Support Care Cancer (2003) 11:383–433 DOI 10.1007/s00520-003-0447-7

Abstracts of the 15th MASCC International Symposium

Supportive

Care in Cancer MULTINATIONAL ASSOCIATION OF SUPPORTIVE CARE IN CANCER

Berlin, Germany June 18–21, 2003

ABSTRACT INDEX Listed numbers are abstract numbers. Aapro, M. 17 Abdollahzadeh, F. 75, 118 Abernethy, A. 81 Adams, M. 104 Aebi, C. 172 Agboola, O. 54 Ahdieh, H. 36, 41, 104 Ahlke, E. 112 Ahmedzai, S. 143 Aielli, F. 37 Aliustaoglu, M. 39 Alivizatos, V. 116 Altinbas, M. 39 Altundag, K. 39 Amà, A. 128 Ammann, R. 172 Anderson, M. 101 Anderson, R. 95, 165, 169 Arcangeli, V. 60 Astara, G. 57 Atahan, L. 39 Atkins, J. 25 Bæksgaard, L. 159 Bainbridge, D. 127 Bakker, D. 62 Balducci, L. 54 Ballatori, E. 16 Bar Deroma, R. 92 Bardenheuer, H. 18 Barnes, E. 82 Bartl, R. 152 Beck, K. 15 Bell, R. 105, 106, 152 Ben-Diane, M. 45 Benjamin, R. 166 Bensadoun, R.-J. 3 Bergstrom, B. 34, 105, 106, 110, 152 Bernardo, M. 157 Berndt, E. 64 Berning, D. 108 Bertoli, L. 17 Bertone, E. 23 Bezjak, A. 84, 133 Birkbeck, G. 72 Body, J.-J. 34, 83, 105, 106, 110 Bogdanova, N. 17 Boni, C. 23 Bonini, A. 168 Börjeson, S. 30 Bosnjak, S. 16 Böttcher, H. 51 Bowman, L. 87 Brady, K. 125 Brazil, K. 127, 148 Brown, N. 77 Brunetti, S. 90 Bruns, F. 6, 108, 144, 145 Bunston, T. 62 Büntzel, J. 6, 4, 49, 74, 144, 145, 160

Bushunow, P. 21, 25, 26 Butow, P. 100, 121 Cabalar, M. 98, 99 Calpona, S. 71 Camargo, E. 14 Campora, E. 16 Canistro, R. 23 Carides, A. 15, 22, 28 Carraro, M. 128 Casey, P. 72, 73 Cassini, J. 119 Castro, M. 98, 99 Cerchietti, L. 98, 99 Chang, S. 87 Charpiot, E. 3 Chawla, S. 15 Cheng, K. 7 Chetver, L. 92 Chow, E. 82, 84 Christopoulou, A. 116 Chye, R. 100 Cialkowska-Rysz, A. 44, 46, 89 Cianci, G. 37 Clark, O. 171 Clarke, S. 69 Clayton, J. 100 Cohen ,L. 31, 61 Colgan, K. 20 Connolly, J. 117 Cooper, R. 39 Coracin, F. 14 Coristine, M. 88 Corrado, C. 1 Correa, M. 14 Cowan, J. 94 Craig, E. 88 Crawford, J. 54, 171 Crepaldi, G. 168 Cross, P. 84 Culman, J. 35 Curran, D. 143 Currow, D. 69, 81 Czerninski, R. 8 Dakhil, S. 26 Dale, D. 54, 171 Dalmasso, C. 3 David, A. 109 Davis, J. 100 Davis, M. 93, 96 Dawel, M. 13 Dazzi, G. 16 de Angelis, V. 23 De Cordé, K. 89 De Galitis, F. 37 de Moor, C. 31, 61 de Souza, C. 14 De Toma, V. 119 De Witte, M. 101 Delgado, D. 53 Demin, E. 138

Demirkan, B. 39 Dempsey, C. 20 Desmery, P. 1 Dessì, M. 57 Deuson, R. 27 DeVries, A. 12 Diel, I. 34, 105, 106, 110, 152 Dignani, C. 1 Dimitrovska, A. 55 Dimitry, S. 148 Dintinjana, M. 86, 102 Diricq, C. 140 Djipalo, I. 86 Djulbegovic, B. 171 Dobrila-Dintinjana, R. 86, 102 Dörr, W. 13 Drechsler, D. 13 Drumea, K. 92 Dukowicz, A. 89 Dvergsten, C. 36 Egerer, G. 18 Eisenberg, P. 31, 61 Elad, S. 5, 8, 9 Ellis, P. 121 Elmer, M. 22, 28 Engin, K. 39 Erder, M. 63, 64 Escalante, C. 163 Evans, J. 22 Ewald, H. 35 Exeler, R. 11 Eychmueller, S. 80 Fabi, A. 23 Farci, D. 23 Farhat, F. 48, 155 Farley, P. 20 Fava, S. 16 Favre, R. 45 Ferrarese, A. 168 Ferrazzi, E. 168 Ferreli, L. 57 Ferri, P. 168 Fickle, H. 169 Ficorella, C. 37 Fitch, M. 62, 135, 136, 137 Fitzgibbon, E. 84 Flomenbaum, N. 164 Flynn, P. 26 Fobker, M. 109 Fochessati, F. 60, 71 Frailey, A. 36, 41 Fraunholz, I. 51 Frei, I.-A. 77 Freidank, A. 114 Friedrich-Rust, M. 18 Frisbee-Hume, S. 50, 166 Fröhlich, D. 49, 74, 160 Gabrail, N. 36 Galili, D. 9 Garfunkel, A. 9 Gasparetto, P. 14

Geling, O. 27 Genest, P. 84 Gentile, S. 90 Gérard, J.-P. 3 Ghafari, E. 155 Gharbanian, N. 118 Gillis, C. 78 Ginopoulos, V. 116 Given, B. 65 Given, C. 65 Glare, P. 80, 81, 100 Glaspy, J. 64, 167 Glatzel, M. 4, 6, 49, 74, 144, 145, 160 Glaus, A. 77 Golabek, M. 56 Goldberg, S. 10 Goldschmidt, H. 18 Gralla, R. 15, 22 Gramignano, G. 57 Grant, N. 84 Grassi, V. 1 Graw, A. 11 Gregg, J. 134 Greve, B. 11 Griggs, J. 129 Grinberg, Ya. 141 Grothey, A. 29 Grunberg, S. 15 Grunfeld, E. 88 Günczler, P. 12 Gusella, M. 168 Gutberlet, S. 123 Haberl, A. 51 Hackett, J. 167 Haddad, P. 133 Hagerty, R. 121 Haghayegh Amin, M. 75 Hajnziac, T. 154, 162 Hajnziac, T.F. 154, 162 Hanlon, A. 2 Hannig, C. 76 Harrison, B. 96 Haun, P. 158 Hedenus, M. 63 Heide, J. 52 Heidenreich, A. 38, 97 Helmold, D. 125 Hérault, J. 3 Herrera, E. 79 Herrmann, Th. 13 Hesketh, P. 15 Hickok, J. 21, 25, 26, 129 Hillebrand, U. 109, 146 Hinke, A. 29 Hirt, A. 172 Ho, V. 50 Höckel, M. 115 Hoeing, M. 68 Hole, D. 78 Hollis, R. 113

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Holmes, F. 167 Homsi, J. 94 Horgan, K. 15, 22, 28 Horn, K. 147 Hossein, M. 75 Howell, D. 132 Hsu, T.-H. 42 Ianus, J. 22 Ibrahim, M. 11 Intile, D. 1 Jackowska, T. 56 Jakimovski, D. 55 Jassak, P. 53 Johnson, J. 30 Jones, G. 132 Jordan, K. 29 Juni, M. 1 Kallich, K. 63, 64 Kanesan, K. 61 Kappauf, H. 123 Kaztelan, M. 154, 162 Kazmierczak, S. 44, 46 Kearney, M. 72, 73 Kim, Y. 31, 61 Kirkbride, P. 84 Kirshner, J. 21 Kisters, K. 109, 144, 145, 146 Kleeberg, U. 68 Kligman, L. 153 Knipping, C. 77 Koch, R. 91 Koczwara, B. 69 Komurcu, S. 39 Kondratyev, A. 47 Kotliñska-Lemieszek, A. 40 Kuhlmann, A. 68 Kurtz, J. 65 Kurtz, M. 65 Kushlinsky, N. 107 Kuten, K. 92 Kutikova, L. 87 Kuznecova, G. 103, 142 Kuznecovs, S. 103, 142 Lacombe, D. 143 Laetsch, N. 153 Lagman, R. 93, 96 Larson, E. 164 Lawson, F. 15 Leday-Jacobs, C. 122 Lee, E. 50 Lee, H. 64 Legrand, S. 93, 96 Leland, C. 132 Leppert, W. 40, 44, 46, 89 Lesauskaite, V. 58 Lessem, J. 2 Levenzon, A. 151 Levin, W. 133 Lichinitser, M. 107 Liekweg, A. 120 Lin, C.-C. 42 Lin, S. 164 Lindley, C. 28 Lindsay, S. 161 Littlewood, T. 63

Lobb, E. 121 Long, S. 87 Lordick, F. 17 Lu, M.-S. 42 Lübbe, A. 143 Luczak, J. 40, 44 Lukas, P. 12 Lusso, M. 57 Lutteral, M. 98, 99 Lyman, G. 54, 171 Lyubimova, N. 107 Ma, G. 28 Ma, T. 36, 41 Macciocchi, A. 17 Macridou, A. 116 Madeddu, C. 57 Mahmoud, F. 93, 96 Makalinao, A. 28 Maltoni, M. 71 Manavoglu, O. 39 Mancini, I. 83 Mangan, M. 72 Mantovani, G. 57, 101 Manzullo, E. 163, 166 Marchetti, P. 37 Marcié, S. 3 Margutti, G. 23 Martelli, S. 37 Martin, A. 28 Massa, E. 57 Matcham, J. 63 Matteson, S. 21, 25, 26 Matzkies, F. 109, 146 Mavros, P. 27 McDermott, L. 2 McEwen 78 McGuire, D. 32, 146 McLean, M. 133 McMahon, L. 50 McMahon, P. 80 Mekhail, T. 93 Menon, D. 168 Merlo, L. 168 Mess, E. 40, 44 Metz, J. 125 Meyer, P. 169 Miccolis, I. 128 Michaeli, E. 9 Michelet, M. 1 Micke, O. 6, 4, 74, 108, 109, 144, 145, 146, 147, 160 Milecki, P. 44 Milone, G. 1 Milroy, R. 78 Ming, E. 31, 61 Mings, D. 62 Minutiello, G. 85 Misiewicz, B. 46 Moghaddasian, S. 75, 118 Monolo, G. 85 Montanari, L. 71 Montazeri, A. 78 Montesano, R. 128 Monticelli, C. 60 Moore, T. 125

Moreira, P. 157 Morelli, S. 37 Moro, F. 119 Morrow, G. 21, 25, 26, 129 Mücke, R. 6, 144, 145, 160 Mulhearn, L. 164 Muller, E. 43 Müller, P. 33 Narducci, F. 37 Navarra, S. 33 Navigante, A. 98, 99 Nelle, I. 124 Nikolova, L. 55 Nirenberg, L. 164 Noel, M. 100 Nunes, O. 157 Obadia, Y. 45 O’Boyle, C. 72, 73 O’Brien, M. 127, 148 Ohlmann, C. 38, 97 Olson, C. 125 Or, R. 5, 8, 9 O’Siorain 72 Østerlind, K. 149 Ottery, F. 139, 150 Ozdemir, F. 39 Ozkok, S. 39 Pacholska, M. 56 Pak, Y. 39 Palmeri, G. 90 Panzini, I. 60 Papi, M. 60, 71 Papke, J. 91 Parma, M. 128 Parsa Yekta, Z. 156 Passarotto, T. 168 Patel, S. 166 Pavlovsky, S. 1 Pawel Wozniak, S. 40, 44 Pawlak, Z. 89 Pecherstorfer, M. 105, 110, 152 Peereboom, D. 93 Pendlebury, S. 121 Pereira, C. 14 Peretti-Watel, P. 45 Petersen, L. 150 Petry, K. 66 Pham, S. 50 Piccart, M. 167 Pierce, H. 21, 25 Pignata, S. 23 Pihut, O. 67 Pleskot, M. 56 Poggi, B. 60, 71 Pogliani, E. 128 Polselli, A. 71 Porta, E. 85 Porzio, G. 37 Postovsky, S. 151 Price, L. 139 Prosiegel, M. 76 Pyette, N. 127, 148 Rades, D. 52 Radziyevska, L. 70 Ramos, R. 14

Ranaldi, P. 90 Ranson, S. 129 Ranuzzi, M. 90, 130, 131 Rao, F. 119 Rapoport, B. 95, 165, 169 Ravaioli, A. 60 Ream, E. 77 Reifsnyder, J. 32 Renard, F. 83 Renwick, J. 167 Reyno, L. 88 Ricevuto, E. 37 Ridolfi-Lüthy, A. 172 Riesenbeck, D. 11, 145 Rittenberg, C. 28, 30 Roberts, S. 132 Robertson, L. 132 Roila, F. 15, 16, 23, 27 Rokicka-Milewska, R. 56 Rolston, K. 50, 163, 166 Roscoe, J. 21, 25, 26, 129 Rosenblatt, E. 92 Rosewicz, S. 101 Rossini, F. 128 Roudnas, B. 60 Roy, I. 84 Rubenstein, E. 31, 61 Rudnas, B. 71 Runge, C. 68 Ruprecht, Th. 68 Russo, F. 130 Ruzic, A. 86, 102 Sabbi, A. 90 Samczewska, G. 46 San Miguel, J. 63 Sanderson, C. 69 Savvina, I. 47 Schäfer, U. 108, 146, 147 Schmoll, H.-J. 29 Schönekaes, K. 74, 144, 145, 160 Schubert, M. 2 Seegenschmiedt, M. 19, 24, 158 Selonke, J. 52 Serbiak, B. 46 Sermasi, A. 60 Serrano, B. 3 Sevean. P. 62 Sgoura, V. 116 Shapira, M. 5 Shelke, A. 21, 25, 26, 129 Shillington, A. 20 Siefert, C. 164 Siena, S. 167 Silva, R. 16 Simmons, K. 161 Slatkin, N. 41 Small, N. 143 Smikodub, A. 70 Soban, F. 133 Soellner, W. 123 Sokalszczuk, M. 46 Sørensen, J. 159 Sougleri, M. 116 Sousa, M. 157

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Sprinzl, G. 12 Stara, A. 57 Steele, R. 135, 136 Stein, M. 43, 59, 92 Stimac, D. 102 Stojkovski, I. 55 Stommel, M. 65 Störing, K. 158 Streiberger, K. 18 Sunga, D. 150 Sussman, J. 127, 148 Syczewska, M. 56 Szamburska, J. 89 Taddei, A. 90, 131 Tamir, A. 92 Tassinari, D. 60, 71 Tattersall, M. 100, 121 Tchekmedyian, S. 139, 150

Terruzzi, E. 128 Tews, J.-T. 68 Theriault, R. 166 Thropay, J. 139, 150 Thumfart, W. 12 Tiernan, E. 73, 72 Todisco, E. 128 Toliusiene, J. 58 Tonini, G. 16 Toso, S. 168 Trikha, M. 111 Tripathy, D. 34, 105, 106, 110, 152 Tsoni, E. 116 Tsou, T.-S. 42 Tuca, A. 143 Turci, P. 71 Turhal, S. 39

Turna, H. 39 Turner, F. 137 Unnebrink, K. 18 Uys, A. 95, 165, 169 Valdres, R. 50 Van den Eynden, B. 143 Vercelloni, R. 90 Vorozheikina, Ye. 141 Walsh, D. 93, 94, 96 Warr, D. 15 Watson, D. 63 Weyl Ben Arush, M. 151 Whelan, T. 84, 88, 127, 148 Whitten, P. 126, 134 Wilhelm, M. 123 Williams, D. 133 Willich, N. 11, 108, 109, 146, 147

Windeler, J. 18 Wolf, H.-H. 170 Wolff, L. 125 Wong, K. 153 Wong, R. 133 Wong, R.K.S. 84 Wróblewska-Kaluzewska, M. 56 Wu, J. 84 Wuttge-Hannig, A. 76 Xu, X. 64 Yavuz, A. 39 Yaylaci, M. 39 Young, B. 122 Zahner, J. 170 Zaidiner, B. 141 Zaki, M. 111 Zgoda, M. 46

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A-1 CRYOTHERAPY FOR HIGH-DOSE-MELPHALAN-INDUCED MUCOSITIS PREVENTION IN AUTOLOGOUS PERIPHERAL BLOOD STEM CELL TRANSPLANT (APSCT): PRELIMINARY RESULTS AT A SINGLE INSTITUTION. Michelet M; Grassi V; Dignani C; Intile D; Desmery P; Corrado C; Milone G; Juni M, Pavlovsky S. Fundaleu–(Fndn to fight against Leukemia)-Buenos Aires-Argentina Objectives: Evaluation of cryotherapy (CRYO) clinical efficacy in ulcerative oral mu-cositis (UOM) prevention and UOM morbidity on patients (pts) undergoing High-dose Melphalan (MEL 200 mg/m2) regimen with APSCT. Methods: Multiple Myeloma eligible pts were included in the interim analysis of this single-blind, rando-mized trial. CRYO (ice-pop eating) was applied for 10 minutes before, during and after MEL administration. All pts were treated with the same oral care protocol. The primary endpoint was the time to development of UOM (TTUOM) (UOM: grades II, III, IV-WHO criteria) since MEL administration. Five outcome variables were considered to correlate UOM morbidity: Days (d) with fever (≥38º); parenteral nutri- tional support; Body Mass Index (BMI) variation; pain analgesic requirement and length of hospital stay. Results: 63 pts (23F/34M) were randomized to CRYO arm (n=32) or control arm (n=31) Median age: 56 years (37–70). MEL median total dose: 350 (200–450) mgIV. Neutropenia (ANC<500) median duration: 5 d-median initiation on D+6 and recovery on D+10. Five (16%) CRYO arm pts and 19(61%) control arm pts developed UOM (p=0.0001). Median TTUOM: 15.3 d on CRYO arm, 11.9 d on control arm. The UOM incidence rate every 10 pts/month was higher in the control arm (15.5 vs 3.1, p=0.0002). The UOM risk was 80% lower in the CRYO arm (Hazard Ratio (HR)= 0.20; 95%CI 0.08,0.54) After stratification prognostic factors adjustment the HR remained at 0.20 (95%CI 0.07,0.57). The analgesic requirement (morphine ≥5mg) and its duration (≥3 days) increased with UOM-adjusted Relative Risk=2.71 (95% CI 1.13,6.5) and 4.06 (95% CI 0.85,19.31) respectively. The median difference of BMI variation was higher in the control arm: 0.65 (95%CI 0.26,1.10, p=0.003) vs CRYO arm: 0.54 (95%CI –1.10, 2.18, p=0.41). No differences were observed in the other variables. Conclusions: This preliminary result proves CRYO is effective in reducing UOM incidence and duration. A larger sample would be required to compare UOM morbidity. Enrollment will continue to complete protocol sample (88 pts). Updated results will be presented.

