in patients with cancer-related pain. Low patient recruitment led to early discontinuation of enrollment. Objectives: To present safety data and discuss recruitment challenges specific to patients with cancer-related pain.
Figure. Site participation and enrollment.
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Methods: Patients with neoplasia causing pain, confirmed OIC, life expectancy ≥3 months, and a stable opioid regimen were randomized to naloxegol 12.5 mg, 25 mg, or placebo once daily for 4 weeks, with an available active-treatment 12-week extension. Consultations with study investigators, site staff, and external advisors were undertaken to identify reasons for slow recruitment. Results: Only 14 (4 %) of the planned 336 patients were randomized over 10 months (Figure). Enrollment challenges included low site interest in participating in an OIC study, complex inclusion/exclusion criteria, and requirements too burdensome for the target population (Table). Mean age was 54.1 years and 71.4 % were women; WHO performance status was 0 (n=3), 1 (n=8) or 2 (n=3). Adverse events (AEs) were reported by 2/4, 3/5, and 2/5 patients in the placebo, naloxegol 12.5- and 25-mg groups, respectively, during the core study and 5/9 patients in the extension. Gastrointestinal AEs were most common. No serious AEs or deaths occurred. Conclusions: Unique approaches are needed to recruit adequate numbers of patients with cancer pain requiring opioid treatment and increase investigator interest in OIC studies. In this limited data set, naloxegol at doses up to 25 mg was well tolerated and safe in patients with OIC and cancer pain.
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and were taking 30–1,000 morphine equivalents/week for pain were randomized to once-daily naloxegol 12.5 mg, 25 mg, or placebo. Primary end point was percentage of responders over 12 weeks, defined as having ≥3 spontaneous bowel movements (SBM)/week with ≥1 SBM/week increase over baseline for ≥9 weeks and ≥3 of the last 4 weeks. Results: There were significantly more responders with the 25mg dose in both studies versus placebo (Table 1). The 12.5-mg dose significantly increased the responder rate only in KODIAC-04. Respective median times to first postdose laxation for placebo, naloxegol 12.5 mg, and naloxegol 25 mg were 35.8, 20.4, and 5.9 h (KODIAC-04; both P < 0.001) and 37.2, 19.3, and 12.0 h (KODIAC-05; both P < 0.001). Pain scores and opioid doses did not increase. Adverse events were more frequent with the 25-mg dose (Table 2); abdominal pain, diarrhea, nausea, flatulence, and vomiting were most common. Major cardiovascular events were rare and similar across treatment groups. Conclusions: Naloxegol significantly improved stool frequency with a rapid onset of action and without reducing opioidmediated analgesia. Naloxegol was generally well tolerated and safe. Ongoing research aims to establish naloxegol safety and efficacy in patients with cancer pain.
MASCC-0737 Efficacy and safety of naloxegol in patients with opioidinduced constipation (OIC): results from 2 identical phase 3, prospective, randomized, multicenter, double-blind, controlled trials J. Tack1, R. Gralla2, L. Webster3, M. Sostek4, J. Lappalainen4, P.N. Barker4, W.D. Chey5 1 Translational Research Center for Gastrointestinal Disorders (TARGID), University of Leuven, Leuven, Belgium, 2Medical Oncology, Albert Einstein College of Medicine Jacobi Medical Center, New York, USA, 3 Clinical Research, CRI Lifetree Research, Salt Lake City, USA, 4 Research and Development, AstraZeneca Pharmaceuticals, Wilmington, USA, 5Department of Internal Medicine, University of Michigan Health System, Ann Arbor, USA Introduction: OIC is a major challenge in palliative care medicine for patients taking opioid analgesics with persistent constipation occurring despite available treatments. Naloxegol is an investigational, oral, peripherally-acting, μ-opioid receptor antagonist for OIC. Objectives: To evaluate the efficacy and safety of 2 doses of naloxegol. Methods: In KODIAC–04 (NCT01309841) and KODIAC–05 (NCT01323790), patients with OIC who did not have cancer
Table 1. Primary end point (intention-to-treat [ITT] population)
Study
Treatment
n
Responders, n (%)
KODIAC-04
Placebo
214
63 (29.4)
KODIAC-05
Difference vs placebo, %
Relative risk
P-value
95 % Cl
Naloxegol 12.5 mg/d
213
87 (40.8)
11.4
1.38
1.06, 1.80
0.015*
Naloxegol 25 mg/d
214
95 (44.4)
15.0
1.51
1.17, 1.95
0.001*
Placebo
232
68 (29.3)
Naloxegol 12.5 mg/d
232
81 (34.9)
5.6
1.19
0.91, 1.55
0.202
Naloxegol 25 mg/d
232
92 (39.7)
10.3
1.35
1.05, 1.74
0.021*
Statistically significant under the multiple testing procedure mandating a critical P value <0.025 for ≥1 of the doses vs placebo for statistical significance.
*
Analysis via Cochran Mantel-Haenszel test, stratified by baseline laxative response. 11 Patients in KODIAC-04 and -05, found to have been randomized and participating at different centers within the program in parallel are excluded from the ITT and safety analysis sets.
Table 2. Safety
KODIAC-04
KODIAC-05
Patients with event, n (%)
Placebo n=213
Naloxegol 12.5 mg/d n=211
Naloxegol 25 mg/d n=214
Placebo n=231
Naloxegol 12.5 mg/d n=230
Any AE
100 (46.9)
104 (49.3)
131 (61.2)
136 (58.9)
137 (59.6)
160 (69.0)
Discontinuation due to AEs
12 (5.6)
9 (4.3)
22 (10.3)
12 (5.2)
12 (5.2)
24 (10.3)
Deaths
0
2 (0.9)
0
0
0
0
Serious AE
11 (5.2)
11 (5.2)
7 (3.3)
12 (5.2)
14 (6.1)
8 (3.4)
AE = adverse event.
Naloxegol 25 mg/d n=232
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MASCC-0738 Emergency cancer unit for the management of acute symptoms in cancer patients M. Merad-Toufik 1 , A. Alibay 1 , K. Yacouben 1 , C. Larue 2 , M. Monhonval2, M. DiPalma1, S. Antoun1 1 Ambulatory care, Institute Gustave Roussy, Villejuif, France, 2 Epidemiology and Biostatic, Institute Gustave Roussy, Villejuif, France Introduction: Advances in cancer patient treatment and supportive care have improved specific survival rates. Unfortunately many cancer patients still experience treatment anddisease-related symptoms that lead them to emergency units (EU). Objectives: Our purpose was to describe acute onset symptoms (AOS) that brings these patients to a specialized emergency unit and the outcome of these consultations Methods: Our EU manages the AOS of cancer patients being treated at our institute. All patients were included prospectively during 6 month- survey. Symptom types were recorded and for patients presenting with more than 3 symptoms, we selected the 3 most severe ones. Results: A total of 3,019 patients went to the EU: age (years) median: 58 [16–98]. Variations by time ranged from the lowest number of visits in the night and the peak in the mid-day: 47 % of patients were seen between 10 am and 2 pm. The patients were sent to the EU by: their oncologist (24 %), another hospital (5 %), their general practitioner (4 %) and it was their own decision in 66 % cases. The most common symptoms were pain (21 %), fever (17 %), gastrointestinal issues (12 %) and respiratory problems (8 %). According to patients’ situation, 58 % of patients were admitted in inpatients units. Conclusions: The occurrence of acute onset symptoms is frequent and severe enough to require hospitalization for more than 50 % of patients. These results justify the existence of emergency units dedicated to cancer patient evaluation and care.
MASCC-0739 Late-onset neutropenia in (NEO)adjuvant chemotherapy in breast cancer patients F. Morgado Gomes1, C. Ribeiro1, L. Parreira2, S. Oliveira1, L. Costa1, P. Barata1, R. Luz1, M.P. Custódio1, M. Sousa1, M.L. Batarda1 1 Medical Oncology, Centro Hospitalar Lisboa Central, Lisbon, Portugal, 2 Medical Internship, Centro Hospitalar Lisboa Norte, Lisbon, Portugal Introduction: Chemotherapy isn’t normally administered if the neutrophil count is <1.5×109/L (late-onset neutropenia-LON), to decrease the probability of infectious complications. Objectives: To identify the incidence, severity (grade 2–4) and recurrence of LON, and to evaluate the benefit of secondary prophylaxis with G-CSF. Methods: A retrospective study including 151 breast cancer patients (pts) who began (neo)adjuvant chemotherapy between January/2011 and August/2012. The chemotherapy used consisted of
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8 cycles: 4xAC plus 4xDTX with trastuzumab if HER2 positive. A total of 1,057 cycles were evaluated for LON at D18-21 before each cycle. Results: LON was registered in 43 % of pts but only during the AC regime, and in 84.6 % of pts it occurred within the first two cycles. Most LON were grade 2 (69 % vs. 7 % grade 4). Half of the febrile neutropenia (FN) registered had a LON previously. Secondary prophylaxis with G-CSF was initiated in 80 % of pts experiencing at least one episode of LON. In those cases, pegylated filgrastim and filgrastim were used with a fiftyfifty percentage, and filgrastim was used mostly (69.2 %) only between D3-5. Under prophylaxis the recurrence was 17.3 %, in 89 % of those with filgrastim (vs. 77.4 % without G-CFS). Conclusions: The incidence of LON, although high, was generally low grade. The use of G-CSF effectively reduced the risk of LON and therefore infectious complications. Filgrastim was associated with higher recurrence suggesting that the use only between D3-5 is insufficient. There was no LON identified during DTX probably because of the high prevalence of secondary prophylaxis already begun.
MASCC-0740 Randomized controlled study of yoga versus strengthening exercises in breast cancer survivors with persistent fatigue D. Stan1, A. Cheville2, I. Croghan3, S. Pruthi1 Internal Medicine, Mayo Clinic, Rochester, USA, 2Physical Medicine and Rehabilitation, Mayo Clinic, Rochester, USA, 3Primary Care Internal Medicine, Mayo Clinic, Rochester, USA 1
Introduction: Fatigue is prevalent in breast cancer survivors and negatively impacts quality of life (QOL). [1] Yoga is a mindful exercise shown to improve fatigue and QOL in breast cancer survivors.[2, 3] The availability and affordability of instructorled yoga classes preferentially selects higher-income people from larger, metropolitan areas; attending an exercise class after cancer treatments can be challenging due to time constraints and fatigue. Moreover, studies of yoga in cancer survivors rarely used an exercise control group. [4] Objectives: To study the feasibility and effects of a home-based, DVD-led yoga vs. strengthening program in a cohort of breast cancer survivors experiencing fatigue. Methods: We designed a RCT of DVD-based yoga versus strengthening exercises, in 70 women with stage 0–2 breast cancer, who experience fatigue (score ≥4 on a scale from 0 to 10). Outcomes (baseline, post-intervention and 6 months from baseline): · Feasibility · Fatigue—Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) · QOL—Functional Assessment of Cancer Therapies, Breast (FACT-B) Results: The study is open to recruitment. Since December 2012, 200 patients were invited; 54 responded; we enrolled 19, excluded 24 and 11 are awaiting screening. Of the five who completed at least 2 weeks of the intervention, 4 were compliant and one was not. See Fig 1 for eligibility, flow through the study and preliminary results.
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Conclusions: So far, the response rate and recruitment are consistent with that reported in literature (40 % and 10 %, respectively) [5–8] and compliance appears good. More results to come over the next few months. 1. Cella, D., et al., Cancer-related fatigue: prevalence of proposed diagnostic criteria in a United States sample of cancer survivors. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2001. 19(14): p. 3385–91. 2. Cohen, D.L., et al., Iyengar Yoga versus Enhanced Usual Care on Blood Pressure in Patients with Prehypertension to Stage I Hypertension: a Randomized Controlled Trial. Evidence-based complementary and alternative medicine : eCAM, 2011. 2011: p. 546428. 3. Bower, J.E., et al., Yoga for persistent fatigue in breast cancer survivors: a randomized controlled trial. Cancer, 2012. 118 (15): p. 3766–75. 4. Stan, D.L., et al., The evolution of mindfulness-based physical interventions in breast cancer survivors. Evidence-based complementary and alternative medicine : eCAM, 2012. 2012: p. 758641. 5. Courneya, K.S., et al., Randomized controlled trial of exercise training in postmenopausal breast cancer survivors: cardiopulmonary and quality of life outcomes. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2003. 21(9): p. 1660–8. 6. Courneya, K.S., et al., Effects of aerobic and resistance exercise in breast cancer patients receiving adjuvant chemotherapy: a
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multicenter randomized controlled trial. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2007. 25(28): p. 4396–404. 7. Irwin, M.L., et al. Recruiting and retaining breast cancer survivors into a randomized controlled exercise trial: the Yale Exercise and Survivorship Study. Cancer, 2008. 112(11 Suppl): p. 2593–606. 8. Segal, R., et al., Structured exercise improves physical functioning in women with stages I and II breast cancer: results of a randomized controlled trial. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2001. 19(3): p. 657–65.
MASCC-0741 Effects of combined aerobic and resistance exercise on quality of life and fitness of individuals who are post cancer treatment M.E. O’Neill1, M. Lemonde1, K. Power2 Faculty of Health Science, University of Ontario Institute of Technology, Oshawa, Canada 2 Human Kinetics and Recreation, Memorial University of Newfoundland, St. John’s, Canada 1
Introduction: The number of individuals living with cancer is growing. Many treatments exist that have long-lasting side effects. What can be implemented following treatments to reduce the side effects? One option is exercise
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Objectives: This study evaluated the effects of an eight-week individualized aerobic and resistance exercise program on physical functioning and quality of life (QOL) in individuals who are post cancer treatment. Methods: Participants were recruited through a local non-profit cancer support centre; eight participants met the inclusion criteria, and approved to participate by physicians through a PARmed-X. Four assessments were performed and an eight-week exercise program. The pre-, post- and 3 month follow-up assessments consisted of an interview, related questionnaires, as well as body composition, cardiovascular and musculoskeletal testing. A questionnaire was also administered at the 4-week point of the exercise program. The exercises prescribed were based on results from the pre-assessment. Groups of three to five participants attended exercise training sessions twice a week for 8 weeks. Training included a warm-up, prescribed cardiovascular and resistance training, and stretching. Results: Preliminary results indicate trends towards improvements in QOL and decreased levels of fatigue Conclusions: A combined resistance and aerobic training program may be beneficial for those post cancer treatment. This research will help provided evidence-based knowledge on the effects of exercise on individuals that are 2–12 months post treatment. Future research should focus on benefits of individualized exercise programs at any stage of cancer on QOL, fatigue and physical functioning.
MASCC-0742 Does anti-igf1r therapy contribute to decreased muscle mass in metastatic pancreatic cancer? D.R. Fogelman1, M.A. Khalil1, M. Hasan1, N. Garg2, M. Javle1, M.H.G. Katz3, H. Holmes4, J. Abbruzzese1 1 Gastrointestinal Medical Oncology, UT MD Anderson Cancer Center, Houston, USA, 2Diagnostic Imaging, UT MD Anderson Cancer Center, Houston, USA, 3Surgical Oncology, UT MD Anderson Cancer Center, Houston, USA, 4General Internal Medicine, UT MD Anderson Cancer Center, Houston, USA Introduction: IGF-1 plays a role in the growth of multiple tumor types, including pancreatic cancer. IGF-1 also serves as a growth factor for muscle. Objectives: To determine if patients receiving anti-IGF1R therapy have additional muscle mass loss as compared to patients on standard chemotherapy. Methods: We evaluated muscle mass at L3 in patients enrolled in a randomized phase II study of MK-0646 (M), a monoclonal antibody directed against the IGF1R protein, in patients with metastatic pancreatic cancer (MPC). We used Slice-o-matic to measure muscle area (cm 2 ) at baseline and after treatment. Patients received either gemcitabine with erlotinib (GE), GEM, or GM. Differences were compared using t-tests. Results: Fifty-eight58 patients had imaging available for analysis. 44 received M and 14 had GE only. Baseline muscle mass was similar (146 vs. 142 cm2, P=0.47). After 2 months of treatment, both groups demonstrated muscle mass loss (8 vs. 6 %). Of 37 patients with PR or SD, there was a non-significant increase in muscle mass among M patients (7.8 vs. 4.5 %, P=0.31). At 4 months, remaining M patients lost 6 % of muscle compared to 3 % among GE patients (P=0.54). Each 1 % loss of muscle increased dropout risk by 13 % (P=0.03) and predicted poor survival (HR 1.08, P=0.02). Conclusions: MPC patients lose muscle mass even while having clinical benefit from chemotherapy. Muscle loss correlates with study
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drop-out and death. There was a non-significant trend towards greater muscle mass loss in patients on anti-IGF1R therapy. It is unclear if this loss translates into functional differences between patients.
MASCC-0743 Febrile neutropenia following (NEO)adjuvant chemotherapy in breast cancer patients F. Morgado Gomes1, C. Ribeiro1, L. Parreira2, S. Oliveira1, P. Barata1, L. Costa1, M.P. Custódio1, M. Sousa1, R. Luz1, M.L. Batarda1 1 Medical Oncology, Centro Hospitalar Lisboa Central, Lisbon, Portugal 2 Medical Internship, Centro Hospitalar Lisboa Norte, Lisbon, Portugal Introduction: Febrile neutropenia (FN) is a feared complication of cancer treatment and occurs most frequently during the nadir of the chemotherapy regimens. Faced with a FN it’s essential to evaluate the risk of complications. Objectives: To identify the incidence, severity and the subsequent approach of FN. Methods: A retrospective study including 151 breast cancer patients (pts) who began (neo)adjuvant chemotherapy between January/2011 and August/2012. The chemotherapy used consisted of 8 cycles: 4xAC plus 4xDTX with trastuzumab if HER2 positive. The MASCC risk score for FN was used to stratify the approach to FN. Results: The global incidence of FN was 12.4 %, however during DTX the incidence was 20.6 %, because it’s responsible for 80.8 % of all recorded FN, of which 61.5 % in its 1st cycle. The average day for the incidence of FN during AC was the 14th, while with DTX it was earlier, on the 8th day. Yet the median level of neutropenia at diagnosis for both regimes was grade 4. A total of 42.3 % FN had <21 points in the MASCC risk score, resulting in hospitalization for a median period of 1 week. There were no microorganisms isolated or deaths. Conclusions: In these chemotherapy regimens infectious complications are uncommon, and there is no recommendation for primary prophylaxis since FN incidence is <20 %. As the highest incidence of FN occurred with DTX, primary prophylaxis with G-CSF may be considered during its cycles. However, the majority of FN were considered low risk and even the ones hospitalized had no major complications.
MASCC-0744 ‘Silent heroes’: the importance of informal caregivers in supportive care of survivors of head & neck cancer A. Timmons1, R. Gooberman-Hill2, E. O’Sullivan3, P. Butow4, L. Sharp1 1 Research, National Cancer Registry Ireland, Cork, Ireland, 2 School of Clinical Sciences, University of Bristol, Bristol, United Kingdom, 3Oral Surgery, Cork Dental School & Hospital, Cork, Ireland, 4Medical Psychology Research Unit, University of Sydney, Sydney, Australia Introduction: Head and neck cancer (HNC) is associated with severe limitations to physical, emotional and social functioning. Evidence from various healthcare systems suggest that the supportive care needs of survivors are not adequately met by existing services. Studies of other cancers suggest Informal caregivers (family members/friends) often fill this gap.
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Objectives: To describe the: (1) roles of informal carers in HNC supportive care and (2) implications of caregiving for carers, survivors, and the health services. Methods: In-depth, semi-structured, interviews were conducted with health professionals (HPs) involved in HNC care in Ireland (consultants, clinical nurse specialists, and allied health professionals). Interviewees were asked about survivors’ support needs post-treatment, if needs are met, barriers to meeting needs, and any other issues. The interviews were analysed using a content analysis approach. Results: Thirty-one HPs were interviewed. Although not specifically included in the topic guide, the role of informal caregivers in supportive care was a major theme. HPs revealed that the health services rely heavily on informal carers to provide medical and psychological support to HNC survivors, but that this support is usually not clearly acknowledged. Taking on these roles has a significant impact on caregivers and families; several factors exacerbate this impact. HPs considered that caregivers had significant needs, and that these should be met. Several barriers to meeting these needs were identified. Conclusions: Given the health services’ reliance on the informal support/care provided by family members/friends, these findings suggest HNC services should provide more supportive services for caregivers.
MASCC-0745 Self discovery of a breast symptom: key issues concerning women’s help seeking behaviour(HSB) M. O’Mahony1, J. Hegarty1, G. McCarthy1 1 Nursing & Midwifery, University College Cork, Cork, Ireland Introduction: Early diagnosis of breast cancer is associated with more favourable outcomes. However, some women postpone presenting to a health care professional with a self-discovered breast symptom. Objectives: To describe women’s help seeking behaviour and the associated influencing factors following self-discovery of a breast symptom. Methods: A descriptive correlational design was used. Following ethical approval, data were collected from women (n=449) attending the breast clinics of two urban hospitals within the Republic of Ireland. Results: The majority of women (69.9 %; n=314) sought help within 1 month, 30.1 % (n=135) delayed help seeking for more than 1 month, following symptom discovery. Within the delay group, 16.7 % (n=75) waited for 3 months or more (eight of whom waited for 1 year and more) before seeking help from a health care professional. Delayed help seeking was significantly associated with women’s symptom knowledge; ignoring the symptom and hoping it would go away and women’s belief that the symptom would persist for a long time. Fear on symptom discovery indicated less delay. Analysis of qualitative comments highlighted the panic and fear that some women associated with discovery of a breast symptom. Conclusions: This study highlights that despite the continued emphasis on early presentation of breast symptoms some women continue to delay. Additionally, symptom discovery is a stressful time for women. Oncologists and oncology nurses have a vital role to play in supporting women to seek help promptly for self-discovered breast symptoms and in supporting women throughout their symptom evaluation journey.
MASCC-0746 Incidence of chemotherapy induced diarrhoea in colorectal cancer patients: a retrospective analysis C.S. Lee1, B. Nolan1, D. Fennelly1, H. Mulcahy1, G. Doherty1, E. Ryan2 1 Centre for Colorectal Disease, St. Vincent’s University Hospital, Dublin, Ireland, 2School of Medicine and Medical Sciences, University College Dublin, Dublin, Ireland
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Introduction: Chemotherapy induced diarrhoea (CID) is a common and extremely debilitating side effect of many chemotherapeutic regimens. Not only does CID negatively impact on cancer patients’ quality of life but also can cause delays in giving treatment or dose reductions; this can have an adverse effect on the overall treatment efficacy and ultimately patient survival. Patients with more severe CID require hospitalisation and this greatly increases the number of patient admissions and has a significant impact on the cost of providing cancer care. Therefore, CID represents both a significant clinical and, importantly, economic burden in oncology. Objectives: Our objective was to ascertain the extent of CID at our centre in a retrospective analysis, additionally if there are certain risk factors and the effect of CID on overall survival. Methods: We performed a retrospective chart review. We included all patients with Stage II or III colorectal cancer who received adjuvant chemotherapy at our centre during the period 2006–2008. Location of tumour and pathological stage, chemotherapy regimen and the number of cycles received, hospitalisations, drug reductions and incidence of CID and other toxicities were noted. We also documented the 5 year survival rate of the patients. Results: To be completed Conclusions: To be completed
MASCC-0747 Why are supportive care needs of survivors of head & neck cancer not being met? Barriers perceived by health professionals A. Timmons1, R. Gooberman-Hill2, E. O’Sullivan3, P. Butow4, L. Sharp1 1 Research, National Cancer Registry Ireland, Cork, Ireland, 2 School of Clinical Sciences, Bristol University, Bristol, United Kingdom, 3Oral Surgery, Cork Dental School and Hospital, Cork, Ireland, 4Medical Psychology Research Unit, University of Sydney, Sydney, Australia Introduction: Head and neck cancer (HNC) survivors may experience significant morbidity resulting in ongoing needs for support posttreatment. Accumulating evidence suggests that survivors’ needs are not always adequately met by existing services. The reasons for this are unclear Objectives: To explore, using qualitative Methods, the barriers faced by health professionals in meeting the supportive care needs of HNC survivors. Methods: In-depth, semi-structured, interviews were conducted with health professionals involved in HNC care in Ireland (consultants, clinical nurse specialists, and allied health professionals). Interviewees were asked about survivors’ support needs post-treatment, if needs are being met, and any barriers they face in meeting needs. The interviews were analysed using a content analysis approach. Results: Thirty-one health professionals were interviewed. Health professionals considered that HNC survivors have considerable unmet supportive care needs in a range of areas. The barriers faced by health professionals in meeting the survivors’ needs fell under two broad themes each with several sub-themes: (1) health service barriers (healthcare/hospital systems; resources, quality-of-care issues; factors related to health professionals, and information/training); (2) barriers related to survivors (factors related to survivors; willingness to use services; stigma; and information). Health professionals suggested that appropriate and adequate post-treatment supportive care should be available for survivors who need it, and made recommendations to help achieve this. Conclusions: This study advances understanding of the barriers to meeting HNC survivors support needs. This, together with recommendations/suggestions from health professionals, could be used to help improve existing supportive care services for survivors.
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MASCC-0748 Venous thromboembolism in hospitalized cancer patients, single centre experience A. Besen1, M. Ulas2, F. Kose1, S. Muallaoglu1, O. Ozyilkan1 1 medical oncology, Baskent University, Adana, Turkey, 2Internal Medicine, Baskent University, Adana, Turkey Introduction: Venous thromboembolism (VTE) is common in cancer patients and associated with certain risk factors such as previous surgery, type of malignancy, cancer stage and the antineoplastic agents used in the treatment of underlying malignancy. Objectives: Our aim was to investigate the frequency of VTE in hospitalized cancer patients and associated risk factors in a certain period of time. Methods: We searched medical charts of the patients admitted to oncology clinic from January 2012 to January 2013 with a diagnosis of venous thrombosis and pulmonary embolism. The data including demographics, type of thromboembolism, type of chemotherapy and co morbidities were analyzed. Results: There were 830 hospitalizations in study period. Fifty-six (6.7 %) patients were identified as having VTE. The mean age of the patients was 56 years (range 20–82) and 41 % were female. Twenty (35 %) patients had co morbid conditions. Twenty-five (44 %) and twenty-nine (51 %) patients were diagnosed to have PTE and deep vein thrombosis (DVT) respectively. Two patients (5 %) had catheter related thrombosis. Lung cancer (34 %) and the pancreatic cancer (16 %) were the most common types of tumours associated with thrombosis. The majority of the patients had advanced stage of cancer. Among patients 40 (71 %) were treated with chemotherapy and 20 of them (50 %) were given regimens containing cisplatin. Conclusions: VTE is a common complication among patients with cancer. Predictors of VTE include cancer type, advanced cancer stage, cisplatin containing chemotherapy.
MASCC-0749 Radical gynaecological oncology surgery: to site or not to site? Y. Anderson1, R.L. ODonnell1, H. Wilson1, G. Marples2, A. Guest1, C. Ang1, K.A. Godfrey1, E. RJ1, R. Naik1, A. Kucukmetin1, K. Roberts2 1 Gynaecology Oncology, Northern Gynaecological Oncology Centre, Newcastle upon Tyne, United Kingdom, 2Faculty of Health and Life Sciences, Northumbria University, Newcastle upon Tyne, United Kingdom Introduction: Bowel surgery, with or without stoma formation, is necessary in a proportion of patients with advanced ovarian cancer but accurately predicting who will need this is not always possible. Subsequently all women receive bowel preparation and are sited for stomas pre-operatively. This is time-consuming and has physical and psychological consequences. Objectives: To explore the frequency of bowel surgery and assess if stoma formation was predictable. Methods: Data regarding pre-operative siting and subsequent stoma formation was prospectively collected over 12 years. With the implementation of Enhanced Recovery, a smaller sub-study was undertaken. Using a standard proforma senior surgeons were asked to predict the liklihood of stoma formation. Results: On average 260 women undergo stoma siting and bowel preparation annually with only 16 % requiring stoma formation. During our study period stoma formation was predicted for 50 patients. 43 women have undergone surgery. Of the 12 women predicted as ‘likely’ to require stoma formation 1 required this and a further 3 women underwent bowel surgery with anastomosis, (PPV 33 %). Of the 31 women predicted as ‘unlikely’ only 3 women required stomas, (NPV 90 %). Conclusions: Stoma formation is infrequent however a significant proportion of patients undergo the side-effects and psychological distress of
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pre-operative stoma preparation. The need for a stoma is difficult to predict however by using clinical judgement we can reduce morbidity for many patients and focus resources on those with greatest need. These results are valuable for provision of accurate counselling for our patients.