A-2 OC-1012 FOR PREVENTION OF ORAL MUCOSITIS: A PHASE 1 STUDY *Mark M. Schubert, Jan N. Lessem, Lori McDermott, Alexandra L. Hanlon Seattle Cancer Care Alliance, Seattle, WA; OraPharma, Inc., Warminster, PA, USA Thirty hematopoietic cell transplant (HCT) patients were enrolled in a randomized, double-blind, placebo-controlled dose escalation trial to evaluate the safety of OC-1012, an oral rinse to prevent oral mucositis. Three dose levels (0.1, 0.3, 1.0 mg/ml) were administered 4 times daily for approximately 30 days. No significant toxicity or safety issues were noted for any of the 3 groups. Secondary outcomes for efficacy were assessed using OMI and NCI-CTC oral mucositis scales at Day 1 of conditioning, and then on Days 0, 7, 14, and 25 days post HCT. At dose level I, there was a trend in favor of the active treatment group over placebo. In dose level II, the percent of patients in the active treatment group with severe ulceration was lower than placebo on Day 7 and Day 14

post HCT. Dose level II for OC-1012 also showed significantly less throat pain at Day 7, and lower mucositis scores on Days 14 and 25 post HCT compared to placebo. Dose level III showed no advantage over Dose level II in this study. This study demonstrates that OC-1012 is safe, and results support continued study of efficacy.

A-3 PAROTID GLAND SPARING WITH STEP-AND-SHOOT INTENSITY MODULATED RADIATION IN OROPHARYNGEAL AND NASOPHARYNGEAL TUMORS. PRELIMINARY RESULTS AT THE CENTRE ANTOINE-LACASSAGNE *Bensadoun, René-Jean1; Marcié, Serge1; Charpiot, Elisabeth1; Serrano, Benjamin1; Dalmasso, Chrystelle1; Hérault, Joël1; Gérard, Jean-Pierre1 1 Department of Radiation Oncology, Centre Antoine-Lacassagne, NICE, FR. Purpose/Objective: Oropharyngeal and nasopharyngeal tumors are some of the best potential indications of Intensity Modulated Radiation Therapy (IMRT). A high radiation dose has to be delivered on a well defined concave shaped anatomic site surrounded with Organs At Risk (OAR). Sequelae of radiation treatment with opposed lateral fields can be quite stressful and have an important impact on Quality of Life (QoL) (xerostomia, trismus, hypoacousi …). Actual radiation modalities (multibeam 3D treatment planning) on last generation linear accelerators with multileaf collimators already result in a better sparing of healthy tissues, with a preservation of dose intensity on the tumor, but preservation of both parotid glands remains very difficult with these techniques. Materials/Methods: We are evaluating at the Centre Antoine-Lacassagne the validity and the efficiency of step-and-shoot IMRT on these tumors, with TMS 6.0* software (MDS Nordion) on PRIMUS* linear accelerator (Siemens). IMRT treatment plans (DoseVolume Histograms) are compared with conformal 3D therapy plans obtained with the same software, regarding encompassment of target volumes and OAR (parotid glands, brain stem, temporomandibular joints). Validation of IMRT treatment plans is performed using phantom devices (with dosimetry recalculation) and Mapcheck* system. In vivo dosimetry is performed at each treatment session in the oral cavity, using Mosfet* dosimeters. Measurement of salivary flow, before and after stimulation (Parafilm*) is performed at D0, at the end of treatment, and will be performed every 3 months during 2 yrs. Results: Our first observations (16 IMRT treatment with curative intent on stage I-III pharyngeal tumors, as of February 14th 2003) are 1) IMRT should be performed on Clinical Target Volumes (CTV), not on prophylactic node areas. 2) Number of segments for each portal beam should be limited to 10. 3) OAR with dosimetric constraints should be limited to parotid glands, brain stem and spinal cord. 4) IMRT treatment plans proposed by TMS 6.0* software significantly increase parotid glands sparing when compared with conformal 3D treatment plans. Long term follow-up should assess whether this gland sparing is correlated or not with a significant improvement of salivary flow.

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A-4

A-6

AMIFOSTINE IN RADIOCHEMO-THERAPY OF HEAD AND NECK CANCER – PRELLIMINARY RESULTS OF THE PLACEBO CONTROLLED TRIAL Jens Büntzel (1), Oliver Micke (2), Michael Glatzel (3) 1 Dept. of Otolaryngology Nordhausen; 2 Dept of Radiotherapy Münster; 3 Dept of Radiotherapy Suhl

AMIFOSTINE AND THE REDOX STATUS OF HEAD AND NECK CANCER PATIENTS DURING RADIOCHEMOTHERAPY Jens Büntzel (1, 2), Michael Glatzel (2), Ralph Mücke (2), Oliver Micke (2), Fank Bruns (2, 3) (1) Dept. Of Otolaryngology Nordhausen; AK Trace Elements and Electrolytes in Radiation Oncology; (2) Dept. Of Radiotherapy Hannover

Objective: Amifostine has shown a broad spectrum activity as radioprotector in head and neck cancer patients in several phase ii and phase iii studies. Material and method: Between 1996 and 2000 we have performed a placebo-controlled, double blind phase III study comparing the unprotected (placebo) toxicity of a simultaneous radiochemotherapy (group A, n=65) with the protected (amifostine) toxicity-profile (group B, n=67). Carboplatin was used as radiosensitizer, amifostine was given in following doses: 300 mg/sqm BSA on the days of chemotherapy, and 200 mg/sqm BSA on the days of radiotherapy. 18 centers from 5 countries included patients. Both groups were stratifid according biometric data, the pretherapeutic situation (adjuvant vs. Primary RCT), tumor stage and localization. Results: Following toxicities were seen in group A: acute xerostomia ≥°2–34,4%, acute mucositis ≥°3–21,9%, late xerostomia ≥°2–24,4%. Toxicities in group B: acute xerostomia ≥°2–38,5%, acute mucositis ≥°3–38,5%, late xerostomia ≥°2–36,6%. No significant difference between both groups were calculated. After the follow-up period of one year 18 (26,9%) patients of group B and 13 (20%) patients of group A died. Conclusion: This first placebo-controlled, double blind, randomized trial in head and neck cancer patients has not shown cytoprotective effects of amifostine during simultaneous radiochemotherapy.

Objective: Amifostine is acting as an exogenous radical scanvanger. Nothing is jnown about its antioxidative capacities compared to the endogenous systems lile the selenium-dependent glutathionperoxidase in tumor patients. Material and methods: We investigated the activity of glutathionperoxidase and the concentration of malondialdehyde in relation to the cytoprotective strategy of 100 head and neck cancer patients during the radiochemotherapy. GroupA (n=32) received 500 µg selenium on all days of radiochemotherapy (2 cycles carboplatinum). Group B received 500 mg amifostine on the days of chemotherapy only (same RCT type), Group C received 500 mg selenium and additional 500 mg amifostine on the days of chemotherapy (RCT with 4 cycles carboplatinum). Results: The application of amifostine leads to a decreased concentration of free radicals (malondialdehyde). The capacity is comparable to the normal detoxifying possibilities of a health individual. The highest potential in scavanging free radicals has shown the normalization of endogenous systems and the additional application of amifostine. The combination of selenium supplementation and amifostine allowed the succesful administration of intensified regimen without increased of free radicals. Conclusion: The application of amifostine offers the possibility to reduce aggressive free radicals in clinical relevant account. Especially the combination with the activation of endogenous detoxifying systems offers the chance to enhance the basic therapeutic index.

A-5 BUDESONIDE – ADVANCEMENT IN THE TREATMENT FOR ORAL CHRONIC GRAFT VERSUS HOST DISEASE * Sharon Elad, Reuven Or, Michael Y Shapira Oral Medicine and Bone Marrow Transplantation departments, Hadassah University Hospital, Jerusalem, Israel Background: chronic graft versus host disease (GVHD) is a common complication post Hematopoietic Stem Cell Transplantation. It often presents as painful oral lesions affecting quality of life, especially when resistant to systemic treatment. This clinical trial aims to evaluate the efficacy of Budesonide, a newly registered steroid with high potency and low bioavailability, for the treatment of oral chronic GVHD. Methods: 12 patients with chronic resistant oral GVHD were treated with 3 mg Budesonide / 5 ml saline x 2–3 day for up to 3 months. Oral manifestations were monitored, and mucosal response scored. Results: All patients responded positively to the mouthwash, 7 of the 12 patients were scored as having a “good” or “complete” recovery by both the examiner and subject. An early response noted within the first 2–3 weeks of treatment was complemented by a probable cumulative effect seen during the first months of treatment. Conclusion: Budesonide is suggested as an alternative treatment for chronic oral GVHD.

A-7 CHILDREN’S ACCEPTABILITY AND TOLERANCE OF CHLORHEXIDINE AND BENZYDAMINE ORAL RINSES IN THE TREATMENT OF CHEMOTHERAPY-INDUCED ORAL MUCOSITIS *Cheng KKF1, Chang, AM2 1 Nethersole School of Nursing, The Chinese University of Hong Kong, Hong Kong; 2 School of Nursing, Queensland University of Technology, Australia Oral care is of great importance to patients receiving chemotherapy for oral mucositis management. Although considerable attention has been given in improving oral care practices, information on the patient’s acceptance and tolerance of the oral care measures that can be of assistance to clinical staff in deciding on the most appropriate protocol is limited. This study was designed to determine the acceptance and tolerance of 0.2% w/v chlorhexidine gluconate and 0.15% w/v benzydamine oral rinses by children receiving chemotherapy. Thirty-four pediatric cancer patients who completed 2 courses of chemotherapy during which they alternately received oral care protocols using chlorhexidine then benzydamine or benzydamine then chlorhexidine. In each course of chemotherapy, subjects were instructed to rinse the mouth with assigned type of oral rinses on the first day of chemotherapy and to continue to do so for the duration of the three weeks. At the end of the study, each subject was asked to compare the two oral rinses in relation to taste and oral stinging, as well as their perception of reduction in oral mucositis and palliation of oral discomfort. Throughout the study none of the subjects discontinued the use of oral rinses, and the number of subjects who required dilution of chlorhexidine and benzydamine with one part of normal saline for the relief of oral stinging was 5.9% and 2.9%, respectively. Ap-

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proximately 60% of children reported that chlorhexidine was more effective than benzydamine in reducing oral mucositis and palliating oral discomfort. Fifty-nine percent of subjects reported that the stinging level associated with benzydamine was more accepted than chlorhexidine. Both the taste of chlorhexidine and benzydamine oral rinses was accepted by 50% of subjects. About 47% and 50% of subjects preferred chlorhexidine and benzydamine in their subsequent chemotherapy, respectively. The most common reasons for subjects preferring chlorhexidine included better soothing effect (93%) and pleasant taste (60%). For subjects preferring benzydamine, pleasant taste (69%), better soothing effect (63%) and less stinging when rinsing (62.5%) were the major reasons for their preference. In conclusion, both the oral rinses were acceptable and tolerable to children.

tients, respectively). Extractions were also prevalent (19%). Radiographic referrals consisted of combinations of bite-wings, panoramic, and single periapical radiographs or full mouth status radiographs (46%, 39%, 30%, 11% respectively). Conclusions: The effective time period for dental treatment is less than 2 weeks before the initiation of the conditioning regimen. The comprehensive dental treatment plan on one hand, and the time needed for healing following dental treatment on the other, require maximal utilization of this short time period. Established routs of referral from hematologists and definition of the role of the peripheral clinics are a major factor in the eradication of dental-oral foci of infection prior to HSCT.

A-10 A-8 ORAL LICHEN PLANUS ASSOCIATED WITH INTERFERON-ALPHA TREATMENT FOR NON-HODGKIN LYMPHOMA * Sharon Elad, Rakefet Czerninski, Reuven Or Oral Medicine and Bone Marrow Transplantation departments, Hadassah University Hospital, Jerusalem, Israel Interferon alpha is used in the treatment of various diseases including hepatitis, autoimmune diseases, hematologic malignancies and several solid tumors. Oral toxicity has not been described in relation to the majority of these treatments, with the exception of hepatitis. An association of hepatitis with oral lichen planus has been noted without Interferon alpha treatment. The potential side effect of exacerbation of pre-existing lichen planus when interferon alpha is administered as therapy for chronic hepatitis has been suggested. No such phenomenon was considered when the indication for interferon treatment was not hepatitis. We present a case of severe deterioration of oral mucosal lesions in association with interferon-alpha treatment of Non-Hodgkin Lymphoma. The clinical and histological presentations were compatible with lichen planus. This report may shed a light on a new oral toxicity of Interferon in the form of a lichenoid reaction.

A-9 TIME LIMITATIONS AND THE CHALLENGE OF PROVIDING ESSENTIAL DENTAL CARE TO HEMATOPOIETIC STEM CELL TRANSPLANTATION (HSCT) CANDIDATES * Sharon Elad, Reuven Or, Eli Michaeli, Adi A Garfunkel, Dan Galili Oral Medicine and Bone Marrow Transplantation departments, Hadassah University Hospital, Jerusalem, Israel Aim: To identify the dental-oral needs of HSCT candidates, considering the limited time period for dental treatment before initiation of the conditioning regimen. Methods: 86 consecutive files of candidates of HSCT were reviewed. Of these, 46 patients were seen in the Hospital Oral Medicine Clinic. The dental-oral diagnosis and treatment plans were collected historically-prospectively. Radiographs were also included in the data collected. The timing of patient arrival to the examination prior to HSCT was used to determine the time available for oral-dental treatment. Results: Oral examinations were preformed at a mean of 20.65±16.82 days before HSCT (median value is 15 days before HSCT). Plaque and dental caries were the most common findings in 54 and 50% of the patients, respectively. The average number of decayed dental surfaces per patient was 2.17. The most common dental treatments required were scaling and oral hygiene instructions and plastic fillings (48% and 39% of the pa-

TOLERABILITY OF EN3247 IN THE PREVENTION OF ORAL MUCOSITIS INDUCED BY CHEMOTHERAPY +/– IRRADIATION * Stuart L. Goldberg for the EN3247 Mucositis Prevention Study Group Hackensack University Med Center, Hackensack, NJ, US Oral mucositis is one of the most common and distressing complications of stem cell transplantation. EN3247 (triclosan 0.1%) is a topical antimucositic agent for the prevention of oral mucositis with direct anti-inflammatory, anticytotoxic, antimicrobial, and analgesic effects. Eighty-six patients on high-dose transplant regimens associated with high rates of oral mucositis were enrolled in a double-blind, placebo-controlled, multicenter trial. Patients rinsed and gargled with 15 mL 4 times per day for up to 30 days. Treatment-related adverse events (AEs) included mouth burning, nausea, and emesis. There were no reports of serious AEs related to EN3247. Withdrawal rates were similar between groups (EN3247, 13%; placebo, 12%; P=NS). Subjects assigned to EN3247 experienced shorter durations of mucositis compared to placebo, decreased rates of any mucositis, and had few ulcers. No differences in the incidence of treatment-related AEs between groups (EN3247, 24%; placebo, 28%; P=NS) were reported. EN3247 is a well-tolerated and safe treatment for the prevention of oral mucositis. A large phase III randomized, double-blind, placebo-controlled trial to further characterize the efficacy and safety of EN3247 for the prevention of oral mucositis is ongoing.

A-11 INFLUENCE OF INTENSIFIED SUPPORTIVE CARE AND TEACHING ON RADIATION MUCOSITIS * Riesenbeck D, Ibrahim M, Greve B, Exeler R, Graw A, Willich N Purpose: To compare the rate of oral complications during radiotherapy with different concepts of documentation, oral care and patient education Methods and Materials: Patients with radio-therapy of 60 to 66 Gy in the head and neck region from 1996 to 2000 had standardized supportive care, eplained once and weekly documentation of toxicities with changing doctors. From 10/01until today, this group of patients has additional teaching with patient leaflets and twice weekly examitation by a limited number of doctors. The severity of oral mucositis compared. Results: In the first group of patients the worst reaction of the oral mucosa, classified with RTOG score was I° in 49,9% of patients, II° in 42,7% and III° in 7,4%. In the latter group with intensified controls maximum score was I° in 18%, II° in 41,6% and III° in 40,4%. Conclusions: It seems the incidence of severe oral mucositis is very much dependent on the frequency and consistency of control and documentation. Improved teaching and closer contact with the doctor did not reduce the rate of III° mucositis.

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LOCAL TREATMENT OF CHEMORADIATION INDUCED MUCOSITIS WITH GM-CSF * DeVries A, Sprinzl G, Günczler P, Thumfart W, Lukas P. University of Innsbruck, AESCA, Austria

MAJOR SALIVARY GLAND DYSFUNCTION – A LATE EFFECTS IN PATIENTS TREATED WITH ALLOGENEIC BMT Correa MEP*; Coracin FL; Ramos RRN; Gasparetto PF, Pereira CM, Camargo EE, de Souza CA Hematology and Blood Transfusion Center of State University of Campinas – Brazil, Nuclear Medicine of Clinical Hospital of State University of Campinas – Brazil

In a controlled open, randomized study the efficacy in the management of chemoradiation induced mucositis and pain of GMCSF mouthwash during the first treatment cycle was observed. Up to now 36 pts. with head-and-neck cancer were included. Treatment consisted of radiation, combined with MMC (day 0) and 5FU during the first 4 days of irradiation. Subjects were randomized either to conventional (groupA, N=17) or GM-CSF mouthwash (groupB, N=19) at the first onset of mucositis. Mucositis was graded with WHO criteria, pain on a scale 0–100. All pts. began treatment with mucositis grad 0. In the first week 5pts of groupA and 6 of groupB (n.s.), in wk2 14 of groupA and 16 of groupB (n.s.), in week3 all pts. developed mucositis ≥ grade 1. 14 pts. of groupA but only 6 of B developed pain ≥30 on the subjective scale (p=0.008). Although the WHO grading system no difference between both groups demonstrated, we showed that pts. using GM-CSF mouthwash developed significantly less pain. Using the RTOG/EORTC toxicity criteria a significant difference between both groups could be observed. Therefore, GM-CSF mouthwash solution is an interesting therapeutic option for the treatment of chemoirradiation induced mucositis. Controlled clinical trials with larger patient population are required to evaluate the role of GM-CSF in this indication.

A-13 QUANTIFICATION OF URINARY BLADDER SIDE EFFECTS OF RADIOTHERAPY * Dörr, W., Dawel, M., Drechsler, D., Herrmann, Th. Dept. of Radiotherapy and Radiation Oncology, Technical University, Fetscherstr. 74, D-01307 Dresden, Germany Impairment of urinary bladder storage function is a frequent side effect of pelvic radiotherapy. For quantitation, micturition frequency is only an imprecise measure. In contrast, routine assessment of micturition volumes, as an exact measure, is barely feasible. Therefore a technique for indirect quantitation of the micturition volume was established. Patients irradiated for prostate cancer were included in this investigation. They were asked for self-documentation (in a provided form sheet) of their body weight at each treatment day, before and immediately after micturition. For this, a scales with a sensitivity of 10 g was provided. The difference in the two weights precisely correlated with the micturition volume (p=0.0001, n=278 measurements). During irradiation, micturition volumes decreased to minimum weekly values of 71±4%, with peak minima of 32±18%, from the third treatment week, representing early radiation effects in the bladder. There was a good correlation with the micturition frequency at night (p<0.04), but not the daytime frequency. Residual bladder volume, studied by ultrasound imaging in 27 pts, did not show any systematical fluctuations. In conclusion, a method for precise and objective quantitation of radiation-induced changes in urinary bladder function was established.

Introduction: Salivary gland involvement after BMT conditioning regimen and cGVHD result in clinicopathologycal changes in minor and/or major salivary glands. These alterations cause a significant morbidity, debilitates nutritionally, communication functions and compromises their oral protective integrity. The aim of the investigation was to study the function of major salivary glands in long-term surviving patients following allogeneic BMT treatment which had any complied by xerostomia, using salivary gland scintigraphy. Methodology: Images were taken with technetium-99mpertechnetate and gallium – Ga-67. For the Galium-67 scintigraphy, the images are done after 48 hours of intravenous injection of 3mCi of Galium Citrate – Ga67. After an intravenous injection of 10 mCi of technetium –99m-pertecnetate, patients received two drops of citric acid (lemon juice) in oral cavity and the images were repeated five minutes later. Radioactivity of salivary glands was measured before and after the stimulation with citric acid. Results: Ten patients were enrolled in that study (4 males and 6 females), one affected by MDS, one by ALL and 8 by CML. The median age was 41 yo (36-43). The conditioning regimen was made according institutional protocol without TBI. All patients had oral cGVHD. The images were taken after 1–6 years from the BMT. The results showed a functional deficit on the parotid gland in five patients, a mild functional deficit on the parotid gland in two patients, two patient had a normal saliva flow and one showed reduced parotid flow. Severe inflammatory response was founded in three patient and obstruction of the parotid ducts in one patient while eight patient didn’t showed any inflammatory alteration. Conclusion: the late activity of the cGVHD or even the late effects of the conditioning regimen could affect the major salivary glands and the salivary glands scintigraphy images should be use for diagnosis. Prospective studies should be performed in order to clarify how high dose chemotherapy followed by allogeneic BMT and cGVHD affect the major salivary glands in transplanted patient.

A-15 TWO RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED TRIALS OF THE ORAL NK1 ANTAGONIST APREPITANT FOR THE PREVENTION OF CHEMOTHERAPY INDUCED NAUSEA AND VOMITING * PJ Hesketh1 , RJ Gralla2 , SM Grunberg3, D Warr4, F Roila5, S Chawla6 AD Carides7, K Beck7, F Lawson7, and K Horgan7 for the Aprepitant Protocol 052 Study Group and the Aprepitant Protocol 054 Study Group 1St. Elizabeth’s Medical Center, Brighton, MA; 2New York Lung Cancer Alliance, New York, NY; 3University of Vermont, Burlington, VT; 4Princess Margaret Hospital, Toronto, Ontario, Canada; 5Policlinico Monteluce, Perugia, Italy; 6Century City Hospital, Los Angeles, CA; 7Merck Research Laboratories, West Point, PA. Background: In the prevention of cisplatin induced nausea and vomiting, the NK1 antagonist aprepitant has been shown to enhance the efficacy of a standard antiemetic regimen consisting of a 5-HT3 antagonist plus a corticosteroid. Two randomized, doubleblind Phase III studies were conducted to confirm the superiority of the aprepitant regimen. Methods: In each study, approximately 520 patients receiving their first cisplatin (≥70 mg/m2) also received either standard antiemetics (ondansetron [O] 32 mg i.v. and

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dexamethasone [D] 20 mg p.o. on day 1; D 8 mg twice daily on days 2–4) or an aprepitant (A) regimen (A 125 mg p.o. plus O 32 mg and D 12 mg on day 1, A 80 mg and D 8 mg once daily on days 2–3, and D 8 mg on day 4). Rescue therapy was permitted for the treatment of established nausea or vomiting. The primary endpoint was complete response (no emesis and no rescue therapy) on days 1–5 (0–120 hours) post-cisplatin. Data were captured in patient diaries and analyzed by a modified intent-to-treat approach, and logistic regression was used to make treatment comparisons. Tolerability was assessed by adverse events and physical/laboratory tests. Results: Patient baseline characteristics were similar between groups. A significantly greater percentage of patients in the aprepitant group had cr on days 1–5, compared with the standard therapy group in both studies (72.7% vs. 52.3% in 1 study and 62.7% vs. 43.3% in the other; p<0.001 for each comparison). The aprepitant regimen was also superior in both studies, in separate comparisons during the acute phase (0–24 hours postcisplatin) (89.2% v 78.1% in one study; 82.8% v 68.4% in the other) and the delayed phase (25–120 hours postcisplatin) (75.4% v 55.8% in one study; 67.7% v 46.8% in the other) (p<0.001 for all comparisons). In both studies, the incidences of adverse events were similar between treatment groups, and the aprepitant regimen was generally well tolerated. Conclusions: Compared with standard therapy in 2 large Phase III trials, addition of aprepitant to standard therapy in patients receiving highly emetogenic chemotherapy provided consistently superior and generally well tolerated antiemetic protection.

A-16 OPTIMAL DOSE OF DEXAMETHASONE (DEX) IN PREVENTING ACUTE EMESIS INDUCED BY HIGHLY-MODERATELY EMETOGENIC CHEMOTHERAPY (HMECT) F. Roila, S. Bosnjak, E. Campora, R. Silva, G. Dazzi, G. Tonini, S. Fava, and E. Ballatori for the Italian Group for Antiemetic Research, Italy No dose-finding studies have been carried out to identify the optimal dose of DEX, combined with a 5-HT3 antagonist, to prevent acute emesis in patients submitted to HMECT. Therefore, we planned a randomized, double-blind, dose finding study. All consecutive naive cancer patients (pts) undergoing HMECT were randomized to receive, for the prevention of acute emesis, one of the following DEX regimens, in combination with ondansetron 8 mg iv: A) 8mg iv before CT plus 4 mg orally every 6 hours, starting at the same time as CT, B) 24 mg iv single dose before CT, C) 8 mg iv single dose before CT. All pts received from day 2–5 oral DEX 4 mg b.i.d. A total of 587 pts were enrolled and 585 were evaluated according to intention-to-treat principle (195 pts in each arm). The rate of complete protection from acute vomiting/nausea was not significantly different among the three groups (A: 84.6%/66.7%, B: 83.6%/56.9%, C: 89.2%/61.0%) as well as the rate of complete protection from delayed vomiting/nausea (A: 81.0%/46.7%, B: 81.3%/45.1%, C: 79.8%/46.1%). Adverse events were mild and not significantly different among the three groups. In conclusion, DEX 8 mg single dose iv before CT should be considered the optimal dose to prevent acute emesis induced by HMECT. The study was carried out with the support of GSK Italy.

A-17 PALONOSETRON (PALO) IS EF-FECTIVE IN PREVENTING ACUTE AND DELAYED CHEMOTHERAPY- INDUCED NAUSEA AND VOMITING (CINV) IN PATIENTS RECEIVING HIGHLY EMETOGENIC CHEMO-THERAPY (HEC) *M S Aapro (Genolier, Switzerland), L Bertoli (Hoover, AL, USA), F. Lordick (München, Germany), N V Bogdanova (Moscow, Russia), A Macciocchi (Lugano, Switzerland) PALO is a potent 5-HT3 receptor antagonist w/ a >100-fold stronger binding affinity than ondanse-tron (OND) & a long plasma half-life (~40 h). This multicenter, randomized, double-blind, stra-tified phase III study assessed efficacy & safety of single IV doses of PALO 0.25 mg or 0.75 mg vs OND 32 mg administered 30 mins prior to HEC (eg, cisplatin >60 mg/m2) for the prevention of CINV; ~67% of pts in each group also received prophylactic corticosteroid. The primary endpoint was complete response (CR=no emesis and no res-cue medication) w/in 24 h after chemotherapy. In the acute phase, PALO 0.25 mg & 0.75 mg CR rates were similar to OND (59.2%, 65.5%, 57.0%, respectively), w/ a trend toward greater efficacy of both PALO doses compared to OND on days 2 (57.0%, 57.8%, 49.8%) and 3 (61.4%, 62.3%, 53.4%). In both PALO groups, a longer time to first emetic episode (TTFE) was observed (median TFFE >120 h, >120 h vs 42.7 h; P=.023 and P=.006, respectively). Incidence & intensity of ad-verse events were similar in the PALO and OND groups. A single dose of PALO prior to HEC is as effective as a single dose of OND 32 mg for pre-vention of acute CINV & may be of greater bene-fit in preventing delayed CINV after HEC.

A-18 ACUPUNCTURE AS ANTIEMETIC PROPHYLAXIS IN HIGH-DOSE CHEMOTHERAPIE- A RANDOMISED, PLACEBO-CONTROLLED, SINGLE-BLIND TRIAL Streiberger K, *Friedrich-Rust M, Bardenheuer H, Unnebrink K, Windeler J, Goldschmidt H, Egerer G University of Heidelberg Purpose: To investigate an additional antiemetic effect to ondansetron with needle acupuncture at P6 compared to non skin penetrating placebo acupuncture in patients undergoing high-dose chemotherapy and autologous peripheral blood stem cell transplantation. Methods: Eighty patients were randomized to receive acupuncture or non-invasive placebo acupuncture at the acupuncture point P6 thirty minutes before first application of high dose chemotherapy and the day after. All patients received 8 mg ondansetron per day intravenously as basic antiemetic prophylaxis. The main outcome measure was the rate of patients who either had at least one episode of vomiting or required any additional antiemetic drugs on the first two days of chemotherapy. Results: The main outcome measure showed no significant difference (p=0.82): 61% failure in the acupuncture group and 64% in the placebo acupuncture group (95%CI of 3% difference: –18.1%, 24.3%). Comparing nausea, episodes of vomiting or retching and number of additionally required antiemetic drugs did not provide any discrepancy with the main result. Conclusion: This study shows that in combination with ondansetron intravenously, invasive needle acupuncture at P6 compared to non skin penetrating placebo acupuncture has no additional effect for the prevention of acute nausea and vomiting in high dose chemotherapy.

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SAFETY AND TOLERABILITY OF GRANISETRON FOR THE TREATMENT OF RADIATION-INDUCED NAUSEA AND VOMITING (RINV) M Heinrich Seegenschmiedt Klinik für Radioonkologie & Strahlentherapie, Alfried Krupp von Bohlen und Halbach Krankenhaus, Essen-Rüttenscheid, Germany

PATIENT’S PRE-CLINIC EXPECTANCY OF NAUSEA PREDICTS THE LIKELIHOOD OF SEVERE NAUSEA FROM CHEMOTHERAPY A.R. Shelke1, J.A. Roscoe1, G.R. Morrow1, J.T. Hickok1, P. Bushunow1, S. Matteson1, H.I. Pierce2, J.J. Kirshner3 1James P. Wilmot Cancer Center, Rochester, NY, 2Northwest CCOP, Tacoma, WA, 3 Syracuse CCOP, Syracuse, NY

RINV often occurs in patients receiving large-field irradiation, upper abdominal radiotherapy or radio-chemotherapy. The 5-HT3-receptor antagonists (-RAs) are recommended for RINV prophylaxis, which are also used for highly or moderately emetogenic chemotherapy. Compared to older antiemetics, these agents are effective and well tolerated with only few side-effects. Special considerations are required for elderly patients receiving multiple medications1 who may have underlying comorbidities like cardiovascular (CV) disease, and on the potential for drug interactions and adverse events following administration of supportive agents. Compared with other 5-HT3-RAs, granisetron (GRA) has no CV warnings and is applicable in renally or hepatically impaired patients without need for dose adjustments.1,2 GRA also has a low potential for drug interactions. Unlike ondansetron and tropisetron, GRA is not linked to the genetically polymorphic cytochrome P450 isoenzyme CYP2D6,3,4 and GRA does not induce or inhibit hepatic metabolism. Therefore, in addition to proven efficacy, the choice of antiemetic agent for RINV should consider individual patients’ preconditions and specific needs including all risks and possible interactions. 1Goodin S, Cunningham R. Oncologist 2002;7:424–36; 2Kytril Prescribing Information; 3Blower P. Cancer J 2002;8:405–14; 4Kaiser et al. J Clin Oncol 2002;20:2805–11.

We examined the predictive strength of patients’ expectations of developing severe nausea and its actual occurrence in 194 chemotherapy naïve breast cancer patients receiving their first infusion of doxorubicin-based chemotherapy. Prior to treatment, patients answered the question “Before you spoke to your doctor about possible side effects of chemotherapy, what did you think the chances were that you would have severe nausea from your treatments?” Responses were given on a 5-point scale that ranged from very likely to very unlikely. Nausea was assessed four times daily (morning, afternoon, evening and night) for five days using a 7point semantic rating scale anchored at one end by 1=“Not at all Nauseated” and at the other end by 7=“Extremely Nauseated.” A rating of 6 or 7 indicated severe nausea. Analysis of covariance controlling for age, susceptibility to motion sickness, and nausea during pregnancy, revealed that patients’ initial expectancy of having severe nausea significantly predicted its actual occurrence. Severe nausea developed at some point during the 5-day assessment period in 64% of patients who responded “very likely,” 17% of those who chose “very unlikely”, and 35% of those who chose one of the three middle responses (P=0.012). Supported by grant U10CA 37420 from the National Cancer Institute.

A-22 A-20 5-HT3 ANTIEMETIC USE IN BREAST CANCER PATIENTS RECEIVING CYCLOPHOSPHAMIDE: A MULTICENTER PRACTICE EVALUATION P. Anne Farley, Alicia C. Shillington, Cindy L. Dempsey*, Kevin Colgan, EPI-Q Inc., Oakbrook Terrace, Illinois, USA Objective: To evaluate chemotherapy induced nausea and vomiting (CINV) outcomes in naïve breast cancer outpatients treated with cyclophosphamide containing regimens given antiemetic doses at standard and lower than approved doses. Methods: Retrospective data from six U.S. cancer centers was collected on 231 patients receiving therapy from January 1998-2002. Excluded were those age > 64 years and bone marrow transplant recipients. Results: Ondansetron 32 mg (standard-dose) was given to 76 patients (33%). Low-dose ondansetron (≤16 mg) was given to 75 patients (32%). Eighty patients (35%) received granisetron 1 mg or 10 µg/kg. Multiple logistic regression analysis was used to examine likelihood of CINV controlling for emetogenic potential, radiation and dexamethasone use. Low-dose ondansetron patients had an increased risk CINV of 2.6 compared with granisetron and standard-dose patients (P<0.01). Forty-four percent of low-dose patients required rescue antiemetics compared to 31.6% in standard-dosed and 23.8% in granisetron patients (P<0.05). Eighteen low-dose patients (24.0%) received antiemetic regimen modification in subsequent cycles. No standard-dose or granisetron patients required modification. Conclusions: Recommendations suggesting effectiveness of low-dose ondansetron may negatively impact CINV protection in breast cancer patients receiving cyclophosphamide.