MASCC-0750 The effect of palifermin on hand-foot syndrome (HFS) in hematopoietic stem cell transplant patients J. Joo1, D. Pon2 College of Pharmacy, Western University of Health Sciences, Pomona, USA 2 Pharmacy, City of Hope National Medical Center, Duarte, USA 1
Introduction: HFS, an adverse reaction associated with certain chemotherapeutic agents, is characterized by dysesthesias in hands and feet. No cases of HFS with total body irradiation (TBI) or etoposide (VP16) have been reported in the literature, but a few cases have been reported with palifermin. Objectives: To determine the incidence, onset, duration, severity and risk factors for HFS in patients receiving TBI/VP16±palifermin, and to evaluate the effects of palifermin on development of HFS. Methods: Institutional review board approved cohort study of adult allogeneic HSCT patients at City of Hope receiving TBI/VP16 (control) and TBI/VP16/palifermin (palifermin) was conducted during 2 time periods. Occurrence of HFS was determined through review of medical records Results: Incidence of HFS was 38 % and 40 % in control and palifermin groups (Fisher’s exact, p=0.85). Mean duration of HFS was 16.8 and 11 days (t-test, p=0.015). Mean onset of HFS occurred on day +7.6 and + 3.7 (t-test, p=0.0001). Severe HFS occurred in 43 % and 13 % (Fisher’s exact, p=0.07). Severity of HFS was associated with duration in the palifermin group (Spearman r=0.85, p<0.0001). Females and patients who developed early skin reactions to palifermin were more likely to develop HFS (Fisher’s exact, p=0.01 and p=0.04). Age, donor type, and palifermin dosing schedule were not risk factors for development of HFS. Conclusions: TBI/VP16 was associated with a 38–40 % incidence of HFS. Palifermin significantly reduced time to onset and decreased duration of HFS and offers a previously unreported benefit in this patient population. Female gender and early skin reaction to palifermin were risk factors for HFS.
MASCC-0751 Prognostic characterization in the terminal phase of cancer P. ermacora1, M. Mazzer1, G. Aprile1, M. Cattaruzza2, A. Orlando2, M. Isola3, G. Gregoracci3, G. Pascoletti4, D. Collini4, F. Puglisi4, G. Fasola4 1 Oncology, Udine Hospital, Udine, Italy, 2ASL Treviso, Hospice Casa dei Gelsi, Treviso, Italy, 3Statistics, University Hospital, Udine, Italy, 4 Oncology, University Hospital, Udine, Italy Introduction: To forecast life expectancy in terminal cancer patients, clinical prediction is often inaccurate and multidimensional scores are used. Objectives: We carried out a prospective cohort study in two distinct palliative care Units to determinate 1) the accuracy of three different prognostic scores: the Palliative Prognostic (PaP) Score, the Objective Prognostic Score (OPS), and the Palliative Prognostic Index (PPI); 2) the accuracy of two differently experienced oncologists and one nurse in the clinical prediction of survival (CPS) and 3) the role of clinical factors in predicting survival. Methods: At the time of admission, clinical and laboratoristic data of 238 advanced cancer patients were collected from April 2011 to August 2012. Pap Score, OPS and PPI were calculated and CPS was estimated by the study team. Survival was evaluated by Kaplan-Meier curves and accuracy was determinated by ROC analysis Results: The median survival was 15 days (range 0–502). The PaP score was the most accurate instrument (AUC=0.81) to predict 30-day
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survival. The CPS estimates’ accuracy was similar among physicians and nurses (AUC=0.78 vs. 0.76); the nurses’ CPS had the greater correlation with the actual survival. Presence of anxiety (p=0.009) and lower score in the Activity of Daily Living (ADL) (p=0.0001) were adverse prognostic factors for survival. Conclusions: The PaP Score showed the highest accuracy in the prognostic evaluation of terminally ill cancer patients. On admission, ADL e anxiety should be evaluate to better estimate prognosis.
MASCC-0752 Chromosomal abnormalities in children with hematological malignancies B.B. Ganguly1, S. Mandal1, M. Ghosh2, T. Dolai2, M. Bhattacharyya2, S. Chandra3, D. Banerjee3 1 Genetics, Genetics Center, Mumbai, India, 2Hematology, NRS Medical College, Kolkata, India, 3Hematology, Clinical Hematology Services, Kolkata, India Introduction: Acute lymphoid leukemia (ALL) is frequently reported among children with hyperdiploid condition with over 50 chromosomes as the most common abnormality and it has been reported to lead a favorable prognosis in B-lineage ALL. However, structural rearrangements alone or in combination with hyperdiploidy are known to cause an unfavorable prognosis. Objectives: An attempt has been made to categorize chromosomal aberrations in childhood leukemia for better understanding of the clonal changes facilitating leukemogenesis in children. Methods: A total of 148 children of 1–16 years of age have been included in the present study who were suffering from fever, hepatosplenomegaly and lymphadenopathy. Unstimulated bone marrow culture and conventional cytogenetic study in classified karyotypic form have recorded the chromosomal status in minimum 20 cells for each child. Results: Solely hyperdiploid condition was observed in 26 % cases where a total of 58 % children were affected with both numerical and/or structural alterations. It is important to mention that many of these hyperdiploid clones also had complex unbalanced translocations. Moreover, 32 % children had myelogenous clonal changes, including t(9;22), t(4;11), t(9;21), t(9;11), t(13;19), t(15;17), t(1;14), t(2;5), t(11;17), del(6q), del(7q), del(5q), del(12p), del(13q), +5, +8, + 12, +21, inv(16) in solo or in multiple combination. Chromatid and chromosome breaks were frequently evidenced in these clones. It has been experienced that many of these cases with structural rearrangements had poor prognosis or could not survive. Conclusions: Chromosomal study at whole genome level is important in diagnosis and management of hematological malignancies in children.
MASCC-0753 Vie aerio: french study on end of life in oncology. evaluation of practices M. Lozach-Brugirard1, E. Viel2, F.R. Ferrand3, E. Bonnet4, S. Lheureux5, P.E. Brachet6, A. Boespflug7, C. Delaruelle7, J. Dubreuil8, A. Barret2, O. Munier2, T. Flament2, V. Paulus9, C. Guy-Coichard10, C. Tournigand11 1 Palliative Care Mobile Team, Hopital Necker Enfants Malades, Paris, France, 2Medical Oncology Unit, Hopital Bretonneau, Tours, France, 3Medical Oncology Unit, HIA Val de Grace, Paris, France, 4Medical Oncology Unit, Hopital Jean Minjoz, Besançon, France, 5Medical Oncology Unit, Centre François Baclesse, Caen, France, 6Medical Oncology Unit, CHU Caen, Caen, France, 7Medical Oncology Unit, CHU Lyon, Lyon, France, 8 Medical Oncology Unit, CHRA Annecy, Annecy, France, 9Medical Oncology Unit, CH Vesoul, Vesoul, France, 10Centre d’Évaluation et Traitement de la Douleur, Hopital Saint Antoine, Paris, France, 11Medical Oncology Unit, Hopital Henri Mondor, Creteil, France
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Introduction: Advanced cancer often lead the question of continuation specific treatments. The development of new therapies complicate oncologists decisions. Objectives: Our study focuses on patients who received specific anti cancer treatment (SACT) in their last weeks of life. Methods: This is a multicenter retrospective study, including patients who died in oncology unit over a period of 3 months. Results: In 7 different simple or teaching hospitals were included 108 patients. Most patients had lung (28.7 %), breast (14.8 %), and colorectal cancer (9.3 %). Sixty four patients were men. Sixty five (60.2 %) patients received SACT in the last 30 days of life, among them 34 (31.5 %) patients who received SACT in the last 2 weeks. Among patients who received SACT in the last 2 weeks, median age was 63,2 at the time of the last treatment, and 10 (30.3 %) patients had a Karnofsky index lower than 30 %. The decision of treatment was discussed in 52.9 %, and 26 % of patients were followed by a palliative care team. In univariate analysis, there is no difference between patients who received SACT in the last 2 weeks and them who did not concerning sex, age, Karnofsky index; there is difference concerning the oncology unit, family environment and palliative care team involvement Conclusions: In this study, 30.3 % of patients who died in hospital received a SACT in the last 2 weeks, despite a bad performans status for a third of them. Their close and medical environment seems important in this choice. Is it possible to avoid those heavy useless treatments?
MASCC-0754 Rural palliative care network: use of a telemedicine interdisciplinary teaching conference to promote palliative care education across a rural state U. McVeigh1, J. Ely2, R. Mitchell1 1 Palliative Care, University of Vermont-Fletcher Allen Health Care, Burlington VT, USA, 2Vermont Cancer Center, Fletcher Allen Health Care, Burlington VT, USA Introduction: The complex physical, emotional and spiritual distress palliative care patients’ face is best supported by specialized skills of an interdisciplinary team (IDT). Rural communities may be challenged to support the array of professionals needed and a forum for IDT learning. Fletcher Allen Health Care (FAHC) is the only tertiary care center in Vermont. The FAHC Rural Palliative Care Network was developed in 2009 to strengthen regional palliative care expertise. The main activity of the network is a weekly palliative care IDT telemedicine case conference. Objectives: To describe the educational impact of a weekly telemedicine palliative care conference. Methods: A retrospective review of conferences held in academic year 2012 was performed by review of sign in sheets and anonymous session and year-end program evaluations. Results: Thirty-five conferences were held, 12 sites participated, mean attendance 18 (9–32). Disciplines: physicians, nurses, social worker, students, and clergy. Two hundred seventy-four evaluations of individual sessions were submitted. 85 % affirmed the session met their educational needs, 77 % affirmed the program will change or improve their practice. Year-end program evaluation asked learners (N=25) to rate if conference increased knowledge of: Definitely
Somewhat
Not at all
Evidence based practice
86 %
28 %
4%
Current medical literature
84 %
12 %
4%
Spiritual impact of palliative care
84 %
16 %
0%
Social impact of palliative care
84 %
16 %
0%
Economic impact of palliative care
32 %
60 %
8%
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Conclusions: A weekly palliative care telemedicine case conference with rural palliative care providers is an effective method for meeting learners’ educational needs and self reported practice improvement.
MASCC-0755 Cancer-related fatigue (CRF) and psychological distress among lesbian, gay, bisexual and transgender (LGBT) cancer patients and survivors C. Kamen1, A. Peoples1, M. Tejani1, M. Janelsins1, L. Peppone1, G. Morrow1, K. Mustian1 1 Department of Radiation Oncology, University of Rochester Medical Center, Rochester, USA Introduction: Recent studies have suggested disparities post-cancer diagnosis between LGBT cancer patients and survivors compared to heterosexual peers. Psychological distress (i.e., depression and anxiety) is higher among LGBT adults in general. Studies have not examined CRF and its link with psychological distress in LGBT cancer patients/survivors. Objectives: We examined prevalence of CRF and psychological distress and compared rates across LGBT and heterosexual patients/survivors. Methods: The LIVESTRONG dataset, a cross-sectional U.S. national survey, sampled 289 LGBT and 4,782 heterosexual cancer patients/survivors (all cancer types, 63.5 % women, mean age 49). Fatigue was assessed with three dichotomous yes/no items (not having energy, feeling tired, and not feeling rested); psychological distress was assessed with two yes/no items (feeling depressed, feeling anxious). Results: Over half of LGBT patients/survivors reported not having energy, feeling tired, and not feeling rested, with prevalence of 54.7 %, 62.1 % and 55.4 % respectively. Chi-square analyses indicated prevalence of not feeling rested was significantly higher among LGBT than heterosexual patients/survivors (p=0.01). Prevalence of feeling depressed and feeling anxious among LGBT patients/survivors was 62.7 % and 43.0 %, respectively; chi-square analyses indicated both were significantly more prevalent among LGBT patients/survivors (both p<0.05). Logistic regression indicated that the association between LGBT identity and fatigue was significantly mediated by endorsement of psychological distress (p<0.01). Conclusions: LGBT cancer patients/survivors report higher rates of certain indicators of fatigue than their heterosexual counterparts. This disparity may be due to increased rates of psychological distress. Research is needed to examine mechanisms linking distress to fatigue and to develop interventions to address these issues among LGBT patients/survivors.
MASCC-0756 Incidence of chemotherapy induced nausea and vomiting following prophylaxis with an I.V. 5-HT3-RA antiemetic and subsequent oral 5-HT3-RA dosing R. Knoth1, C. Faria1, A. Powers1, N. Nagl2, E. Chang3, M. Broder3 1 Health Economics and Outcomes Research, Eisai Inc., Woodcliff Lake, USA, 2 Medical Affairs, Eisai Inc., Woodcliff Lake, USA, 3Research Consulting, Partnership for Health Analytic Research, Beverly Hills, USA Introduction: Chemotherapy-induced nausea and vomiting (CINV) is a significant adverse effect of chemotherapy. The 5-hydroxytryptamine-3 receptor antagonists (5-HT3-RA) are recommended for the prevention of CINV. Objectives: This study compared the incidence of CINV after prophylaxis with palonosetron vs. another I.V. 5-HT3-RA (ondansetron, dolasetron, or granisetron) with subsequent dosing of an oral 5-HT3-
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RA. Patients in the other I.V.+oral 5-HT3-RA group received an infusion on day 1 of chemotherapy and filled a prescription for the oral 5-HT3-RA any time during the period 2 weeks prior to 5 days after chemotherapy. Methods: A retrospective cohort analysis was conducted using the Optum LabRx database. Adult patients, treated with moderately or highly emetogenic chemotherapy, who received a 5-HT3-RA from 1/1/08 to 3/31/09, were identified. Of interest was the incidence of CINV by cohort in the first cycle of chemotherapy. CINV was defined by medical claims with a primary diagnosis of nausea, vomiting, fluid depletion or replacement, or use of a rescue antiemetic. Results: A total of 4,818 patients were identified, 4,245 treated with palonosetron (88.1 %) and 573 (11.9 %) treated with another I.V.+oral. The mean age was 55.6 years and 79 % were female. Overall, 17.8 % of patients experienced CINV. However, patients treated with palonosetron had significantly less CINV (16.7 %) compared to those treated with the other 5-HT3-RA (26.0 %), p<.001. Conclusions: The results of this study showed that patients who received prophylactic palonosetron prior to chemotherapy experienced significantly less CINV than those receiving the other I.V. 5-HT3RAs with subsequent dosing of an oral 5-HT3-RA in the days following chemotherapy.
MASCC-0757 Oncoloy nurses’ use and effect of aromatherapy for cancer patients M. Kamizato1, S. Jahana1, R. Takamiya1, K. Tamaki1, Y. Aihara1, N. Tamai1, M. Taira1, K. Hamada1, K. Nagano1, K. Saeki1, K. Shimizu1, R. Yoshizawa1 1 Nursing, Okinawa Prefectural College of Nursing, Okinawa, Japan Introduction: The half of oncology nurses who work in some palliative care unit in Japan using aromatherapy for end of life care patients. However, low rate usage for general hospitals. Objectives: To identify nurses’ use and effect of aroma therapy for cancer patients in Japan. Methods: We provided oncology nurses essential oils and carrier oils for free to use for cancer patients in 5 general hospitals and 4 palliative care units in Okinawa for 1 year. After providing it, we evaluated oncology nurses’ use and effect of aromatherapy for cancer patients. The survey was conducted by a self-administered questionnaire without name for oncology nurses. Ethical approval was obtained from the college and hospitals. Descriptive statistics were used to analyze oncology nurses’ responses to each question with SPSS. Results: The response rate was 57.4 %(166/289). The mean age of the nurses was 37.0(SD9.6, range 22–59 years); 87.2 % were female; nursing experience were 12.8(SD9.5, range 0–35). Forty nigh percent of aroma massage, 36.7 % of carrier oil massage, 26.5 % of aroma fragrance, 23.5 % of aroma hand bath, and 30.1 % of aroma foot bath were used for cancer patients by nurses. Sixty one percent nurses felt effect of aromatherapy (2.5 % non-effect). Effect of using aromatherapy were relaxation, feeling of change, and enhance of communication between nurses and cancer patients. The reasons for not effect of aromatherapy were time concerns and fragrance difficulty. Conclusions: Using aromatherapy for cancer patients will be effect for relaxation and enhance of communication.
MASCC-0759 The prevalence of hospitalizations, emergency department/urgent care visits for unrelieved symptoms during chemotherapy K. Mooney1, S.L. Beck1, B. Wong2, W.A. Dunson Jr.3, D. Wujcik4 1 College of Nursing and Huntsman Cancer Institute, University of Utah, Salt Lake City, USA, 2College of Nursing, University of Utah, Salt Lake City, USA, 3Huntsman Cancer Institute and School of
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Medicine, University of Utah, Salt Lake City, USA, 4Vanderbilt Ingram Cancer Center, Vanderbilt University, Nashville, USA
Results: Power1(n=317)
Power2(n=317)
Introduction: Unrelieved symptoms may lead to increased health resource use adding to the cost and fragmentation of cancer care. Objectives: To describe the frequency of unscheduled hospitalizations (HOS) and emergency department/urgent care visits (ED/UC) during outpatient chemotherapy and their association with common symptoms. Methods: In a descriptive sub-analysis, we evaluated unscheduled HOS/ED/UC visits in 358 cancer patients during chemotherapy. Patients called an automated telephone monitoring system daily reporting presence and severity of common symptoms (fever, pain, nausea/vomiting, fatigue, mucositis, numbness/tingling, difficulty thinking, depressed mood, anxiety, sleep disturbance, appearance concerns). Patients also reported on the frequency and nature of unscheduled HOS/ED/UC visits. Results: Eighty-seven participants (24 %) reported 129 unscheduled events: 43 hospitalizations and 86 ED/UC visits (83 average study days/participant). 34 (79 %) of hospitalizations began as ED/UC visits. The average HOS/ED/UC participant was White (85 %), 57 years, female (83 %) with breast cancer (45 %) (no demographic difference between those without a HOS/ED/UC visit). 28 (65 %) unplanned hospitalizations were due to monitored symptoms including 17 (61 %) for fever, 12 (43 %) pain, 8 (35 %) nausea/vomiting, and 2 (7 %) fatigue (multiple symptoms could be reported). Of ED/UC visits, 49 (57 %) related to monitored symptoms including pain, 22 (45 %), fever, 14 (29 %), nausea/vomiting, 8 (16 %), and fatigue, 5 (10 %). Mixed modeling indicated both pain (p<.001) and fever (p<.001) were worsening during the week or spiked prior to HOS/ED/UC visit but various symptom patterns were present for nausea/vomiting and fatigue. Conclusions: Unplanned HOS/ED/UC visits are common, especially for fever and pain and underscore the need for better models of emergent symptom care.
Median Age(range)
61(34–88)
61(40–81)
Male
73 %
71 %
ECOG1
69 %
70 %
3A
14 %
9%
3B
16 %
19 %
4
70 %
72 %
−4.8 %(−33.8to+16.1)
−5.6 %(−32.8to+13.6)
MASCC-0760 Randomized trials in nsclc investigating the selective androgen receptor modulator (SARM) enobosarm to prevent and treat muscle wasting: feasibility and characteristics of patients at baseline J. Crawford2, C.M.M. Prado1, M.A. Johnston3, M.L. Hancock3, J.T. Dalton4, M.S. Steiner5, R.J. Gralla6 1 Nutrition Food and Exercise Sciences, Florida State University, Tallahassee, USA, 2George Barth Geller Professor of Research in Cancer, Duke University, Durham, USA, 3Medical Affairs, GTx Inc., Memphis, USA, 4CSO, GTx Inc., Memphis, USA, 5 CEO, GTx Inc., Memphis, USA, 6Jacobi Medical Center, Albert Einstein College of Medicine, Bronx, USA Introduction: Although muscle-wasting and cancer cachexia occur in >80 % of patients w/advanced cancer, few well-powered scientificallybased trials have been conducted. Using enobosarm(SARM) we have now enlisted 650 patients(pts) w/advanced NSCLC in two phase3 trials. Recent studies indicate major advantages for supportive care in NSCLC at chemotherapy initiation(Temel,NEJM.2010). Objectives: We examine the feasibility of pt enlistment at chemo initiation, the major characteristics of these pts, and trial design for the prevention/treatment of muscle-wasting. Methods: Both double-blind, placebo-controlled, international trials evaluate the effect of enobosarm in NSCLC. ~300 pts w/Stage 3 or 4 NSCLC were randomized in each trial at initiation of first-line chemo(platinum + taxane(Power1) or platinum + non-taxane(Power2) to receive additionally enobosarm or placebo for 5mths. Pts were males and postmenopausal females ≥30y, ECOG ≤1. Co-primary endpoints (Day84) are physical function assessed by stair climb power(SCP) and lean body mass(LBM) by DXA.
Stage
%Wt-loss Docetaxel
8.5 %
Paclitaxel
91.5 %
Gemcitabine
71 %
Pemetrexed
17 %
Vinorelbine
12 %
SCP(watts)
156(26–435)
163(30–485)
LBM(kg/m2) Females
14.5(1.8)
14.8(1.7)
Males
17.3(1.9)
17.2(1.9)
Conclusions: These results indicate it is feasible to enlist pts receiving firstline chemo in trials designed to prevent or treat muscle-wasting/cachexia; their presenting characteristics are typical for NSCLC. Median weight-loss at baseline was 5 %. LBM and SCP were lower than typically observed in healthy individuals indicating significant functional decline before starting chemo for NSCLC. These Phase3 trials will determine the effect of enobosarm on preventing/treating muscle-wasting in NSCLC. MASCC-0761 Serum levels of micronutrients (ferritin, copper, and zinc) in patients with oral cancerous lesions M. Baharvand1, H. Mortazavi1, R. Akkafan1 1 oral and maxillofacial medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran Introduction: It seems serum changes of micronutrients play a role in the pathogenesis of oral cavity malignancies Objectives: The aim of the present study was to determine the serum levels of ferritin, copper and zinc in patients with oral cancerous lesions. Methods: In this cross sectional study, 60 patients (35 men, 25 women) with oral malignancies, and 66 age and sex-matched controls (40 men, 26 women) were selected from patients referred to Cancer Institute of Tehran University of Medical Sciences and Shahid Beheshti University of Medical Sciences Dental School, Tehran, Ir\an. The serum levels of ferritin, copper and zinc were measured by means of Immunoenzymatic Kits (Pad-Tan Elm, Iran for ferritin and Grainer, Germany for copper and zinc) in patients and healthy individuals. SPSS software version 18 and Mann–Whitney U test were used to analyze the data. Results: Serum levels of ferritin (mg/dl) were 267.4±248.45 and 106.1± 72.96 in patients with oral cancer and controls respectively. Furthermore, copper levels (mg/dl) measured as 209.8±160.3 and 114.2±38.7 in the above groups. Finally, serum zinc levels (mg/dl) estimated to be 113.5±52.3 and 64.5±31.5 in the oral cancer patients and controls. The mean serum values of three micronutrients in the cancer people were significantly higher than controls (p<0.001). Conclusions: Serum levels of ferritin, copper and zinc were significantly increased in patients with oral cancer.
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MASCC-0762 A comparison study of symptoms associated with cancer and non-cancer related lower limb lymphedema
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SCC/KA (n=25) 8.68 (3.4)
Verruca (n=87) 5.2 (2.4)
p value
Nodule
6
1
<0.001
Filiform
0
28
Introduction: It is unknown if symptoms experienced by cancer survivors with secondary lower limb lymphedema (LLL) differ from those symptoms experienced by individuals with LLL not related to cancer. Objectives: To compare number of symptoms and symptom intensity and distress among cancer related secondary (CRS), non-cancer related secondary (NCRS), primary, and unknown types of LLL. Methods: A cross-sectional, web-based, descriptive study was conducted in 213 volunteers with LLL. Demographic and lymphedema data were collected. Patients completed the 36-item Lymphedema Symptom Intensity and Distress Scale-Leg. If a symptom was present, intensity and distress were rated on separate 1–10 point scales. Results: CRS (n=37), NCRS (n=45), primary (n=96), and unknown (n=35). The groups differed demographically only on age (p<.001) with primary and unknown type being younger than CRS. Primary and unknown type LLL were more likely to have bilateral swelling (68 % and 56 % respectively) than others (<40 %, p=.001), less likely to have truncal swelling (~35 % vs. 69 % CRS, 53 % NCRS, p = .047), and less likely to perform self-care activities (39 % and 43 % respectively) than others (>55 %, p = .013). Eleven symptoms were present in >50 % of participants in each group. Strongest findings indicated CRS less likely to experience coldness in legs (p = .029), lack of self-confidence (p =.014), and feeling less sexually attractive (p = .049) than other groups. Patterns of intensity and distress from the symptoms coincided with the reported differences in prevalence. Conclusions: Patients with cancer-related LLL experience problematic symptoms that require intervention. However, their symptom experience is somewhat less pronounced than those whose lymphedema is not cancer related.
Papule
16
85
Plaque
3
1
MASCC-0763 Differentiation of benign versus malignant keratinizing skin tumors (KST) induced by BRAF-Inhibitors
MASCC-0764 Sexuality in nursing care for women with gynecological and breast cancer: recognizing the need to recast the assistance
V.R. Belum1, A.C. Rosen1, S. Dusza1, A.A. Marghoob1, M.P. Pulitzer2, A.C. Halpern1, K.J. Busam2, P.B. Chapman3, M.E. Lacouture1 1 Dermatology, Memorial Sloan-Kettering Cancer Center, New York, USA, 2 Pathology, Memorial Sloan-Kettering Cancer Center, New York, USA, 3 Medicine, Memorial Sloan-Kettering Cancer Center, New York, USA
S.M.A. Ferreira1, T.O. Gozzo1, M.S. Panobianco1, A.M. Almeida1 Public Health and Maternal-infant Department, Ribeirão Preto Nursing School University of São Paulo, Ribeirão Preto, Brazil
S. ridner1, M.S. dietrich1 1 school of nursing, vanderbilt univeristy, Nashville, USA
Introduction: BRAF inhibitors induce KSTs which include verrucae or verrucous keratosis (VK), keratoacanthomas (KA) and cutaneous squamous cell carcinomas (cuSCC). These may necessitate interventions, impact QOL and consistent dosing. While most lesions have a benign clinical and histological phenotype (e.g. VK, KA), a minority (KA/cuSCC) exhibit malignant features. Objectives: To describe the clinico-morphological characteristics that differentiate KSTs induced by BRAF-inhibitors. Methods: The clinical, dermoscopic, and histologic features of KSTs (n=112) induced by vemurafenib/dabrafenib/XL281 (BMS908662), were retrospectively analyzed. Features (5) were correlated with histopathology. Pearson’s chi-square, Student’s T-test were utilized. Results: A majority (78 %) of the lesions were benign, whereas larger ones (p=<0.001), those with a central keratin plug (p=<0.001) or ulceration/crust (p=0.04), adherent scale (p=0.02), peripheral erythematous halo (p=0.03), scaly ring (collarette; p=<0.001) corresponded to a KA/cuSCC (22 %). Filiform morphology was exclusive to benign lesions (32 %).
Characteristic Size (mm)
<0.001
Morphology
Keratin structures Mass/amorphous keratin
17 (68.0)
50 (57.5)
0.34
Central keratin plug
14 (56.0)
5 (5.8)
<0.001 0.04
Central ulceration/crust
4 (16.0)
3 (3.5)
Keratin domes/horns
1 (4.0)
11 (12.6)
0.22
Adherent scale
14 (56.0)
26 (29.9)
0.02
Periphery Erythematous halo
13 (52.0)
25 (28.7)
0.03
Scaly ring
17 (68.0)
23 (26.4)
<0.001
Thrombosed vessels within keratin Pathology
17 (68.0)
38 (43.7)
0.03
Verruca/VK
–
83 (95)
–
Verruca with KA features
–
4 (5)
–
KA
6 (24)
–
–
SCC, well-differentiated
9 (36)
–
–
SCC, well-differentiated with KA features - Invasive SCC
10 (40)
–
–
4 (16)
–
–
Conclusions: We identified features that aid clinical differentiation of benign from malignant KSTs. These may be important in minimizing patient morbidity associated with KST treatment and BRAF-inhibitor dose modifications. NA
1
Introduction: In view of the problems faced by women after breast and gynecological cancer, the nursing staff must overcome the obstacles that prevent the approach of sexuality and reassess the care provided. Objectives: To discuss the reformulation of nursing care related to sexuality, in the care of women with gynecological and breast cancer. Methods: A qualitative study was conducted with 16 nursing professionals in two sectors at a university hospital located in the state of São Paulo, Brazil, in 2011. To identify and classify the participants’ answers, Content Analysis was used. Results: According to professionals’ testimonies, the reformulation of the practices requires lineup changes in values, personal and professional, and the recognition of intervention possibilities. The lack of preparation affects the ability of communication and generates an uncomfortable when sexuality emerges in clinical practice. In relation to personal and professional values is necessary that health professionals recognize the importance of sexuality for the individual as well as assume its approach as an assignment. Nursing consultation led sexual health should be included in the planned actions to health care and should be combined with other activities and services. Conclusions: The reformulation that aims undergoes a bold paradigm shift in healthcare. Cultural issues, both personal and professional
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training, must be rethought so that sexuality can be seen as essential to human and present in all life, even in a disease situation.
MASCC-0765 Improved physical functioning is associated with increased lean body mass (LBM): Findings from a phase II trial of the selective receptor modulator (SARM) enobosarm J. Crawford2, C.M.M. Prado1, M.A. Johnston3, M.L. Hancock3, J.T. Dalton4, M.S. Steiner5, R.J. Gralla6 1 Nutrition Food and Exercise Sciences, Florida State Univeristy, Tallahassee, USA, 2George Barth Geller Professor of Research in Cancer, Duke University, Durham, USA, 3Medical Affairs, GTx Inc., Memphis, USA, 4CSO, GTx Inc., Memphis, USA, 5CEO, GTx Inc., Memphis, USA, 6Jacobi Medical Center, Albert Einstein College of Medicine, Bronx, USA Introduction: Muscle wasting and cancer cachexia are common and can begin early in malignancy. This trial was designed to test whether the SARM enobosarm can prevent or treat cancer cachexia and muscle wasting while improving physical functioning. Objectives: To investigate associations between changes in LBM and physical functioning in this enobosarm trial. Methods: This randomized, blinded study assessed enobosarm versus placebo for 16 weeks for muscle wasting and physical functioning. Subjects had a ≥2 % weight loss over 6 months, were males >45 years or postmenopausal females. Diagnoses included NSCLC, colorectal cancer, breast cancer, NHL, and CLL. Endpoints included change in LBM by DEXA scan and physical functioning measured by stair climb power (SCP). A substantially meaningful response in physical functioning was defined as ≥10 % improvement in SCP. We report physical functioning response based on changes in LBM. Results: One hundred fifty-nine patients were enlisted; this analysis focuses on the 90 patients who had DEXA and SCP testing pre- and post-enobosarm/placebo.. Patients with ≥0.25 kg gain in LBM were more likely to have a substantially meaningful response in physical functioning (62 % versus 34 %, p=0.017). These subjects also had improvement in percentage change in SCP, median +12 % versus + 0.8 % (p=0.017). Enobosarm and placebo were well-tolerated; adverse events included fatigue, anemia, nausea and diarrhea. Conclusions: These results demonstrate that even small improvements in LBM are associated with improvements in physical functioning. This finding validates the value of these endpoints in the ongoing Phase III trials with enobosarm directed at treating and preventing muscle wasting.