EQUAL EFFICACY IN WOMEN AND MEN WHEN THE ORAL NK1 ANTAGONIST APREPITANT IS ADDED TO STANDARD ANTIEMETICS IN PATIENTS RECEIVING HIGHLY EMETOGENIC CHEMOTHERAPY *R. Gralla1, AD Carides2, J Ianus2, M Elmer2, JK Evans2, K Horgan2 1New York Lung Cancer Alliance, New York NY, U.S.; 2Merck Research Laboratories, West Point, PA, U.S. Background: Large randomized trials with the best standard antiemetic regimens have repeatedly demonstrated that it is more difficult to control chemotherapy-induced emesis in women than in men. Recently, the NK1 antagonist aprepitant demonstrated significantly enhanced efficacy when added to standard therapy (5-HT3 antagonist plus corticosteroid) against chemotherapy-induced emesis. With these favorable results, we analyzed the data to determine whether aprepitant could overcome these gender differences in emetic control. Methods: 1044 patients (42% women, 58% men) receiving their first cisplatin (≥70 mg/m2) were randomly assigned to standard therapy (ondansetron [O] 32 mg i.v. and dexamethasone [D] 20 mg p.o. on day 1; D 8 mg twice daily on days 2–4) or an aprepitant (A) regimen (A 125 mg p.o. plus O 32 mg and D 12 mg on day 1; A 80 mg and D 8 mg once daily on days 2–3; and D 8 mg on day 4). The primary endpoint was complete response (no emesis and no rescue therapy) on days 1-5 (0120 hours); data were analyzed by a modified intent-to-treat approach. Treatment comparisons were made using logistic regression. All analyses accounted for gender; subgroup analysis was performed on the overall, acute and delayed periods to estimate the effect of the treatments, separately in men and women. Tolerability was assessed by reported adverse events and physical and laboratory tests. Results: The percentage of patients with complete response (days 1–5) was significantly higher in the aprepitant group versus standard therapy for each gender (66% vs 41% for women; 69% vs 53% for men; p<0.001 both comparisons). As

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seen, control rates for each gender were nearly identical for the aprepitant regimen. The previously reported inferior control rate was seen for women receiving only the standard regimen. Similar superiority was observed for the aprepitant regimen in separate comparisons for day 1 (acute emesis) and days 2–5 (delayed emesis) (p<0.001 in both comparisons for women; p <0.05 in both comparisons for men). Conclusions: This analysis of two large randomized trials in over 1000 patients indicated: 1) aprepitant added to standard antiemetics was generally well tolerated and improved emetic control significantly in both genders; 2) the degree of improvement with the aprepritant regimen provided equal control for both men and women; and 3) this equal and improved control was observed in both the acute and delayed emesis periods. This level of control and equalization of efficacy for men and women has not previously been observed for any class of antiemetic in large randomized trials with highly emetic chemotherapy.

and compliance to therapy. Antiemetic guidelines state that patients should receive a 5-HT3-receptor antagonist (5-HT3-RA) as prophylaxis during moderately or highly emetogenic regimens. Granisetron (GRA) has been shown to be highly effective for use in patients undergoing RT with or without chemotherapy compared with placebo or ‘conventional’ antiemetics (e.g. metoclopramide). For example, in the first 24 hours after RT, a single dose of oral GRA has been shown to significantly increase the time to first V vs comparator (p=0.001),1 and to completely prevent N & V in 56% of patients.2 In contrast, underlying pharmacological differences between the available 5-HT3-RAs suggest that there may be dosing issues with ondansetron compared with GRA, necessitating twice- or three-times daily administration.3 Clinical trial data will be presented highlighting the full 24-hour efficacy of GRA for the treatment of RT-induced N & V. 1Prentice et al. Bone Marrow Transplant 1995;15:445–8; 2Hunter et al. Bone Marrow Transplant 1991;7:439-4; 3Blower. Support Care Cancer 2003;11:93–100.

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INTERMEDIATE EMETOGENIC CHEMOTHERAPY (IEC): PROPHYLAXIS FOR ACUTE AND DELAYED EMESIS IN CLINICAL PRACTICE V. De Angelis, R. Canistro, G. Margutti, C. Boni, A. Fabi, E. Bertone, D. Farci, S. Pignata and F. Roila for the Italian Group for Antiemetic Research, Italy.

DIFFERENT EXPECTANCIES FOR CHEMOTHERAPY-INDUCED SEVERE NAUSEA HELD BY PATIENTS AND PROFESSIONAL STAFF A.R. Shelke1, J.A. Roscoe1, G.R. Morrow1, J.T. Hickok1, P. Bushunow1, S. Matteson1, J. N. Atkins2, H.I. Pierce3 1James P. Wilmot Cancer Center, Rochester, NY; 2SCCC CCOP, Winston-Salem, NC; 3Northwest CCOP, Tacoma, WA

ASCO antiemetic guidelines suggest a prophylaxis with corticosteroids/no regular preventive use of antiemetics for the prevention of acute/delayed emesis induced by irinotecan, topotecan, paclitaxel, docetaxel, mitoxantrone, gemcitabine, mitomycin, etoposide and teniposide. From March 25 to April 6, 2002, 607 consecutive patients (pts) refered to 92 Italian oncological centers to be submitted to IEC administered in only one day entered the study. The following rates of antiemetic prescriptions for acute/delayed emesis were recorded: DRUGS

Acute

Delayed

No treatment 5HT3+steroids 5HT3 alone Steroids Steroids+benzamides Other

4.6 42.9 30.3 5.9 5.4 10.9

54.2 9.4 20.3 3.2 2.8 10.1

Such antiemetic prescriptions were not related to the pts previous experience of emesis. In conclusion, an antiemetic overtreatment was shown in this study; in fact, about 75%/30% of patients submitted to IEC received a 5-HT3 antagonist prophylaxis for acute / delayed emesis. The study was carried out with the support of GSK Italy.

We asked 194 chemotherapy naïve breast cancer patients, about to receive their first infusion of doxorubicin-based chemotherapy, what they had learned about the likelihood they would have nausea after treatment. Patients were asked what their expectations of developing severe nausea were before they had information from the oncology clinic and also what their doctor and nurse told them their chance of experiencing it would be. Responses to all three questions were made on a 5-point scale ranging from very likely to very unlikely. (See companion abstracts in this Journal by Shelke and Hickok for details on the expectancy question and nausea assessment.) Patients’ expectancies for developing severe nausea prior to talking to their physician were significantly higher than their doctor and nurse said the likelihood of their having this symptom would be (both, Ps <0.05). Whereas the initial measure of expectancy held by patients predicted the occurrence of severe nausea (P <0.05), subsequent measures, and predictions of severe nausea development made by doctors and nurses, as interpreted by the patient, did not predict its occurrence (all, Ps >0.05). The strongest predictor of severe ausea was the patient’s expectation before it was modified by information from doctors and nurses. Supported by grant U10CA 37420 from the National Cancer Institute.

A-26 A-24 THE EFFICACY OF GRANISETRON FOR RADIOTHERAPY-INDUCED NAUSEA AND VOMITING: THE IMPORTANCE OF 24 HOUR CONTROL M Heinrich Seegenschmiedt Klinik für Radioonkologie & Strahlentherapie, Alfried Krupp von Bohlen und Halbach Krankenhaus, Essen-Rüttenscheid, Germany Nausea and vomiting (N & V) significantly impact cancer patients’ quality of life during radiotherapy (RT) and radiochemotherapy (RCT). Fractionated RT/RCT – often administered over 4–6 weeks – can prolong symptoms of N & V. Effective 24 hour control of N & V is an important factor for patient quality of life

OCCURRENCE OF SEVERE NAUSEA IN 194 WOMEN TREATED WITH DOXORUBICIN FOR BREAST CANCER J.T. Hickok1, J.A. Roscoe1, G.R. Morrow1, P. Bushunow1, A.R. Shelke1, S. Matteson1, S.R. Dakhil2, P.J. Flynn3 1James Wilmot Cancer Center, Rochester, NY; 2Wichita CCOP, Wichita, KS; 3Metro-Minnesota CCOP, St. Louis Park, MN We examined the severity of nausea in 194 chemotherapy-naïve women (mean age=52.5, range 25-84) with breast cancer following their first infusion of doxorubicin-based chemotherapy. The subjects were assigned to a standard treatment control group of a multicenter clinical CCOP trial. All patients received a 5-HT3 receptor antagonist on the day of chemotherapy. Corticosteroids and other antiemetics were administered at the physicians’ discretion.

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Nausea was assessed four times daily (morning, afternoon, evening and night) for five days by patients at home using a 7-point semantic rating scale anchored at one end by 1=“Not at all Nauseated” and at the other end by 7=“Extremely Nauseated.” Fortytwo (22%) of the 194 women reported having severe nausea (a rating of 6 or 7 on the 7-point scale) on Day 1 of chemotherapy (acute nausea). Fifty-eight (30%) of the patients had severe nausea at some point during Days 2–5 (delayed nausea). The proportion of patients with severe nausea on each of these four days was 16%, 17%, 12%, and 10%, respectively. Overall, 73 (37%) of the women experienced severe nausea at some point during the five days. Severe nausea is prevalent throughout the acute and delayed phases of treatment for breast cancer. Supported by grant U10CA 37420 from the National Cancer Institute.

A-27 CHEMOTHERAPY INDUCED NAUSEA AND VOMITING (CINV) IMPAIR SIGNIFICANTLY DAILY LIFE OF PATIENTS: ANCHOR REGISTRY *Fausto Roila; Robert Deuson, Olga Geling, Panagiotis Mavros Ferrara Hospital, Perrugia, Italy; Merck & Co. Inc., Whitehouse Station NJ, USA. PURPOSE: To assess impact of acute and delayed CINV on patients’ daily lives. STUDY: 300 CT-naïve patients from 14 oncology practices in Denmark, France, Germany, Italy, UK, and USA completed 5-day diaries following moderately to highly emetogenic CT, on nausea, vomiting and the Functional Living IndexEmesis (FLIE). RESULTS: Mean age 55; 71% female; 49% breast cancer. 21% received cisplatin-based regimens. 97% received a 5HT3 antiemetic, 76% a corticosteroid. 60% reported nausea (36% had acute and 54% delayed nausea). 36% reported vomiting (13% had acute and 33% delayed vomiting). Among patients with nausea (vomiting), only 25% (39%) reported that CINV had NO impact on their ability to carry out activities and tasks of daily living. CONCLUSION: Despite modern antiemetic treatments, more than half and more than one third of treated patients still experienced chemotherapy induced nausea and vomiting, respectively. The majority of patients affected by CINV reported significant worsening of their daily lives.

A-28 THE ORAL NK1 RECEPTOR ANTAGONIST, APREPITANT, WAS EFFECTIVE IN MAINTAINING PATIENTS’ DAILY LIFE ACTIVITIES IN BOTH MALE AND FEMALE PATIENTS RECEIVING HIGHLY EMETOGENIC CHEMOTHERAPY. AR Martin1, GJ Ma1, AD Carides1, K Horgan1, M Elmer1, C Rittenberg2, A Makalinao3, C Lindley4 1Merck Research Laboratories, West Point, PA; 2Rittenberg Oncology Consulting, New Orleans, LA; 3California Oncology/Hematology Medical Center, Los Angeles, CA; 4University of North Carolina, Chapel Hill, NC. In a prior Phase IIb study, a significantly greater proportion of patients treated with the NK1 receptor antagonist aprepitant reported no impact of chemotherapy-induced nausea and vomiting (CINV) on daily life activities compared to standard antiemetic therapy as assessed by the Functional Living Index-Emesis (FLIE) questionnaire. The objective of this analysis was to determine if differences in FLIE results were observed between males and females participating in the Phase III studies. Data from two randomized, double-blind Phase III studies were analyzed. 1044 patients (58% male; 42% female) receiving their first cisplatin (≥70 mg/m2) were given either standard therapy (ondansetron [O] 32 mg i.v. and

dexamethasone [D] 20 mg p.o. on day 1; D 8 mg twice daily on days 2–4) or an aprepitant (A) regimen (A 125 mg p.o. plus O 32 mg and D 12 mg on day 1, A 80 mg and D 8 mg once daily on days 2–3, and D 8 mg on day 4). The FLIE is a validated nauseaand vomiting-specific questionnaire that was completed by the patients on day 6 post-cisplatin. The primary FLIE endpoint was no impact on daily life (NIDL) defined as a Total FLIE score >108 (possible range: 0–126). Treatment comparisons were made using logistic regression with a modified intent-to-treat approach. The FLIE analysis accounted for gender, and a subgroup analysis was performed to estimate the effect of the treatments separately in the subgroups of males and females. The percentage of male and female patients meeting the criteria for NIDL over the 5 days postchemotherapy was significantly higher in the aprepitant group versus standard therapy group (78% vs 67% for males, p<0.01 and 69% vs 60% for females, p<0.05). Regardless of gender, aprepitant was effective in maintaining patients’ daily life activities during the 5 days after receiving highly emetogenic chemotherapy in these Phase III studies. This research was supported by Merck & Co., Inc..

A-29 A META-ANALYSIS COMPARING THE FOUR 5-HT3-RECEPTOR ANTAGONISTS (5-HT3-RAS) AS PROPHYLAXIS OF ACUTE CHEMOTHERAPY-INDUCED EMESIS. *K Jordan, A Hinke, A Grothey, H-J Schmoll University of Halle, Departement of hematology/oncology, Germany 5-HT3-RAs in combination with steroids are regarded as the optimal prophylaxis of chemotherapy-induced nausea and vomiting. Four different 5-HT3-RAs are currently available: granisetron (GRA), tropisetron (TRO), ondansetron (OND) and dolasetron (DOL). GRA, TRO and OND were compared in a previously meta-analysis of antiemetic studies in cisplatin- and non-cisplatinbased chemotherapy regimens, but the small number of studies directly comparing 5-HT3-RAs available at that time limited the validity of the analysis.1 Our current analysis is based upon a direct comparison of the efficacy of all four agents in preventing acute vomiting. It supplements the data of the earlier analysis, highlighting differences between 5-HT3-RAs. The results show a significant advantage of GRA over TRO overall (p=0.042), in the prevention of acute vomiting, particular in pts. receiving moderate emetogenic chemotherapy (∆: 7.3% vs cisplatin-based 5.4%). Complete results will be presented at the MASCC meeting. In conclusion 5-HT3-RAs differ in their antiemetic profile which should be considered when comparing antiemetic trials. 1 du Bois, A. In: Emesis in der Tumortherapie. Hamburg: Ellyott Medizin Verlag, 1999: 40–97.

A-30 SURVEY OF NURSES FROM ONCOLOGY AND EUROPEAN ONCOLOGY NURSING SOCIETIES (ONS AND EONS) AND MULTINATIONAL ASSOC. OF SUPPORTIVE CARE IN CANCER (MASCC): IMPLICATIONS FOR ANTIEMETIC TREATMENT Judi Johnson PhD RN,1 Cindy Rittenberg MN RN AOCN,2 Sussanne Börjeson PhD RN3 1HealthQuest, Minneapolis, MN 55423, USA. 2Rittenberg Oncology Consulting, New Orleans, LA, USA. 3Linkopings University, Sweden. Oncology nurses (n=390) attending 2002 meetings of ONS, EONS and MASCC were questioned on their workload, time constraints and views of antiemetic therapy. The majority of their 38-plus

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hour week was spent on patient care/counselling and all reported a shortfall between time spent and time needed for the task, with other tasks suffering similarly. As a specific time barrier, all nurses cited that 30-second injections are much quicker to prepare and administer than 15-minute infusions; thereby saving valuable nursing time. On a 7-point scale (1=no impact, 7=impacts very badly), the majority of nurses ranked chemo- or radiotherapy-induced nausea and vomiting highly (5–7) in affecting patients quality of life (QoL) and future compliance (3–6). Lack of 24-hour control was ranked first of four factors affecting successful antiemetic therapy. This control is important as administering additional rescue doses adds to nurse workload, as do delayed adverse events. Administration of antiemetics with good 24-hour control, good safety and tolerability, and a straightforward dosing regimen could help conserve patients’ QoL, improve compliance and decrease nurses’ workload and thus save them time.

A-31 PATTERNS OF CHEMOTHERAPY INDUCED NAUSEA AND VOMITING (CINV) IN PATIENTS (PTS) RECEIVING CHEMOTHERAPY (CT) Carl de Moor, Lorenzo Cohen, Peter Eisenberg**, Young Kim, Eileen Ming*, and Edward B. Rubenstein UT M. D. Anderson Cancer Center, Houston, TX; *Merck & Co, Inc., PA, USA; **California Cancer Care, CA, USA To identify patterns of CINV among pts receiving CT, 57 pts (77% female, mean age 56; 52% breast cancer) recorded emetic episodes and nausea severity for days 1 to 7 (D1-D7) of their 1st cycle of CT. A cluster analysis was conducted to identify subgroups of pts with different patterns of CINV (≥1 emetic episode, >5 mm nausea on 100 mm scale). This analysis revealed 3 groups of pts. Group 1 (n=6) had a high rate of CINV across all days, (50% D1, nearly 100% D2-D6, ~70% D7); Group 2 (n=15) had a moderate rate of CINV, (50% D1; decreasing linearly to 0% D7); and Group 3 (n=36) had a low rate of CINV (<10% D1-D7). The average number days of CINV was: Group 1=5.8 days, Group 2=2.9 days, and Group 3=0.3 days. The 3 groups were similar on medical factors but differed on age (Group 1=46.5, Group 2=52.9, Group 3=59.5; p<0.05). Importantly, the 3 groups differed significantly on the Functional Living Index–Emesis scale during follow-up (Group 1=84.4; Group 2=92.0; Group 3=112.9; p<0.001; lower scores=worse functioning). CINV occured in distinct patterns for different subgroups of pts during D1-D7 after CT, with a substantial proportion of pts suffering multiple days of CINV and experiencing marked disruption of daily functioning.

A-32 TESTING AN INSTRUMENT TO MEASURE PAIN IN NON-COMMUNICATIVE HOSPICE PATIENTS *D.B. McGuire, PhD, RN; J. Reifsnyder, PhD, RN University of Pennsylvania, Philadelphia, PA, US The gold standard of pain measurement is subjective self-report, but many hospice patients are unable to report their pain. The purpose of this study was to conduct an initial evaluation of the reliability and validity of the Multidimensional Objective Pain Assessment Tool (MOPAT), designed to measure two dimensions of pain in non-communicative hospice patients. The Behavioral subscale (BS) rates restlessness, muscle tension, facial expression, and vocalization on a scale of 0=none or normal to 3=severe. The Physiologic subscale (PS) rates blood pressure, heart rate, respirations, and diaphoresis on a scale of 0= normal or no change from baseline to 1=abnormal or change from baseline. The sample included 2 groups of hospice patients with pain. Group 1 (n=28) was alert and

oriented; they self-reported their pain using the McGill Pain Questionnaire Present Pain Intensity (PPI) scale and had their pain assessed by study nurses using the MOPAT. Group 2 (n=30) was noncommunicative and had their pain assessed by hospice nurses using the MOPAT before (T1) and after (T2) a pain intervention. Group 1 had little variance on the MOPAT subscales and modest variance on the PPI, which was not correlated with either subscale. Group 2 had Cronbach’s alpha coefficients of 0.85 and 0.78 for the BS and PS at T1, respectively. Mean scores for the BS and PS were 6.67 and 2.23 at Time 1, and 2.55 and 0.86 at Time 2, respectively; these differences were statistically significant (p=0.000). The MOPAT has initial evidence of reliability and validity, and warrants further testing (funded by ONS and NINR/NIH).

A-33 THE GAP BETWEEN GUIDELINES AND CLINICAL PRACTICE IN THE TREATMENT OF CHRONIC PAIN – A QUALITY MANAGEMENT APPROACH *Sascha Navarra, Peter R. Müller Swiss Cancer League, Berne, Switzerland There is no lack of practice guidelines for the treatment of chronic pain. However surveys in the US and Europe suggest that the actual treatment is far from satisfactory. The Swiss Cancer League offers a quality management project with the aim of bridging the gap between expert knowledge and clinical practice. The project accompanies health care institutions in a 12month process to achieve 10 quality criteria. During this process standard procedures for the assessment, documentation and treatment of chronic pain are defined by an interdisciplinary group within the institution. This work includes the development, adaptation and implementation of appropriate tools as well as the education of the staff. The process is monitored and evaluated with regular audits. The data gathered in these audits are of a non-experimental nature. The results of the 8 institutions that have achieved the 10 quality criteria show significant improvements on a structure level (e.g. a dossier on pain management for new staff members), a process level (e.g. systematic pain assessment) and a level of patient outcomes (e.g. pain-intensity). The results and our experience indicate that a quality management approach is feasible and leads to satisfactory results.

A-34 IMPACT OF IBANDRONATE ON BONE PAIN IN PATIENTS WITH METASTATIC BONE DISEASE FROM BREAST CANCER Body JJ*, Diel I, Tripathy D, Bergstrom B Université Libre de Bruxelles, Institut Jules Bordet, Brussels Metastatic bone disease (MBD) is a common complication of advanced breast cancer, affecting up to 80% of patients. Reducing bone pain, which is often severe and disabling, is an important aim of palliative therapy in these patients. An acute analgesic effect has previously been reported in an independent, open label study of non-standard, intensive ibandronate treatment (4 mg infused intravenously [i.v.] over 2 hours for 4 days) in patients with opioidresistant bone pain from MBD (MASCC 2002). Over 96 weeks of treatment, phase III clinical trials have assessed the impact of long-term ibandronate treatment on bone pain in patients with MBD from breast cancer. Bone pain scores were assessed on a 5point scale from 0=none to 4=intolerable. The results of a trial of i.v. ibandronate demonstrated that a 6mg dose infused over 1-2 hours every 3-4 weeks significantly reduced mean baseline bone pain scores compared with placebo (-0.28 vs +0.21, p<0.001). Utilization of analgesics was lower in the ibandronate group, al-

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though the difference did not reach statistical significance (p=0.08). In clinical trials (n=846) of oral ibandronate in breast cancer patients with MBD, mean baseline bone pain scores were reduced by –0.10 with a 50 mg daily dose, compared with an increase in score of +0.20 with placebo (p=0.001). These results demonstrate that long-term treatment with 6mg i.v. and 50mg oral ibandronate has a marked analgesic effect in patients with MBD from breast cancer. Unlike other bisphosphonates, pain reduction with ibandronate is marked, sustained and prolonged below baseline levels over 2 years of treatment.

A-35 AMITRITPYLINE – USING IT´S LOCAL ANESTHETIC EFFECT IN PAINFUL TUMOR ULCERS *Ewald H, Clinic for Radiooncology, Culman J, Institute for Pharmacology University Hospital of Schleswig-Holstein, Camups Kiel, Germany Purpose: The purpose of this trial was to test unusual local measures to improve superficial local pain in ulcerating cancer. This case study will discuss an efficient new method of local pain treatment using the local anesthetic effect of amitriptyline.Description Situation: Painful recurrence of rectal cancer in the anal chanal with exulcerating components. Paintreatment according to the WHO-ladder step 3 had not been effective during touchment or walking. Treatment: Local treatment had been tried with usual local anesthetics, with local morphine and finally with local amitriptyline. Results and conclusions: Usual local anesthetics gave a burning sensation and their effect lasted only a few minutes. Local morphine had a somewhat better effect, did not result in burning sensations and acted somewhat longer. Both are well known treatment options. By far the best result we got using local amitriptyline as a gel. Pain improved some minutes after it´s application which proves the local effect although we found therapeutic blood levels after some weeks. A prospective clinical study has been started to investigate the relevance of this new local treatment option.

A-36 OXYMORPHONE EXTENDED RELEASE (ER) IN OPIOID ROTATION *Nashat Y. Gabrail,1 Chris Dvergsten,2 Tina Ma,3 Amy Frailey,3 and Harry Ahdieh3 1Canton, OH, US; 2INC Research, Charlottesville, VA, US; 3Endo Pharmaceuticals, Inc., Chadds Ford, PA, US A phase III, 2-way crossover study compared the efficacy of oxymorphone extended release (ER) and oxycodone CR in moderate-tosevere cancer pain. Patients requiring WHO step 3 analgesics were stabilized on oxycodone CR during a 7- to 10-day screening phase, followed by 7 days of double-blind treatment with oxycodone CR or oxymorphone ER, then 7 days of alternate treatment (estimated potency 2:1 for oxycodone CR:oxymorphone ER). Dosages were fixed from day 4 to 7; 2 doses of morphine sulfate 15 mg/d were allowed as rescue. Efficacy was assessed by pain intensity and relief, Brief Pain Inventory, global evaluations, and Karnofsky performance status. Forty-four patients received ≥1 dose of study drug. Mean pain intensity was 2.5 for oxymorphone ER and 2.8 for oxycodone CR— statistically but not clinically different. Results of other efficacy parameters were equivalent for the 2 groups. The mean daily dose of oxycodone CR was 91.9 mg versus 45.9 mg for oxymorphone ER, confirming a 2:1 dose ratio. Rescue medication use was low in both groups, but lower with oxymorphone ER. Side effects were similar between groups. Patients on oxycodone CR can be converted to oxymorphone ER and rapidly achieve a stable dose that provides adequate pain relief with similar side effects.

A-37 KNOWLEDGE AND ATTITUDES OF ITALIAN MEDICAL ONCOLOGY RESIDENTS TOWARDS THE APPROACH AND TREATMENT OF PAIN Porzio G1, Aielli F1, Narducci F1, Martelli S1, Morelli MF2, Cianci G2, De Galitis F2, Ricevuto E2, Ficorella C2, Marchetti P2 1 Supportive Care and Rehabilitation Unit and 2 Medical Oncology Department, University of L’Aquila, Italy To evaluate knowledge and attitude about pain a 16 items questionnaire based on three main topics (attention paid to pain, use of analgesics, and pain in children) was administered to 100 italian medical oncology residents during the 4th National Congress of Medical Oncology, September 28-October 1 2002. The residents anonymously completed the questionnaire, in the presence of the interviewers, and without any help by other colleagues. The questionnaire was the same used by Visentin in a previous published study (Visentin M et al. Knowledge and Attitudes of Italian Medical Staff towards the Approach and Treatment of Patient in Pain. J Pain Symptom Manage 2001; 22:925-930) Correct answers were 75.4% for items regarding use of analgesics, 87.2% for items regarding attention paid to pain and 73.3% for items regarding pain in children. No major statistical differences were evidenced regarding year of residency, availability of consultants in pain therapy and/or palliative care, colleagues with main interest on palliative care in the oncological staff and beds dedicated to palliative care in the oncological department. Our data suggest that among the italian medical oncology residents, knowledge and attitudes on treatment of pain can be considered satisfactory. The next step is to evaluate how this satisfactory knowledge the residents in oncology have is used in the clinical practice. We are planning a prospective study to clarify this issue.

A-38 EFFICACY OF IBANDRONATE IN THE MANAGEMENT OF PAINFUL OSSEOUS METASTASES DUE TO HORMONE REFRACTORY PROSTATE CANCER C. Ohlmann, A. Heidenreich* Department of Urology, Philipps University Marburg, Germany An estimated 90–95% of patients with HRPCA will go on to develop metastatic bone disease (MBD). Bone pain is a cause of considerable morbidity in these patients, with impaired mobility and poor quality of life. Palliative treatment options for MBD pain include analgesics, opioids and bisphosphonates. In a previous study, we demonstrated that clodronate, a first-generation bisphosphonate, relieves pain in some patients with metastatic bone pain due to HRPCA. Here we report data from an open-label, non-randomized study that evaluated the impact of ibandronate, a new, highly-potent bisphosphonate, on bone pain in 45 patients with HRPCA. Patients received 6mg intravenous (i.v.) ibandronate over 1 hour each day for 3 days, followed by 6mg ibandronate i.v. every 4 weeks. Ibandronate therapy significantly relieved pain (assessed on a visual analogue scale from 0=no pain to 10=severe pain) in 89% of patients (n=40). Approximately 25% of these patients (n=11) were completely pain free following treatment. Pain relief was accompanied by reductions in daily analgesic requirement, and improvements in patient functioning (particularly mobility) as assessed by Karnofsky index and Eastern Cooperative Oncology Group (ECOG) performance status. In conclusion, i.v. ibandronate has a marked analgesic effect that provides meaningful clinical benefits in patients with skeletal metastases from HRPCA.

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A CLINICAL EVALUATION OF TRANSDERMAL FENTANYL IN ADULTS WITH CANCER PAIN: PHASE IV, MULTICENTRE TRIAL *Komurcu S, Turhal S, Altundag K, Atahan L, Turna HS, Manavoglu O, Yavuz AA, Ozkok S, Aliustaog˘lu M, Altınbas M, Pak Y, Cooper R, Yaylaci M, Demirkan B, Engin K, Ozdemir F. Turkish Oncology Group, Supportive Care Study Group

THE ROLE OF METHADONE IN OPIOID ROTATION IN THE TREATMENT OF SEVERE CANCER PAIN Wojciech Leppert*, Jacek Łuczak*, Slawomir Paweł Wo´zniak**, Aleksandra Kotli´nska-Lemieszek*, Eleonora Mess*** * Chair and Palliative Care Department, Karol Marcinkowski Medical University, Pozna´n, Poland; ** Palliative Care Department, Down Silesian Oncology Centre, Wrocław, Poland; *** Clinical Nursing Department, Medical University, Wrocław, Poland

INTRODUCTION: Transdermal fentanyl (TTS – F) is an effective alternative to oral opioids for the control of chronic pain in cancer patients. TTS – F was released in Turkey in May 2000. The aim of this study was to evaluate prospectively the efficacy, toxicity and convenience of the TTS–F in cancer patients with pain requiring opioid analgesics. MATERIAL AND METHODS: This was a phase IV open, multicentre uncontrolled study initiated on 28th February 2001 and completed on 26th April 2002. Ninety nine patients (41 men and 58 women) were enrolled in the study; mean age was 55.1 (range 16-58 years). The study duration was 28 days. Patients were evaluated by three visits (on days 1, 16 and 28) and seven phone contacts (on days 4, 7, 10, 13, 19, 22 and 25). RESULTS: Pain severity fluctuated between day 2 and day 28. Most patients reported a decrease in pain severity after day 2. The amount of morphine equivalent of rescue medication used decreased from day 4 to day 28. Overall evaluation of pain treatment (pain control, side effects and overall impression) improved significantly from visit 1 to visit 3. The majority of the patients rated the convenience of the use of the patches as excellent. Treatment preference was in favour of the TTS-F patches. The main reasons for this preference were better pain relief, less side effects and more convenience. Karnofsky Performance Status score did not change significantly between the visits. At each visit the majority of patients did not experience abdominal pain, bloating or had used laxatives during the last 7 days. Abdominal pain and bloating decreased from visit 1 to visit 3, while the use of laxatives increased between the visits. Overall bowel function improved from visit 1 to visit 3. Disease status remained unchanged for the majority of the patients. Less than a quarter of the patients (22.2%) exhibited adverse events probably or very likely related to study drug, and very few patients mentioned severe adverse events. The majority of the adverse events mentioned were related to the digestive system, nausea being the most common. Eighteen serious adverse events were reported by 13 patients. There were four withdrawals due to death. None of these deaths were attributed to the study drug. CONCLUSION: This is the first TTS-F study done in Turkish population. It showed that this non-invasive and continuous drug delivery system appeared as an effective, safe and well tolerated method of managing chronic cancer pain.

PATIENTS AND METHODS: In an open clinical study we assessed analgesic efficacy, side effects of methadone and equianalgesic doses of oral morphine and methadone used in opioid rotation. Methadone was administered in 10 opioid – tolerant patients with severe cancer pain. Patients received methadone because of inadequate pain control (VAS >5) during treatment with morphine (7 patients) or transdermal fentanyl (2 patients). In 1 patient the indication for switching methadone was severe drowsiness during morphine treatment. RESULTS: Mean time of the treatment was 30 (range 3–90) days. Good analgesia expressed by decrease of pain intensity VAS <4 was achieved in 6 patients, partial effect (VAS 4–5) in 3 patients. Unsatisfactory analgesia (VAS >5) was observed in 1 patient – methadone was withdrawn after 2 days. The most frequent side effects were drowsiness (4 patients), constipation (3 patients) and nausea (2 patients), however they did not caused cessation of the treatment. No serious adverse reactions such as respiratory depression or allergy were observed during methadone treatment. CONCLUSIONS: Results of this study confirmed high analgesic efficacy and good tolerance of methadone treatment as an second opioid. Our preliminary experience and review of the literature indicate for the following change rates of oral morphine to oral methadone: 4: 1 (up to 100 mg morphine daily), 8: 1 (100–300 mg morphine daily) and 12: 1 (daily dose of morphine over 300 mg). This allows for safe and effective treatment in morphine tolerant patients. Methadone seems to be very effective drug used in opioid rotation when morphine and transdermal fentanyl do not allow for satisfactory pain relief and/or cause intolerable side – effects.

A-41 LONG-TERM SAFETY, EFFICACY, AND DOSE STABILIZATION OF OXYMORPHONE ER IN CANCER PAIN *Neal Slatkin,1 Amy Frailey,2 Tina Ma,2 and Harry Ahdieh2 1City of Hope National Medical Center, Duarte, CA, US; 2Endo Pharmaceuticals Inc., Chadds Ford, PA, US Cancer patients with moderate to severe chronic pain who completed a randomized controlled trial and met study criteria entered a 2-year, open-label, multicenter trial (N=44) to determine the long-term safety, efficacy, and dosing of extended-release (ER) oxymorphone. Patients began treatment at the stabilized dose in the previous study and had stable pain scores. Oxymorphone ER was given every 12 hours (q12h) and titrated as necessary. Oxymorphone immediate release (IR) was available as rescue medication. Efficacy was assessed by pain intensity scores and patient’s global assessment of study medication. For patients completing 52 wks (n=16), the degree of pain relief was maintained (average VAS score: at baseline, 33.5 mm; at 52 wks, 31.7 mm). The average dosage of oxymorphone ER was 80 to 140 mg q12h. Average daily dose of oxymorphone IR rescue was 20 to 25 mg. Study medication was rated “excellent”, “very good”, or “good” at relieving pain by >90% of patients. Average time to discontinuation was 253 days. The most common adverse events were nausea, vomiting, constipation, and sedation. Long-term use of oxymorphone ER was safe and effective in cancer patients with moderate to severe chronic pain, with stable pain scores at 80 to140 mg q12h with minimal rescue medication.

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THE RELATIONSHIP OF PAIN, UNCERTAINTY, AND HOPE IN TAIWANESE LUNG CANCER PATIENTS Chia-Chin Lin, Tsui-Hsia Hsu, Meei-Shiow Lu, Tsung-Shan Tsou School of Nursing, Taipei Medical University, 250 Wu-Hsing Street, Taipei, 110, Taiwan

THE ROLE OF TRAMADOL IN THE TREATMENT OF CANCER PAIN IN POLAND Wojciech Leppert*, Jacek Łuczak*, Piotr Milecki**, Sławomir Paweł Wo´zniak***, Eleonora Mess****, Aleksandra Ciałkowska– Rysz*****, Sylwia Ka´zmierczak****** * Chair and Palliative Care Department, Karol Marcinkowski Medical University, Pozna´n; ** Radiotherapy Department, Greatpoland Oncology Centre, Pozna´n; *** Palliative Care Department, Down Silesian Oncology Centre, Wrocław; **** Clinical Nursing Department, Medical University, Wrocław; ***** Palliative Care Department, Chair of Oncology, Medical University, Łód´z, Poland; ****** Palliative Care and Radiotherapy Department, Mikołaj Kopernik; Hospital, Łód´z, Poland

The impact of cancer pain on the quality of life of lung cancer patients is obvious, but the relationship of cancer pain to uncertainty and levels hope in cancer patients is not clear and has been the subject of only a few studies. This purpose of this study is to look at the relationship of pain to uncertainty and hope in Taiwanese lung cancer patients. A cross-sectional and descriptive correlational design was used in this study. Lung cancer patients were recruited by convenience sampling from chest medicine and oncology inpatient units at three teaching hospitals in the Taipei area of Taiwan. The research instruments included the Brief Pain Inventory-Chinese vision (BPI-C), Mishel’s Uncertainty Illness Scale (MUIS), and the Herth Hope Index (HHI). Data were analyzed using descriptive statistics, Pearson’s correlation, and multiple regression. A total of 164 subjects were recruited, including 79 patients with cancer pain and 85 patients without cancer pain. The major findings of this study were as follows. (1) There were significant differences in level of uncertainty and level of hope between patients with cancer pain and those without. Patients with cancer pain reported higher levels of uncertainty and lower levels of hope than did patients without cancer pain. (2) Pain severity was not significantly related to level of uncertainty; however, pain interference with daily life was positively correlated to level of uncertainty. (3) Both pain severity and pain interference were negatively correlated with level of hope. (4) After controlling for pain severity and pain interference, uncertainty was a significant predictor of level of hope. Important implications for directions for future studies are discussed in this study.