MASCC-0766 Impact of 5-HT3 receptor antagonist selection on the incidence of delayed chemotherapy induced nausea and vomiting and resource utilization in patients receiving highly emetogenic chemotherapy C. Faria1, L. Lamerato2, J. Jackson3, R. Knoth1, A. Powers1 1 Health Economics and Outcomes Research, Eisai Inc., Woodcliff Lake, USA, 2 Public Health Sciences, Henry Ford Health System, Detroit, USA, 3Global Health Economics and Outcomes Research, Xcenda, Palm Harbor, USA Introduction: The 5-hydroxytryptamine-3 receptor antagonists (5-HT3RA) are recommended for the prevention of chemotherapy-induced nausea and vomiting (CINV), a significant adverse effect of chemotherapy. Objectives: The purpose of this study was to evaluate the impact of 5-HT3 −RA antiemetic selection on the incidence of chemotherapy-induced nausea and vomiting (CINV) and healthcare resource utilization in patients receiving prophylaxis with palonosetron or ondansetron prior to highly emetogenic chemotherapy (HEC) in an integrated healthcare system. Methods: Patients diagnosed with cancer, treated with HEC, and who received either palonosetron or ondansetron were identified in the Henry Ford Health System from the period 7/1/2000 and 12/31/2009. Incidence of
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CINV was defined by a claim for nausea, vomiting, rehydration, and/or use of a rescue antiemetic on days 2–5 after chemotherapy. Health care resource utilization on days 2–5 following chemotherapy was also examined. Results: A total of 553 patients were identified. Of these, 53.3 % were treated with palonosetron and 46.6 % were treated with ondansetron. Patients treated with palonosetron were significantly less likely to experience delayed CINV compared to patients treated with ondansetron (14.9 % vs. 22.9 %, respectively, p=.02). Analysis of resource utilization showed that patients treated with palonosetron vs. ondansetron were also significantly less likely to have a CINV-related visit (18.9 % vs. 29.5 %, respectively, p<.01) and lower CINV-related mean total costs per cycle ($559 vs. $924, respectively, p<.02.) Conclusions: The results showed that patients receiving HEC who received palonosetron were significantly less likely to experience delayed CINV and had significantly lower CINV-related utilization and health care costs than those who were treated with ondansetron.
MASCC-0767 Subjective sleep problems predict survival in 240 patients with metastatic colorectal cancer O. Palesh1, G.A. Bjarnason2, C. Deguzman1, K. Haitz1, S. Giacchetti3, D. Spiegel1, F. Levi3, P. Innominato3 1 Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, USA, 2Division of Medical Oncology Sunnybrook Odette Cancer Centrers", University of Toronto, Toronto, Canada, 3INSERM U 776 “Rythmes biologiques et cancers”, Hôpital Paul Brousse, Villejuif Cedex, France Introduction: Previous studies have highlighted the importance of sleep in cancer patients’ quality of life (QOL). However, no study has evaluated the effect of sleep disruption on other clinical outcomes. Objectives: This study aimed to clarify the relationship between sleep disruption and survival in patients with metastatic colorectal cancer (MCC). Methods: Two hundred forty pts (37.1 % female, mean age=58.5; SD= 11.0) treated for MCC in 1st to 5th line of 5-fluorouracil based chemotherapy completed the QOL Questionnaire (EORTC QLQ-C30). We considered sleep to be disrupted if patients reported little to severe trouble sleeping (scores >0). Multivariate Cox models included age, gender, stage at diagnosis, site of primary tumor, number of metastatic sites, performance status and prior chemotherapy. Results: 65.4 % of the patients sleep disruption according to EORTC QLQ-C30. Patients with trouble sleeping had better overall survival as compared to those without sleep disruption (HR: 1.47 [1.11 to 1.95]; p= 0.008). Respective median survival times (months) were 14.2 [95%CI: 12.3 to 16.1] and 17.7 [10.0 to 25.3]. The survival benefit observed in patients without sleep disruption remained statistically significant after adjustment for other prognostic factors. The final multivariate prognostic model included subjective sleep disruption (HR: 1.49 [1.11 to 2.00]; p = 0.009), number of metastatic sites (p < 0.001), performance status (p=0.023), and prior chemotherapy (p<0.001). Conclusions: Our findings show that patients reported sleep disruption is an independent prognostic factor for overall survival in metastatic colorectal cancer. Future research is needed to determine the mechanisms of sleep disruption and its effect on survival, and whether treatment of sleep disruption can improve survival.
MASCC-0768 Smileon: supporting innovative learning approaches through mobile integration in the workplace—oncology nursing P. Fernandez1, M. Montserrat1, A. Sedano1, A. Company1, M. Markova2, J. Fendrychová3, A. Milani4, K. Lokar5, M. Bernot5, M. Matkovic5, A. Blazeviciene6, A. Vaskelyte6, O. Riklikiene6, S. Kav7, A. Karahan7, E.A. Citak7
Support Care Cancer (2013) 21 (Suppl 1):S1–S301 1 Nursing, Institut Català d’Oncologia, Barcelona, Spain, 2Nursing, National Centre of Nursing and Other Health Care Professions, Brno, Czech Republic, 3 Nursing, National Centre of Nursing and Other Heatlh Care Proffesions, Brno, Czech Republic, 4Nursing, European Institute of Oncology, Milan, Italy, 5Nursing, Institute of Oncology Ljubljana, Ljubljana, Slovenia, 6 Nursing, Lithuanian University of Health Science, Kaunas, Lithuania, 7 Nursing, Baskent University Faculty of Health Sciences, Ankara, Turkey
Introduction: Use of mobile technology can allow the learning process to be facilitated outside and beyond the classroom contexts in which most oncology nursing training currently takes place. Objectives: The aim of the project is to develop a new approach to training using mobile devices to extend learning activity into daily practice. This methodology was supported by a toolkit designed for tablets that use the Android operating system. Using these devices, nurses will be able to communicate in real time in the work place and access relevant content according to their needs. Methods: The project has involved needs analysis, development of appropriate learning methodology and mobile toolkit to support it. The approach will be piloted in each of the partner countries in two steps; first pilot focuses on the validation of the learning approach, the second pilot will also pay attention to exploitation and sustainability issues and the possible extension of the approach to other contexts. Results: Needs analyses performed by semi-structured interview (n=75) and quantitative survey among 201 nurses from Spain, Czech, Italy, Slovenia, Lithuania and Turkey. Pharmacotherapy, acute conditions and procedures in oncology nursing were listed as priority areas for learning. These integrated in a manual describing the approach and example activities to be used in the methodological implementation. The software toolkit, developed initially for Android-based devices. Sixty six nurses from partnering countries were involved into first pilot and have been using the system. Conclusions: Nurses appear to benefit from the opportunity to discuss and explore what they are learning. References: *Funded with support from the European Commission (518383-LLP-1-ES-LEONARDO-LMP)
MASCC-0769 Dental extractions in oncology patients receiving intravenous bisphosphonates. A case series report E. Vardas1, O. Nicolatou-Galitis1, E. Papadopoulou1, D. Galiti2, E. Galitis3, M. Kouri1, E. Razi4, N. Anagnostopoulos5, K. Megalakaki6, D. Bafaloukos7 1Dental Oncology Unit Clinic of Hospital Dentistry, School of Dentistry, Athens, Greece, 2Department of Oral Diagnosis and Radiology, School of Dentistry, Athens, Greece, 3Orofacial Pain Management Clinic, School of Dentistry, Athens, Greece, 43rd Oncology Department, Ygeia Hospital, Athens, Greece, 5Clinic of Hematology, Gennimatas Hospital, Athens, Greece, 6Clinic of Hematology, Metaxa Cancer Hospital, Athens, Greece, 7Clinic of Oncology, Metropolitan Hospital, Athens, Greece Introduction: Dental extractions are reported as the main risk factor for osteonecrosis in patients receiving i.v. bisphosphonates. Objectives: To present the clinical course of 42 dental extractions performed in oncology patients who received intravenous bisphosphonates. Methods: Twenty five patients (mean age 61.8 years) receiving i.v. BPs (mean time of administration 36 months) for multiple myeloma (11), breast cancer (13) and lung cancer (1) were included in the study. Patients were informed about the risk of ONJ and gave their consent. Antibiotics were administered for > week before the extraction and until healing. Local ozone oil applications were performed in 17 patients. Results: Twenty nine extractions were located in the mandible and 13 in the maxilla. All patients received zoledronic acid; 3 patients also received ibandronate or pamidronate. Twenty four dental extractions were performed because of pain, purulence, and tooth mobility compatible with ONJ stage 0. Five extractions were adjacent to ONJ stage II and the lesion
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subsided to stage I. Dental pathology was the cause for 13 extractions. Healing was observed in 35 extractions. Twenty patients did not receive BPs during the extraction and healing period. Patients with ozone oil applications had mean time of healing 4.9 weeks versus 15 weeks in the patients without ozon applications. Mean follow-up was 4.5 months. Conclusions: The high healing rate (35/37, 94.59 %) following the extractions questions the dental extraction as the main risk factor for ONJ.
MASCC-0770 Low level laser therapy for trismus: a report of three cases K. Bektas-Kayhan 1 , D. Ayvalioglu 2 , B. Gokcen-Röhling 2 , G. Karagöz1, U.G.U.R. Erdemir3, M. Ünür1 1 Oral and Maxillofacial Surgery, Istanbul University Faculty of Dentistry, Istanbul, Turkey, 2Prosthodontics, Istanbul University Faculty of Dentistry, Istanbul, Turkey, 3Restorative Dentistry, Istanbul University Faculty of Dentistry, Istanbul, Turkey Introduction: Trismus is a well recognized late side effect of head-neck radiotherapy. The intensity of trismus depends on the dose of radiation and the orofacial structures which are in the radiation field. The pterygoid muscles seems to be the most responsible structures in the field. Objectives: Different therapeutic approaches were tested to solve the trismus. Low level laser therapy (LLLT) is a conservative and cost effective treatment modality with different degrees of success. In this report we would like to focus on three patients with severe trismus and their succesfull treatment outcomes. Methods: The biostimulation of related muscles were performed in 4 courses with diode laser. Each course were 10 days long and between courses 10 days of resting period was left. First course was 320 MPV, 5 joule, 14 s, second course 320 MPV, 6 joule 16 s, third course 320 MPV, 7 joule, 19 s, and the last course 320 MPV, 6 joule, 21 s. Results: First patient had a progression of 7 mm, second patient 3 mm and third patient 5 mm mouth opening which had improved their abilities of speaking, eating and oral hygiene. Conclusions: LLLT is a promising therapy option for head neck cancer patients with trismus. For more reliable and evidence based outcomes its necessary to standardize the interventions for assesment of effect of LLLT in trismus.
MASCC-0771 The psychosocial issues of caregivers in cancer trajectory, a comparative analysis among urban and rural caregivers in central kerala P.S. Satheeshkumar1, M.P. Mohan1, J. Jacob1 1 Oral Medicine, Mar Baselios Dental College, Cochin, India Introduction: Caregivers experience heightened psychosocial issues as comparable to the cancer patients. Objectives: To assess the caregivers’ psychosocial issues in different cancer trajectory stages and comparing among rural and urban population. Methods: Semi structured interview based questionnaire was developed to assess the psychosocial issues’ of caregivers of patients diagnosed as cancer in different stages of cancer trajectory namely diagnostic, treatment, survival and bereavement stage. Twenty five caregivers from an urban population were compared to the 25 caregivers of rural population. Results: The caregiver’s distress was higher in the diagnosed stage in both the urban and rural population, with both the group facing the financial problems as the most worrisome factor. In all other the stages both the urban population and rural population shared similar issues; information needs, side effects of cancer therapy, concern about other family members. Spending too much of his/her time leading to loss of job, cancer coming back was the main issue in the urban population, which was negligible in the rural population. Outcomes over the period (higher
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psychosocial issues ratio [IR], survival versus earliest diagnostic period: 0.62, p<0.0001). (IR, Urban versus rural: 1.47, CI 1.23–1.76). Issues varied according to age group (p<0.001), sex (IR, female versus male: 0.76, 95%CI: 0.72–0.81), Education (IR, rural versus urban: 1.23, CI 1.14–1.30) and socioeconomic status (IR, p<0.02).
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Conclusions: The factors mitigating the role of the difference in the psychosocial issues in population points to the cultural variants and the role of the society. Caregivers experience poor psychological, social, financial and physical well-being when staging cancer trajectories.
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MASCC-0772 Postoperative complications in women with breast cancer after neoadjuvant chemotherapy T.O. Gozzo1, M.A.S. Prado1, T.G. Nascimento1, A.M. Almeida1 1 Public Health and Maternal-infant Department, Ribeirão Preto Nursing School University of São Paulo, Ribeirão Preto, Brazil Introduction: In the treatment of breast cancer, the surgical procedure is of great importance as it makes the local control of the disease, and help to define the indication for adjuvant treatment. Objectives: To evaluate the complications presented by women after surgery for the treatment of breast cancer. Methods: Retrospective study, with analysis of records of women diagnosed with breast cancer submitted to neoadjuvant chemotherapy with epirubicin and docetaxel followed by surgery, between the years 2003 and 2006. Results: Seventy-two files were included, 28 % of women aged between 51 and 55 years and the clinical stage more observed was IIIa (34.7 %). Of the 72 women studied, two were not subjected to the surgical procedure, 14 had conservative surgery, 69 % had no history in their records as the complications and 29,2 % had some type of complications after surgery, and this 10 were obese and three had a diagnosis of diabetes. Complications presented were: eight surgical wound dehiscence; seven wound infection, one skin necrosis; six had seroma formation and four presented hematoma. Conclusions: From the point of view of nursing, the implementation of a formal orientation program on postoperative care to surgical wound, and the use of systematic instrument, designed specifically for outpatient care, are important measures for control and prevention of surgical complications.
MASCC-0773 Phase 2 trial safety profile of single-agent carfilzomib in patients with relapsed and/or refractory multiple myeloma (RRMM) D. Siegel 1 , T. Martin 2 , A. Nooka 3 , R.D. Harvey 3 , R. Vij 4 , R. Niesvizky 5 , A.Z. Badros 6 , S. Jagannath 7 , L. McCulloch 8 , K. Rajangam9, S. Lonial3 1 Myeloma Division, John Theurer Cancer Center at Hackensack University Medical Center, Hackensack NJ, USA, 2Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco CA, USA, 3Winship Cancer Institute, Emory University, Atlanta GA, USA, 4Division of Medical Oncology, Washington University School of Medicine, St. Louis MO, USA, 5Departments of Medicine and Hematology/Oncology, Weill Cornell Medical College, New York NY, USA, 6Greenebaum Cancer Center, University of Maryland, Baltimore MD, USA, 7Hematology and Medical Oncology, Mount Sinai Medical Center, New York NY, USA, 8Onyx Pharmaceuticals Inc., Drug Safety and Pharmacovigilance, South San Francisco CA, USA, 9Onyx Pharmaceuticals Inc., Clinical Science, South San Francisco CA, USA Introduction: Treatment of RRMM is complicated by comorbidities of the disease, many of which can be exacerbated by targeted agents and/or chemotherapy. Carfilzomib is a selective proteasome inhibitor recently approved as a single agent in the US for RRMM. Objectives: Herein, we summarize the integrated safety data from 4 phase 2 trials: PX-171-003-A0, PX-171-003-A1 (both NCT00511238), PX-171-004 (NCT00530816), and PX-171-005 (NCT00721734). Methods: Carfilzomib was dosed at 20–27 mg/m2 intravenously over 2–10 min on days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for all studies except 005 (15–27 mg/m2). Adverse events (AEs) were graded by NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0.
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Results: Safety data were analyzed for 526 patients. AEs ≥ Grade 3 in ≥15 % of patients were thrombocytopenia (23.4 %), anemia (22.4 %), and lymphopenia (18.1 %). Hematologic AEs were common, yet transient. Worsened renal function was reported in 13 % of patients; nearly half of which were transient. While cardiac failure events regardless of causality were reported in 7 % of patients, 73.6 % had a past medical history of cardiovascular events. Dyspnea was the most common respiratory AE (42.2 %); pneumonia was the most common pulmonary infection (12.7 %). While 71.9 % of patients had active peripheral neuropathy (PN) at baseline, new PN was reported infrequently (13.9 % overall). Dose reductions (14.6 %) and treatment discontinuations (14.8 %) due to AEs were infrequent. Conclusions: Single-agent carfilzomib has an acceptable safety profile in heavily pretreated patients with RRMM. The AEs observed in these studies were manageable and resulted in few dose reductions and discontinuations.
MASCC-0774 Risk of unplanned presentations in colorectal cancer (CRC) outpatients (PTS) treated with chemotherapy. A case-crossover design L. Foltran1, P. Ermacora1, G. Aprile1, F. Pisa2, E. Poletto1, G.G. Cardellino1, N. Pella1, M. Giovannoni1, E. Iaiza1, M. Mazzer1, E.S. Lutrino1, L. Ferrari1, M. Casagrande1, G. Fasola1 1 Oncology, University Hospital, Udine, Italy, 2Statistic, University Hospital, Udine, Italy Introduction: Unexpected presentations of cancer pts cause pressure on oncology services. Chemotherapy pts frequently ask for unplanned visits particularly within 4 weeks from last chemotherapy (McKenzie, Support Care Cancer 2011; Aprile, Support Care Cancer 2012). Objectives: This study aimed to evaluate a) the impact of chemotherapy on the risk for unplanned visit, b) causes for unplanned presentation and c) risk factors for hospital admission. Methods: Clinical data of 229 consecutive CRC pts who unplannedly presented between 2006 and 2009 were collected. A case-crossover statistical design was applied to assess the association between exposure to the trigger event (chemotherapy) and the onset of an acute outcome (unplanned presentation) in three time windows (7, 15 and 21 days). A Cox model was used to assess the risk factors for hospitalization. Results: Four hundred sixty-nine unplanned visits were registered. Most of pts (median age 70 years) had ECOG PS 0–1 (80 %) and advanced stage (78 %). 72 % of unplanned presentations occurred within 30 days since last therapy. The most frequent causes for presentation were: pain, fatigue, anorexia, nausea/vomiting and fever. 10 % of unplanned visits resulted in hospital admission, and predictors for hospitalization were number of symptoms >1 and ECOG PS >1. Conclusions: Among CRC pts receiving systemic chemotherapy the risk for unplanned presentations is higher during the 2nd and 3rd week since the treatment. The management of those presentations may be cost- and time- saving and reduce pressure on oncology services. Tab.1 Risk of unplanned presentation according to time window of exposure to chemotherapy
Time window (days)
Early stage OR
95%CI
OR
95%CI
21
3,8
1,4
10,2
3
1,5
5,9
15
3,8
1,4
10,2
1,71
1
2,9
7
0,8
0,4
1,5
0,78
0,5
1,2
Advanced stage
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MASCC-0775 Oral potentially malignant disorders: an overview of more than 20 entities H. Mortazavi1, M. Baharvand2 1 Oral and Maxillofacial Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran, 2Oral and Maxillofacial Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran Introduction: Cancer of the oral cavity accounts for approximately 3 % of all malignancies and found in 270.000 patients annually worldwide. Many oral squamous cell carcinomas develop from potentially malignant disorders (PMDs) which means the risk of malignancy being present in a lesion or condition either during the time of initial diagnosis or at a future date as defined by WHO. Objectives: The aim of this review article was to update and improve the knowledge of healthcare providers about oral PMDs. Methods: In order to achieve a comprehensive information regarding oral PMDs, the key words of precancerous conditions, mouth neoplasms, malignancy, and leukoplakia were searched in all relative databases, search engines, and indexing systems such as Pubmed, Pubmed central, Scopus, Copernicus and Google scholar without any time limitation. All entities were gathered and classified according to their pathogenesis. Results: WHO classified PMDs into two subgroups: a)“precancerous lesion, a benign lesion with morphologically altered tissue which has a greater than normal risk of transforming into malignancy. b)” precancerous condition, a disease or patients’ habit that does not necessarily alters the clinical appearance of local tissues but is associated with a greater than normal risk of precancerous lesion or cancer development in that tissue”. Each category includes several entities, which will be discussed in details Conclusions: Sufficient awareness about signs and symptoms of oral PMDs among healthcare providers and even general population may help reach timely diagnosis as well as better prognosis.
MASCC-0776 From clinical trials to clinical practice: management of adverse events following carfilzomib administration to patients with relapsed and refractory multiple myeloma (RRMM) L. McBride1, C.O. Samuel2 1 John Theurer Cancer Center, Hackensack University Medical Center, Hackensack NJ, USA, 2Lymphoma/Myeloma Center, MD Anderson Cancer Center, Houston TX, USA Introduction: Carfilzomib is a selective proteasome inhibitor with favorable safety and efficacy as a single agent in phase 1 and 2 trials of RRMM. Carfilzomib was recently approved in the United States for RRMM, the treatment of which is challenging due to the heterogeneity of the disease, patient comorbidities, and treatment side effects. Objectives: To provide recommendations on the prevention and management of AEs for patients being treated with carfilzomib. Methods: Clinical trial safety data and nursing clinical practice experience are combined to provide recommendations for adverse event management before, during, and after carfilzomib administration. Results: Prior to carfilzomib treatment, it is necessary to establish a patient baseline profile including evaluation of cardiac and renal function. Many of the more frequently reported AEs such as fatigue, dyspnea, and infections can be prevented with proper prophylactic measures including
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hydration, dexamethasone, and antiviral/antibacterials. During and immediately following carfilzomib administration, infusion-related and injection-site reactions are possible. Hematologic AEs, while common, are generally transient, infrequently dose limiting, and managed with conventional therapies. Carfilzomib-associated renal impairment is not typical, however transient increases in serum creatinine are observed between consecutive doses. Patients with cardiac risk factors should be identified before treatment and monitored. Similar to clinical trials, PN is rarely observed in the clinic. Conclusions: AEs in varying frequencies occur in response to carfilzomib and are generally managed with prophylaxis and routine care. Maximizing carfilzomib efficacy while minimizing AEs and discomfort in patients can be achieved by utilizing the clinical practice experience with carfilzomib presented herein.
MASCC-0777 Neurocognitve dysfunction in newly diagnosed high-grade glioma patients: utilization of standardized computerized neurocognitive battery K. Peters1, S. Woodring1, M.L. Affronti1, A. Desjardins1, T. Ranjan1, G. Vlahovic1, H. Friedman1 1 Medicine, Duke University Medical Center, Durham, USA Introduction: High grade gliomas (HGGs) consist of WHO grade III and WHO grade IV primary brain tumors that are aggressive and are associated with a poor MOS at 1–3 year. Patients not only have an oncologic diagnosis but also a neurological diagnosis that can cause neurocognitive (NC) dysfunction. Objectives: In order to understand NC burden that HGG patients experience, we evaluated NC functioning in newly diagnosed HGG patients using a computerized NC battery. Methods: Eight-two HGG patients were identified and consented. Clinical and demographic information was obtained. NC testing was performed with computerized program CNS Vital Signsâ and included domains of executive functioning, psychomotor speed, verbal and visual memory. Descriptive statistics were performed along with regression analyses to evaluate factors associated with NC function. Mean standardized score for normative age-matched subjects for all NC domains is 100 and lower scores identify poorer NC performance. Results: Sixty-eight (83 %) subjects completed NC testing. Mean age at testing was 56.8 year (sd=12.6 year) and mean educational level was 15.1 year (sd=2.6 year). Majority of patients had a KPS at time of testing≥80 (85 %). Despite high performance status and high educational level, the mean standardized score on domains was below 100 (executive functioning =67.9 (sd =34.3), psychomotor speed=79.8 (sd=28.6), verbal memory=81.8 (sd=24.4), and visual memory= 89.7 (sd=19.9). Performance on NC testing was independent of age, KPS, grade, education, and location. Conclusions: Based on these results, we can conclude that most newly diagnosed HGG patients experience significant NC dysfunction at baseline and NC can be measured using a computerized battery.
MASCC-0778 Treatment and prevention of bisphosphonate-associated osteonecrosis of the jaws: 2009–2012 E. Papadopoulou1, O. Nicolatou-Galitis1, E. Vardas1, T. Sarri1, E. Gatou1, M.C. Kyrtsonis2, P. Repousis3, E. Razi4, I. Athanasiadis5, D. Bafaloukos6 1 Dental Oncology Unit Clinic of Hospital Dentistry, School of Dentistry, Athens, Greece, 21st Department of Propaideutic Clinic of Internal Medicine, Laiko Hospital Medical School, Athens, Greece, 3Clinic of Hematology, Metaxa Cancer Hospital, Piraeus, Greece
Support Care Cancer (2013) 21 (Suppl 1):S1–S301 4 3rd Oncology Department, Ygeia Hospital, Athens, Greece, 52nd Oncology Clinic, Mitera Hospital, Athens, Greece, 6Oncology Department, Metropolitan Hospital, Athens, Greece
Introduction: ONJ if not diagnosed early can seriously affect patients’ quality of life. Objectives: To present our 4-year experience in the treatment and prevention of bisphosphonate-related jaw osteonecrosis and compare it with our experience during 2005–2008. Methods: Two hundred fifty seven patients were evaluated during 2009–2012. Underlying diagnosis was multiple myeloma (48.2 %), breast cancer (26.8 %), lung cancer (8.6 %) and other malignancies. Patients received zoledronic acid (71.6 %) and other bisphosphonates (median time 31.5 months). Ninety patients presented with osteonecrosis. Tooth extraction preceded osteonecrosis in 63.8 % of the cases. One hundred sixty five patients were referred for prevention of osteonecrosis, before/after the initiation of bisphosphonates. Oral care included clinical/rediographic evaluation, patient education and hygiene measures. Results: The 90 osteonecrosis patients (stage 0:33, stage I:24, stage II:27, stage III:6) were treated with long-term antibiotics, continuous or with treatment-free intervals. Ozone oil applications were performed in 24 patients. Today, 13 patients (14.4 %) have healed, 25 (27.8 %) are stable, without pain and 44 (48.9 %) have no pain, but with minor mucosal inflammation. Of the 33 patients with clinical/radiographic signs compatible with ONJ stage 0, 11 progressed to ONJ stage I (3 following dental extraction), 9 healed (4 after dental extraction) and 11 showed partial remission. Of the 165 patients, who were included in the prevention protocol, 164 patients continue their bisphosphonate therapy, while 1 patient developed osteonecrosis (0.6 %) after dental extractions. Conclusions: With increasing knowledge, low prevalence (0.6 %) of osteonecrosis can be achieved, compared with our previous series (2005–2008).
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Objectives: To determine the protective capacity of ACEI, betablockers, and G-CSF against cardiotoxicity in breast cancer patients who received anthracycline and trastuzumab without well-known cardiac risk factors (>70 years old, valvular disease, diabetes, radiation therapy to left breast, and cumulative epirubicin dose >900 mg/m2). Methods: A questionnaire on the usage of ACEI, beta-blockers, and G-CSF in patients with chemotherapy-induced cardiotoxicity (reduced left ventricular ejection fraction [LVEF] <50 % or discontinuance of cardiotoxic chemotherapy due to decreasing LVEF) was sent to 44 institutions. The same questionnaire was sent to matched controls. Patients with well-known cardiac risk factors who received either anthracycline or trastuzumab were excluded from the analysis. Results: Data for 24 patients with cardiotoxicity from 10 institutions and for controls from 7 institutions were obtained. Cardiotoxicity patients without well-known cardiac risk factors were defined as the cardiotoxicity group (n=13). No difference was noted for age, cumulative epirubicin dose, and ACEI and beta-blocker usage between the cardiotoxicity group and the controls. A trend for a higher cumulative dose of G-CSF was evident among the controls (Figure).
MASCC-0779 Determining possible cardiotoxicity risk modifiers (ACEI, Beta-blockers, and G-CSF) in breast cancer patients who received anthracycline and trastuzumab: a case–control study M. Namura1, H. Ishiguro2, K. Yamagami3, H. Abe4, S. Tsuyuki5, A. Yamauchi6, T. Inamoto7, N. Kan8, H. Yoshibayashi1, H. Suwa9, Y. Ichinose10, H. Kato11, N. Shinkura12, M. Toi13 1 Breast Surgery, Japanese Red Cross Wakayama Medical Center, Wakayama, Japan, 2Outpatient Oncology Unit, Kyoto University Hospital, Kyoto, Japan, 3 Breast Oncology, Shinko Hospital, Hyogo, Japan, 4Surgery, Shiga University of Medical Science Hospital, Shiga, Japan, 5 Breast and General Surgery, Osaka Red Cross Hosopital, Osaka, Japan, 6 Breast Surgery, Kitano Hospital, Osaka, Japan, 7Breast Surgery, Tenri Hospital, Nara, Japan, 8Oncology, Kan Norimichi Clinic, Kyoto, Japan, 9Breast Surgery, Hyogo Prefectual Tsukaguchi Hospital, Hyogo, Japan, 10 Breast Surgery, Takatsuki Red Cross Hospital, Osaka, Japan, 11 Breast Surgery, Kobe City Medical Center General Hospital, Hyogo, Japan, 12Breast Oncology, Sawai Kinen Nyusen Clinic, Kyoto, Japan, 13Breast Surgery, Kyoto University Hospital, Kyoto, Japan Introduction: Anthracycline and trastuzumab are associated with cardiotoxicity. On the other hand, randomized clinical trials showed that beta-blockers and angiotensin converting enzyme inhibitors (ACEI) exhibit myocardial protective effects. Preclinical study also suggested that granulocyte colony-stimulating factor (G-CSF) protects cardiomyocytes from mitochondrial damage caused by doxorubicin.
Conclusions: G-CSF might have a cardioprotective effect. A further prospective study, ideally double-blinded randomized, is necessary to confirm this finding.
MASCC-0780 Symptoms and needs of neurooncological palliative care patients—the physicians’ perspective E. Heilmann1, H. Rock1, F. Nauck2, H. Strik1 1 Neurology, Philipps University, Marburg, Germany, 2Palliative Care, Georg August University, Goettingen, Germany Introduction: Symptoms and needs in the terminal phase of life of neurooncological patients and of patients with systemic cancer are different. Objectives: Specific symptoms and distress of neurooncological patients and their caregivers were assessed with a survey among treating physicians. Methods: Forty-six palliative-care physicians of various specializations in out- and inpatient instutions were asked with questionnaires for most frequent symptoms and distress-causing factors during the last phase of life of neurooncological patients.
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Results: Palliative care structures were most often contacted earlier during the course of the disease (48 %) than directly at the beginning of the palliative care phase (39 %). General weakness, pain and nausea were regarded to be the three most frequent general symptoms, followed by therapy-induced symptoms—most often steroid-induced. Paresis, loss of cognitive functions and anxiety were named to be the three most frequent neurological symptoms. Depression was valued to be the most frequent psychiatric symptom, while paranoid symptoms and suicidal tendency were less frequent. The time needed by caregivers was estimated to be more than 20 % or even more than 50 % of the daily awake time. The direct financial burden for families was estimated intermediate, indirect burden as high. Conclusions: The survey presented here indicates a number of specific symptoms during the terminal phase of neurooncological disease with a high incidence of psychiatric symptoms. The financial and time burden of the caring families is estimated intermediate to high. An extension of the survey to a larger number of colleagues and a parallel survey among caregivers is warranted.
MASCC-0781 GSTP1 EXON 5 polymorphism in colorectal cancer outcome using HYB-probe real-time PRC M. Aghajany-Nasab1, S. Samiee2, A. Movahedian3, M. Panjehpour3 1 Biochemistry, Guilan Uni. of Medical Sci., Rasht, Iran, 2Biochemistry, Food and Drug Laboratory Research Center Ministry of Health and Medical Education, Tehran, Iran, 3Clinical Biochemistry, School of Pharmacy and Pharmaceutical Sciences Isfahan University of Medical Sciences, Isfahan, Iran Introduction: Glutathione S-transferases (GSTs) play important role in cellular detoxification (1). The GSTP1 gene encods a protein of 209 amino acids(2). There are ethnic variations in GSTP1 genotypes frequency which were investigated mainly by use of conventional PCR and follow by RFLP(3,4). Objectives: The aim of this study was to evaluate the frequency of of the polymorphisms of GSTP1 result in amino acid substitutions in codons 104 (Ile/Val). GSTP1 single nucleotide polymorphism frequencies were done using probe-based real-time PCR as a one-step and reliable method to compare with other studies. Methods: Genomic DNA was extracted from blood of colorectal cencer and normal individuals and amplified in LightCycler instrument. A set of hybridization probes and melting curve analysis were used for identification of amplified fragments Results: The frequency of GSTP1 Ile/Ile was 21.7 % in left-sided tumors versus 48.7 % in rectal tumors, although it is different but didn’t reach to significant level (X2 =0.55, P value=0.5, df=1).No significant association between the GSTP1 genotypes was shown when tumor sites are considered as a colorectal outcome. No significant trend was observed between GSTP1 Ile/Val genotype and tumor differentiation but there was a trend of increasing incidence of moderately differentiated tumors in GSTP1 Val/Val genotype individuals, OR=3.35, 95%CI=1.05–10.73. Conclusions: GSTP1 may play a role in differentiation of colorectal tumors that need to confirm by further studies. References: 1-Grando JP, Kuasne H. Clin Exp Med 2009; 9:21–8. 2-Griffiths-Jones, S., Khanna. Nucleic Acids Res.2004:, 32; D138– 141. 3-Gurbben M.J.A.L., Braak C.C.M., Nagengast F.M., Peters W. Eur. J. Investigation 2006,36:188–192
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MASCC-0782 Adherence to G-CSF-guidelines to prevent febrile neutropenia—a sample survey in Germany H. Link1, J. Nietsch2, M. Kerkmann2 1 Internal Medicine I, Westpfalz-Klinikum, Kaiserslautern, Germany, 2 MMF, MMF, Dortmund, Germany Introduction: Primary G-CSF prophylaxis after chemotherapy is recommended in guidelines (GL), if the risk of febrile neutropenia (FN) is high (≥20 %), or intermediate (≥ 10 %–20 %) in case of additional risk factors. Objectives: The aim of this sample survey was to evaluate, if G-CSF is used as proposed by GL, to identify determinants of GL implementation and adherence, and to analyze the oncologists’ behavior. Methods: The sample size was calculated at 2 % of the incidence of malignant lymphoma, breast and lung cancer in Germany. One thousand nine hundred twenty-eight patients who had received 3– 9 cycles of chemotherapy with a FN risk ≥10 % were documented. Results:
Adherence to G-CSF GL
FN intermediate risk chemotherapy 1st/2nd/3rd cycles Physicians compliance with the EORTC G-CSF GL in high/intermediate FN-risk, Chemotherapy cycles %
Lymphoma pts %
Lung cancer pts %
Breast cancer pts %
FN high risk chemotherapy 1st/2nd/3rd cycles 71,2/67,9/ 70,8
82,4/77, 8/82,9
11,1/13, 3/15,5
26,8/ 29,3/ 31,2
69,3/ 69,9/ 71,5
84,2/68,9
13,9/ 27,3
76,3/ 67,6
72,6/77, 4/78,3
Conclusions: Patient risk factors are underestimated therefore resulting in a possible underuse of G-CSF. Physicians may underestimate FN risk in pts who have an intermediate risk of FN and they overestimate their adherence to the GL.
MASCC-0783 Quality of life and physical activity in polish breast cancer survivors after 5 years of treatment K. Hojan1, O. Ozga-Majchrzak1, P. Milecki2 1 Of Rehabilitation, Greater Poland Cancer Centre, Poznan, Poland, 2 Chair and Department of Electroradiology, Poznan University of Medical Sciences, Poznan, Poland Introduction: Physical activity is an important factor in prevention many disorders (including cancer). After breast cancer treatment in women is commonly used rehabilitation aimed at reducing the consequences of cancer treatment and improve quality of life. Objectives: An assessment of physical activity and quality of life among polish women over 5 years from breast cancer treatment. Methods: The study was conducted on 88 women (mean age 63,2 years old) after breast cancer treatment. The assessment of physical activity were used by Godin Leisure-Time Exercise Questionnaire and quality of life questionnaires using EORTC questionnaires (QLQC30, QLQ-BR23). Results: 45.6 % of the women resulted in physical activity of low intensity (without fatigue during exercise), most of which were mild exercises (yoga, free fighting, bowling), while moderate exercise group
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ran 25.5 % of women (tennis, swimming, cycling, aerobics). 28.4 % of women did not perform any regular physical exercise. The mean ofTotal Quality of Life scale was 58 points. including functional score of 72 points. Conclusions: Along the time from the end of breast cancer treatment in women lead less physical activity. This may result in reduced assessment the quality of life, especially by reducing the overall functional scale. Therefore, in order to increase cancer prevention and improving the quality of life should be made a regular meeting increasing physical activity in this group of patients. References: Andrykowski MA, Beacham AO, Jacobsen PB. Prospective, longitudinal study of leisure-time exercise in women with early-stage breast cancer. Cancer Epidemiol Biomarkers Prev. 2007;16(3):430–8.
MASCC-0784 Safety and tolerability of lipegfilgrastim in breast cancer patients receiving chemotherapy: an integrated analysis of phase II and III studies O. Gladkov1, R. Elsaesser2, A. Buchner3, P. Bias3 1 Oncology, Chelyabinsk Regional Clinical Oncology Dispensary, Chelyabinsk, Russia, 2Innovative R&D and Biosimilar, Teva ratiopharm, Ulm, Germany, 3Biosimilars, Teva ratiopharm, Ulm, Germany Introduction: Lipegfilgrastim is a long-acting glycoPEGylated granulocyte-colony stimulating factor (G-CSF) under review for the prevention of neutropenia in cancer patients receiving chemotherapy (CTx). Objectives: To report the safety and tolerability findings from an integrated analysis of two Phase II/III studies of lipegfilgrastim versus pegfilgrastim (Neulasta®) in CTx-naïve breast cancer patients. Methods: All patients who received full-dose CTx (doxorubicin 60 mg/m2 + docetaxel 75 mg/m2) and either a single 6 mg s.c. injection of lipegfilgrastim or pegfilgrastim were included in this analysis. The incidence and severity of treatment-emergent adverse events (TEAEs) and those the investigator deemed related to study drug (TEADRs) over all 4 cycles were compared. Results: TEAEs were consistent with the underlying medical condition and administration of CTx. Type, incidence, and severity of TEADRs are provided in the Table. AE category, n (%)
Lipegfilgrastim 6 mg (n=151)
Pegfilgrastim 6 mg (n=155)
· Any TEAE
143 (94.7)
138 (89.0)
· TEADR
46 (30.5)
49 (31.6)
· Serious TEADR
2 (1.3)
1 (0.6)
· Severe TEADR
1 (0.7)
2 (1.3)
· Death due to TEADR
0 (0.0)
0 (0.0)
· Alopecia
120 (79.5)
109 (70.3)
· Nausea
83 (55.0)
76 (49.0)
· Asthenia
42 (27.8)
38 (24.5)
· Neutropenia
30 (19.9)
35 (22.6)
· Bone pain
24 (15.9)
22 (14.2)
· Diarrhea
23 (15.2)
19 (12.3)
Most frequent TEAEs*
*Preferred term ≥15 % in any cohort Conclusions: Lipegfilgrastim has a favorable safety profile consistent with the G-CSF class of molecules and is an acceptable alternative to pegfilgrastim for the prevention of neutropenia in cancer patients receiving chemotherapy.
MASCC-0785 The effect of breast prostheses on changes in paraspinal muscle bioelectrical activity in postmastectomy women K. Hojan1, F. Manikowska2, P.B. Chen2 1 Of Rehabilitation, Greater Poland Cancer Centre, Poznan, Poland, 2Of Pediatrics Orthopedics and Traumatology, Poznan University of Medical Sciences, Poznan, Poland Introduction: External breast prostheses is an important part of improving static and kinematic trunk and shoulder as well as the quality of life in post-mastectomy women. Improper selection is the cause of the disorder of posture and back pain occurrence. Objectives: Assessment of changes in erector spine activity in women after mastectomy and the impact of different types of external breast prostheses on the outside activity. Methods: To the study were included 86 survivors after one side mastectomy. From the study were excluded patients with rheumatic diseases, trauma and spinal metastases. The study of bioelectric activity of muscles of the spine were performed using MyoTrace 400 (Noraxon, US) in accordance with the guidelines of the project SENIAM. Measurements prostheses were made of various weight using functional test for the lumbar spine. Results: With the following months of mastectomy were observed increasing difference between muscle activity on right and left side of erector spine. The introduction of external breast prostheses caused symmetry in bioelectric activity of muscles of the spine. Conclusions: The use of breast prostheses for post-mastectomy women is an important factor in the improvement of static and kinematic body which can significantly reduce the likelihood of postural disorders and back pain. References: 1.Glaus SW, Carlson GW. Long-term role of external breast prostheses after total mastectomy. Breast J. 2009;15(4):385– 393.2.Piot-Ziegler C, Sassi ML, Raffoul W, et al. Mastectomy, body deconstruction, and impact on identity: a qualitative study. Br J Health Psychol. 2010;15(3):479–510.
MASCC-0786 Efficacy and safety of the granisetron transdermal system for chemotherapy-induced nausea and vomiting in elderly patients D. Braccia1, J. Howell2 1 Medical Affairs, ProStrakan Inc, Bridgewater, USA, 2Clinical Development, ProStrakan Inc, Bridgewater, USA Introduction: A previously reported phase 3 clinical study compared the efficacy and safety of a novel transdermal formulation of granisetron (the granisetron transdermal system [GTS]) with oral granisetron for preventing chemotherapy-induced nausea and vomiting (CINV) in patients receiving moderately emetogenic and highly emetogenic multi-day chemotherapy (NCT00273468). Objectives: The objectives of this retrospective analysis were to examine the efficacy and safety of GTS for CINV in various age groups, including elderly patients ≥65 years of age. Methods: This was a phase 3, double-blind, placebo-controlled, noninferiority study. Patients were randomized to oral (2 mg/day, 3–5 days) or transdermal granisetron (one GTS patch, 7 days), before receiving multi-day chemotherapy. The primary endpoint was complete control of CINV (CC; defined as no vomiting and/or retching, no more than mild nausea, and no rescue medication) from chemotherapy initiation until 24 h after the start of the last day’s chemotherapy. Results: A total of 582 patients were included in the preliminary subanalysis; 136 patients ≥65 years of age, 253 patients 50–64 years of
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age, and 193 patients <50 years of age. CC was similar between the GTS and oral treatment groups for all age groups, and was maintained
irrespective of increasing age (Figure). GTS was well tolerated in all age groups, including elderly patients.
Conclusions: Based on a preliminary sub-analysis of a phase 3 study, the GTS was found to be safe and effective in various age groups, including elderly patients ≥65 years of age.
MASCC-0788 Comparison of the transdermal granisetron patch to oral granisetron for controlling chemotherapy-induced nausea and vomiting (CINV) in multi-day chemotherapeutic regimens for breast cancer patients
MASCC-0787 Effects of body mass index on the efficacy and pharmacokinetics of granisetron transdermal system J. Gilmore1, S. Haislip1, D. Braccia2 1 Research Department, Georgia Cancer Specialists, Atlanta, USA, 2 Medical Affairs, ProStrakan Inc, Bridgewater, USA Introduction: Granisetron transdermal system (GTS) is indicated for the prevention of chemotherapy-induced nausea and vomiting in patients receiving moderately or highly emetogenic chemotherapy for up to 5 consecutive days. Objectives: Data from a single-center, open-label, phase 1 study (NCT00868764) and a double-blind, placebo-controlled phase 3 study (NCT00273468) were analyzed to determine effects of body mass index (BMI) on GTS pharmacokinetics and efficacy. Methods: In the phase 1 study, GTS (3.1 mg/24 h) was applied for 7 days; pharmacokinetic testing occurred 8 h after application on Day 1 and for ≤9 days thereafter. In the phase 3 study, patients were randomized to oral (2 mg/day, 3–5 days) or transdermal granisetron (one GTS patch, 7 days), before receiving multi-day chemotherapy. The primary endpoint was complete control of CINV (CC; no vomiting/retching, no more than mild nausea, no rescue medication) from chemotherapy initiation until 24 h after final administration. Results: In the phase 1 study, 30 healthy volunteers were divided by BMI <19.5 kg/m2 in men or <18.5 kg/m2 in women (n=12), 30.0– 39.9 kg/m2 (n=12), and 20.0–24.9 kg/m2 (n=6). No significant correlations were noted with BMI for maximum granisetron plasma concentration (Cmax), area under the concentration-time curve (time 0 to time point of last quantifiable concentration, AUC[0-z]), or average granisetron plasma concentration (Cavg24-168). An on-going subanalysis of the phase 3 study will assess the impact of BMI on CC. Conclusions: BMI does not affect GTS pharmacokinetics. Final results presented in a late-breaking abstract will examine the impact of BMI on GTS efficacy.
A. Brufsky1 1 Hematology/Oncology, UPMC Cancer Center Magee-Womens Hospital, Pittsburgh, USA Introduction: While the granisetron transdermal system (GTS) is as effective as oral granisetron (OG) in controlling multi-day CINV across multiple tumor types, it is not clear if this is also true for individual tumor subsets such as breast cancer. Objectives: To compare the rates of complete control (CC; no vomiting, mild nausea, no rescue medication), complete response (CR; no vomiting, no rescue medication), and need for rescue medication in a post-hoc subset analysis of breast cancer patients using either GTS or OG. Methods: We conducted a randomized, active control, doubleblind, parallel-group, phase 3 study (clinicaltrial.gov identifier: NCT00273468). Patients receiving either moderately or highly emetogenic chemotherapy (emetogenic potential of level 3–5 by Hesketh classification) for 3–5 days were randomized to either GTS (7 day application) or OG (2 mg/day). Data for this analysis were limited to patients with ‘breast’ listed as the primary tumor. Descriptive data are reported. Results: The number of patients with metastatic breast cancer was similar between treatment arms. More GTS patients achieved overall CC and CR than in the OG group. Fewer GTS patients required rescue medication.
N
Complete control
Complete response
Metastatic breast cancer
21/30 (70.0 %)
Rescue medication use 4/30 (13.3 %)
Patch
30
Oral
35
21/30 (70.0 %) 17/35 (48.6 %)
18/35 (51.4 %)
9/35 (25.7 %)
14/35 (40.0 %)
13/30 (43.3 %)
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Conclusions: This post-hoc subset analysis suggests that GTS may be more effective in treating multi-day CINV in breast cancer patients than OG. Statistical analyses for a late-breaking abstract will examine these findings, as well as differences in CINV risk factors (therapy duration, chemotherapy regimen, chemotherapy naivety, age), type and frequency of adverse events, and global satisfaction.
MASCC-0789 Types of quality of life trajectories and related factors in advanced lung cancer patients—exploration the first 6 months QOL from cancer diagnosis Y.H. Lai1, Y.C. Liao2, Y.H. Lee1, W.Y. Liao1, S.C. Shun1, C.J. Yu1, P.C. Yang1 1 College of Medicine, National Taiwan University, Taipei, Taiwan, 2 Department of Nursing, Yuanpei University, Hsinchu, Taiwan Introduction: Quality of life (QOL) is one of the major indicators to reflect cancer patients’ condition. Limited information has been reported about the different types of QOL trajectories. Objectives: Explore the potential types of QOL trajectories in advanced lung cancer patients during the first 6 month of diagnosis and related factors. Methods: A prospective longitudinal study with 4 times of patient assessments (pre-treatment, 1, 3, 6 months from receiving first treatments, T1-T4) was conducted in a medical center in Taiwan. QOL trajectory was measured by the overall QOL item from the EORTCQLQ-C30. Physical function, symptoms, depression, uncertainty and self-efficacy (confidence) in coping with cancer were assessed as potential related factors to predict each QOL. The Latent Class Growth Analysis (LCGA) was used to identify the potential QOL types. Results: A total of 170 patients were recruited with types of QOL trajectories being identified. The first QOL type covered 41.8 % of patients which represented a “declining form moderate level of QOL to lower QOL and then back to moderate levels of QOL”. The second type of QOL covered those patients with higher level of QOL (19.6 %). The third type of QOL represented those patients with “steadily moderate level of QOL (39.6 %). Overall, physical function, pain, poor appetite, uncertainty, depression and self efficacy were those factors identified to most of these different types of QOL trajectories. Conclusions: Tailoring interventions should be applied and tested of their effects on patients with different types of QOL. Acknowledgement National Health Research Institute (NHRI) in Taiwan.
MASCC-0790 Factors contributing to elevated distress in caregivers of individuals with head and neck cancer C.C. Bornbaum1, P.C. Doyle1, K. Fung2, J. Franklin2, A. Nichols2, J. Yoo2 1 Health & Rehabilitation Sciences, The University of Western Ontario, London, Canada, 2Department of Otolaryngology - Head & Neck Surgery, London Health Sciences Centre The University of Western Ontario, London, Canada Introduction: Head and neck cancer (HNC) presents a distinct set of challenges as treatment often results in deficits related to swallowing, communication and participation in daily activities. These challenges may create a crisis for not only those being treated, but also for their caregiver(s). The caregiver often plays a crucial role in the patient’s ability to address myriad concerns related to his/her disease and treatment.
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Objectives: This study investigated the impact of HNC on caregiver quality of life (QOL) and perceived levels of distress. Methods: The study was a cross-sectional, self-report, survey design. Adult participants (n=117) completed questionnaires including the Distress Thermometer to measure distress, and the Caregiver Quality of Life Index—Cancer Scale to measure caregiver-specific QOL. Associations between these outcome measures and caregiver characteristics were assessed. Patient characteristics were used to predict caregiver distress. Results: Elevated distress was observed among 45.2 % of participants and QOL concerns appeared related to elevated rates of caregiver distress (r = –0.533, p = 0.000). Data indicate that perceived level of burden (r = −0.631, p = 0.000) and disruptiveness to one’s life (r = −0.471, p = 0.000) were most distressing for caregivers. Further, caregivers of individuals undergoing active treatment were 5 times as likely to experience distress as those with loved ones not currently in active treatment (OR = 5.206, CI = 1.939–13.977). Conclusions: Our findings support the growing evidence that not only the patient, but also members of his/her family are the appropriate recipients of comprehensive care. Additionally, caregiver distress screening during active treatment of individuals with HNC may provide an effective means of identifying distressed caregivers.
MASCC-0791 Brief behavioral therapy for insomnia (BBT-I) in breast cancer (BC) during chemotherapy: a randomized pilot study O. Palesh1, P. Innominato2, K. Mustian3, M. Janelsins3, E. Neri1, C. Koopman1, D. Spiegel1, G. Morrow3 1 Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, USA, 2INSERM U, Hôpital Paul Brousse, Paris, France, 3Radiation Oncology, University of Rochester, Rochester, USA Introduction: Up to 80 % of cancer patients will experience insomnia symptoms during chemotherapy. Current treatments are sometimes burdensome and sleep medications may have side effects. Objectives: To examine the feasibility and acceptability and preliminary evidence regarding the efficacy of BBT-I, a brief form of Cognitive Behavioral Therapy for Insomnia adapted to BC patients receiving chemotherapy. Methods: Forty-six BC patients (mean age=50, SD=7.9; 67 % Caucasian, 15 % Asian) who reported insomnia symptoms were randomized to either receive BBT-I (2 face to face sessions + 4 phone calls, 6 weeks) or a Sleep Hygiene Brochure (SHB). Patients completed the Insomnia Severity Index (ISI) at baseline, at the end of intervention (6 weeks), and 1-month post-intervention (10 weeks). Results Research: Hierarchical linear modeling analyses showed that patients who received BBT-I exhibited a clinically and statistically significant overall improvement in their symptoms, compared to those receiving SHB at 6 and 10 weeks p=0.027, (Cohen’s d= 0.35 at 6 weeks and d=0.43 at 10 weeks). At 10 weeks, only 12.5 % of the BBT-I still met insomnia criteria, compared to 60 % of the SHB condition. 83.3 % of patients who received BBT-I found it to be helpful for improving insomnia compared to 36.4 % in the SHB condition (p<.001). 80 % of patients who received BBT-I would recommend the intervention to others, compared to 54.6 % who received the SHB (p=0.04). Conclusions: BBT-I is an acceptable and feasible intervention for BC patients receiving chemotherapy that may improve insomnia. Further confirmatory studies are warranted to confirm the efficacy of BBT-I in ameliorating insomnia. NCI K07CA132916.
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MASCC-0792 Chemotherapy-induced peripheral neuropathy: a new treatment option J. Koerber1, T. Vogt.2, B. Kaden3 1 Internal Medicine, Klinik Nahetal, Bad Kreuznach, Germany, 2 Neurology, Klinik und Poliklinik für Neurologie U Mainz, Mainz, Germany, 3Internal Medicine, Klinik Nordfriesland, Sankt Peter Ording, Germany Introduction: Neurotoxic side effects of chemotherapy occur freuquently. Neuropathies cannot be treated and protective treatment strategies have not been effective. Objectives: We developed a new treatment for therapy of drug induced peripheral neuropathy. Methods: A total of 401 cancer patients (28%male, 72 % female, 38.4 % of patients had breast cancer, 22.4 % cancer of GI tract, 12.4 % Lymphoma) after chemotherapy in remission or stable partial remission were included into this prospective study. Patients with other causes of neuropathy were excluded. All patients underwent at admission (day1) and after therapy (day 20) a scripted interview and clinical examination. Patients had symptoms like paresthesias, numbness, tingling or pain in fingers and/or feet. Patients received 6 units of special ergotherapy, physiotherapy, high-frequency transcutaneous etectrical stimulation and alternative cold and warm foot bath in the follwing 2 weeks. Classifcation of results: severe, medium, low and none. Results: 366 of 401 patients underwent all units. (nb/patients,%).
Symptoms
severe
medium
low
none
day 1
306(76.9)
62(15.6)
29(7.3 %)
1
day 20
56(16.7 %)
82(24.4 %)
81(24.2 %)
116(34.6 %)
day 1
79(24.6 %)
101(31.5 %)
51(15.9 %)
90(28 %)
day 20
20(6.3 %)
43(13.6 %)
54(17.1 %)
199(63 %)
Paresthesia
Tingling
Pain day 1
49(13.5 %)
91(25.1 %)
95(26.2 %)
128(35.3 %)
day 20
38(11 %)
62(17.9 %)
59(17 %)
188(54.2 %)
day 1
91(26.1 %)
76(21.8 %)
71(20.3 %)
111(31.8 %)
day 20
23(6.6 %)
67(19.2 %)
107(30.4 %)
152(43.6 %)
Ataxia
Vibratory sensitivity (scale 0–4 are pathologic, 5–8 are normal) decreased in patients toes 166 (41.8 %) at day 1 and 133 (34.4 %) at day 20. Conclusions: Non-drug treatment improves symptoms, ataxia and vibratory sensitivity in patients with chemotherapy-induced neuropathy. References: VerstappenC.P.,(2003): Neurotoxic complications of chemotherapy in patients with cancer. Drugs;63;1549–1653
MASCC-0793 The role of an integrative oncology program in the care of lung cancer patients T. Tran1, G. Kasymjanova1, N. Swinton1, D. Vales1, F. Manceau1, T. Jagoe2, J. Agulnik1 1 The Peter Brojde Lung Cancer Centre, Jewish General Hospital, Montreal, Canada, 2Cancer Nutrition Rehabilitation, Jewish General Hospital, Montreal, Canada
Introduction: Weight loss, fatigue and symptom distress correlate negatively with health-related QoL and functional status in lung cancer patients. Exercise, nutrition, acupuncture and relaxation techniques to maximise potential mind-body interactions and optimise symptom control and function have recently being used. Objectives: We investigated the impact of these modalities in improving symptoms, physical function and well-being in lung cancer patients. Methods: Sixteen patients attending the Peter Brojde Lung Cancer Centre Integrative Oncology clinic were evaluated. Each patient received acupuncture, physiotherapy and instruction in breathing relaxation techniques 1–2 times/week as well as nutritional counselling at baseline. Assessments were performed at baseline, 6 and 12 weeks which included Edmonton Symptom Assessment System (ESAS), 6minute walk test (6MWT), sit-to-stand test (STS) and body weight. Results: Sixteen patients (5 M, 11 F), mean age 62 (47–82) years with histologically confirmed adenocarcinoma (14), squamous carcinoma (1), or sarcomatoid carcinoma (1), stages 1A/2B (7), 3A/3B (6), 4 (3). 8/16 received acupuncture during their treatment. 8/16 after completion of standard treatment. Significant improvement was observed in symptoms of fatigue, strength, overall QoL and well-being (p<0.05). Objective tests showed improvements in mean in 6MWT (from 413 m to 471 m (p=0.005)), STS (from 4.3 s. to 3.4 s. (p=0.004)) and weight (from 69.7 kg to 71.2 kg (p=.039)). Conclusions: Our results show that a multimodal integrated program using nutrition, exercise, acupuncture and relaxation techniques is feasible in a mixed population of lung cancer patients. The improvements are encouraging, but further studies are needed to validate the impact of this approach in patients at different stages of their disease trajectory.