A-43 PAIN MANAGEMENT: THE FIRST STEP IN PALLIATIVE CARE. ME Stein MD, E. Muller RN MA. Department of Oncology, Rambam Medical Center, Haifa, Israel As nurses and specialists working in one of the largest oncology facilities in Israel, we felt a lack of knowledge and ability to represent our patients in relation to pain management. Therefore, two years ago, we formed a Pain Care Committee whose aims included improving patient care and increasing staff knowledge. We began by researching the subject of pain management and questioning patient needs and staff knowledge. We visited pain clinics throughout the country, attended lectures and conferences, research conventional and alternative modalities for pain management. The VAS scale and pain assessment evaluation form were introduced and adapted to our practice. Staff education is ongoing and has become a permanent part of our monthly staff meeting agenda. As a result, our patients report a feeling of seriousness with regard to pain treatment. The medical staff in various department consult us before ordering or changing treatment. Our staff now feels adequately equipped to suggest induction of and changes in treatment. Comments: Although we have come a long way, we are aware that pain management is just one step on the way to complete palliative care. We plan to expand our project to include additional symptoms, aiming at optimizing our quality of management.

INTRODUCTION: Tramadol is a synthetic weak opioid analgesic of the 2 step of the WHO analgesic ladder from aminocycloheksanol group with opioid agonist properties and acting on neurotransmission of noradrenaline and serotonine. In addition it possess anti–inflammatory and local analgesic activity. The drug entered West German market in 1977, Poland in 1983, the U.S.A. in 1995 and Great Britain in 1996. Tramadol is widely use in Poland in the treatment of cancer and also in non – malignant pain. PATIENTS AND METHODS: Analysis of 601 patients treated with normal and modified release oral tramadol was performed. 459 (76%) patients had moderate pain (VAS 3–5.5), 142 (24%) suffered from severe and very severe pain (VAS >5.5). In 45 (7.5%) patients after achieving adequate pain relief with normal release preparations (drops, capsules) Tramal Retard tablets (100, 150 or 200 mg) were administered. The rest 556 (92.5%) patients received normal release preparations. The starting single dose of normal release tramadol was 12.5–50 mg every 4 hours with 1.5 or twice higher dose before sleep. RESULTS: Daily dose range was 50–800 (mean 320) mg. Most (574) patients received metoclopramide or haloperidol as the profilaxis of nausea and vomiting. The time of the treatment ranged from 1–687 (mean 35) days. Good analgesia (VAS <3) was observed in 453 (75.4%): in 402 (87.6%) with moderate, in 51 (35.9%) with severe and very severe pain and in 31 (68.8%) patients treated with Tramal Retard. Partial effect (VAS 4–5) was noted in 78 (13%) patients: in 42 (9.1%) with moderate, in 36 (25.3%) with severe and very severe pain and in 8 (17.8%) patients treated with Tramal Retard. Unsatisfactory analgesia (VAS >5) was observed in 70 (11.6%) patients: in 15 (3.3%) with moderate and in 55 (38.8%) with severe and very severe pain and in 6 (13.3%) patients receiving Tramal Retard. Side effects caused cessation of the treatment in 28 (4.6%) of patients. The most frequent side effects were as follows: constipation in 156 (26%), nausea 85 (14%), drowsiness in 34 (5.6%), sweating in 19 (3.2%), palpitations in 14 (2.3%) patients. In 242 (40.2%) patients treated with tramadol it was necessary to substitute tramadol with morphine or transdermal fentanyl after mean time of 35 days of the treatment because of unsatisfactory analgesia in spite of escalating doses of tramadol 400–800 mg per day. CONCLUSIONS: Tramadol is an effective and safe treatment of cancer pain of moderate and sometimes severe intensity with tolerable side-effects. In Poland tramadol has substituted significantly for codeine (in contrast to tramadol there are no parenteral formulations of codeine) at the second step of the WHO analgesic ladder in the treatment of cancer pain of moderate intensity. It causes less constipation in comparison to codeine and careful titration rarely induces other side effects. Tramadol can be recommended in patients with nociceptive and neuropathic cancer pain of moderate and sometimes severe intensity especially in patients with gastrointestinal tumours.

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FACTORS ASSOCIATED WITH THE PRESCRIPTION OF MORPHINIC ANALGESICS TO TERMINAL CANCER PATIENTS. A FRENCH RETROSPECTIVE SURVEY. PERETTI-WATEL P.1, BENDIANE MK.(*), FAVRE R., OBADIA Y. 1,2 and the South-Eastern France Palliative Care Group 1. Regional Centre for Disease Control of South-Eastern France, Marseilles, France; 2. Health and Medical Research National Institute, Research Unit 379, “, Marseilles, France; 3. Assistance Publique Hôpitaux de Marseilles, oncology unit, Marseilles, France.

GENERAL STRATEGY OF PAIN CONTROL IN NEUROSURGICAL ONCOLOGICAL PATIENTS *Irina A. Savvina, Anatoly N. Kondratyev

This study aimed to examine non-clinical factors associated with the prescription of morphinics to terminal cancer patients. A survey was carried out on a sample of French general practitioners and oncologists. Respondents were asked to describe the last three terminally-ill patients they had followed up to death. A total of 502 GPs and 217 oncologists described 1,082 cancer patients, among which 85.4% received morphinic analgesics. This prescription was less frequent for female patients followed by male physicians (OR=0.53), and more frequent for patients followed by physicians trained in palliative care (2.70). Once controlled this training, GPs no longer differed from oncologists. Patient age, cancer type and family assistance were also linked with this prescription. Although non-prescription of morphinics does not necessarily means undertreatment of pain, our findings suggest the need for developing specialised training in palliative care in order to homogenise practices of GPs and specialists, and they also suggest to pay more attention to age and gender differences.

A–46 THE USAGE OF MORPHINE HCL PREPARATIONS IN TREATMENT OF PAINFUL MALIGNANT ULCERS A. Cialkowska-Rysz, S.F. Kazmierczak2, B. Misiewicz2, B. Serbiak2, M. Sokalszczuk2, W. Leppert4 , G. Samczewska3, M. Zgoda3 1 Department of Oncology Medical University – Lodz, Poland; 3 Department of Applied Pharmacy Medical University -Lodz, Poland; 2 Department of Palliative Care and Radiotherapy Copernicus Hospital - Lodz, Poland; 4 Department of Palliative Care K. Marcinkowski Medical University - Poznan , Poland Opioids may successfully modulate the experience of pain by binding to the opioid receptors on sensory nerve terminals located at the inflamed peripheral tissues. Aims: In the current study we estimated efficacy and compared local analgesic effect of hydrogel and ointment containing morphine HCL and also determined time of use and side effects. Methods: The study comprised16 patients with painful malignant skin ulcerations. Hydrogel and ointment of an absorption cream type was prepared in the Department of Applied Pharmacy at medical University of Lodz and they contained 0,2% of Morphine HCL. Results: In all cases we observed reduction of pain aliments. Patients did not recognize any differences between hydrogel and ointment analgesic activity. The application of morphine HCL preparations to the painful skin lesions produced from 6 to 16 hours of analgesia. The administration frequency of preparations was 2-3 times a day. Systematic effects have not been observed during the treatment process. Conclusions: Locally administrated preparations containing morphine HCL caused significant analgesia in patient with painful malignant ulcers. Ointment and hydrogel containing morphine HCL applied on the skin have comparable analgesic effect.

Pain control experience in neurosurgical oncological patients aged from 36 to 73 y.o. treated by anaesthesiologist in Russian Polenov’s Neurosurgical Institute is reported. Analgesics choice is based on the pain heaviness and it’s aetiology. Pain of low and moderate intensity is treated by paracetamol or another non-steroid anti-inflammation medicine. Agonist-antagonist butorphanol tartrate (stadol) is usually used for moderate pain treatment summary 48 mg/day without any complications (breath depression,hallucinations, hemodynamics instability) often together with paracetamol. Opioids must be the first choice medicine for pain treatment from moderate to severe intensity. Auxiliary and nonpharmacological methods are the important supporting of opioids therapy. Individual approach to pain control is very important: nerve blockade or operation are the choice path.

A-48 EVALUATION OF PAIN CONTROL IN A COHORT OF LEBANESE CANCER PATIENTS Fadi Sami Farhat; Hammoud Hospital, Sidon Background: Unrelieved cancer pain is one of the most feared symptoms for cancer patients and their families. At diagnosis and during illness, 30% to 45% of people experience moderate to severe pain; the incidence increases to 70% to 90% at those with advanced cancer. Objectives of the Study: In the study we tried to assess first the patient’s educational level about the disease and the treatment strategy, and second the relationship between patients and the health team. Material and Methods: A questionnaire was designed to address all questions and variables we are interested in studying. “Target population” were patients with cancer complaining of severe pain and taking analgesics. Results: Only 28% of patients know that their illness is cancer. 58% have intermittent pain and 42% have continuous pain. 36% think that their pain is due to the effect of their treatment, 39% to cancer, 25% to unrelated medical condition. Even though 91% of patients take analgesics according to prescriptions, there is still 21% of patients who got only 50% of relief. This is maybe because patients are not trans-mitting their suffering to their doctors clearly, or because doctors themselves are not emphasizing on the problem properly. Level of rest periods after taking analgesic varies between patients but most of them complained of short relief intervals. This could be due to the 59% who take their analgesic when pain becomes unbearable and only 19% take analgesic at the beginning of pain or because 56% believes that analgesic may cause addiction. 60% of patients report their pain only when it becomes at maximum. Discussion: Most of the patients do not know the cause of their pain or their disease which probably increases the anxieties and fears, thus the pain level. When enough education and knowledge for the patients and medical team exist these misconceptions can be corrected and therefore management of pain succeed.

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LATE TOXITIES DUE TO MUTIMODAL TRETAMENT OF HEAD AND NECK CANCER Jens Büntzel, Michael Glatzel, Dietmar Fröhlich 1 Dept. of Otolaryngology Nordhausen; 2 Dept. of Radiotherapy Suhl

ACUTE AND LATE TOXICITY OF COMBINED RADIOCHEMOTHERAPY IN HIV-POSITIVE PATIENTS WITH ANAL CANCER *I.B. Fraunholza, A. Haberlb, H.D. Böttchera Departments of aRadiation Oncology and bMedicine, HIV Division, J.W.Goethe-University, Frankfurt/Main, Germany

Objective: Longtime survivors of head and neck cancer are confrontated with serious late toxicites due to the multimodal therapy of their cancer. Material & methods. 851 patients were included in a prospective follow-up unvestigation between 1998 and 2002. The median follow-up time was 21 month (range 6-122), the mean age of the patients was 60+/-9,9 years. All patients were treated by surgery + radio(chemo)therapy (n=392) or radiochemotherapy alone (n=459). Results: We observed late xerostomia (88,5%), dysphagie (73,1%), secondary lymph edema (46,3%), loss of taste (34,5%), and development of esophageal stenosis (16,4%) as the main toxicities. Where as the loss of taste is an early and most completely reversible side effect, xerostomia and lymph edema are recovering during the first 2 years. The development of esophageal stenosis was observed only after 3 years and later. Especially the combination of primary laser surgery and adjuvant radiotherapy developed dysphagia and stenosis as late toxities. Conclusions: About 80% of all longtime survivors are suffering from late toxicities due to succesful treated head and neck cancer. The management of these toxicites is important for the quality of life for the patients.

A-50 OUTPATIENT THERAPY FOR NEUTROPENIC FEVER – NURSING CONSIDERATIONS SE Frisbee-Hume*, EL Lee, V Ho, R. Valdres, L.McMahon, S Pham, K Rolston The University of Texas MD Anderson Cancer Center, Houston, TX USA Neutropenia is the most significant contributing factor to infection and morbidity in patients with cancer who have undergone chemotherapy. Traditionally, antibiotic therapy for neutropenic fever is administered in the inpatient setting where patients are monitored closely for complications. Today, due to dramatic changes in health care delivery and advances in risk assessment for this patient population, more patients are receiving their antibiotic therapy in the outpatient setting. Outpatient treatment of neutropenic therapy presents a unique nursing challenge. Nurses are key in educating patients and caregivers on safety issues related to fever and neutropenia, managing side effects of the chemotherapy and antibiotics, insuring compliance with therapy, and providing emotional support to caregivers who must cope with the stress of caring for a loved one who is ill and has limited energy. To date, we have successfully treated over 1000 neutropenic fever patients in the outpatient setting. One of the elements that contributes to our thriving outpatient program is the nursing care. The strengths and challenges of our outpatient neutropenic fever program will be described.

Purpose: Due to the compromised immunological status and occasionally reported disproportionate normal tissue toxicity individual treatment modification is common in radiotherapy of HIV-positive patients. Since anal cancer – which is more frequent in HIVpositive patients – is curable by adequate radio(chemo)therapy, feasability and acute and late toxicity of a standard radiochemotherapy protocol should be evaluated for this patient-group against the background of the sparse reports in literature. Material and Methods: Between 1997 and 2002 12 HIV-positive men were treated with simultaneous radiochemotherapy (50,4 Gy in single fractions of 1,8 Gy per day; 5-FU: 1000 mg/m2 57 on day 1-4 and 29-32 and mitomycin C: 10 mg/m2 on day 1 and 29). 6 pts had prior AIDS defining diagnoses. The median pretreatment CD4-count was 400 cells/ul (range: 63-770). Acute and late side effects (RTOG/EORTC) were correlated with CD4-count (pre- and posttreatment count), viral load and antiretroviral therapy. Results: In all patients treatment could be completed with minor variations to the protocol in 3 pts. Complete response was attained in 10 pts (83%) and partial remission in 2 pts (17%). Acute grade 3-toxicity (myelosuppression, skin, mucosal or gastrointestinal reaction ) was recorded in 4 pts, 8 pts had grade 2- and 10 pts grade 1-reactions. At a median follow-up of 26 months (range 6-50 months) 3 of 11 evaluable patients have died (2 pts from anal cancer, 1 pt from treatment related consequences). In 1 pt each a grade 5- (gastrointestinal), grade 4- (skin) and grade 3- and in 2 pts a grade 2-late toxicity was recorded. The extent of side effects did not correlate with CD4-count, viral load or antiretroviral therapy. Conclusions: Combined radiochemotherapy can achieve good disease control with acceptable but in accordance to literature probably increased morbidity. Factors influencing the extent of reactions have to be identified in further investigations.

A-52 LATE TOXICITY AFTER ADJUVANT RADIOCHEMOTHERAPY IN RECTAL CANCER: COMPARISON OF THE RTOG/EORTC AND LENT/SOMA SCALE J. Heide*, D. Rades, J. Selonke Department of radiation oncology, university hospital Eppendorf, Hamburg, Germany Purpose: Assessement of long-term toxicity after adjuvant radiochemotherapy in rectal cancer patients and comparison of the RTOG/EORTC and LENT/SOMA scales. Patients and methods: 77 rectal cancer patients who underwent postoperative radiochemtherapy were evaluated for late effects after a median follow-up of 30 months (9–96). Therapy was given according to the NCI-criteria with a median radiotherapy dose of 50.4 Gy and 6 cycles of 5 FU. Lower GI-tract, urinary bladder, bone and skin toxicity were evaluated with the RTOG/EORTC system and the corresponding LENT/SOMA components. Additionally, the LENT/SOMA scale was used for assessment of male and female sexual dysfunction. Results of the RTOG/EORTC score were opposed to the maximum score of the subjective, objective and management criteria of the corresponding LENT/SOMA organ system. Spearman`s rank correlation coefficient was used for statistical comparison of both scales. Results: 33 women and 44 men with a median age of 60 years (33–78) entered the study. 51 (66%) underwent sphincter saving

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tumor resection prior to adjuvant therapy, 24 (31%) had abdominoperineal resection and 2 (3 %) received a Hartmann procedure as initial surgery. Grade 3–4 lower GI tract late toxicity occurred in 9% according to the RTOG/EORTC system while assessement of rectal toxicity with the LENT/ SOMA system revealed grade 3–4 late effects in 29% and small/large bowel side effects in 15%. Late effects in the urinary bladder were detected in 1 % by the RTOG/EORTC system and in 13% by LENT/SOMA scoring. 10 out of 23 (43%) evaluated women and 26 out of 41 (63%) evaluated men reported grade 3–4 side effects in sexual function. No late effects in bone and only grade 1/2 skin toxicity were found. Statistical comparison revealed a significant correlation (p <0.01) between RTOG and LENT SOMA scores for lower gastrointestinal, rectum, small and large bowel effects (spearman’s rho 0.667 and 0.772) , urinary system (0.608) and skin (0.633). Conclusion: The LENT SOMA system does allow a more detailed analysis of long-term side effects resulting in an elevated percentage of grade 3/4 toxicity compared to the RTOG/EORTC system. Nevertheless, the results of both scales show a clear correlation in rectal cancer patients.

A-53 RECEIVING REDUCED DOSE INTENSITY IS COMMON AMONG OLDER PATIENTS (PTS) WITH NON-HODGKIN’S LYMPHOMA (NHL) P Jassak and DJ Delgado Evanston Northwestern Healthcare, Evanston, IL, and Amgen Inc, Thousand Oaks, CA Studies of NHL pts treated with CHOP suggest dose reductions in cyclophosphamide (C) or doxorubicin (A) may be associated with poorer response and lower survival. Older pts who receive full dose chemotherapy have survival rates similar to younger pts. Objective: Determine factors influencing delivered dose intensity in NHL pts. Methods: A retrospective survey of oncology practice patterns using Amgen’s Project ChemoInsight© used a convenience sample of 147 mostly community-based oncology practices. Medical records from a sample of 1413 NHL pts receiving primary therapy for intermediate-grade lymphoma (IGL) were reviewed. These 1413 pts received CHOP, R-CHOP, CNOP or CVP. The impact of clinical parameters (eg, age, stage and comorbidity) on delivered average relative dose intensity (ARDI) were examined. ARDI was averaged over C and A for CHOP or R-CHOP, over C and N for CNOP, and over C for CVP. Results: 46% of pts were age >65 and 51% were female. Older pts had a planned ARDI ≤80% more often than younger pts (18.8% vs 9.5% p<0.05). A greater proportion of older pts received ARDI≤80% during their treatment than younger pts (36.7% vs 19.4% p<0.05). A greater proportion of older pts received <80% of standard dose than younger pts (42.8% vs 28.4% p<0.05). Multiple logistic regression indicated older pts were 2.4 (95% CI:1.67-3.37 p<0.001) times as likely to receive ARDI≤80%, after controlling for gender, stage, G-CSF use, BSA and comorbidity. Conclusion: These findings may support that elderly IGL patients may not consistently receive the same chemotherapy doses as others with IGL.