MASCC-0794 YOCAS©® Yoga: improved memory and memory-mediated improvements in fatigue and quality of life (QOL) in a nationwide phase III RCT M. Janelsins1, L. Peppone1, C. Heckler1, L. Sprod2, S. Mohile3, G. Morrow1, K. Mustian1 1 Radiation Oncology, University of Rochester, Rochester, USA, 2 Health and Applied Human Sciences, University of North Carolina, Wilmington, USA, 3Medical Oncology, University of Rochester, Rochester, USA Introduction: Fatigue and cognitive difficulties are related and significant side effects of cancer treatments in which effective interventions are needed. The University of Rochester Cancer Center (URCC) Community Clinical Oncology Program (CCOP) and 23 affiliate CCOPs previously showed that YOCAS©® yoga significantly improved fatigue and QOL in cancer survivors. Objectives: The current analyses assess the effects of YOCAS©® on memory and possible YOCAS©®-mediated effects of memory on fatigue and QOL. Methods: Survivors between 2 and 24 months post adjuvant therapy were randomized to standard care (SC) or YOCAS©® (75 min./session; 2/week for 4 weeks) + SC. YOCAS©® includes breathing exercises, gentle Hatha and Restorative yoga postures and meditation. Participants (N=358, mean age=54, 75 % breast cancer) who provided preand post-intervention data on difficulty remembering things (MD Anderson Symptom Inventory), fatigue, and QOL (FACIT-F) were included. ANCOVA was used to determine the effects of YOCAS©® on memory at post-intervention. Path Modeling assessed mediating effects of memory on YOCAS©®-produced changes in fatigue and QOL. Results: ANCOVA, controlling for demographic, and baseline memory and sleep scores, revealed a significant group effect of YOCAS©® on memory difficulty at post intervention (mean change: Yoga -
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Control=−0.44; p<0.05) representing a 19.2 % improvement in the yoga group compared to a 5.4 % improvement in the control group. Mediation analyses identified changes in memory as a significant partial mediator for improved fatigue (p <0.05) and QOL (p<0.05). Conclusions: YOCAS©® significantly reduces perceived memory difficulty in cancer survivors compared to SC; improved memory partially mediates improvements on fatigue and QOL. References Funding:U10CA37420, K07CA120025
MASCC-0795 Post-traumatic growth and social identification: a longitudinal study on liver transplant patients M. Scrignaro1, F. Sani2, E. Bianchi3, L. Gangeri3, V. Mazzaferro4, M.E. Magrin5 1 Psychology, Università degli Studi di Milano-Bicocca, Milano, Italy, 2 Psychology, University of Dundee, Dundee, United Kingdom, 3Psychology, IRCCS Foundation National Cancer Institute, Milan, Italy, 4Gastrointestinal and Hepato-Pancreatic Surgery and Liver Transplantation Unit, IRCCS Foundation National Cancer Institute, Milan, Italy, 5Psychology, Università degli Studi di Milano-Bicocca, Milan, Italy Introduction: A growing literature documents that positive psychological changes may accompany the experience of cancer (Park et al., 2010) and defines them posttraumatic growth (Tedeschi & Calhoun, 2004). Further a recent literature on social identification and health (Haslam, 2009) highlighted the role of social capital as resilience resources. Objectives: The aim was to verify the presence of growth in a group of liver transplant patients, Further, the casual relationship between the PTG scores and the social identification with liver transplant people has been tested. Methods: A longitudinal study was conducted with a group of 170 liver transplant patients. Data were collected by means of a written questionnaire, at two time points (T1 and T29 that were 24 months apart. The questionnaire was composed by the Post-traumatic Growth Inventory (Tedeschi, Calhoun, 2004), and by the Family In-group identification scale (Doosje et al., 1995). Results: Results show that the 35 % of patients grew highly and the 35 % grew moderately. The positive changes included an increased appreciation for life, an increased sense of personal strength, changed priorities, and a richer existential life. Further, we tested a cross-lagged model including PTG T1 and T2, and family identification T1 and T2, using structural equation modelling. This revealed an excellent fit of the model: χ2 (1)=.91, ns; CFI=1.00; RMSEA=.00, and confirmed that PTG exerted a significant effect on family identification over time but not viceversa Conclusions: The growth’s process fosters a crucial social resilience resources highlighting its salutogenic nature.
MASCC-0796 Parenteral nutrition surveyx R. Simanek1, K. Nestor2, F. Bozzetti3, M. Chasen4, K. Fearon5, A. Jatoi6, S. Lundstöm7, M. Muscaritoli8, Y. Orrevall9, H. Watzke10, F. Strasser2 1 5th Medical Department with Oncology and Palliative Care Unit, Hietzing Hospital, Wien, Austria, 2Department of Internal Medicine and Palliative Care Centre, Kanton Hospital St. Gallen, St. Gallen, Switzerland, 3Faculty of Medicine, University of Milan, Milan, Italy, 4 Division of Palliative Care, University of Ottawa, Ottawa, Canada,
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Department of Clinical Surgery, University of Edinburgh, Edinburgh, United Kingdom, 6Department of Medicine, Mayo Clinic, Minnesota, USA, 7Department of Palliative Medicine, Stockholms Sjukhem Foundation, Stockholm, Sweden, 8Department of Clinical Medicine, Sapienza University of Rome, Rome, Italy, 9Department of Clinical Science Intervention and Technology, Karolinska Institute, Stockholm, Sweden, 10Department of Internal Medicine I, Medical University of Vienna, Vienna, Austria Introduction: The role of parenteral nutrition (PN) in patients with incurable cancer and malignant bowel obstruction remains controversial. Objectives: We aim to investigate current practice of PN by surveying selected groups from ESMO (ESMO-designated centers of integrated oncology & palliative care), MASCC (nutrition working group), ESPEN (special interest groups PN and cachexia) and EAPC. Methods: Internet-based survey of clinicans with substantial involvement in decisions on PN in patients with malignant bowel obstruction. Two comprehensive case-vignettes explore participants’ views about indications for and goals of PN, their current practice (e.g., application, monitoring, setting), and outcomes. The analysis of the 113 categorical and open questions is descriptive. Results: Between December 2012 and October 2012 the survey was accessed 143 times, 81 participants (56.6 %) completed the survey. Most of the participants were medical oncologist (34.5 %), palliative medicine specialists (26.4 %) and nutritionists (17.3 %) with a large experience treating patients with incurable cancer disease (> 10 years, 81.7 %). Frequently named conditions to decide about starting PN were knowledge about patient preferences (>90 %), life expectancy (>80 %), followed by physical function and comorbidities. As life expectancy (>3 months, 73 %) and Karnofsky Index (>50, 89 %) the definition of cachexia stages supported up to 66 % of the participants in their decision on PN, only 14 % would deliver PN in patients with refractory cachexia. Sixty percent ranked quality of life improvement as very important goal of PN, infections are the most common expected side effect (by 61 %). Conclusions: Our data will allow catalyzing data-driven consensus processes leading to updated, multiprofessional guidelines.
MASCC-0797 Trajectories of social isolation in adult survivors of childhood cancer A.F. Howard1, J. Tan de Bibiana1, K. Smillie1, K. Goddard2, S. Pritchard3, R. Olson4, A. Kazanjian1 1 School of Population and Public Health, University of British Columbia, Vancouver, Canada, 2Department of Radiation Oncology, BC Cancer Agency, Vancouver, Canada, 3 Division of Hematology/Oncology, BC Children’s Hospital, Vancouver, Canada, 4Department of Surgery, University of British Columbia, Vancouver, Canada Introduction: Long-term childhood cancer survivors may be at increased risk for poor social outcomes as a result of their cancer treatment, as well as physical and psychological health problems. Yet, important challenges, namely social isolation, are not well understood. Moreover, survivors’ perspectives of social isolation as well as the ways in which this might evolve through young adulthood have yet to be investigated. Objectives: The purpose of this research was to describe the trajectories of social isolation experienced by adult survivors of a childhood cancer.
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Methods: Data from 30 in-depth interviews with survivors were analyzed using qualitative, constant comparative Methods. Results: Experiences of social isolation evolved over time as survivors grew through childhood, adolescence and young adulthood. Eleven survivors never experienced social isolation after their cancer treatment, nor to the present day. Social isolation among 19 survivors followed one of three trajectories; (1) diminishing social isolation: it got somewhat better, (2) persistent social isolation: it never got better, or (3) late and progressive social isolation: it hit me later on. Conclusions: Knowledge of when social isolation begins and how it evolves over time for different survivors is an important consideration for the development of interventions that prevent or mitigate this challenge.
MASCC-0798 The attitudes of cancer patients about morphine usage for pain management D. Çolak1, A. Oguz2, D. Yazilitas3, G.I. Imamoglu1, M. Altinbas1 1 Medical Oncology, Diskapi Yildirim Beyazit Education and Reserach Hospital, Ankara, Turkey, 2Medical Oncology, Kayseri Education and Research Hospital, Kayseri, Turkey, 3Medical Oncology, Konya Education and Research Hospital, Konya, Turkey Introduction: Pain is a highly prevalent symptom and often a cause for severe distress in patients with cancer. In management of cancer pain, opioids have a special role. Objectives: In Muslim majority countries opioid usage for pain management is low. Obstacles preventing opioid usage for pain management are not well defined. In this study we aimed to study the attitude of the cancer patients about morphine usage for pain management and the factors that influence their decision to accept or refuse morphine to treat cancer pain. Methods: Cancer patients were questioned if they had pain or not, the severity of the pain, their knowledge about morphine, what would be their decision if morphine was needed for pain management and their reasons if they were against to morphine usage. Results: Of 488 patients, 217 had breast, 97 colorectal, 63 gastric, 37 lung cancer. The stages were; 180 early stage, 130 locally advanced and 171 metastatic.
The age (0,010) and the gender (0,038) and the knowledge about morphine had a statistically significant effect onthe preference of the patients (p=0,000). The patients who definedmorphine as narcotic were less likely to use morphine (p=0,015). There was no relationship between the patients’ preference and the diagnosis (p=0.247), the stage (p=0,552), the education status (p=0,112) and the pain. Conclusions: The risk of addiction to opioids remains a major obstacle preventing effective pain management.
MASCC-0799 Impact of socioeconomic status (SES) on the relationship between physical activity (PA) and sleep among children with cancer A.D. Orsey1, T.L. Ruiz BS2, D.B. Wakefield MS3 1 Hematology/Oncology, Connecticut Children’s, Hartford, USA, 2 Clinical Trials Unit, Connecticut Children’s, Hartford, USA, 3Center for Public Health & Health Policy, University of Connecticut Health Center, Farmington, USA Introduction: Compared to healthy children, pediatric oncology patients have impaired sleep and less PA. Greater PA is associated with improved sleep. Objectives: To examine the relationship of SES with sleep and PA measures in pediatric oncology patients. Methods: Between 11/12/09 and 01/03/13, 45 pediatric oncology patients between 8 and 18 years of age completed the study. PA and sleep were assessed by actigraphy and diaries collected over 7 days. Fatigue was assessed using the Fatigue Scale1. SES was assessed by primary payer status: Medicaid (n=16) or private (n=28), and zip code median annual household income: <$70 K (n=20) and >=$70 k (n= 25). Kruskal-Wallis tests evaluated the differences in sleep variables, fatigue, and PA by SES. Results: Participants consisted of 28 children (8–12 year) and 17 adolescents (13–18 year). Children in the lower income group had lower 24-hr fatigue and lower 7-day fatigue scores than those in the higher income group. The difference in parent fatigue scores by income neared significance (p=.07). There were no differences in fatigue scores by insurance. Although there were no differences in PA by income, children on Medicaid had significantly higher PA. Table 1: Differences in Physical Activity and Fatigue by SES
Income
Insurance
Variable mean (SD)
< 70 K (n=20)
≥ 70 K (n=25)
P-Value
Medicaid (n=16)
Private (n=28)
24-hr Fatigue Score
32.96 (10.58)
39.71 (10.82)
0.04
35.19 (11.69)
37.30 (10.90)
0.31
7-day Fatigue Score
33.27 (12.28)
39.32 (9.62)
0.03
34.92 (14.64)
37.28 (9.07)
0.19
Total AC
311,273.67 (91,302.70)
272,570.94 (110,117.71)
0.24
343,620.25 (85,510.91)
261,061.08 (102,482.39)
0.01
Average AC/min
385.99 (112.20)
320.16 (118.35)
0.10
418.35 (108.14)
312.65 (110.36)
0.004
Maximum AC
2645.29 (755.35)
2,312.46 (808.40)
0.22
2,805.30 (758.15)
2263.27 (773.21)
0.05
Conclusions: Pediatric oncology patients of lower SES had lower fatigue and higher PA scores. Since SES was not related to sleep quantity or quality, it does not explain the relationship between PA and sleep. Future randomized studies investigating biomarkers are needed to understand the relationships between sleep, PA and fatigue. References: 1. Hockenberry MJ, Hinds PS, Barrera P, et al. Three instruments to assess fatigue in children with cancer: Journal of pain and symptom management 2003;25:319–28.
P-Value
MASCC-0800 Correlation between measures of frailty and muscle mass in patients with newly diagnosed pancreatic cancer H. Holmes1, M.H.G. Katz2, M.A. Khalil3, J.K.A. des Bordes1, N. Parker2, R. Luo4, A.B. Cooper2, V. Gottumukala5, D.R. Fogelman3 1 General Internal Medicine, UT MD Anderson Cancer Center, Houston, USA, 2Surgical Oncology, UT MD Anderson Cancer Center, Houston, USA
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3
Gastrointestinal Medical Oncology, UT MD Anderson Cancer Center, Houston, USA, 4Biostatistics, UT MD Anderson Cancer Center, Houston, USA, 5Anesthesiology & Perioperative Medicine, UT MD Anderson Cancer Center, Houston, USA
knowledge among professionals is essential for prevention and early diagnosis of BRONJ. Dental schools must act as reference centers and participate in the multidisciplinary care of bisphosphonate users.
Introduction: Sarcopenia is associated with an increased risk of mortality in pancreatic cancer. Sarcopenia is a key feature of the frailty syndrome, which is also characterized by weight loss and exhaustion. Objectives: We determined whether the frailty or measures of muscle function (gait speed and grip strength) were associated with objective measures of muscle mass in pancreatic cancer. Methods: We enrolled consecutive patients with newly diagnosed, previously untreated pancreatic cancer. We evaluated patients for Fried’s criteria (grip strength, gait speed, weight loss, exhaustion, and physical activity). Baseline CT scans were used to calculate muscle mass at L3 in cm2, using Slice-o-Matic software, and corrected for body surface area. We used Spearman’s test to determine whether the Fried’s criteria score (0 to 5), grip strength, or gait speed correlated with adjusted muscle mass. Results: Among 82 patients with pancreatic cancer and available muscle data, the mean age was 63.5 (+/−10.7) years, 28 % were female, 46 % had metastatic disease, 89 % had ECOG 0 or 1, and 77 % had at least 1 comorbidity; 21 (25.6 %) were frail. Fried’s score and grip strength correlated with muscle mass (r = −0.25, P= 0.02 and r = 0.64, P= 0.0001, respectively). Neither gait speed nor ECOG performance status correlated with muscle mass. Conclusions: Frailty indices, and grip strength in particular, may be used to identify sarcopenia in pancreatic cancer patients. Further study is underway to determine the prognostic significance of frailty and sarcopenia.
MASCC-0802 The analysis of the patients taking opioids with diagnosis of lung or gastric cancer
MASCC-0801 The occurence and treatment of biphosphonates related osteonecrosis of the jaws in a Brazilian Dental School L. Mathias-Duarte1, H.B. Reis2, D.L. Cortizo2, L.L. Dib1 1 Stomatology, Paulista University, São Paulo, Brazil, 2Implantology, Paulista University, São Paulo, Brazil Introduction: Bisphosphonate-related osteonecrosis of the jaws (BRONJ) is an adverse effect of drugs used to treat bone metabolism diseases, such as osteoporosis and bone metastases. Objectives: The aim of the study was to evaluate the clinical characteristics and evolution of BRONJ cases that were diagnosed and treated at a dental school. Methods: The Stomatology clinic archives of the School of Dentistry at the Paulista University (UNIP) for the period from January 2004 to December 2011 were reviewed in search of records of cases diagnosed with osteonecrosis of the jaws caused by bisphosphonates. Results: Thirteen patients met the criteria of the study among a population of 2342 patients with oral lesions. Of the 13 patients, 12 were females. Ten were intravenous bisphosphonate users, and nine had breast cancer as the primary disease. Eight mandibular cases were observed. Eight patients interrupted the use of the bisphosphonates temporarily during the treatment. Surgical treatment was conducted in 10 patients, which was associated with platelet-rich plasma in six cases, which led to a regression to Stage I in 50 % of these and cure in 33.3 %. Of the total sample, four (30.8 %) cases were cured, six (46.1 %) regressed to Stage I, and three (23.1 %) remained in Stage II after treatment. Dental rehabilitation occurred in seven patients. Conclusions: Orientation and dental care on cancer patients is important once they are known as users of bisphosphonates drugs. Dissemination of
M. Altinbas 1 , O. Aydin 2, D. Colak1 , U. Ersoy1 , S. Urvay 1, I. Hacibekiroglu1, G.I. Imamoglu1, E. Sari1, N. Kose1 1 Medical Oncology, Diskapi Yildirim Beyazit Education and Research Hospital, Ankara, Turkey, 2Internal Medicine, Diskapi Yildirim Beyazit Education and Research Hospital, Ankara, Turkey Introduction: Pain management is very important in comprehensive cancer care. Pain itself may cause hospitalization or expand the duration of hospitalization. Objectives: We analyzed the duration of hospitalization of lung or gastric cancer, in the focus of opioids. Methods: Between June-December 2012, totaly 490 patients were hospitalized in our clinic. Of them, 45 were lung cancer and 81 were gastric cancer. The electronic records and the files of these patients were examined. The analysis of the data was done with SPSS 18.0 Results: Of 45 patients with lung cancer, 23 were taking oral tramadol (50–200 mg/day), 10 fentanyl TTS (25–200 microgram/72 h) and 2 parenteral morphine. Of 81 patients with gastric cancer, 12 were taking oral tramadol (50–200 mg/day), only 1fentanyl TTS (125 microgram/72 h). The median duration of hospitalization was 6.9±4.9 days in the patients who were not taking opioid analgesics and 8.8±5.7 days in the patients taking opioids (p=0.061). The duration of hospitalization was longer in patients taking fentanyl TTS than taking tramadol (12.4±6.5 vs 7.3±4.6; p=0.011). When we looked at the morphine equivalance of the opiods they were taking we found that the duration of hospitalization in patients taking more than 100 mg/day oral morphine equivalance were longer than the others (12.4±7.2 vs 7.7±4.6; p=0.029). There was no difference in the duration of hospitalization between patients taking fentanyl. Conclusions: In our study we found that the gastric or lung cancer patients who were taking high dose opioids were hospitalized longer than the others.
MASCC-0803 Post-operative pain management after single port laparoscopic oncologic surgery S.W. Byun1, K. Lee1, J.S. Park1 OBGYn, Catholic University of Korea, Seoul, Korea
1
Introduction: As a minimally invasive surgery, single port laparoscopic surgeries (SPLS) were introduced in many of oncologic surgery. Post-operative pain would be reduced by means of SPLS, but compared to single port laparoscopic benign surgery, property of postoperative pain management was not accessed in single port laparoscopic oncologic surgery. Objectives: We are aim to show the post-operative pain management after SPLS for ovarian cancers. Methods: Cases of SPLS for ovarian cancer and borderline tumor were retrospectively reviewed in term of postoperative pain control and prescription patterns of pain killer in oncologic surgeries were compared to that in benign surgeries. Results: Seven SPLS for ovarian cancer and 26 for ovarian benign tumor were compared. All of subjects were received IV patient-
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controlled analgesia. Additional IV pain killer were needed in 5 out of 7 oncologic and 17 out of 26 benign surgeries. But duration of PO pain killer was shorter in oncologic surgery compared to benign surgery (1.6 days vs. 1.9 days). Conclusions: Post-operative pain control after single port laparoscopic oncologic surgeries were varied and were not adequately transferred to the patients compared to that for benign disease. Considering the operative field in oncologic surgery, prescription patterns of pain killers should be modified to relief the postoperative pain.
MASCC-0804 Do healthcare professionals and the public understand the same when it comes to palliative sedation? E. López-Romboli 1 , J. Porta-Sales 1 , S. Llorens-Torrome 1 , J. Gonzalez-Barboteo1, A. Calsina1 1 Palliative Care Service, Institut Català D’Oncologia-IDIBELL, Hospitalet de Llobregat, Spain Introduction: Palliative sedation (PS) has been defined by professional bodies, but there’s a sense that it doesn’t coincide with the public perception. Objectives: Describe and compare beliefs about PS of health professionals [HP] and non-health professionals [NHP] regarding PS, as defined by the Spanish Society of Palliative Care (SECPAL). Methods: We developed a self-administered questionnaire, using the current SECPAL’s definition and gave it to HP and NHP. Results: We included 100 HP (doctors, nurses) and 149 NHP (relatives of patients, public). All HP and 80.7 % of NHP (P<0.0001) had heard of PS, and 25.6%of the latter knew it as “sedation before death”. Degree of agreement was 76.7 % for HP and 55.9 % for NHP. Main points of disagreement were: HP) NHP11.2 % and4% HP believe that PS is intended to provide a quick and painless death, b) 54 % of NHP believe that the PS should be administered only for physical suffering and 36.2 % for physical and emotional suffering. 82.2 % of HP believe it should be used for both. c) PS must be requested by the patient or family (22.1%NHP vs 9.1 % HP), and the consent of patient and family, even in autonomous patients (30.9 % vs NHP 24, 8 % of HP). HP & NHP believe sedated patients don’t suffer, and PS isn’t euthanasia. Conclusions: PS is widely known within this sample, confirming the disagreement between HP and NHP regarding SECPAL definition. Most think that patients don’t suffer.
MASCC-0805 Adherence to antiemetic guidelines in patients with malignant glioma: translating evidence into practice M. Affronti1, S.M. Schneider2, J.E. Herndon II3, S. Schlundt4, K.B. Peters1, A. Desjardins1, T. Ranjan1, S. Cheshire1, C. Cone1, K. Kalinowski1, J.Y. Kim1, H. Lay1, V. Poillucci1, C. Southerland1, J. Tetterton 1, D. Levacic 1 , S. Lindhorst 1, J.J. Vredenburgh1 , H.S. Friedman1 1 Surgery, Duke University Medical Center, Durham, USA, 2Duke School of Nursing, Duke University Medical Center, Durham, USA, 3 Statistics, Duke University Medical Center, Durham, USA, 4Health System Technology, Duke University Medical Center, Durham, USA Introduction: Poorly controlled chemotherapy-induced nausea and vomiting (CINV) reduce cancer treatment efficacy and significantly impair quality of life (QOL). Review of the Duke Brain Tumor
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Center’s usual practice demonstrates a high CINV incidence (45 %), despite short-acting 5-HT3 serotonin receptor antagonist (5-HT3-RA). National Comprehensive Cancer Network’s evidence-based guidelines recommend combining a long-acting 5-HT3-RA (palonosetron) and dexamethasone for the prevention of acute/delayed CINV with moderately emetic chemotherapy (MEC). Low guideline adherence (58 %) explained our high CINV incidence. A project was implemented to improve adherence to evidenced-base guideline antiemetic ordering by providers for glioma patients treated with MEC. Objectives: To determine if a combination intervention including (a) an education session, (b) risk assessment tool with (c) computerized standard guideline order-sets with a monthly audit-feedback strategy improves the primary outcome: Adherence rate to guideline order-sets. Secondary outcomes: CINV complete response (CR- no emesis, or rescue antiemetic) rates; QOL. Methods: A one-sample study design to compare historical and postintervention adherence rates was conducted to detect a difference between a 60 % and 80 % order-set adherence and CINV CR rate. Validated tools assessed QOL: Osoba, FACT-BR/FACIT-Fatigue. Results: Adherence to MEC antiemetics guideline increased significantly, to a sustained 90 % (55/61 order-sets; 95 % CI: 80, 96; p<0.05). The acute (1 day post-treatment) and delayed (2–5 days post-treatment) CINV CR rate significantly increased to 75 % and 84 % of patients, respectively. QOL was maintained. Conclusions: A combination intervention and audit-feedback strategy to translate evidence into an oncology practice improves and sustains antiemetic guideline adherence, nausea/vomiting efficacy, and preserves QOL.
MASCC-0806 Functional assessment in patient’s undergone treatment for odontogenic tumors P.S. Satheeshkumar1, M.P. Mohan1, A. Balan2 1 Oral Medicine, Mar Baselios Dental College, Cochin, India, 2Oral Medicine, Government Dental College, Trivandrum, India Introduction: Quality of life (QoL) is an important outcome in patient’s undergoing treatment for odontogenic tumors which is as comparable to malignant tumors of head and neck cancer. There is an increase in need for assessment of functional outcome in head and neck odontogenic tumors.To monitor the QoL in these patients we are assessing the functional outcome with the Malayalam FACT-H&N. Objectives: To assess the functional outcome of patient’s undergone treatment for odontogenic tumors with the Malayalam FACT-H&N. The goal was to identify patients’ highest symptoms. Methods: Ten personal interviews were conducted in order to explore patients’ opinions about the scale and its items in detail. The questionnaire was administered to 52 patient’s undergone treatment for odontogenic tumors. They were asked to respond to each statement in terms of their own degree of agreement or disagreement. Typically, they are instructed to select one of five responses: strongly agree, agree undecided, disagree, or strongly disagree. Results: The FACT-H&N subscales and total score demonstrated good internal consistency (0.82–0.91). Most scores also demonstrated good responsiveness. Significant associations were observed. Associations were observed between subscales measuring physical and functional areas of performance, social functioning, and emotional well-being. Related symptoms endorsed as high priority by patients were selected. Overall, the FACT-H&N was a valid measure for monitoring QoL over time in patients with odontogenic tumors. Conclusions: The FACT-H&N meets or extends all requirements for use in odontogenic tumors trials, in responsiveness of administration, reliability, validity, and adaptation in clinic
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MASCC-0807 Addressing the needs of cancer patients and caregivers through multi-disciplinary psychosocial interventions
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CACS. Of 41 % who completed at least 1 PRO survey, 13 % reported severe loss of weight or appetite. Table – Weight loss 3 or 6 months after diagnosis
P.J. Atherton1, M.I. Lapid2, T.A. Rummans3, M.M. Clark4, J.A. Sloan1 1 Health Sciences Research, Mayo Clinic, Rochester, USA, 2Psychiatry and Psychology, Mayo Clinic, Rochester, USA, 3Psychiatry, Mayo Clinic, Rochester, USA, 4Phychology, Mayo Clinic, Rochester, USA Introduction: Cancer patients experience symptom and quality of life (QOL) challenges. Caregivers experience associated burdens. Objectives: This report describes a Mayo Clinic Comprehensive Cancer Center ten-year program of research utilizing multi-disciplinary interventions to improve QOL and alleviate burden Methods: Multi-disciplinary psychosocial interventions were designed to address key patient QOL deficits and were tested in two randomized clinical trials with the primary endpoint being overall QOL postintervention (4 weeks). Secondary endpoints were various QOL domains. Intervention content was refined utilizing systematic reviews of literature, study results, and patient feedback. Caregiver needs were identified. A caregiver-specific 6-session intervention is in development based on a supplementary survey assessing burden and benefits or barriers of using technology as a resource to enhance wellness and facilitate caregiving. Results: Study 1 (JCO, 2006) provided 8 intervention sessions to 103 evaluable patients (49 Intervention, 54 Standard care). Intervention patients showed improvements in overall QOL (p=0.047) and spirituality (p=0.003) at week 4. Study 2 (Cancer,2013) utilized 6 sessions and enrolled 117 evaluable patient/caregiver pairs (54 Intervention, 63 Standard care). Patient overall QOL (p<0.01), physicality (p<0.01) and functionality (p=0.04) were maintained at 4 weeks, as was caregiver spirituality (p=0.048), mood (p=0.02) and adaptation (p=0.01). The current caregiver intervention proposal (Study 3) will be delivered via a web-based application, as indicated per caregiver survey responses, and will be tested in a subsequent clinical trial. Conclusions: Multi-disciplinary interventions are an effective strategy to improve patient QOL and caregiver burden, and technology holds promise for its electronic delivery in the future.
MASCC-0808 Cancer anorexia-cachexia syndrome (CACS) is under-recognized among patients with metastatic non-small cell lung cancer (MNSCLC) A. Benner1, B. Hirsch1, A. Abernethy1 Duke Clinical Research Institute, Duke University Medical Center, Durham, USA 1
Introduction: CACS is a debilitating condition that negatively impacts the quality of life and prognosis of cancer patients. Despite its severity, CACS is widely under-recognized. Objectives: Determine the prevalence of CACS in mNSCLC population using established clinical criteria. Methods: A retrospective study of patients diagnosed with mNSCLC between 5/2007–11/2010 at Duke University was conducted regarding the prevalence of CACS including (a) weight loss ≥5 % or BMI <20 and weight loss >2 % within 6 months of diagnosis, (b) ICD-9 codes of CACS, (c) self-reported severe loss of weight or appetite via patient reported outcomes (PRO) or (d) medications prescribed to treat CACS (dronabinol, megesterol, somatropin, oxandrolone). Records of identified mNSCLC patients were queried to collect data at predetermined time points. Results: Of 495 patients with mNSCLC, 215 had weight documented at diagnosis, 3 and/or 6 months (Table). 49 % of these met one of the weight criteria for CACS. Of the overall cohort, 22 % were assigned ICD-9 codes of CACS and 5 % were prescribed medications to treat
3 months
6 months
Weight loss >5 %
42 %
39 %
BMI <20 & Weight loss >2 %
8%
6%
Conclusions: CACS in patients with mNSCLC is under-diagnosed. Limitations to the study include variable documentation, a single institution perspective, and the retrospective approach. Earlier recognition of CACS and effective interventions may improve quality of life of cancer patients.