A-54 EFFICACY OF CSFS IN ELDERLY PATIENTS WITH AGGRESSIVE NHL: A META-ANALYSIS Olayemi Agboola, Lodovico Balducci, David Dale, *Jeffrey Crawford, and Gary H Lyman for the ANC Study Group University of Rochester Medical Center, Rochester, NY; H.Lee Moffitt Cancer Center, Tampa, FL; University of Washington Medical Center, Seattle, WA; Duke University Medical Center, Durham, NC. CSFs have been shown to reduce the incidence and severity of neutropenic complications associated with cancer chemotherapy. Older patients are at greater risk of neutropenic complications, including febrile neutropenia (FN). A systematic review of the published literature on CSF use in elderly patients with aggressive NHL was conducted, and 10 studies were identified that provided age-specific data on primary CSF prophylaxis in the elderly. Four of these were comparative trials, of which two were randomized controlled trials. Five studies used CHOP, and five used other third-generation NHL regimens. Data were extracted from these studies on the risk of severe (grade 3, 4) neutropenia (SN), FN, relative dose intensity (RDI), complete response (CR), and survival. Rates of SN and FN in the no-CSF arms ranged from 43% to 82% and from 11% to 42%, respectively. Overall, rates of SN and FN with CSFs ranged from 19% to 52% and from 3% to 26%, respectively. Reported average RDI was 90%. Summary estimates of odds ratios for treatment effect favoring the CSFs were SN: 0.236; 95% CI, 0.169–0.329; P<0.001; FN: 0.451; 95% CI, 0.318–0.639; P<0.001; CR: 2.11; 95% CI, 1.56–2.85; P<0.001. Thus, the prophylactic use of CSFs in elderly patients with aggressive NHL is associated with lower SN and FN along with higher CR rate. A direct impact on survival has not been established, but the available clinical data support a policy of primary CSF prophylaxis starting in the first cycle of chemotherapy in elderly patients with NHL.

A-55 LATE TOXICITY OF RADIOTHERAPY (RT) AND CHEMOTHERAPY (CT) FOR MALIGNANT LYMPHOMAS *A Dimitrovska, L Nikolova, I Stojkovski, D Jakimovski Institute of Oncology, Faculty of Medicine, Skopje, Macedonia Long-term side effects were evaluated in 142 patients who were in a complete remission for 3 years or more after having received 3545 Gy and/or minimum 3 courses of CT (101 patients). The following investigations were performed: clinical examination, pulmonary function tests, chest X-ray, cardiological investigations including echocardiography, haematological investigations, bone marrow cytology and thyroid function tests. Results: Reduced performance status and deteriorated general condition was found in 48%, mediastinal or paramediastinal fibrosis in 72% (severe in 7% and moderate in 39%), slight (20%) and moderate (8%) fibrosis of the apical parts of the lung, ventilation disorder in 64%, mostly of restrictive type, ventricular ventilation disorder in 18%, cardiac insuficiency in 11%, pericarditis in 7%, granulocytopenia in 11%, lymphocytopenia in 33%, slight anemia in 24%, aplasia in 60% and hypoplasia in 27% on sternal marrow cytology (previously irradiated) and hypoplasia in 16% on the iliac crest cytology (not irradiated), clinically manifested hypothyroidism in 2 patients, elevated TSH in 27%. 13% of investigated patients received suported therapy. Conclusion: The fact that more than 50% of patients showed pathological findings signals the need for further detection of late complications of RT and CT and the need for administration of additional suportive therapy.

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A-56 LATE ANTHRACYCLINE CARDIOTOXICITY IN CHILDREN WITH ACUTE LYMPHOBLASTIC LEUKAEMIA *T. Jackowska1, M. Pleskot, M. Golabek2, J. Pacholska1, M. Syczewska3, M. Wróblewska-Kaluzewska2, R. Rokicka-Milewska Acute Lymphoblastic Leukaemia (ALL) is the most common childhood malignancy. Present successful treatment of low and intermediate risk ALL patients who account for about 80 % of leukaemic children and young adults up to the age of 20 years old makes it mandatory to ensure them a proper comfort of living after their successful cure. Anthracyclines (ANTR) play a key role in ALL treatment. However, a potential heart damage caused by ANTR in patients who have been cured of cancer may lessen the success of their cure, worsen their comfort of living and/or adversely affect and limit their job choice. Late ANTR cardiotoxicity was evaluated in 66 ALL patients who had completed their treatment with cumulative doses of ANTR of 240 mg/m2; over one year earlier. 34 children whose median age at diagnosis was 6.0 years received ANTR under the protective cover of deksrazoksan. In prospective studies systolic and diastolic parameters were examined after two and four years respectively since the completion of treatment with ANTR. The longest follow-up since diagnosis was 7.5 years. In only one case abnormal parameters of contractility of the left ventricle were detected. These were decreased shortening fraction (%SF) and ejection fraction (%EF). Diastolic dysfunctions-indicative of impaired relaxation (prolonged deceleration time, lowered E wave deceleration (E/Dec) and increased ventricle rigidity (shorter isovolumetric relaxation time (IVRT) – which were present before treatment, resolved by the time of cardiac evaluation carried out four years after the end of treatment with ANTR and deksrazoksan. 32 children whose median age at diagnosis was 4.5 years received ANTR without cardioprotection. A retrospective study compared ECHO parameters of these children, which were evaluated two times after the end of their treatment with ANTR, with a control group.The first follow-up assessment was carried out at a median time of about 5.6 years while the second follow-up assessment took place at a median time of about 8.5 years after ANTR treatment completion. More than 15% of the children treated with ANTR and not receiving deksrazoksan were found to have abnormal systolic functions. Their shortening fractions (%SF) and ejection fractions (%EF) became significantly lowered at each evaluation. More than 20% of the children had abnormal diastolic function with impaired relaxation. Lowered deceleration of the E wave (E/Dec) showed no tendency towards normalisation in the successive follow-up evaluations after the end of treatment. In seven patients evaluated at a median time of 5.6 years after the end of treatment and in six patients evaluated at a median time of 8.5 years after treatment completion the deceleration of E wave (E/Dec) was below the minimum values seen in the control group. Conclusion: Cardioprotection with deksrazoksan in ALL patients treated with 240 mg/m2; of ANTR was justified and effective. *KBN grant 3 PO5E 123 23

A-57 THE “COMPREHENSIVE GERIATRIC ASSESSMENT” EVALUATION: A SELECTION OF INFORMATIVE QUESTIONNAIRES FOR ESSENTIAL PARAMETERS. PRELIMINARY EXPERIENCE BY A SINGLE INSTITUTION. *Mantovani G, Massa E, Ferreli L, Astara G, Gramignano G, Lusso MR, Madeddu C, Stara A, Dessì M. Department of Medical Oncology, University of Cagliari, Italy Comprehensive geriatric assessment (CGA) is a structured approach aiming at measuring the most important parameters to identify needs and to plan care in elderly patients. They may be identified as: functional, cognitive, presence of comorbidity and

nutritional. The selected instruments were: the activity of daily living (ADL) and the instrumental activities of daily living (IADL) scales in addition to PS for function, the Mini-Mental Status Examination and the Beck’s Depression Inventory (cognitive); the Charlson’s scale (comorbidity) and the Mininutritional Assessment (MNA) for nutrition. The aim of our study was to develop a best-practice model both exhaustive and feasible for geriatric assessment of elderly cancer patients (i.e. aged 65 years or older). 58 elderly patients (M/F: 31/27, mean age 72 years, range 65-86) with cancer at different sites were assessed. 10% of patients had stage II, 22% stage III and 68% stage IV disease. 13.8% of patients had PS 0, 62% PS 1, 13.8% PS 2, 5.2% PS 3 and 5.2% PS 4. Overall, 46.6% of patients had no limitations for ADL, 6.8% were completely dependent. Approximately 30% of patients had no limitations for IADL. 53.4% showed symptoms of depression (15.4% of them had an heavy depression). 39.7% of patients showed a mild to serious cognitive defects: no correlation was observed with increasing age and education. 43.1% of patients showed comorbidities and 17.3% were malnourished. Patients showed an optimal compliance for the instruments used. The study is ongoing to assess the prognostic role of CGA on the disease outcome.

A-58 THE NUTRITION’S CONDITION AND FACTORS AFFECTING IT OF THE ELDER MEN, WITH ADVANCED PROSTATE CANCER Jolanta Toliusiene, Vita Lesauskaite Department of nursing and care, Clinic of Geriatrics, Kaunas University of Medicine, Kaunas 3000, Lithuania The goal of investigation was to study nutritional status of elderly men, receiving treatment for advanced prostate cancer. Method. Were assessed 80 patients aged 65 years and above: 40 patients with advanced prostate cancer (research group) and 40 (control group) with benign prostatic hyperplasia. Regarding other subject characteristics the two groups were closely comparable. The instruments were used: Mini Nutritional Assessment (MNA); Yesavage Geriatric Depression Scale (GDS) – Short Form. Complementary were asked questions reflecting nutritional status. Results. Patients with prostate cancer were more like to be overweight and they had rapid loss of weight –15 (37.5%) of patients had lost more than three kilo per three months. Depressive symptomatology was higher for research group (p<0.05). Age did not has influence on depressive symptomatology. Digestive disorders troubled 23 (57.5%) of research group and 14 (20%) of control group patients. Digestive troubles had influence on apetite in both groups p<0.05, r=0 0.54 and r=0.46. Nobody from patients who had digestive symptoms was trained how to control them. Conclusions. Assessment of nutritional status has to be complex and routinely performed.

A-59 RADIATION-INDUCED TUMORS IN IRRADIATED STAGE 1 TESTICULAR SEMINOMA: RESULTS OF A 25 YEAR FOLLOW-UP ME Stein MD Department of Oncology, Rambam Medical Center, Haifa, Israel Testicular seminoma is a very radiosensitive and curable tumor. Survival rates can reach 90-98%. However, long-term survival following exposure to radiation therapy can results in the late appearance of radiation-induced tumors. From 1968-93, 81 patients with stage 1 testicular tumors were irradiation with the conventional ‘hockey stick’ method [para-aortic+ipsilateral pelvic regions]. Three [4%] patients developed second cancers within the high-

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dose volume, after a follow-up of 96, 12 and 168 months, respectively. Two patients [urinary bladder and sigmoid cancer] received a total dose of 35-40 Gy and the third patient who died of pancreatic carcinoma received the usual total dose of 26 Gy; however, this patient was also treated with mediastinal irradiation and a cisplatin/ VP-16 regimen for a former seminomatous relapse. Comments. The elimination of causative factors through lowering the total dose and field size reduction may reduce the even further the low incidence of radiation-induced cancers among cured testicular seminoma patients.

A-60 QUALITY OF LIFE (QOL) AND RANDOMIZED CLINICAL TRIALS (RCT) IN ONCOLOGY. I. Panzini*, D. Tassinari, C. Monticelli, A. Sermasi, B. Roudnas, B. Poggi, F. Fochessati, V. Arcangeli, M. Papi, A. Ravaioli Dept. Of Oncology, City Hospital Rimini, Italy Although QOL represents one of the main outcomes in oncology, it still holds an ancillary place in RCT. We present a critical review of literature to evaluate the real weight of QOL in RCT. We review all the RCT in oncology from 1966 to 2000, classifying the trial on the basis of an arbitrary relative score (combining the Nicolucci and the Schumacher scores). Only 13 out of 89 retrieved RCT presented QOL as primary end point (14.6%); on the other side, QOL represented an important but secondary end point in 46 RCT (51.6%), or a secondary end point in 30 RCT (33.8%). Selecting only the RCT with QOL as primary end point, 10 (76.9%) used a validated instrument of evaluation, 3 (23%) presented an adequate design of the trial, 6 (46.1%) evaluated more than 150 patients (median number of enrolled patients: 74, range 28-1320), and 8 (61.5%) adequately described the weight of missing data. The median quality score was 75%, with a significative correlation with year of publication (p=0.007), kind of paper (p=0.05), presence of a statistician between the authors (p=0.001) and number of involved groups in the trial (p=0.009), using a logistic regression model. Our data confirm that although QOL represent one of the main patient-outcomes in oncology, its role in RCT is still marginal; otherwise, it is to be hoped that in the next future QOL evaluation could go beyond the limits of the present research, holding the place QOL should hold in clinical research. (supported by IOR).

A-61 EXPECTATIONS OF SIDE EFFECTS ARE ASSOCIATED WITH HEALTH STATUS AND FATIGUE IN PATIENTS RECEIVING CHEMOTHERAPY (CT) Lorenzo Cohen, Carl de Moor, Peter Eisenberg**, Young Kim, Eileen Ming*, Kumari Kanesan, Edward Rubenstein UT M. D. Anderson Cancer Center, Houston, TX; *Merck & Co, Inc., PA; **California Cancer Care, CA, USA The association between perceived expectations of developing CTrelated side effects (nausea and fatigue) and general health status (EuroQoL thermometer) and quality of life (EORTC QLQ-C-30: Physical Functioning (PF), Fatigue) was examined during the 1st cycle of CT. Measures were completed by 53 pts (53% breast ca) at baseline (all measures), daily (EuroQoL), and on day 8 (EORTC) after receiving CT. Prior to CT, 6% reported they were “certain they would not” develop nausea, 70% were “unsure”, and 25% were “certain they would.” Similarly, 6% reported they were “certain they would not” develop fatigue, 43% were “unsure”, and 51% were “certain they would.” After controlling for the respective baseline variable, pts who were “certain they would” develop nausea had lower mean (over all days) EuroQoL and PF scores

than pts who were “unsure” (adjusted means - EuroQoL: 68 vs 79, P <0.02; PF: 74 vs 86, P <0.02). Pts who were “certain they would” develop fatigue had lower EuroQoL scores and higher fatigue scores than pts who were “unsure” (adjusted means - EuroQoL: 70 vs 83, P <0.0001; Fatigue: 50 vs 37, P <0.04). The relationship between expectations of side effects and general health status, quality of life, and fatigue should be further explored.

A-62 EVALUATING A NEW CLINICAL ASSESSMENT TOOL: THE FATIGUE PICTOGRAM *Margaret I. Fitch, RN PhD, Terry Bunston, PhD, Deborah Mings, RN, MscN, Pat Sevean, RN, MScN, Debra Bakker, RN PhD Toronto Sunnybrook Regional Cancer Centre, Toronto, Canada Fatigue, a common and distressing symptom, has wide ranging implications for the lives of patients living with cancer. Unfortunately, health care providers are often not aware that patients are suffering from fatigue, despite reports that as many as 90% of cancer patients experience it. Patients are also reluctant to mention their fatigue to health care providers. It would be helpful if fatigue were assessed regularly as part of a standard assessment. However, one of the significant hurdles in assessing fatigue in the clinical setting is the lack of clinical assessment tools. The desirable characteristics of such a tool include: brief, reliable, valid, easy for patients to understand, easy for health care providers to administer, and provides immediate results so as to facilitate intervention. A new clinical assessment tool to measure fatigue was designed and validated. The Fatigue Pictogram was developed to meet the criteria above. It makes use of pictures and colours to assess patient fatigue. This presentation will describe the psychometric properties of this new tool with 2 groups: 1) lung cancer patients (N=140) and 2) mixed group of cancer patients receiving treatment (N=100). When compared to the longer standardized tool, the Multidimensional Fatigue Inventory, this new tool produced similar results.

A-63 IMPROVED FATIGUE SCORES WITH DARBEPOETIN ALFA M Hedenus,1 J Kallich,2 J San Miguel,3 D Watson,4 J Matcham,4 MH Erder,2 and TJ Littlewood5 1Sundsvall Hospital, Sweden; 2Amgen Inc., Thousand Oaks, CA, USA; 3Hospital Universitario de Salamanca, Spain ; 4Amgen Inc., Cambridge, UK; and 5Oxford Radcliffe Hospital, UK A multicenter, randomized, double-blind trial of 12-week treatment with darbepoetin alfa (DA; Aranesp®) administered once weekly at 2.25 mcg/kg versus placebo (pbo) in anemic (hemoglobin [hb] <11.0g/dL) patients (pts) with lymphopro-liferative malignancies receiving multicycle chemotherapy included evaluation of healthrelated quality of life (QOL) using the FACT-Fatigue (FACT-F) scale score. 349 pts were enrolled (176 DA; 173 pbo). Discounting for the effects of RBC transfusions, a statistically significant difference (p<0.001) in the mean (SE) change in hb during the study was observed between the DA (1.80 [0.17] g/dL) and pbo (0.19 [0.10] g/dL) groups. Pts with lower baseline FACT-F scores exhibited greater improvements by end of treatment phase compared with pts with higher baseline scores. After adjusting for baseline FACT-F score, DA increased the mean change in FACT-F score by a difference of 2.28 points (95% CI, 0.19, 4.37) compared with pbo (p=0.032). Darbepoetin alfa significantly increases hb and reduces self-reported fatigue compared with pbo in pts with lymphoproliferative malignancies receiving concurrent chemotherapy.