MASCC-0810 Nausea and disturbed sleep as predictors of cancer-related fatigue in breast cancer patients A.R. Peoples1, C.E. Heckler1, J.A. Roscoe1, C.S. Kamen1, L.J. Peppone1, K.M. Mustian1, M.C. Janelsins1, D.F. Moore2, C. Coles3, K.L. Hoelzer4, J.P. Williams1, G.R. Morrow1 1 Radiation Oncology, University of Rochester Medical Center, Rochester, USA, 2Internal Medicine, Cancer Center of Kansas, Wichita, USA, 3Oncology, Metro-Minnesota Community Clinical Oncology Program, Minneapolis, USA, 4Hematology & Oncology, Springfield Clinic, Springfield, USA Introduction: Cancer-related fatigue (CRF) is one of the most distressing side effects of cancer treatment, and its underlying pathophysiology is poorly understood. The relative contributions of disease, cancer therapies, and comorbid conditions (e.g., nausea, sleep disorders) remain unclear. Objectives: These secondary analyses examine the association between post-treatment fatigue with nausea and disturbed sleep. Methods: Analyses were performed on 549 breast cancer patients (mean age 54, 100 % female) from a RCT study examining antiemetic efficacy, who completed a three-day diary assessing nausea (1–7 scale) and disturbed sleep (0–10 scale) following initial chemotherapy. Fatigue at its worst during the prior week (0 = none to 10 = as bad as you can imagine) was assessed both prior to chemotherapy and on Day 4. To determine the associations between these variables, a linear regression was performed. Age, pre-treatment fatigue, pre-treatment nausea, and occurrence of vomiting (yes/no) were also included in the model. Results: CRF was significantly associated with nausea (r =0.37, p<0.0001) and disturbed sleep (r=0.44, p<0.0001). Linear regression showed that one unit increases in nausea and disturbed sleep were associated with increases in CRF by 0.49, and 0.35, respectively, all p’s<0.0001. Occurrence of vomiting was not significantly associated with CRF. Conclusions: These findings suggest that nausea and disturbed sleep are important predictors of CRF. Given the current limitations in treating fatigue directly, interventions targeting nausea and disturbed sleep could be potential alternate approaches to reduce CRF.
MASCC-0811 Randomized controlled clinical study of exercise program on functional and emotional response in women with surgery breast cancer L.M. Menzel1, V.T.K. Ferreira2, H.H.A. Carrara1, I. Garavello3, T.O. Gozzo4 1 Faculty of Medicine Ribeirao Preto/Department Obstetrics and Gynecology, University of Sao Paulo, Ribeirão Preto, Brazil, 2Faculty of
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Medicine Ribeirao Preto/Department of Rehabilitation and Functional Performance, University of Sao Paulo, Ribeirão Preto, Brazil, 3 Faculty of Physical Therapy, University of Triangulo Mineiro, Uberaba, Brazil, 4Department of Maternal-Infant and Public Health Nursing, University of Sao Paulo College of Nursing, Ribeirao Preto, Brazil Introduction: Physiotherapy acts preventively, before and after surgery in women with breast cancer and has as main objective to get the woman back to their daily activities, social and professional with minimal consequences. Objectives: To evaluate the effectiveness of a supervised exercise program in women who underwent axillary dissection for breast cancer and the emotional impact of this practice in these women. Methods: Women treated for breast cancer in the Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (HCFMRP- USP) were invited to participate. They’re randomized in Study Group (GE) and Control Group (GC) that did not participate in supervised exercise protocol. This evaluation consisted of measurement of range of motion (ROM) of the scapular-humeral and the perimeter of the upper limbs. GE supervised exercises were conducted twice a week, but with guidance to perform them daily. Results: The ROM of the scapular-humeral joint in GE improved significantly in all evaluations since PO1 regarding the movement of flexion, what was not observed in GC. In the evaluation of abduction the GE showed consistently higher measurements than the GC, but in some evaluations the difference between the two groups was not significant. Conclusions: ROM of the scapular-humeral joint showed faster recovery in women undergoing axillary dissection for breast cancer when they participated in a supervised exercise protocol with early onset. References: SPRINGER, B. A. et al. Pre-operative assessment enables early diagnosis and recovery of shoulder function in patients with breast cancer. Breast cancer research and treatment, The Hague. 2010: 120 (1): 135–147.
MASCC-0812 After decades of antiemetic advances, the distress of chemotherapy-induced nausea and vomiting (CINV) remains E. Rubenstein1, L. Schwartzberg2, S.T. Sonis3, S.M. Weidner3, G. Alterovitz4 1 Executive Administration, Inform Genomics Inc., Boston, USA, 2 Hematology/Oncology, The West Clinic, Memphis, USA, 3 Research & Development, Inform Genomics Inc., Boston, USA, 4Center for Biomedical Informatics, Harvard Medical School, Boston, USA Introduction: Ondansetron (OND) became available more than 20 years ago, representing the first 5HT3-receptor antagonist (5HT 3 RA) in oncology. Palonosetron (PALO) and aprepitant (AP) for prevention of CINV were introduced approximately 10 years ago. Along with dexamethasone (Dex), these antiemetics have become standard-of-care. Yet, how well do they work in current oncology care in preventing CINV? Objectives: Determine CINV incidence in patients receiving antiemetics prior to emetogenic chemotherapy (CT). Methods: In order to develop Bayesian single nucleotide polymorphism networks predicting CINV and 5 other CT-induced side effects, we enrolled 383 patients with breast, colorectal, lung, ovarian, and prostate cancer in a prospective, multi-cycle, observational study. Patients reported side effects using a validated tool, Patient Care Monitor©. Nausea and vomiting were categorized: none = 0, Mild =
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1–3, Moderate = 4–6, Severe = 7–10. Antiemetic regimens were catalogued. CINV rates were reported for first 3 cycles. Results: Three hundred fifty-seven patients received combination CT: doxorubicin/cyclophosphamide-based (AC) [N = 110], oxaliplatin-based (Ox) [N=72], other moderately-emetogenic chemotherapy (MEC) [N =175]. Median age was 54 years, 82 % female. PALO-based regimens constituted ~89 % of antiemetics; 28 % received 5HT3RA + Dex + AP. Overall, 62 % reported CINV: 36 % had moderate to severe nausea, 11 % had vomiting. For AC, 71 % reported CINV. For 5HT3RA + Dex + AP, 36 % reported moderate to severe nausea; 10 % had vomiting. MEC and Ox regimens had CINV rates similar to the overall group. Conclusions: Despite multiple-class antiemetic use, CINV burden remains significant for patients receiving emetogenic CT. Newer agents and strategies to identify at-risk, chemo-naïve patients are needed to reduce the impact of CINV.
MASCC-0813 Problems encountered during cultural adaptation of the epic questionnaire for prostate cancer into Punjabi and Chinese T.K. Lee1, S. Singh-Carlson2, G. Oshan3, W. Kwan3 1 Radiation Oncology, British Columbia cancer Agency, Surrey, Canada, 2 School of Nursing, California State University Long Beach, Long Beach, USA, 3Research assistant, British Columbia cancer Agency, Surrey, Canada Introduction: EPIC(Expanded Prostate Inventory Composite) is a widely adopted quality of life assessment tool. It has been translated successfully into Spanish, Dutch, Japanese, and Korean. Objectives: Our Objective is to develop and validate EPIC in Punjabi and Chinese. Methods: Each language version has been translated into a prototype based on EORTC protocol. Two forward translations (FTs) were created by two translators, which were reviewed by our team members fluent in the corresponding language. Fifteen participants with prostate cancer fluent in Punjabi or Chinese will be recruited for each language version. Each participant will complete a prototype followed by a semi-structured interview, using qualitative methdology. Interviews are recorded digitally, translated and transcribed verbatim and analyzed. Validation will then take place to finalize the questionnaire. Results: Eighteen and two modifications were needed during FT and BT for Chinese, mostly related to word order. Forty and seventeen modifications were needed during FT and BT for Punjabi. Most changes related to replacing difficult words with those used in common language to make it easy. Some questions in English EPIC could not be translated literally as the meaning was lost in translation. Punjabi version also required 4 FT and BT revisions compared to one revision in Chinese. The overall process took 4 months for Punjabi and 3 months for Chinese. Sixteen Punjabi patients were approached to date: eight agreed to participate. Three sixty-minute interviews are completed. Conclusions: Translation/validation of the EPIC questionnaire is labour intensive. Unexpected cultural/social related problems encountered during process will be discussed.
MASCC-0814 Palliative therapy for lymphedema in metastatic breast cancer V. Tlaker Zunter1, T. Planinsek Rucigaj1 1 Department of Dermatovenereology, University medical Centre Ljubljana, Ljubljana, Slovenia
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Introduction: In metatstatic cancers, lymphedema can present as a very distressing condition that is hard to manage. Objectives: The objective of our case report is to present therapy of severe lymphedema (stage III) in metastatic breast cancer, causing pain, lymphorrhea, skin ulcerations and pain. Methods: The patient was treated with short-stretch adhesive and nonadhesive bandages, combined with manual lymph drainage by Vodder method. Results: Th e t h er a p y re s u l t ed i n re d u c t io n o f e d em a , lymphorrhea and skin ulceration, and improvement of the quality of life. Conclusions: Supportive therapy of lymphedema, including appropriate bandaging and manual lymph drainage, successfully reduces burden of the end-stage metastatic disease in breast cancer. References: 1. Thomson M, Walker J. Collaborative Lymphoedema Management: Developing A Clinical Protocol. Int J Palliat Nurs. 2001 May;17(5):231–8. 2. Clemens KE, Jaspers B, Klaschik E, Nieland P. Evaluation Of The Clinical Effectiveness Of Physiotherapeutic Management Of Lymphoedema In Palliative Care Patients. Jpn J Clin Oncol. 2010 Nov;40(11):1068–72. doi: 10.1093/jjco/hyq093. Epub 2010 Jun 17. 3. Hamner JB; Fleming MD. Lymphedema Therapy Reduces the Volume of Edema and Pain in Patients with Breast Cancer. Ann Surg Oncol 2007 Jun;14(6):1904–8. Epub 2007 Mar 8.
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and timely intervention for LE can minimize or eliminate more advanced LE among women undergoing ALND.
MASCC-0815 Detection of subclinical lymphedema; does a preoperative prediction model work? A. Soran1, A. Ibrahim1, L. DeGore1, M. Bonaventura1 1 Surgical Oncology, MWH, Pittsburgh, USA Introduction: Severe lymphedema (LE) development is associated with profound functional, psycho-social and medical consequences. Bioimpedance spectroscopy (BIS) has been demonstrated to be sensitive for subclinical LE (SLE) detection. A Nomogram for predicting the risk of arm LE after axillary dissection (ALND) was presented for early diagnosis of the disease. Objectives: To test the preoperative prediction model in the diagnosis of SLE in ALND patients prospectively monitored by BIS. Methods: One hundred twenty-three patients were monitored at 3–6 monthly intervals using an L-Dex® U400 after the preoperative measurements was obtained. The 5 year probability of LE after ALND for breast cancer was predicted by using web page. The discrimination of the nomogram was assessed by calculating the area under (AUC) the ROC; AUC values between 0.7 and 0.8 represent considerable discrimination. Results: The mean age was 57 (27–90), and the mean BMI was 28.2 (17.1–48.2) kg/m2. Dominant hand and surgery side was the same in 59 % of patients. The mean number of LN dissection was 16 (6–49). Mastectomy represented the majority (63 %) of cases, 77 % of patients received RT, and 90 % of patients received chemotherapy. Since BIS monitoring began a total of 18 % (n =22) patients were diagnosed with SLE and received early intervention. The AUC was 0.59. In the short-term followup, SLE patients being monitored remain stable with no worsening of LE. Conclusions: The created nomogram is not accurate in predicting SLE. Periodic monitoring for LE, early detection of LE with BIS,
MASCC-0816 Impact of chemotherapy dose intensity and supportive care on survival of patients with advanced solid tumors N. Kuderer1, E. Culakova1, M.S. Poniewierski1, A.F. Wogu1, J. Crawford1, D.C. Dale2, G.H. Lyman1 1 Medicine, Duke University and the Duke Cancer Institute, Durham NC, USA, 2General Internal Medicine Center, University of Washington, Seattle WA, USA Introduction: The value of full-dose chemotherapy and supportive care for patients with advanced/metastatic solid malignancies remains uncertain. Objectives: Evaluate the impact of chemotherapy dose intensity and supportive care on survival in randomized controlled trials (RCTs). Methods: A systematic review was conducted of RCTs in which patients were randomized to receive chemotherapy with or without supportive care with G-CSF and overall survival was reported. Treatment effect was based on Mantel-Haenszel estimates of relative risk (RR) or absolute risk (AR). Results: Of the 61 RCTs identified, 45 were in solid tumors including 22 in patients with stage IV disease. All-cause mortality was significantly reduced in patients with stage IV solid tumors randomized to chemotherapy with G-CSF support (RR=0.95; 95 % CI: 0.92–0.98; P=.003). In subgroup analyses, reductions in mortality were observed in non-small cell lung cancer trials (RR=0.90; AR=−7 %; P = .014) and in RCTs of patients with sarcomas (RR = 0.73; AR = −22 %; P= .004) and urothelial tract cancers (RR = 0.87; AR=−11 %; P=.016). Reductions in mortality were seen in RCTs of dose dense chemotherapy (RR = 0.88; AR = −10 %; P=.019)
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and trials adding one additional agent to the comparison regimen (RR=0.95; AR=−4 %; P=.015). A trend was observed between greater reductions in mortality and longer duration of patient follow-up across trials (P=.071). Greater treatment effect was also observed in 11 RCTs where survival was the primary outcome (RR=0.92; AR=−5 %; P=.001). Conclusions: Pooled results of RCTs of patients with advanced and metastatic solid tumors demonstrate a modest but significant impact of greater chemotherapy dose intensity with G-CSF support with greater reductions in the risk of mortality.
MASCC-0817 The association of myelosuppression and survival in patients with advanced or metastatic solid tumors G. Lyman1, M.S. Poniewierski1, A.F. Wogu1, E. Culakova1, N.M. Kuderer1, J. Crawford1, D.C. Dale2 1 Medicine, Duke University and the Duke Cancer Institute, Durham NC, USA, 2General Internal Medicine Center, University of Washington, Seattle WA, USA Introduction: The value of full-dose chemotherapy and supportive care for patients with advanced/metastatic solid malignancies has recently been questioned. To address the impact of chemotherapy dose intensity and myelosuppression on subsequent survival, a systematic review was conducted. Objectives: Evaluate association between chemotherapy-induced myelosuppression and subsequent survival. Methods: A systematic review of clinical trials was conducted to assess the relationship of chemotherapy dose intensity associated with myelosuppression and subsequent survival in patients with advanced or metastatic cancer. Treatment effect was based on hazard ratios (HR) for mortality. Results: Of the 25 studies identified, 11 were in patients with advanced or metastatic disease including 10 in patients with solid tumors. These included non-small cell lung cancer (5), gastric (3), colorectal (1), and breast cancer (1). Among the 7 studies in patients with solid tumors reporting survival outcomes, a consistent association between chemotherapy intensity resulting in myelosuppression and reduced all-cause mortality was observed in patients with advanced/metastatic solid tumors (HR = 0.69; 95 % CI: 0.61–0.77; P < .0001). A significant interaction between tumor type and myelosuppression was observed for mortality (P= .046) including significant reductions in mortality in patients with colorectal cancer (HR = 0.35; 95 % CI: 0.19–0.64; P= .001), gastric cancer (HR = 0.61; 95 % CI: 0.48– 0.78; P < .001); and non-small cell lung cancer (HR = 0.73; 95 % CI: 0.64–0.84; P < .001). No difference in effect estimates were observed in studies using landmark analysis. Conclusions: Chemotherapy treatment resulting in myelosuppression in patients with advanced solid tumors is associated with reduced mortality overall and across cancer types.
MASCC-0818 Implementation of short and brief interventions for alcohol and tobacco program in surgical oncological unit: analysis of pre and post-implementation process at 6 months M.B. BARRAULT M1, V.B. Barthelemy2, E.B. Bussieres E2, F.L. Lakdja F3, V.G. Garguil V4, M.A. Auriacombe M4 1 Social Sciences and Humanities Group, Bergonie Institute, Bordeaux Cedex, France, 2Surgical Oncology Department, Bergonie Institute, Bordeaux Cedex, France, 3CARE Department, Bergonie Institute,
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Bordeaux Cedex, France, 4Addictology Department, Charles Perrens Hospital, Bordeaux Cedex, France Introduction: Alcohol and tobacco reduce treatments efficacy, increase their side effects, may increase relapse and/or secondary cancers and affect quality of life of cancer patients. Because it represents a ‘teachable moment’, cancer may create a window of opportunity in which to intervene, to help patients identify behaviors at risk for poor health outcomes, and provide them with the support required. Despite scientific, clinical and political incentive, short and brief intervent i o n s ( S B I ) fo r a l c o h o l i n c a n c e r s e t t i n g s a r e p o o r l y implemented. Objectives: This study aims to present the framework of specific implementation of a SBI for alcohol and tobacco linked with screening and management of psychological distress in a surgical oncological department, at 6 months. Methods: The Consolidated Framework for Implementation Research, an integrative conceptual model has been used for the construction and in order to analysis in a mixed method, at 6 months, implementation brakes and facilitators. 25 health stakeholders’ knowledge, attitudes, practice and implication have been explored through focus groups and standardized questionnaires online. Results: Lack of confidence in assuming a prevention role, insufficient knowledge and negative attitudes are key inhibitors of health stakeholders’ involvement in screening and brief interventions. Organizational limits have been described: the pilot team needs more interprofessional collaboration, communication and support from physicians and head leader. Conclusions: SBI program in oncological setting coupled with distress screening could be an interesting clinical avenue to reduce risk behaviors. Implementing specific training courses may help health professionals placing the problem of alcohol in a new perspective and reduce fatalism and resignation which are so often observed.
MASCC-0820 Patients’ views on the timing and benefits of early palliative care: a qualitative study
B. Hannon1, N. Swami1, A. Pope1, M.K. Krzyzanowska2, N. Leighl2, A. Oza2, M. Moore2, G. Rodin1, C. Zimmermann1 1 Psychosocial Oncology & Palliative Care, Princess Margaret Hospital, Toronto, Canada, 2Medical Oncology & Haematology, Princess Margaret Hospital, Toronto, Canada
Introduction: Early palliative care referral can improve quality of life and satisfaction with care, and is increasingly encouraged. However, little is known about patients’ attitudes towards early referral. Objectives: We conducted qualitative interviews seeking the opinions of advanced cancer patients regarding the timing of palliative care referral, and to determine whether patients referred early perceived a benefit. Methods: We recruited participants from medical oncology clinics at a comprehensive cancer centre, following completion of a randomized controlled trial comparing early palliative care referral with standard oncology care. Forty-eight interviews (26 intervention and 22 control) completed interviews. Selective sampling was employed to ensure equivalent numbers of participants based on study arm, age, gender, high vs. low quality of life scores, and high vs.
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low satisfaction with care. A grounded theory approach was used to explore emerging themes. Results: Control patients held a traditional view of palliative care services being relevant only at the end of life. Intervention patients favoured referral following a diagnosis of advanced cancer or in the presence of substantial symptom burden, irrespective of proximity to death, and identified several benefits of early referral. These included: prompt attention to symptom needs; timely, sensitive information about prognosis or end-oflife care options; destigmatization of palliative care through routine referral; and provision of a safety net or additional support. Conclusions: Although early palliative care was not understood as relevant by those who had not experienced it, for those who had, it was perceived as a valuable adjunct to standard oncology care.
MASCC-0821 Study on a combined compounded therapy for oral mucositis M. Pinto1, T. Vasconcelos2, R. Palmeira de Oliveira1 1 , CICS - Health Sciences Research Center Faculty of Health Sciences University of Beira Interior, Covilhã, Portugal, 2R&D department, Laboratory of pharmaceutical development BIAL Trofa Portugal, Covilhã, Portugal Introduction: Mucositis is usually observed in oncology patients who have been exposed to radiotherapy and/or chemotherapy. It is a severe inflammation of the oral mucosa that can limit the cancer treatment and affect the quality of life of the patient, which justifies the need to identify the best therapy for oncology patients with this condition. According to a simple survey made in Portuguese hospitals, the most frequent therapeutic approaches to mucositis are cryotherapy, an antiseptic compounded formulation based on chlorhexidine and a compounded combination of sodium bicarbonate, lidocaine and nystatin. The later formulation proves to be very helpful in the management of mucositis and is largely used in Portuguese Hospitals because of its very easy and quick preparation process. However, due to the lack of stability data this formulation in only given 14 days of stability after preparation. Objectives: To optimize the combined formulation and study its stability. Methods: A new manufacturing process was studied and the formula was modified by including different viscosity-increasing agents. Formulations were studied regarding appearance, viscosity, pH, microbiologic quality and drug content. Results: The inclusion of cellulose derivatives, in different concentrations, or xanthan gum did not alter the initial parameters apart from viscosity, in a concentration dependent manner, as expected. Overtime measurements are being performed in order to assess overall stability of the formulation. Conclusions: A more economic and easy preparation was developed.It was also concluded that the inclusion of a viscosity-increasing agent may potentiate the adhesion of drugs to the mucosa, improving therapeutic efficacy.
MASCC-0822 Analysis of implementation process of collaborative care plans for palliative cancer patients in surgical oncology unit : systemic analysis of brake and facilitators factors M.B. Barrault1, V.B. Barthelemy V2, V.M. Mollo V3, A.P. Pernet A3, S.C. Colombani S4, A.F. Floquet A5, F.G. Guyon F2
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Social sciences and humanities Group, Bergonie Institute, Bordeaux Cedex, France, 2Oncological Surgery Department, Bergonie Institute, Bordeaux Cedex, France, 3 MSH, Certop, Toulouse, France, 4Anesthesic Department, Bergonie Institute, Bordeaux Cedex, France, 5Oncological Department, Bergonie Institute, Bordeaux Cedex, France Introduction: Implementing palliative care standards in surgical oncology remains a challenge. Most health providers report conceptual confusion between palliative and end-of-life stage. Effective teamwork and communication is a crucial determinant of cancer advanced patient safety. Communication failures are often underpinned by the inherent differences in professional practices across disciplines, and collaborative processes. In order to promote high standards for palliative cancer patients in surgical oncology unit, implementing collaborative care plans in clinical routine is needed. Objectives: Describe the framework of the implementation of CCP for palliative cancers patients in surgical oncology unit (brakes and facilitators factors) Methods: Analysis of factors facilitating and impeding this implementation at 6 months have been done with the systems analysis of clinical incidents (Taylor-Adams & Vincent, 2004). Before and after CCP implementation for all palliative cancer patients, 25 health stakeholders’ representations of collaborative care planning, interdisciplinary communication and teamwork have been explored by standardized online questionnaires. Fifteen cases of cancer patients with high-complexity palliative surgeries were analysed. MMC reports, medical and nurse notes were analysed with a Structured Chart tool that defined measurable elements of good palliative care. Results: Analysis of the evolution of stakehorlder’s mental representations of collaboration and palliative care underlines that CCP promote building of shared mental model about patient, interprofessional collaboration process and group cohesion. Conclusions: Analysis of clinical cases shows a better anticipation of adverse events, effective communication with family. Nevertheless, intervening to improve interprofessional teamworking is challenging : specific training is needed.
MASCC-0823 Fertility preservation in prepubertal boys diagnosed with cancer A. Meißner1, A. de Melker 2, A.M.M. van Pelt 2, M.D. van de Wetering3, F. van der Veen2, S. Repping2 1 Center for Reproductive Medicine and Department of Urology, Academic Medical Center, Amsterdam, Netherlands, 2Center for Reproductive Medicine Department of Obstetrics and Gynaecology, Academic Medical Center, Amsterdam, Netherlands, 3Department of Pediatric Oncology Emma Children’s Hospital, Academic Medical Center, Amsterdam, Netherlands Introduction: Fertility preservation in prepubertal boys diagnosed with cancer might be possible by freezing a testicular biopsy before chemotherapy and propagating and autotransplanting spermatogonial stem cells (SSCs) from this biopsy when the child is mature but azoospermic. Objectives: The long time period between biopsy and autotransplantation legitimates to now start the cryopreservation in a research setting. After obtaining ethical approval we set up an interdisciplinary team consisting of pediatric oncologist, urologist-andrologist and clinical embryologist. Methods: For every suitable patient the clinical research team alerts the pediatric oncologist who checks the in- and exclusion criteria and discusses with patient and parents the possibility of
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fertility preservation. If interested the boy is seen with his parents by the urologist-andrologist who also informs the clinical embryologist. The testicular biopsy is taken from one testis only in microsurgical technique under general anesthesia linked to central line placement for chemotherapy, so that no separate anesthesia is required. Postoperatively the patient who usually immediately after the surgery starts with chemotherapy is followed frequently for healing or late effects of the surgery. Results: From 18-03-2011 until 31-01-2013 37 boys were included. In 24 of them a testicular biopsy was performed without any complications. 13 patients refused for conflicts with religious belief, acute aggravation of the cancer, fear of the procedure, found to be too experimental or logistic problems. Conclusions: Fertility preservation in prepubertal boys with cancer should be offered in an adequate interdisciplinary setting at a limited number of centers to ensure worldwide coverage with sufficient expertise.
MASCC-0824 The efficacy of knee disarticulation in an elderly cancer patient: a case report A. Ng1 1 Palliative and Rehabilitation Medicine, University of Texas MD Anderson Cancer Center, Houston, USA Introduction: 80-year-old female presented with right anterior knee mass with progressive worsening lower extremity edema. Biopsy of the mass showed soft tissue spindle cell sarcoma with mixed cellularity. She underwent chemotherapy and radiation treatment and subsequent right knee disarticulation. Objectives: To highlight a case where knee disarticulation was considered in lieu of above knee amputation Methods: A case report -the patient’s course in rehabilitation was followed and reported. Results: She presented to acute rehab 11 days after knee disarticulation. Postoperatively, she complained of a burning sensation and was started on a small dose of Neurontin 100 mg po TID. Her pain is well controlled with a small minimal dose of gabapentin. She remained on the same dosage of Neurontin throughout her hospitalization. She had no phantom limb sensation or phantom limb pain. She tolerated ACE wrapping and shrinker application on the stump site. She tolerated bearing weight on the stump site. Since the initial date of surgery, she has had no complications to date. The sutures on her incision were removed on the day of discharge. Her wound continues to heal without any complications. Her overall hospital stay was 20 days, which included 9 days in inpatient rehabilitation. Conclusions: Knee disarticulation is a rare type of amputation but should be evaluated as an option before above-knee amputation, regardless of age and etiology. Knee disarticulation in this patient resulted in little to no pain and improved tolerance to physical therapy. References: Baumgartner RF. Knee disarticulation versus above-knee amputation. Prosthetics and Orthotics Internation, 1979, 3:15–19.
MASCC-0826 Psychological problems during systematic rehabilitation of patients with colorectal cancer. What we can do for support those people? K. Pietkun1, I. Glowacka2, J. Siminska1, K. Nowacka1, M. Nowacki3, W. Hagner4, W. Zegarski5 1 Department of Health Science, Rehabilitation Clinic, Bydgoszcz, Poland, 2Department of Health Science, Surgical Oncology Clinic,
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Bydgoszcz, Poland, 3Faculty of Medicine, Tissue Engineering Department, Bydgoszcz, Poland, 4Department of Health Sciences, Rehabilitation Clinic, Bydgoszcz, Poland, 5Department of Health Sciences, Surgical Oncology Clinic, Bydgoszcz, Poland Introduction: Rehabilitation of patients with colorectal cancer is mainly correlated with some specific psychological and behavioral problems. This problems are not only correlated with typical psychological problems of people suffered on cancer. The number of designed targeted supportive psychological procedures are still insufficient. Probably this problem is correlated with current short knowledge about psychological and behavioral changes in different groups of patient from each TNM clinical classification groups. Objectives: The aim of the work was to present one university clinic analysis of psychological problems during systematic rehabilitation of patients with colorectal cancer with compressive analysis of used in our department innovative supportive psychological programs. Methods: We have analyzed 3 groups of patients rehabilitated in our clinic in last 5 years (2008–2013) with colorectal cancer. The groups were constructed and based on the clinical staging and grading classification. All analyzed patients were previously operated. For the data collection we have used standard psychological procedures and standardized, individual questionnaire forms analysis. Results: In our study we have analyzed 70 cases of patients from all selected and created groups (I,II,III). In our one center study we have created an suportive psychological program individualy designed for patients rehabilitated after colorectal cancer surgery. Conclusions: Psychological problems during systemic rehabilitation of patients with colorectal cancer are very different in patients from each of TNM clinical classification group. Each group need a special program for psychological supportive care during all days of systemic rehabilitation especially in the first period of time after rehabilitation program beginning.
MASCC-0827 Does it matter whether it is online or offline: testing relative significance of alternative sources of supportive relations in cancer care of aging adults G. Seckin1 1 Social Sciences, Isik University, Istanbul, Turkey Introduction: Study of stress and coping has mainly emphasized the importance of offline supportive relationships in coping with cancer. This study is among the first to include offline and online social support as separate measures in assessment of appraisal of cancer experience and post-diagnosis self-appraisal. Objectives: Whether online and offline social support a) are significantly associated with alternative appraisals of cancer experience and b) predict positive post-diagnosis self-appraisal. Methods: This is a cross-sectional study of a 157 adults with cancer (Mage=57; age range: 50–79). Comparisons of regression models and simple slope analyses were performed. Results: (1) Online social support has a significant effect on positive selfappraisal subsequent to cancer diagnosis among older adults (β=.24, p<.01) (2) Online social support is perceived to be helpful if cancer is judged to be traumatic experience (β=.18, p<.05), or as a challenge that life presents (β=.23, p<.01) (3) Online social support is not perceived to be helpful if cancer is perceived to be an opportunity for personal growth (β=.10, p<.23) (4) Offline social support has no significant effect on selfappraisal (β=.04, p<.12) when it is entered into regression estimations simultaneously with online support. Offline support is not associated with appraisals of cancer experience either. Conclusions: Supportive communication in online cancer groups can be a valuable resource for older people to draw upon when coping with
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cancer given that offline social support resources tend to decline in old age.
MASCC-0828 Impact of decompressive surgery in patients with metastatic spinal cord compression J. ocaña1, Y. Garcia1, E. Dalmau1, R. Pellejero2, M. Ferrer1, J. Pardo1, T. Bonfill1, M. Pampols1, E. Garcia1, I. Moya1, J. Soler3, F. Girvent2 1 Oncology, Hospital de Sabadell, Barcelona, Spain, 2Spine Unit, Hospital de Sabadell, Barcelona, Spain, 3Radiotherapic Oncology, Hospital General de Catalunya, Barcelona, Spain Introduction: There is evidence of benefit in recovery after decompressive surgery (DS) in patients with metastatic spinal cord compression (MSCC). There are no data on the impact of the DS in clinical improvement leading to chemotherapy with a possible survival benefit. Objectives: To determine the outpatient group at discharge after DS in the MSCC and analyze the number of patients getting chemotherapy after DS Methods: We retrospectively reviewed the medical records of all patients (n=36) diagnosed with MSCC for solid tumors treated with DS plus radiotherapy between January 2001 and September 2012 in our institution. The characteristics were collected: age, sex, primary tumor type, performance status (PS) on admission, ambulatory status (EA) at admission, EA at discharge and PS at discharge. Results: The median age was 67 years (range: 31–84, 25 M, 11 F). Primary tumors were lung (n=17), breast (n=5), kidney (n=3), prostate (n=4) and others (n=7). Ambulatory patients at discharge were 23 (63.9 %). Patients receiving chemotherapy were 23 (63.9 %). The median overall survival was 227 days. We found a relationship between receiving chemotherapy with EA at discharge and PS at discharge (p=0.001). No association between EA at admission y PS at admission (p>0,05). Conclusions: The DS in the MSCC has an impact on clinical improvement leading to chemotherapy with a possible survival benefit. References: 1. Patchell R, Tibbs PA, Regine WF, Payne R, Saris S, Kryscio RJ, Mohiuddin M, Young B: Direct decompressive surgical resection in the treatment of spinal cord compression caused by metastatic cancer: a randomized trial. Lancet 2005, 366:643–648.
MASCC-0829 Effect of YOCAS®© yoga on fatigue and circadian activity rhythms among breast cancer patients receiving hormone therapy: a URCC CCOP randomized, controlled clinical trial L. Peppone1, M.C. Janelsins1, C. Kamen1, A.R. Peoples1, C. Heckler1, J.J. Kirshner2, J.N. Atkins3, R. Gaur4, G.R. Morrow1, K.M. Mustian1 1 Radiation Oncology, University of Rochester Medical Center, Rochester, USA, 2Oncology, Hematology Oncology Associates of CNY, Syracuse, USA, 3Oncology, Southeastern Medical Oncology Center, Clinton, USA, 4Oncology, Saint Luke’s Cancer Institute, Kansas City, USA Introduction: Fatigue and disrupted circadian activity rhythms (CAR) are highly prevalent in breast cancer survivors (BCS) receiving hormone therapies; yoga is a promising therapy for these symptoms. Objectives: To conduct a secondary data analysis of a multi-site, phase III RCT examining the efficacy of yoga for improving fatigue and to explore whether changes in CAR and fatigue are associated among BCS receiving hormone therapies. Methods: The original RCT was conducted in the U.S. through the URCC CCOP Research Base and randomized BCS with any type of non-metastatic cancer and no previous yoga participation into 2 arms: 1) standard care monitoring [controls] or 2) 4-week
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yoga intervention (2x/wk; 75 min/session) plus standard care. The yoga intervention utilized the URCC Yoga for Cancer Survivors (YOCAS©®) program consisting of breathing exercises, 18 Hatha and Restorative postures, and meditation. Only BCS currently receiving aromatase inhibitors (N=95) or tamoxifen (N=72) were included in this analysis. Fatigue (MFSI and FACIT-F) and CAR (via actigraphy 12 & 24 h) were assessed pre- and postintervention. Results: Table 1 shows yoga participants demonstrated greater improvements in multiple dimensions of fatigue compared to controls. Linear regression shows significant associations between fatigue and CAR in the yoga group but not in the control group; as fatigue decreases in the yoga group 24 h and 12 h morning amplitudes increase and 12 h afternoon amplitude decreases (Table 2). Table 1: ANCOVAs* for the effect of YOCAS yoga on fatigue Control
Yoga
p-value
Change in MFI General
−0.6
−2.9
0.002
Change in MFI Physical
−0.9
−2.3
0.008
Change in MFI Emotional
−0.4
−1.6
0.027
Change in MFI Mental
−1.1
−1.7
0.217
Change in MFI Vigor
0.1
1.5
0.016
Change in MFI Total
−3.0
−9.9
0.001
Change in FACIT-F
0.3
3.7
0.002
*
Models adjusted for baseline score and age Negative scores in the MFI signify decreased fatigue while positive scores in the FACIT-F signify decreased fatigue Table2: Linear regression: Correlation between changes in fatigue and circadian rhythm in the yoga group
Change in 24-hour Amplitude Change in 12-hour Amplitude Morning Change in 12-hour Amplitude Evening
Change in FACIT-F Correlation* 0.271
p-value
p-value
0.04
Change in MFSI Correlation* 0.221
0.267
0.04
0.222
0.05
−0.102
<0.20
−0.233
0.09
0.05
*
Model adjusted for baseline CPAR scores and age
Conclusions: The YOCAS©® intervention improved fatigue and changes in CAR amplitudes are associated with changes in fatigue. Funding: MRSG-13-001-01-CCE, NCIU10CA37420, K07CA120025 and OCCAM supplement.
MASCC-0830 Controlled clinical trial: effect of high voltage electrical stimulation (HVES) in the sensitivity tactile and blood flow of breast cancer survivors V.T.K. Ferreira1, B.P. Dias2, E.C.O. Guirro1 1 Department of Rehabilitation and Functional Performance, University of Sao Paulo, Ribeirão Preto, Brazil, 2Physical Therapy, University of Sao Paulo, Ribeirão Preto, Brazil
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Introduction: The surgical treatment of breast cancer, especially axillary lymphadenectomy (AL), can cause blood circulatory changes, also partial or total lesion of the sensory nerve intercostobrachial, often causing anesthesia or hypoesthesia in the corresponding dermatome ipsilateral upper limb surgery. Objectives: To investigate the influence of high voltage electrical stimulation (HVES) in the blood flow and tactile sensitivity in nerve pathway intercostobrachial of women undergoing AL. Methods: Sample of 10 volunteers, treatment (G1) and control (G2). The G1 and G2 were undergone 30 min of HVES during 14 sessions and were evaluated by means of continuous wave Doppler Ultrasound and the sensitivity tactile was accomplished through esthesiometer. Results: The tactile sensitivity demonstrates reduction of 5.6 to 3.6 gf gf homolateral upper limb surgery. The Vmax artery and vein were 78.2 and 32.2 in the first evaluation and 89.2 and 28.2 in the final evaluation, respectively. Conclusions: The results obtained on this study aim to justify therapies for intervention with that equipment in the treatment of morbidities caused by axillary linfadenectomy References: Gomes NCMC, Packer AC, Bigaton DR. Effect of cathodal highvoltage electrical stimulation on pain in women with TMD. RevBrasFisioter2012;16(1);10–5. Garcia LB, Guirro ECO, Montebello, MIL. Effects of high-voltage electrical stimulation in postmastectomy bilateral lymphedema: case report. Braz J PhysTher2005;9(2);243–248. Matheus, CM, Guirro, ECO. Change in blood flow velocity demonstrated by Doppler ultrasound in upper limb after axillary dissection surgery for the treatment of breast cancer. Breast Cancer Res Treat 2011;127:697–704.
MASCC-0831 Modern artificial nutrition products as a part of fast-track conception used in esophageal and gastric cancer oncological surgery— application analysis K. Pietkun1, K. Nowacka1, J. Siminska1, W. Hagner1, I. Glaza2, M. Nowacki3, W. Zegarski4, I. Glowacka4 1 Department of Health Sciences, Rehabilitation clinic, Bydgoszcz, Poland, 2Faculty of Medicine, Department of Farmacology and Therapy, Bydgoszcz, Poland, 3Faculty of Medicine, Tissue Engineering Department, Bydgoszcz, Poland, 4Department of Health Sciences, Surgical Oncology Clinic, Bydgoszcz, Poland Introduction: The esophageal and gastric cancer cases according to European statistics and meta-analysis are now still an important clinical and epidemiological problem. Surgical resection is one of the most common method of first choice treatment in operating cases. Patients with a cancerous tumor within the esophagus or stomach in various stages of clinical staging values of T and N, usually are characterized by a considerable degree of malnutrition, mostly as a protein—calorie type. Malnutrition in this patient group is a factor significantly influencing onto the quality of life and prognosis in the 5-year’s survival classification system. Objectives: The analysis was designed to present the latest guidelines, recommendations, and specific producers examples of the use of artificial diet system products in patients with esophagus or stomach cancer, with indications for non-palliative surgical tumor resection, based on Fast-Track system conception Methods: In the study, we have analyzed a group of scientific publications, guidelines and recommendations, selected from international gastroenterological, surgical, nutritional and dietary literature as well
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as material obtained in the selection of publicated material of the artificial diet system and clinical supplementation international producers. Results: In our study we have strictly shown the curent data according to the new gudelines and recomendations corelated with modern nutritional alghoritms. Conclusions: In our analysis and literature review we have shown, that the use of modern artificial diet products and systems under the FastTrack conception in oncological surgery of patients operated due the esophagus and stomach cancer, is important and has a positive clinical effect.
MASCC-0832 Advanced cancer symptom data collection with modern mobile technology S. Thomas1, D. Walsh1, A. Aktas1, S. Shrotiya1, B. Estfan1 1 Palliative Medicine, Cleveland Clinic, Cleveland, USA Introduction: The HITECH (Health Information Technology for Economic and Clinical Health) Act, enacted as part of the American Recovery and Reinvestment Act of 2009, was implemented to improve health and management of complex conditions like cancer through appropriate technology. The ease and portability of iPads (© 2013 Apple Inc, Cupertino, California) is attractive for use in outpatients. REDCap (Research Electronic Data Capture; REDCap Software - Version 5.1.3 - © 2013 Vanderbilt University) allows users to build and manage secure online databases. Objectives: To assess the feasibility and acceptability of an iPad as an electronic self-report symptom assessment instrument in Oncology outpatients. Methods: Consent obtained from participants over the phone. Electronic symptom assessment instrument on iPad given to the participants prior to their first Oncology visit. The instrument with 34 questions (symptoms, quality of life) was adopted from European Palliative Care Cancer Symptom Study1. Responses downloaded to REDCap simultaneously. Printed assessment results given to the Oncologist for effective symptom management. Results: Sample size=10; Mean age=65 year; Females=50 %; College education of ≥4 years=50 %; Completion rate=100 %; Selfcompleted=70 %; Mean time to complete=8 min. Conclusions: 1. Self completion=70 % in an older population group with college education of 50 %. 2. Secure web-based data collection ensured compliance with patient privacy regulations. 3. New technologies may offer practical comprehensive symptom assessment in complex illness References: 1. Hjermstad MJ, Lie HC et al. Computer-based symptom assessment is feasible in patients........multicenter study. EPCRC-CSA. J Pain Symptom Manage. 2012 Nov;44(5):639–54
MASCC-0833 Treatment complications in elderly with lung cancer D.E. dilek erdem1, B.Y. bahiddin yilmaz2, G.D. güzin demirag2, I.Y. idris yücel2 1 Medical Oncology, Samsun Education and Research Hospital, Samsun, Turkey, 2Medical Oncology, Ondokuzmayis University, Samsun, Turkey Introduction: Older patients with lung cancer have worse prognosis. Pre-existing comorbid conditions may severely affect treatment and
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recovery. Also, haematological and nonhaematological complications affect the outcomes. Objectives: This study aims to identify the characteristics of lung cancer in older patients. Methods: Three hundred thirteen lung cancer patients included in the study between 1997 and 2011. Several characteristics were described in a questionnaire. SPSS-16 was used. Results: Among 313 patients, 102 were higher than or equal to 65 years old. Most crowded group consisted of patients between ages of 65 and 69 (n=50, 49 %). Only one patient had age higher than 85 years. 9 female and 93 male patients were examined. In general, performance status was mostly ECOG II. Most of the patients had smoking status. The most common initial symptoms were hemoptysis, cough and dyspnea. Tumor was mostly included in the right lung. Stage IV was the most common stage at the diagnosis. Haematological toxicity was the major concern in this study. Among all of the older patients, most common toxicity associated with therapy was anemia which was followed by neutropenia. Second and third cycles of chemotherapy were two common cycles for anemia. Grade 3 and 4 toxicities were uncommon. Nonhaematological toxicities were also seen. Emesis, fatigue and poor appetite were three most seen toxicities. Conclusions: Lung cancer is one of the most important issues in oncology practice. Older patients occupy a very different place among those patients. Aging, comorbid conditions may impair patients’ status during chemotherapy and may increase toxicities. More attention should be given about treatment- related toxicities in elderly.
MASCC-0834 Quality of life for ostomy patients in the republic of Moldova: changes through the years
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MASCC-0835 Control of breast cancer: the nurses performance of primary health care Y. Barbosa1, P. Rabêlo1, S. Ferreira1, T. Gozzo1, A. Almeida1 1 Maternal-Infant Nursing and Public Health, University of São Paulo at Ribeirão Preto College of Nursing, Ribeirão Preto, Brazil Introduction: The nurses should be qualified for early diagnosis, since breast cancer is responsible for high mortality rates. Objectives: To investigate the knowledge, attitude and practice of nurses regarding the early detection of breast cancer. Methods: Partial results from cross-sectional study with completion scheduled for June 2013 in 42 Primary Health Services of São Luis/Brazil, using a structured questionnaire directed to the 94 Primary Care Nurses. The project was approved by the Ethical Committee in Research—2012.01.06.06-24 protocol. For partial analysis used the Epi Info 3.5.2. Results: Thirty-five nurses of 16 Primary Health Services were interviewed of which 34.3 % has been working since 2 years at Primary Health Services, are specialists (85.7 %), mainly in the Family Health Strategy. 51.4 % didn’t received training about the actions recommended for the control of breast cancer. Most investigates the presence of risk factors for breast cancer at the time of collection of the Pap smear. The women at high risk are monitored for 6 months at less than 1 year (50 %). 97.1 % of nurses reported to the Clinical Examination of the Breasts, to 54.3 % the frequency is annual, 48.6 % in women under 35 years-old. If has changes, 65.7 % prioritize the routing of user. Mammography has annually (45.7 %) for more than 40 years-old (57.1 %). 71.4 % highlight the difficulty in scheduling the examination. Conclusions: We identified the need for training with a focus on the actions of organized screening for breast cancer.
N. Carafizi1 Hospice “Angelus”, Charity Foundation for Public Health “AngelusMoldova”, Chisinau, Moldova
MASCC-0836 Cancer and cognitive impairments induced by chemotherapy: effects of cognitive rehabilitation
Introduction: From 2002 to 2012 in the prevalence structure of malignant tumors in the Republic of Moldova localization in rectum and colon have been achieved a significant growth, moving from the 6th place to the first one. There is no accurate data about patients with applied stomas, but their total number is also in permanent increase. There is not a state program to support ostomy patients, as well as state centers where ostomy patients could get stoma bags and other accessories for stoma and skin care. Objectives: To access the activity of the Charity Foundation for Public Health “Angelus-Moldova” in regards of the provided services for ostomy patients. Methods: Review of the annual reports of the Charity Foundation for Public Health “Angelus-Moldova” about its activity for ostomy patients. Results: Charity Foundation for Public Health “Angelus-Moldova” is one of the non-governmental organizations that has been providing palliative care services to incurable cancer and non-cancer adult patients and children in the capital of the country since November 2001. Simultaneously with the medical activity, it has been offering services for ostomy patients who live in different regions of the country. The main goal of these services is to improve quality of life of the ostomy patients, providing basic information about stoma and its care, medical consultations and psycho-emotional support. Conclusions: Despite the fact that the national state program to support ostomy patients is not developed, the Charity Foundation “Angelus-Moldova” is the only provider of qualitative services for ostomy patients for the whole country.
J. LE FEL1, F. Joly2, K. Rovira3, V. Roy3, O. Rigal1 1 Supporting care, Centre Henri Becquerel, Rouen, France, 2Supporting care, Centre François Baclesse, Caen, France, 3Psychology, University of Rouen, Rouen, France
1
Introduction: Cancer and chemotherapy can have adverse effects on cognitive functions and quality of life. To date, no specific prevention or treatments have been developed despite a large number of patients who report subjective cognitive changes related to cancer and its treatment. Objectives: This abstract presents data from a pilot study of a cognitive rehabilitation program aimed at helping breast cancer patients manage cognitive dysfunction associated with adjuvant chemotherapy. Methods: Participants were 19 women (mean age=58) who were an average of 5 month after chemotherapy for breast cancer. All had reported complaints regarding memory and attention. Patients were randomized to one of three support groups. We compared the effects of rehabilitation using computerized software RehaCom® (n=4), to those of a home rehabilitation with a workbook (n=6). Both support were confronted with patients not receiving cognitive rehabilitation (n=9). Results: Results of the management indicate that computerized rehabilitation can improve cognitive function and quality of life in all patients who received chemotherapy compared to performance before support. This improvement is also found in patients receiving a support at home with a workbook. In contrast, subjects who were unable to participate in these two types of support indicate a stagnation or even a deterioration of their performance and this a few months after the end of chemotherapy.
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Conclusions: This cognitive well-being is essential to the return of a professional activity for younger patients, or of maintaining independence for older patients. The results will be detailed at the congress.
MASCC-0837 Nursing care for chemotherapy-induced peripheral neuropathy: systematic review A.P. Zandonai1, N.O. Sawada1 1 Ribeirão Preto College of Nursing, University of São Paulo, São Paulo, Brazil Introduction: Chemotherapy-induced peripheral neuropathy (CIPN) is a significant, debilitating symptom directly related to the administration of neurotoxic chemotherapy (vinca alkaloids, taxanes, platinum analogs, thalidomide and bortezomib) for the treatment of cancer. CIPN compromises quality of life and results in physical pain or discomfort(1–3). Objectives: Investigate the latest nursing care for CIPN. Methods: The PRISMA Checklist (4) for reporting a systematic review was followed in this study to guide the search and synthesize the scientific literature. The research was conceived to study and report the nursing cares for CIPN. The databases LILACS, PUBMED, CINAHL, EMBASE, COCHRANE LIBRARY, SCOPUS, SCIELO and COCHRANE LIBRARY were consulted and ten relevant studies were selected. Results: The nursing care for CIPN still consists in developing a screening and surveillance model for patients undergoing chemotherapy treatment with neurotoxic drugs; creating a baseline evaluation for CIPN or preexistent neuropathy; evaluating each chemotherapy session for CIPN; using validated tools to assess CIPN; informing patients about the risk of neuropathy and educating them to recognize early signs and symptoms; teaching strategies of adaptation to patients with functional impairment by CIPN; teaching safety precautions to prevent injuries associated with CIPN. Conclusions: Currently, there is no specific intervention or nursing care to CIPN, however, nursing supports and educates CIPN patients and their families. Nursing plays a key role in the screening and assessment of the main signs and symptoms of CIPN and helps to measure and understand how it affects the performance of activities of daily living.
MASCC-0838 Survival patterns in squamous cell carcinoma of the head and neck: pain, depressed mood and fatigue as prognostic factors of survival C. Reyes-Gibby1, K.W. Merriman1, K.O. Anderson2, E. Hanna3 1 Emergency Medicine, MD Anderson Cancer Center, Houston, USA, 2 Symptoms Research, MD Anderson Cancer Center, Houston, USA, 3 Head and Neck Surgery, MD Anderson Cancer Center, Houston, USA Introduction: There is limited information on the influence of symptoms on survival outcomes of patients with squamous cell cancer of the head and neck (HNSCC). Objectives: We assessed the importance of self-reported pain, depressed mood and fatigue in predicting survival outcomes of patients newly diagnosed with squamous cell cancer of the head and neck (HNSCC). Methods: Pain, depressed mood and fatigue were assessed at initial presentation to the Cancer Center, prior to any cancer treatment. Kaplan–Meier survival curves and log-rank tests were used to evaluate the effect of these symptoms on 5-year survival. We also assessed the extent to which these symptoms influenced survival using multivariate Cox proportional hazards regression analysis, adjusting for age, race, sex, alcohol and smoking, comorbidities, TNM stage. Results: The sample included 2,662 HNSCC patients (oral=1349; pharynx=800; larynx=513) presenting to the Cancer Center. Five-
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year relative survival rates for the total sample were higher for those with non-severe symptoms of pain (non-severe=50 %; severe=34 %); depressed mood (non-severe=50 %; severe=38 %) and fatigue (nonsevere=56 %; severe=34 %). Stratified by cancer site, multivariable Cox regression analysis showed that among those with oral cancer, severe pain (HR=1.5; 95 % CI=1.1,2.0) and fatigue (HR=1.5; 95% ci=1.1,2.0) were significantly associated with survival. Only severe fatigue was significantly associated with survival among those with pharyngeal (Fatigue HR=1.5; 95%CI=1.05,2.2) and laryngeal cancer (Fatigue HR=1.5; 95 % CI=1.05,2.2). TNM stage, smoking, alcohol intake, race, age and comorbidities were also associated with survival. Conclusions: Our findings provied evidence on the importance of prompt treatment and control of symptoms in cancer patients.
MASCC-0839 How removing metastasis surgically will impact the course of rehabilitation S. Elmi1, S. McEwen1 Research, St.John’s Rehab Sunnybrook Health Science, Toronto, Canada 1
Introduction: Improved cancer treatments have increased survivorship, and more patients are coming with metastasis after years of living with special cancer. These days we see more cases of patients who are going under operation to remove their metastasis. Little is known about this group of patients course in rehabilitation and outcome. Objectives: To explore the difference between the outcome of rehabilitation in the patients who had their metastasis removed surgically and other patients with cancer (with or without metastasis) we recorded different characteristics of the patients admitted in the general Oncology Rehabilitation Program, St. John’s Rehab Hospital, Toronto, Canada (ORP-SJRH) over 4 years. Methods: We extracted pre-admission and discharge FIM score(motor, cognitive, total Data elements included age, sex, cancer diagnosis, comorbidities, admis-sion and discharge Functional Independence Measure (FIMTM) scores, history of chemotherapy and/or radiation or surgery, type of surgery, CBC and electrolyte level, Berg score, urine incontinency and return to acute care. Results: There were 310 eligible records. The patients’ age ranged from 38 to 97 years; 59.5 % were women, The most common diagnoses were colorectal cancer(28 %) metastatic disease (15.7 %), and cancer of the urinary organs (9.2 %). Patients improved an average of 17.1 points on the FIMTM but patients with metastasis resection had significantly lower improvement in their FIMTM score. Berg score was different in 2 groups. Conclusions: FIM and Berg score and the presence of urine incontinence were different in 2 groups. References: cEwen S, Elmi S, Waldman M, Bishev M. Inpatient oncology rehabilitation in Toronto: a descriptive 18-month retrospective record review. Support Care Cancer. 2012 Jul;20(7):1541–7
MASCC-0840 Oral rehabilitation after oral oncolgyc surgery with dental implants J. Rosello1, C. Arranz2, C. Ros3, R. Rodriguez3, E. Jane3, J. López3 1 Oral Medicine, University of Barcelona, Hospitalet de Llobregat, Spain, 2Maxillo Facial Surgery, Hospital Universitario de Bellvitge, Hospitalet de Llobregat, Spain, 3Odontology in oncologic and immunocompromised patients Master, University of Barcelona, Hospitalet de Llobregat, Spain
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Introduction: The treatment of OSCC is mainly based on surgical excision of the lesion. In many cases the diagnosis of malignancy does not occur in the early stages of the disease, so that the surgery carries significant mutilations that will be difficult to rehabilitate. The microvascular grafts have revolutionized the techniques for tissue reconstruction in oral cancer patients. Objectives: To achieve a good stability of the prostheses is possible to use osseointegrated implants which will help the patient to have a better quality of life. Presurgical planning with the restoring prosthodontist is mandatory before implant surgery to get the best possible result. A surgical guide can be fabricated based on the information of the cone beam computed tomographic scans, the implant planning software and the prosthodontist’s estimation of the location of the reconstructed bone and his/her ideal locations for implant fixtures. Methods: We report two cases of patients who have had important resections in the treatment of her oral cancers and have been rehabilitated using osseointegrated implant prostheses. Results: The use of dental implants in oral cancer reconstruction has become an important aspect of the reconstructive plan for these patients. Conclusions: With improvements in technology and sophistication in prostheses fabrication, extremely functional and cosmetic outcomes can be achieved. It is a heavy process for patients to endure, but the end result permits the patients to minimize the consequences, limitations, and stigmata of ablative cancer surgery.
MASCC-0841 Referral practices of paediatric oncologists to specialized palliative care K. Wentlandt1, M.K. Krzyzanowska2, N. Swami3, G. Rodin4, L.W. Le5, L. Sung6, C. Zimmermann4 1 Psychosocial Oncology and Palliative Care, Toronto General Hospital UHN, Toronto, Canada, 2Oncology, Princess Margaret Hospital, Toronto, Canada, 3Palliative Care, Princess Margaret Hospital, Toronto, Canada, 4Psychosocial Oncology and Palliative Care, Princess Margaret Hospital, Toronto, Canada, 5Biostatistics, Princess Margaret Hospital, Toronto, Canada, 6Hematology and Oncology, Hospital of Sick Children, Toronto, Canada Introduction: Little is known regarding the practice patterns and attitudes of pediatric oncologists (PO) towards referral to specialized palliative care (SPC). Objectives: To examine the SPC referral practices and attitudes of PO and compare them to those of adult oncologists (AO). Methods: Physician members of the Canadian Association of Medical Oncologists, Canadian Association of Radiation Oncologists, Canadian Society of Surgical Oncology and Canadian members of the American Society of Pediatric Hematology/Oncology were invited to participate in an anonymous survey assessing SPC referral practices. Participants received two e-mailed and two mailed invitations. Results: The response rate was 72 % (603/839) for AO (223 medical oncologists/haematologists, 302 radiation oncologists, 78 surgical oncologists); and 50 % (41/82) for PO. Fewer PO than AO had completed a palliative care rotation (26 % vs 51 %). Inpatient SPC consultations were available for 95 % of PO but only 31 % had access to a Palliative Care Unit (vs. 82 % AO) and only 27 % had access to an outpatient SPC clinic (vs 73 % AO). Eighty-nine percent of PO usually/always referred symptomatic patients with a short prognosis to SPC and 87 % referred at diagnosis of metastatic disease or during
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palliative chemotherapy. Attitudes of PO to palliative care and those perceived of their patients tended to differ from those of AO (Table 1). Oncologists’ attitudes towards SPC Adds too many additional care providers Neutral
Strongly Agree/ Agree 9 (18.8)
Pediatric Onc n(%) N=48 8 (16.7)
Adult Onc n(%) N=595 37 (6.6)
p-value1
183 (32.6)
0.0001
43 (7.7)
0.57
242 (43.1)
0.02
12 (2.1)
0.81
25 (4.4)
0.41
0.002
60 (10.7)
Disagree/Strongly Disagree More likely earlier if it is renamed as Supportive Care Neutral
31(64.6)
466 (82.8)
Strongly Agree/ Agree 13 (27.1)
28 (58.3)
Disagree/Strongly Disagree Patients decline/ refuse PC referral Neutral
7 (14.6)
198 (35.3)
Strongly Agree/ Agree 17 (35.4)
2 (4.2)
Disagree/Strongly Disagree Patients have negative perceptions of Palliative Care Neutral
29 (60.4)
418 (74.5)
Strongly Agree/ Agree 11 (22.9)
29 (60.4)
Disagree/Strongly Disagree Referral to PC is an abandonment of patients Neutral
8 (16.7)
143 (25.4)
Strongly Agree/ Agree 3 (6.3)
1 (2.1)
Disagree/Strongly Disagree Uncomfortable referring patients to PC until they are close to death Neutral
44 (91.7)
527 (93.4)
Strongly Agree/ Agree
3 (6.3)
4 (8.3)
31 (5.5)
Disagree/Strongly Disagree
41 (85.4)
506 (90.0)
180 (32.1)
100 (17.8)
177 (31.5)
25 (4.4)
Conclusions: PO have less training in and less access to SPC than AO. Stated referral practices are similar, although PO are more likely to report their patients have negative perceptions of palliative care, and to favor renaming the specialty ‘supportive care.’
MASCC-0842 Presenting symptoms of primary non-hodgkin lymphoma in the oral cavity and jaws: analysis of 53 cases Y. Zadik1, F. Shokaier2, T. Neuman3, R. Zeltser4, K. Blal4 1 Oral Medicine, Hebrew University-Hadassah School of Dental Medicine and Israel Defense Forces Medical Corps, Jerusalem, Israel, 2 Oral Medicine, Hadassah-Hebrew University Medical Center, Jerusalem, Israel, 3Pathology, Hadassah-Hebrew University Medical Center, Jerusalem, Israel, 4Oral and Maxillofacial Surgery, Hadassah-Hebrew University Medical Center, Jerusalem, Israel Introduction: Non-Hodgkin lymphoma (NHL) is the third most common oral malignancy; yet many cases are diagnosed late due to misleading and indistinctive disease features that may mimic other oral conditions.
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MASCC-0843 Can be the osseointegrated implants an adjuvant treatment for the chronic oral candidiasis?
Introduction: Patients with bone metastases often require multiple trips to the Radiation Oncologist for treatment. We developed a novel TomoTherapy-based workflow, called STAT RAD, which condenses standard of care simulation, planning, quality assurance, and conformal hypofractionated treatment delivery into 5–6 h for simulation and treatment initiation in a single day. Objectives: Here we present the preliminary results of a pilot clinical trial to assess the effect of the STAT RAD workflow on pain, opioid use, and patient satisfaction in patients with painful bone metastases. Methods: A prospective clinical trial was designed to enroll 30 cancer patients with 1–3 painful bone metastases. Patients were to receive 2–5 fractions of 5–10 Gy of conformal radiation therapy using the STAT RAD workflow. Pain, opioid use, and patient satisfaction was recorded prior to treatment and at 1, 4, 8, 12, and 24 weeks after treatment. Results: Fifteen patients have enrolled since 11/2011. All were treated with the STAT RAD workflow and received kVCT simulation and conformal hypofractionated radiotherapy in the same day. Post-treatment pain scores at each time point were significantly lower than pre-treatment scores (p<0.03). There was no significant difference between mean pre-treatment and posttreatment opioid intake at any time point (p>0.12). At 6 months 83 % of patients were completely satisfied with the results of their treatment. Conclusions: Preliminary results indicate that STAT RAD, a workflow that allows for same-day simulation, planning, and delivery of conformal hypofractionated radiotherapy for bone metastases, results in a significant reduction in pain scores and high patient satisfaction.
A. Rosello1, J. Rosello2, J. Espejo1, P. Castañeda1, E. Jane1, J. López1 1 Odontology in oncologic and immunocompromised patients Master, University of Barcelona, Hospitalet de Llobregat, Spain, 2Oral Medicine, University of Barcelona, Hospitalet de Llobregat, Spain
MASCC-0845 Relationship between genetic markers, quality of life (QOL) and fatigue (F) in cancer patients prior to treatment
Objectives: To review the presenting symptoms of all NHL diagnosed during one decade at our institute, aiming to evaluate reasons for late diagnosis. Methods: We retrospectively collected all 53 cases of oral/jaw primaryNHL that were diagnosed at the Hadassah-Hebrew University Medical Center from 2002 to 2011. Patients’ demographics and complaints, and clinical, radiological, and morphological findings were analyzed. Results: Mean patient age at diagnosis was 56.6 ±23.1 years; male-tofemale ratio was 32:21. Morphologic diagnoses were diffuse large B-cell (41.5 %), follicular (22.6 %), marginal zone B-cell (11.3 %), and Burkitt (9.4 %) lymphomas. All lesions were symptomatic at time of diagnosis; with swelling (81.1 %), pain (24.5 %), B-symptoms (weight loss, fever, sweats; 13.2 %), and neuropathy (13.2 %) the most prevalent complaints at presentation. Prior to diagnosis, 13.2 % of patients sought dental care for “toothache”. However, vast majority of initial clinical-radiological differential diagnosis of the lesions, made by the oral and maxillofacial surgeon prior to biopsy, included malignant (and benign) tumors. Conclusions: Although majority of lesions were clinically considered malignant, some lesions mimicked benign conditions. Of importance are lesions that masqueraded as toothache, infections, reactive lesions, and osteonecrosis (total of more of one-fifth of lesions), which may not be routinely subjected to histologic evaluation. Facial neuropathy in patient with no history of facial trauma should be carefully evaluated for malignancy. Clinicians should keep in mind that lymphoma has many faces, and it may mimic a wide variety of lesions.
Introduction: Candidiasis is an opportunistic infection caused by fungi of gender Candida and the most common is Candida albicans. The transformation of a C. albicans into a pathogenic organism is determined by systemic and local predisposing factors. We report a 59 year old caucasian white woman diagnosed with a chronic erythematous oral candidiasis and treated with various antifungal from 9 years ago. Currently candidiasis has become refractory to treatment. Objectives: The dermatologist, who treats her candidiasis, suggests the possibility of raising an implant rehabilitation to minimize local factors that favorices the development and perpetuation of oral candididasis. Methods: Given her advanced periodontal disease we decided to proceed with the extraction of the all remaining teeth and rehabilitate the patient with two implant supported fixed prostheses. Results: Once the sanitation of the oral cavity was achieved, the patient has had no suffered significant outbreaks of candididasis. Conclusions: We propose the possibility that teeth in poor condition and dentures act as a reservoir of candida and facilitate reinfection.
MASCC-0844 A phase ii pilot single arm prospective clinical trial of the stat rad workflow for osseous metastases: preliminary results D. Wilson1, A. Sim1, L. Handsfield1, Q. Chen1, L. Blackhall2, T. Showalter1, P. Read1 1 Radiation Oncology, University of Virginia, Charlottesville, USA, 2 Medicine - Division of Palliative Care, University of Virginia, Charlottesville, USA
J. Sloan1, B. Diasio2, Q. Shi1, P. Yang1 Health Sciences Research, Mayo Clinic, Rochester, USA, 2Oncology, Mayo Clinic, Rochester, USA 1
Introduction: Previous studies suggested potential relationships between certain drug metabolizing (DM) genes in metastatic colorectal cancer patients and QOL/F prior to receipt of chemotherapy (Sloan, Plenary Session ASCO 2004). Objectives: This presentation summarizes subsequent studies in adjuvant colorectal and lung cancer patients in an attempt to expand and replicate previous findings. Methods: Two studies involved 1,583 stage III colorectal cancer patients and 1,299 patients with non–small-cell lung cancer respectively. Genomic DNA and baseline QOL/F data via linear analogue self assessment (LASA) scales with QF were obtained. 53 DM SNPs and 470 SNPs respectively of three biologic pathways were assessed for association with QOL/F. Logistic regression with training/validation samples was used to test the association of SNPs with deficits in QOL/F. Results: In the colorectal study, 14 relationships between DM genes and QOL were detected including those seen in our earlier study related to DPYD and TYMS (p < 0.05). GSTP1 I105V and OPRT 5’UTR 28 A>G markers related to fatigue scores (p = 0.04, 0.005, respectively). In the lung study, three SNPs in the MGMT gene (rs3858300; rs10741191 and rs3852507) from DNA repair pathway were associated with overall QOL. Two SNPs (rs2287396 [GSTZ1] and rs9524885 [ABCC4]) from the glutathione metabolic pathway were associated with fatigue. These relationships remained after adjusting for covariates.
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Conclusions: Similar to the earlier study in metatastatic colorectal cancer patients, we observed possible relationships in patients with Stage III colorectal cancer patients and nonsmall cell lung cancer patients with regard to genes and QOL/fatigue. Further association studies are needed to clarify these relationships.
MASCC-0846 Prescribing practices of antiemetics using a computerized physician order entry system K.C. Kadakia 1 , A.D. Leal 1 , D.K. Seisler 2 , R. Qin 2 , K.C. Fee-Schroeder3, D.C. Grendahl4, K.M. Sorgatz3, C.L. Loprinzi4 1 Division of Internal Medicine, Mayo Clinic, Rochester, USA, 2Department of Health Sciences Research, Mayo Clinic, Rochester, USA, 3 Department of Oncology, Mayo Clinic, Rochester, USA, 4Division of Medical Oncology, Mayo Clinic, Rochester, USA Introduction: Providing guideline-consistent chemotherapy-induced nausea and vomiting (CINV) prophylaxis is suboptimal Methods to improve the appropriate use of prophylactic antiemetics are needed. Objectives: The primary objective was to evaluate the degree of compliance to institutional guideline-directed CINV prophylaxis using a computerized physician order entry system. A survey of
MASCC-0847 How to successfully connect rural cancer patients and their supporters with supportive care: a culturally acceptable, online South Australian example K.M. Gunn1, D. Turnbull1, L. McWha1, M. Davies1, N. Bidargaddi2, I. Olver3 1 School of Psychology, University of Adelaide, Adelaide, Australia, 2Mental Health Observatory Research Unit, Country Health SA, Adelaide, Australia, 3CEO, Cancer Council Australia, Sydney, Australia Introduction: Rural cancer patients lack rural-specific information on how to cope with supportive care issues and their access to support services is often hindered by attitudinal barriers.
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nurses was performed to evaluate how oncology practices, within a cooperative group, manage clinician orders for the prevention of CINV. Methods: The electronic medical records of 100 consecutive patients were reviewed. The primary endpoint was the incidence of compliance to provide all aspects of institutional CINV prophylaxis for acute (Day 1) and delayed (Days 2–4) CINV for patients receiving minimal, low, moderate, and highly-emetogenic chemotherapy. Descriptive analyses were performed on the convenience sample. Logistic regression was applied to determine the influence of potential factors with noncompliance. Results: On Days 1–4, the incidence of compliance was 94 % (See Figure 1). A high-degree of compliance to institutional guidelines for delayed CINV (97 %) was observed. Patients receiving doxorubicin/cyclophosphamide were numerically less likely to receive institutional guideline-directed CINV prophylaxis, compared to patients receiving other regimens (OR: 0.24 (0.04, 1.36), p-value: 0.05). No other factors were significantly predictive for noncompliance. The nurse survey demonstrated significant differences in the management of clinician orders for the prevention of CINV. Conclusions: Computerized physician order entry is associated with impressive adherence to institutional guideline-directed CINV prophylaxis for the prevention of both acute and delayed CINV. References Figure 1. Compliance for Scheduled Antiemetics, by Day
Objectives: A) to involve rural cancer patients in the development of online rural-specific, supportive-care cancer information, B) document the lessons learnt and C) evaluate the website for its ability to increase users’ help-seeking intentions and decrease self-perceived levels of isolation and distress. Methods: Using a Participatory Action Research (PAR) framework, 11 rural cancer patients and one rural health professional/rural cancer patient’s carer, worked with the authors to develop http:// www.countrycancersupport.com.au/. Academic literature also informed the website design (e.g. behaviour change theory). 111 rural South Australian cancer patients or their family, friends, carers (i.e. “supporters”) or health professionals, then participated in the online website evaluation. Results: Participants reported a sense of empowerment from being involved in the development of the website. There were 3957 visits to the 84 page website in the first 5 months.
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Website evaluation participants reported it was easy to use, helpful and relevant, written by people who understood what they were going through and that it made them more motivated and confident to access professional psychosocial support services and/or travel for medical treatment (if relevant). 73.33 % of patients and supporters (to whom it was relevant) said using the website made them feel less isolated and 53.57 % felt less distressed. Conclusions: This unique research demonstrates the efficacy of PAR in developing culturally acceptable interventions and provides a framework to inform the development and evaluation of other online, consumer-driven supportive-care interventions.
MASCC-0848 From consensus to bedside: is the staging of cancer cachexia clinically feasible and relevant? A. Vigano1, E. Del Fabbro2, J.A. Morais3, R.D. Kilgour4, M. Borod5 1 McGill Nutrition and Performance Laboratory, McGill University Health Centre, Montreal, Canada, 2Palliative Care, Virginia Commonwealth University Medical Centre, Richmond VA, USA, 3Geriatric Medicine, McGill University Health Centre, Montreal, Canada, 4Exercise Science, Concordia University, Montreal, Canada, 5Supportive and Palliative Care, McGill University Health Centre, Montreal, Canada Introduction: The clinical relevance of the Cancer Cachexia Stages remains to be established. Objectives: To propose criteria for identifying the CCS and exploring their relevance, in the clinical setting. Methods: Two hundred and nine patients with advanced nonsmall cell lung or gastrointestinal cancers were categorized as non-cachectic, pre-cachectic, cachectic, and in refractory cachexia through simple bed-side measures: presence/severity of anorexia, food intake, functional status, hand-grip strength, hemoglobin, albumin, c-reactive protein and white blood cell counts. Results:
NC
PC
C
n=54
n=22
n=54
n=79
aPG-SGA total score (0–36; 36 worst) McGill QoL Total Score (0–10; 0 Worst) ESAS total score (0–90; 90 worst) # Hospital days/ follow-up days (%) Chemotherapy Dose Reduction† Total fat mass by DXA (kg)
1.8 (1.2– 2.4)*
7.1 (4.6– 9.6)
9.7 (8.2– 11.2)
13.9 (12.6– 15.2)
7.2 (6.7– 7.6)
5.5 (4.7– 6.4)
5.3 (4.6– 5.9)
5.0 (4.3– 5.5)
Appendicular lean mass by DXA (kg) Survival (weeks)†† Median (95 % CI)
RC
21.9 (18.4– 25.3)
39.2 (30.4– 48.0)
37.8 (32.0– 43.1)
46.1 (42.4– 49.8)
3.2 (2.1– 4.4)
10.5 (2.0– 20.0)
5.4 (2.0– 8.8)
30.2 (22.1– 38.3)
5/18 (27.8 %)
2/6 (33.3 %)
7/17 (41.2 %)
9/18 (50.0 %)
25.8 (21.9– 29.7)
20.0 (12.2– 27.8)
17.0 (13.5– 20.6)
12.4 (9.1– 15.7)
19.6 (17.6– 21.7)
19.5 (16.4– 22.6)
19.0 (17.4– 20.6)
18.2 (16.2– 20.3)
67.1 (58.1– 76.2)
42.6 (10.9– 74.3)
36.0 (24.4– 47.6)
12.8 (8.2– 17.5)
* Mean (95 % CI). † Chi-square test: p=0.16. †† Log-rank test: p<0.01. NC: non cachectic; PC: pre-cachectic; C: Cachectic; RC: refractory cachectic; aPG-SGA: abridged Patient-Generated Subjective Global Assessment; McGill QoL: McGill Quality of Life Questionnaire; ESAS: Edmonton Symptom Assessment System; DXA: Dual-energy X-ray absorptiometry. Conclusions: Our study supports the clinical applicability and relevance of the CCS.
MASCC-0849 Making mouth care matter C. Thamm1 1 Cancer Services, Princess Alexandra Hospital, Brisbane, Australia Introduction: Mucositis is one of the most dose limiting toxicities related to anticancer therapies such as chemotherapy or radiation therapy. Mucositis is a source of infection and pain and impairs a patients’ ability to obtain adequate nutrition during their treatment phase and beyond. A small exploratory study conducted by a student allied health professional at the Princess Alexandra Hospital in Brisbane, Australia found that patients’ mouths were not routinely being assessed by nursing staff. They also discovered that there were no clear guidelines for standard mouth care interventions across the division of cancer. Objectives: A group of senior oncology nurses from inpatient, outpatient and radiation departments along with a pharmacist, therefore, developed a procedure to standardize mouth care across all departments in cancer services. To compliment this they also developed a form using the WHO grading tool, and matching interventions to assist nursing staff care for patients’ mouths safely. Methods: This form and procedure were introduced concurrently with extensive education sessions, making sure nurses in each area given the opportunity to receive training. Results: Early evaluation through auditing has shown mixed results of compliance, but that when used, mouths are being assessed regularly and graded correctly. Evaluation also shows that nurses are more aware of the importance of good mouth care and mucositis management. Conclusions: Further evaluations are being conducted to correlate evidence of grading being linked to interventions and decreased complications related to mucositis.
MASCC-0850 Aprepitant for prevention of chemotherapy induced nausea vomiting (CINV) in anthracycline-based regimes for breast cancer I. Ghosh1, A. Dwary1, D. Dabkara1 1 Medical Oncology, Tata Medical Center, Kolkata, India Introduction: Anthracycline-cyclophosphamide combinations for breast cancer have a high risk of CINV and hence an aprepitantbased regime is recommended. Objectives: To retrospectively analyze the efficacy of aprepitant-based regime for prevention of CINV in anthracycline-cyclophosphamide chemotherapy at our center. Methods: We retrospective analyzed the records of breast cancer cases treated with anthracycline-cyclophosphamide combinations between October 2011 and Dec 2012. Recommended antiemesis regimen consisted of aprepitant 125 mg PO 1 h before chemotherapy
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and 80 mg PO D2-3, dexamethasone 12 mg IV 30 min before chemotherapy and 8 mg PO D2-4 and palonosetron 0.25 mg IV (or ondansetron 8 mg IV) 30 min before chemotherapy. Fosaprepitant was available for use after July 12. Complete response (CR) was defined as no vomiting and no use of rescue medications. Results: We identified 189 such patients; 15 were metastatic. 765 cycles (3–6/patient) were administered; 59 % were fluourouracilepirubicin-cyclophosphamide, 28 % adriamycin-cyclophosphamide, 8 % fluourouracil-adriamycin-cyclophosphamide and 5 % others. In cycle 1, 27 (14 %) patients did not receive aprepitant, 155 (82 %) patients received aprepitant and 7 received fosaprepitant (4 %). Combining all cycles, aprepitant was not used in 84 (11 %) cycles, oral aprepitant was used in 654 (85 %) cycles and fosaprepitant in 27 (4 %) cycles. Data regarding emesis and rescue medications were available for 709 cycles. In cycle 1, CR rate was 62 % (acute 85 %, delayed 63 %) in aprepitant/fosaprepitant group versus 51 % (acute 73 %, delayed 54 %) in no aprepitant group. In subsequent cycles- CR rate was 61 % versus 51 % respectively. Conclusions: Aprepitant showed significant activity in preventing CINV and the efficacy persisted over the entire course of chemotherapy.
MASCC-0851 The relationship between family caregivers’ psychological distress and empathic accuracy of perceiving cancer patients’ symptoms C.T. Hung1, B. Given2, L. Spence2 1 School of Nursing, National Taiwan University, Taipei, Taiwan, 2College of Nursing, Michigan State University, East Lansing, USA Introduction: Family caregivers play an important role in assisting patients’ symptom management at home. Davis’ Empathy suggests that family caregivers’ psychological distress can influence their accurate perception with patient symptoms. Objectives: This study aimed to examine the levels of congruence of pain and fatigue severity and frequency between cancer patients, and the associations between caregivers’ psychological distress and symptom congruence. Methods: This was a cross-sectional correlative study adopting the data from the study entitled Family Home Care for Cancer—A Community-Based Model (# R01CA-79280). Variables included the severity and frequency of pain and fatigue, caregiver depressive symptoms (Center for epidemiologic studies depression scale, CES-D), caregiver burden (Caregiver rea ct io n as s e ss me n t , C RA ), an d ca re g iv e rs ’ b a c k g r o u n d information. Statistic analysis included Intra-class correlation coefficient and logistic linear regression. Results: A total of 225 cancer dyads was at a fair-to-moderate level of congruence of pain severity and frequency (ICC=0.3– 0.5). Congruence of pain severity was predicted by more selfesteem, and also by a fewer caregivers’ depressive symptoms, a fewer patient symptoms, and living with patients. The underestimation of pain frequency, comparing to congruence, was more likely predicted by perceiving more schedule interruption. The underestimation of fatigue severity and frequency comparing to congruence, was more likely predicted by perceiving more patient symptoms. Conclusions: Less congruence of symptom perception may be a common caregiving situation. Caregivers’ self-esteem indicates congruence, while their psychological distress indicates non-congruence of pain perception. The number of patients’ symptoms and caregivers’ living arrangement were also the important factors affecting congruence of symptom perception.
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MASCC-0852 How office based gyneco-oncologists in Germany apply antiemetic guidelines during the first cycle of ac-containing (NEO)adjuvant chemotherapy J. Schilling1, H.J. Hindenburg2 1 Vice president, German Professional Association of GynecoOncology in Practices (BNGO), Berlin, Germany, 2President, German Professional Association of Gyneco-Oncology in Practices (BNGO), Berlin, Germany Introduction: Supportive Care guidelines are an important instrument to maintain quality of treatment and quality of life in cancer patients. However, there are limitations in the application and adherence and changes of guidelines may not be implemented on short notice. Objectives: The aim was to evaluate the awareness of modern antiemetic guidelines (GL) and their practical use in patients receiving anthracycline plus cyclophosphamide (AC)-containing chemotherapy. The ASCO GL (1) recommend prophylaxis with 5-HT3-receptorantagonist (RA), Neurokinin1-receptorantagonist and dexamethasone. Methods: Thirty-six practices used the ODM Quasi® GYN system for documentation. Demographical data about institutions and patients and knowledge and practical application of antiemetic GL were documented. Antiemetic treatment documentation was performed from Oct. 2012 during 6 consecutive weeks in 150 breast cancer patients who received the first cycle of an AC chemotherapy (77 % adjuvant, 33 % neoadjuvant). Results: Awareness of antiemetic GL: AGO* (71 %), ASCO (65 %), NCCN (22 %), MASCC (19 %), application of GL: AGO (49 %), ASCO (33 %); none (9 %), MASCC (7 %), others (2 %). 93 % were aware of the change of the emetic group of AC in the ASCO GL. Active use of triple drug antiemesis 74 %, planned use 17 %, no use 9 %. Treatment documentation in 150 pts: 56/150 (37 %) received the triple drug schedule according to GL, 94/150 (63 %) received a combination of 5HT3-RA and DEX. * AGO- German Working Group of Gynecologic Oncology Conclusions: Only 37 % of pts received the triple combination according to the guidelines in the first cycle of AC. References: Basch E et al. J Clin Oncol 2011;29(31):4189–98
MASCC-0853 Microbes, mucins and mmps in the pathobiology of mucositis A. Stringer1, N. Al-Dasooqi2, R. Logan3, R. Gibson4, J. Bowen4, D. Keefe4 1 School of Pharmacy and Medical Sciences, University of South Australia, Adelaide, Australia, 2School of Medicine, University of Adelaide, Adelaide, Australia, 3School of Dentistry, University of Adelaide, Adelaide, Australia, 4School of Medical Sciences, University of Adelaide, Adelaide, Australia Introduction: Chemotherapy-induced mucositis is characterised by weight loss and diarrhoea. Mucins (secreted by goblet cells) play a role in mucosal protection and may influence intestinal microbes, and matrix metalloproteinases (MMPs) degrade the extracellular matrix. All are thought to be involved in mucositis. Objectives: To determine the relationship between microbes, mucins and MMPs in a rat model of irinotecan-induced mucositis. Methods: Female DA rats received 200 mg/kg irinotecan, were monitored for diarrhoea and killed 0.5–72 h following administration. Samples of jejunum and colon, and faeces were collected for analysis. Alcian Blue/PAS staining, immunohistochemistry for Muc2, and MMPs -1, -3, -9 and -12, and quantitative real time PCR for bacteria were completed. Data were compared using Spearman correlation. Results: In the jejunum, MMP-1 and MMP-12 expression were shown to be inversely correlated (p=0.036). MMP-12 expression
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correlated with reduced weight loss, and goblet cell number (p< 0.03 for both). MMP-1 expression correlated with decreased goblet cells and Muc2 expression (p<0.02 for both). Muc2 expression correlated with reduced weight loss and diarrhoea (p<0.002 for both), and E. coli levels (p=0.006). In the colon, MMP-3 expression correlated with decreased faecal Lactobacillus spp. levels (p=0.047). MMP-9 expression correlated with decreased Muc2 expression and goblet cells (p<0.03 for both). Muc2 expression correlated with reduced diarrhoea and weight loss, and levels of Bifidobacterium spp. (p<0.005 for all). Bacteroides spp. levels correlated with goblet cells (p=0.013). Conclusions: MMPs have roles in regulating Muc2 expression. Muc2 expression and goblet cells are likely to have a role in regulating bacterial levels, which may be implicated in mucositis.
MASCC-0854 “What about me…it isn’t fair!” Establishing appropriate and sustainable cancer services that meet the needs of adolescents and young adults L. Stone1 1 Division of Cancer Services, Princess Alexandra Hospital, Brisbane, Australia Introduction: Adult and paediatric cancer care are worlds apart in terms of health care delivery, with increasing awareness and recognition of a unique patient group who fall into a gap that does not meet their needs for appropriate treatment, psychosocial support, education and outcomes. Objectives: With a paucity of clinical research data and limited participation in clinical trials, hampered by delays in diagnosis and referral, there is an increasing need for age—appropriate, safe and effective services provided as locally as possible. Methods: Given the Adolescent and Young Adult (AYA) group are neither children nor adults, they demonstrate characteristics that span across both groups, and some that do not fit into either. A state—wide AYA Cancer network is planned, to include age appropriate integrated care that better supports this at risk population across Queensland building on work that has been done locally in other states of Australia and internationally. Results: Design and implementation of a Statewide AYA network of care provision that is fair and equitable and sustainable. Conclusions: Navigation of gaps, improved physcial space and care provision to acieve better outcomes in the AYA patient with cancer. References: (1) Burns KC, Boudreau C, Panepinto J. Attitudes regarding fertility preservation in female adolescent cancer patients. J Pediatr Hematol Oncol. 2006;28(6):350–4
MASCC-0855 Team nursing, what’s the point? Changing the model of care in a busy tertiary cancer inpatient ward L. Stone1 1 Division of Cancer Services, Princess Alexandra Hospital, Brisbane, Australia Introduction: Across the history of nursing care delivery, there seem to be four traditional care models that have dominated the inpatient care landscape. Functional and team nursing are task orientated and require a varied skill mix of nurses; the primary nursing model or total patient care are patient focused an operate using a Registered Nurse (RN) model. Objectives: Care modeling does not necessarily relate to the way we deliver nursing care in the modern contemporary context, and often includes other healthcare professionals, and significant changes in nursing skill mix.
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Methods: Team Nursing requires strong leadership and advanced communication skills, bringing together small groups of nurses, led by a shift coordinator, to work collaboratively and cooperatively in order to deliver a higher standard of care. Results: The management team of our busy cancer inpatient ward felt that we could maximise staff potential and provide an environment that both allowed and encouraged staff to utilise their education and skills whilst working with others providing care under the supervision and direction of the RN. Conclusions: According to Kalisch et al., (2009), where teamwork is effective nurses stay in nursing, they are more productive, errors are reduced, quality is improved and patients are more satisfied. This paper will discuss our journey to providing best supportive care to our cancer patients using an evidence based approach that improves patient satisfaction and outcomes. References: Kalisch BJ, Weaver SJ, Salas E. What does nursing teamwork look like? A qualitative study J Nursing Care Quality. 2009;24(4):298–307
MASCC-0856 Paulinia cupana (guaraná) purified dry extract (PC-18) for chemotherapy related fatigue in patients solid tumors: an early discontinuation study T.G.L.,C.S.G.,L.P., A.B. del Giglio1 1 Oncology, FMABC, 2Kyolab, Sao Paulo, Brazil Paulinia cupana (guaraná) is an amazonicplant shown to be effective for chemotherapy related fatigue (CRF) in patientswith breast cancer. Purpose: to evaluate the efficacy of a purified dry extractof Paulinia cupana (PC-18) inpatients with various solid tumors treated with chemotherapy and to comparemaintenance with PC-18 versus placebo after an induction phase. Methods: We includedpatients with solid tumors older than 18 years of age who had an increase intheir Brief Fatigue Inventory (BFI) scores after 1 week of systemicchemotherapy. PC-18 was given at 37.5 mg PO bid, starting after 1 week ofchemotherapy for 3 weeks (induction). Patients who had an improvement orstabilization of their BFI scores, were randomized to either maintain PC-18 atthe same dose or to placebo for the following 3 weeks (maintenance). Results: We included 41 patients. After PC-18 treatment, BFI scores improved orstabilized in 37 out of the 41 patients (mean BFI score difference=2.503;95%CI 1.690–3.315, p<0.0001). After 3 weeks of randomization (16 patients to PC-18 and 17 to placebo) we observed no significant differences in BFI, FACIT, HADS and PSQI scoresbetween patients randomized to PC-18 versus Placebo. Conclusions: We concludethat PC-18 is active for treatment of CRF in patients with a variety ofsolid tumors. An insufficient wash out period or a conditioning effect onpatients by the earlier PC-18 positive effects on CRF may explain the betterthan expected fatigue scores of the placebo treated patients.
MASCC-0857 The effectiveness of a brief telephone based intervention to reduce fatigue in prostate cancer: a feasibility study J.A.,L.E.,J.J.,E.R. B. Langston1,2 1 King’s College London, 2Prostate Cancer UK, London, UK Introduction: Cancer-related fatigue is a significant clinical symptom commonly experienced by men during and following treatment for prostate cancer. It is distressing, interferes with functioning, and is often under-acknowledged by healthcare professionals.
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Objectives: To evaluate the effectiveness of a brief telephone-based intervention for fatigue delivered by Specialist Nurses at Prostate Cancer UK. Methods: A randomised control trial design was adopted. Men experiencing fatigue during or following treatment for prostate cancer were eligible to participate and were randomly allocated between waiting list control group receiving usual care or the intervention. The intervention comprised psychological support, self-care education and goal setting for behaviour change. It was delivered using motivational interviewing via 4 telephone calls over 10 weeks. Outcomes were assessed at baseline and at trial completion using the BFI, FDS, HADS, NRS (fatigue management)
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and EORTC-QLQ-C30. Analysis consisted of Mann–Whitney Tests for between group comparisons. Results: Seventy-Six men were recruited. Fatigue in study groups was equivalent at baseline. Post-trial between group analysis showed the intervention group reported improved global fatigue (p=.005), fatigue severity (p=.001), fatigue management (coping with fatigue in daily life) (p=.031), social functioning (p=.028) and fatigue symptoms (p=.018). Conclusions: The findings show the effectiveness of brief a telephone intervention at improving fatigue, fatigue management and social functioning. This represents a sustainable model of intervention delivery which is acceptable to men with prostate cancer and is effective in producing positive outcomes.