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A-64 PRODUCTIVITY IMPROVES WITH REDUCTIONS IN ANEMIA AND FATIGUE E Berndt,1 J Kallich,2 X Xu,3 MH Erder,2 H Lee,4 J Glaspy4 1MIT, Cambridge, MA, USA; 2Amgen Inc., Thousand Oaks, CA, USA; 3Covance Health Economics and Outcomes Services, Inc., Gaithersburg, MD, USA; 4UCLA, Los Angeles, CA, USA Using data from a randomized, 12-week, phase 2 trial of darbepoetin alfa (Aranesp®) or epoetin alfa in anemic (hemoglobin <11.0 g/dL) cancer patients (pts) on chemotherapy, we examined the relationship between anemia, fatigue, and productivity. At baseline (BL) and end of treatment, pts completed the FACT Fatigue subscale (13 items), indicated their ability to do activities (on a 100-point scale), and reported hours (hrs) lost from work and hrs of assistance required. Hgb improvements were significantly associated with improvements in fatigue (p=0.0032). Pts with a clinically meaningful improvement in the FACT Fatigue subscale score (≥3 points) had a mean gain in productivity of 11 hrs and a mean reduction in caregiver burden of 11 hrs. Improvement (≥3 points) in FACT-Fatigue Scores

Mean (95% CI) Change From BL Yes

No

p-value

Productive time losta (hrs) (n=215)(–10.5, 1.4) Caregiver time requireda (hrs) (n=299) Ability to do activities scoreb (n=293)

–4.5 (–3.5, 16.2) –1.9 (–6.2, 2.4) 19.2 (15.0, 23.4)

6.3

0.0625

9.1 0.0068 (2.4, 15.7) 9.4 <0.0001 (–13.3, –5.6)

a: higher values=poorer outcomes (ie, more time lost) b: higher values=better outcomes (ie, more able to do activities)

A-65 DEPRESSIVE SYMPTOMATOLOGY AMONG PATIENTS WITH COLORECTAL CANCER– A PANEL STUDY *M.E. Kurtz, J.C. Kurtz, M. Stommel, C.W. Given and B. Given Michigan State University, East Lansing, MI 48824 USA Purpose. Colorectal cancer constitutes a major health problem for elderly patients. The disease, its stage, treatment and attendant symptoms can have significant negative impact on the mental functioning of these patients. Methods. As part of a larger longitudinal study, 158 patients 65 years of age or older with an incident diagnosis of colorectal cancer were recruited from 23 sites within the state of Michigan, USA. Random effects regression analysis techniques were used to analyze how age, gender, race, presence of a family caregiver, comorbid conditions, stage of disease at diagnosis, as well as the time dependent variables marital status, employment status, symptoms, physical functioning, social functioning and treatment predict depressive symtomatology at four assessments over the first year following diagnosis. Results. Gender, race, comorbid conditions, physical functioning, social functioning and symptoms were significant predictors of depressive symptomatology over the four waves of the study. Women, African Americans and patients with two or more comorbid conditions exhibited more depressive symptomatology. More symptoms, as well as more restricted physical and social functioning corresponded to higher levels of depressive symptomatology. Conclusions. At a clinical level of patient care, these findings mandate early identification of psychosocial difficulties experienced, an individualized symptom management plan and the ap-

plication of other interventions such as information giving, reassurance and referral to other resources, with particular attention to African American and female patients.

A-66 EPOETIN BETA (NEORECORMON®) IMPROVES QUALITY OF LIFE IN CANCER-ASSOCIATED ANAEMIA TO A SIMILAR DEGREE IN PATIENTS WITH LYMPHOID MALIGNANCIES OR SOLID TUMOURS K.U. Petry on behalf of the Epoetin Beta QOL Working Group Department of Gynaecological Oncology, University of Hannover, Hannover, Germany Introduction: Anaemia related to cancer and its therapy has a profound detrimental effect on the quality of life (QoL) of many patients. Epoetin beta (NeoRecormon®) has been shown to increase haemoglobin levels, reduce transfusion needs and ameliorate the symptoms of anaemia in patients with cancer. In this study, we assessed whether the effect of epoetin beta on QoL was comparable in patients with either lymphoid malignancies or solid tumours. Methods: Patients with anaemia (Hb ≥11 g/dL) associated with multiple myeloma, non-Hodgkins lymphoma, chronic lymphocytic leukaemia or any solid tumour who were treated with myelosuppressive chemotherapy were randomised to 12 weeks of open-label treatment with subcutaneous epoetin beta 150 IU/kg three times weekly or control (blood transfusions initiated at guide Hb level of 8.5 g/dL). QoL was assessed using the Short-Form-36 physical component summary (SF-36 PCS) score and the Functional Assessment of Cancer Therapy fatigue and anaemia subscales (FACT-F and FACT-An). Results: A total of 213 patients were evaluable for QoL assessment after 12 weeks of therapy, of whom 123 had lymphoid malignancies (epoetin beta, n=62; control, n=61), and 90 had solid tumours (epoetin beta, n=42; control, n=48). QoL scores for the SF-36 PCS, FACT-F and FACT-An subscales significantly improved with epoetin beta but were either unchanged or had decreased after 12 weeks in the control group both in patients with lymphoid malignancies (SF-36 PCS, +2.5 vs –1.0; FACT-F, +5.9 vs +0.2; FACT-An, +1.0 vs +1.0) and solid tumors (SF-36 PCS, +3.8 vs –0.8; FACT-F, +3.0 vs +1.0; FACT-An, +1.0 vs 0.0). Improvements in QoL with epoetin beta were generally comparable in patients with either lymphoid malignancies or solid tumours. Median increases in Hb levels were greater with epoetin beta compared with control in patients with lymphoid malignancies (1.9 vs 0.9 g/dL) and solid tumours (2.1 vs 0.9 g/dL). Overall, changes in SF-36 PCS and FACT-F were correlated with changes in Hb levels (p<0.05). Conclusions: Epoetin beta improves QoL compared with standard therapy in patients with cancer. These improvements are similar irrespective of whether patients have lymphoid malignancies or solid tumours.

A-67 ON PATIENTS CARE AND REHABILITATION AT TUMOURS OF SUPPORTING AND MOVING SYSTEM Oxana Pihut Institute of Oncology of Moldova The Section of General Oncology and Rehabilitation at the Institute of Oncology of Moldova cares patients with tumours of skin, bones and soft tissues. The section has a waste experience in rehabilitation in such cases as: safe operations; artificial appliances after limb amputation; plastic operations after skin tumour resection. Patients at stages III and IV makes up to 40% in Moldova. Therefore, rehabilitational anti-pain care, cahexia and special diets became very important and are subject of prolonged investigations. We discuss also psychological aspects of rehabilitation.

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AREAS OF IMPROVEMENT IN AMBULATORY ONCOLOGICAL CARE – THE PATIENT PERSPECTIVE *1Runge, C., 1Tews, J.-T., 2Ruprecht, Th., 3Hoeing, M., 3Kuhlmann, A., 4Kleeberg, U.R. 1GlaxoSmithKline, Munich, 2Picker Institut Deutschland, Hamburg, 3Nursing Group of the German Cancer Society, Frankfurt, 4Hamburg Cancer Society, Hamburg, all in Germany

APPLICATION OF HEMATOPOIETIC EMBRYONIC STEM CELLS FOR THE IMPROVEMENT OF LIFE QUALITY OF INCURABLE PANCREATIC CANCER PATIENTS Alexander Smikodub, Larysa Radziyevska Cell Therapy Clinic of National Medical University and Embryonic Tissues Center EmCell

Assessing patient satisfaction and quality of life has become accepted as an approach to measure quality of care. As these indicators had not been measured on a larger scale in ambulatory cancer care in Germany, a nation-wide multi-centre study (n=24) was conducted in 2002. A validated self-administered questionnaire including the SF-36 was mailed to a sample of 3384 eligible patients out of a total of 5500. A total number of 2659 questionnaires were evaluable. 1488 patients were female, mean age was 62. Among the most frequently reported problems was the alternation of attending nurses (n=1719), no joint planning of the care process (n=1471) and insufficient information on side effects (n=1081). Quality of life varied strongly between cancer entities. Compared to a healthy standard population patients showed highly significant impairment in their role functioning and emotional functioning as measured by the SF-36. Overall satisfaction was rated high, but more specific reporting questions revealed many areas for improvement such as shared decision making, doctor-patient communication and organisation of care.

A-69 DO PATIENTS WHO USE COMPLEMENTARY AND ALTERNATIVE MEDICINE (CAM) REQUIRE DIFFERENT PRACTICE STANDARDS FROM THOSE RECEIVING STANDARD MEDICAL CARE? *Christine Sanderson(A), Bogda Koczwara(B), David Currow(A), Stephen Clarke(C) (A) Southern Adelaide Palliative Services, Daw Park, SA; (B) Department of Medical Oncology, Flinders Medical Centre, Bedford Park, SA; (C) Department of Medical Oncology, Royal Prince Alfred Hospital, Sydney, New South Wales Widespread acceptance and use of CAM represents a complex challenge for providers of health care. Increasingly it is assumed that CAM can and should be seamlessly integrated within medical practice – as evidenced by the increasing coverage of CAM treatments by health insurance, provision of CAM treatments by medical practitioners, and arguments about including aspects of CAM within undergraduate medical education. However we suggest that the nature of the competing and sometimes incompatible paradigms makes this problematic, and that if CAM is to enter the medical mainstream it needs to be compatible with usual standards of care. Problems which will be addressed include: ● standards for communication between CAM and medical care providers ● responsibility for adverse effects and treatment interactions ● informed consent. We argue that protective frameworks are under-developed, and go on to address broader issues including funding of CAM, the legitimacy of provision of CAM within a publicly funded health care system, and implications of provision of CAM by medical practitioners. We use a series of clinical vignettes involving patients receiving CAM alongside standard medical therapy in order to identify critical issues, and go on to propose working principles for use by standard clinical practitioners.

Observed were 20 patients with advanced pancreatic cancer (T3N1-2 M0-1, T4N1-2 M0-1) after palliative surgery for mechanical jaundice. Transplantation of hematopoietic embryonic stem cells (HESC) was performed in 8 patients, who made the main group. HESC transplantation was performed in 12±3 days after surgery. Evaluation of life quality (LQ) of the patients was performed in accordance with Visual Analogue Scale (VAS). Before transplantation, all patients showed low LQ indices (2.1-4.6, mean 3.28±0.48, in the main group, and 3.20±0.33 in the control group). HESC transplantation resulted in reliable increase of LQ indices in 1-2 months after the procedure, in comparison with pre-treatment data, and in 6 months, in comparison with control data. Improved LQ was manifested by decreased fatigue, with reliable changes of this index in 1-2 months after the procedure, in comparison with pre-treatment data, and in 2-6 months, in comparison with the control data. The most considerable effect of HESC transplantation was observed in such aspects of fatigue as general, emotional, and will, in the dynamics of which the reliable decrease was noted in 1 month after the procedure. Statistically important changes were also observed in the analysis of life expectancy of the patients: 9.4±0.6 months, in comparison with 6.9±0.5 months in the control group (p<0.05). Detailed information can be found at www.emcell.com

A-71 THE COST OF WELLBEING IN CANCER CACHEXIA: PRELIMINARY DATA OF A COST UTILITY ANALYSIS D.Tassinari(1), S.Calpona(2), F.Fochessati(1), L.Montanari(3), M.Papi(1), B.Poggi(1), A.Polselli(1), B.Rudnas(1), P.Turci(4), M.Maltoni(2)*. Palliative Care Unit of Rimini (1), Forlì (2), Lugo (3), and Cesena (4), Italy Progestins represent the treatment of choice in cancer cachexia. To better define their role in palliative care, we present preliminary data of a cost utility analysis in the treatment of cancer cachexia with medroxiprogesterone acetate (MPA). All the patients with a weight loss greater than 10% and hormone-insensitive metastatic neoplasm were considered eligible and enrolled into the trial. All the patients were treated with MPA 1000 mg/day and were evaluated every 21 days for wellbeing (visual-analogue scale, VAS), weight, performance status asthenia (VAS) and appetite (VAS). Till today 23 patients were considered eligible and enrolled into the trial. Basal median wellbeing score on VAS was 50mm and an improve greater than 20% was observed in 13 patients (56.6%), with a median time to not-response of 29 days. The mean costutility value (costs/response-time x wellbeing score) was 32.50 Euro/day (range 9.10-355.60), with a significative correlation with the basal score of wellbeing (p=0.006) and asthenia (p=0.007). Median survival was 80 days, and median weight gain was 1.8 kg. Our preliminary data seem to suggest that MPA is an active and costly-favourable palliative treatment of cancer cachexia, improving both weight and appetite, but even wellbeing with an accettable cost. (Supported by IOR).

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DESIRE FOR DEATH AND DEPRESSION IN PATIENTS WITH ADVANCED CANCER E.Tiernan1, P. Casey2, C. O’Boyle3, G. Birkbeck4, M. Mangan5, L. O’Siorain5, M. Kearney5. 1St Vincents University Hospital, Dublin, Ireland.; 2Dept of Adult Psychiatry, UCD, Mater Hospital Dublin, Ireland; 3Dept. of Psychology, RCSI,, Dublin, Ireland.; 4National Research Agency, Dublin, Ireland; 5Our Lady’s Hospice, Dublin, Ireland

USE OF COMPLEMENTARY / ALTERNATIVE MEDICINE AFTER SUCCESSFUL TREATMENT OF MALIGNANT TUMORS Michael Glatzel (1,2), Dietmar Fröhlich (1), Klaus Schönekaes (2), *Jens Büntzel (2), Oliver Micke (2) (1) Zentralklinikum Suhl, Dept. of Radiotherapy, Albert-Schweitzer-Str. 2, D-98527 Suhl, Germany; (2) Arbeitskreis Trace Elements and Elektrolytes in Radiation Oncology

The purpose of this study was to examine the relationship between depressive symptoms and desire for early death (natural, suicidal or by euthanasia) in terminally ill patients with cancer being cared for by a specialist palliative care team. 142 patients completed the Hospital Anxiety and Depression Scale and answered four supplementary questions on desire for early death. Only 2 patients expressed a strong desire for death by some form of suicide or euthanasia. 120 patients denied any desire for an early death. The desire for early death correlated with depression scores. Conclusions: Desire for death was rare amongst this group of patients with advanced cancer receiving palliative care. When present, it was associated with significant depressive symptoms. Better recognition and treatment of depression might lessen the desire for early death in patients with advanced cancer. Full study published:Tiernan E. et al. Relations between desire for early death, depressive symptoms and antidepressant prescribing in terminally ill patients with cancer. J R Soc Med 2002; 95:386-390.

Complementary/alternative medicine (CAM) is gaining ever more importance in the treatment of cancer patients. The purpose of this study was to find out the frequency of use of CAM after successful primary treatment of cancer. We studied the use of CAM in 140 pts. (men:55; women:85; mean age 61 ys.) before start of radiotherapy in a multimodal treatment setting. At time of primary treatment of cancer 32/140 pts. (22,9%) used CAM. 1 year after successful close of therapy we studied the use of CAM in these pts. with a questionnaire. At this time 66/140 pts. (47,1%) inform on use of CAM (Table).

A-73 DEPRESSION IN ADVANCED CANCER – DECISIONMAKING AMONGST PALLIATIVE CARE AND PSYCHIATRIC PROFESSIONALS *E. Tiernan1, C O’Boyle2, P. Casey3, M. Kearney4 1St Vincents University Hospital, Dublin, Ireland; 2Dept of Psychology, RCSI, Dublin, Ireland; 3Dept. Adult Psychiatry, UCD, Mater Hospital, Dublin, Ireland. 4Our Lady’s Hospice, Dublin, Ireland Evidence suggests that depression is under-recognised and possibly under-treated in patients with advanced cancer. The purpose of this study was to identify and compare the decision-making strategies palliative care physicians and psychiatrists use when judging severity and deciding on treatment of depression in patients with advanced cancer. The procedures and analytical techniques of clinical judgement analysis were used. 20 palliative care physicians and 20 psychiatrists were interviewed. There was little agreement between doctors on the criteria most important in judging depression in patients with advanced cancer. Given identical cases to judge, there was little agreement on the severity of the depression experienced by patients, or on the appropriate treatment. As a group, the psychiatrists were more likely to prescribe antidepressant medication than the palliative care physicians. It was also possible to demonstrate a significant intuitive component to decision making that the doctors were unaware of consciously. Our research confirms that there is little agreement in diagnostic and treatment strategies for depression in patients with advanced cancer, and points to the need for validated guidelines for management of this common and distressing symptom.

Tumor N At therapy After 1 yr.

All

Breast Prostate Gynecol. Rectum H&N

140 54 25 22,9% 33,3% 20,0% 47,1% 59,3% 44,0%

16 0% 31,2%

11 18,2% 54,5%

10 30,0% 40,0%

After successful treatment of malignant disease the frequency of use of CAM is rising up more than 2 times. We think that these patients wanted to maximize their chances for further survival without local or systemic relapse.

A-75 QUALITY OF LIFE IN BRAIN TUMOR PATIENTS Sima Moghaddasian, Farahnaz Abdollahzadeh, Mohammad Hossein Haghayegh Amin Faculty of Nursing & Midwifery, Tabriz University of Medical Sciences, Shariati-e-Djunubi Ave., P.O.Box 51745-347, Tabriz, Iran Background and Objectives: Patients with primary brain tumors frequently have difficulty coping because of the cognitive and/or physical changes resulting from their diagnosis and treatment. The diagnosis of a malignant brain tumor has the potential for not only devastating psychosocial impact, but also physical disability. Despite the attention given to quality of life(QOL) in persons with cancer, very little is currently known about QOL in persons with brain tumors. The objectives of this study were:(1) To document the physical dimension, such as activities of daily living.(2) The second is psychological dimension, including cognitive and emotional components. (3)The third is the social dimension, which includes the individual’s roles and functions. Materials and Methods: A cross-sectional questionnaire-based survey of patients with brain tumor who presented to a brain tumor clinic for ongoing care. 30 patients were asked to participate. The questionnaire package included:EORTC QLQ-C30, & QLQ-BN20. Results: Approximately half of the patients reported moderately to severely compromised physical fitness and overall health, whereas most of them reported moderate limitations in daily role activities. Impaired emotional functioning was reported by approx. half of the patients. Moderate to sever fatigue and headache was reported by 57% and 75% of the sample, respectively. Conclusion: Living with a serious disease is not easy. Everyone involved , faces many problems and challenges. Finding the strength to cope with these difficulties is easier when people have helpful information and support services. Doctors, nurses, social workers, and other members of the health care team may be able to calm fears and ease confusion. They can also provide information and suggest helpful resources.

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A-76 ANALYSIS OF THE RESIDUAL SWALLOWING FUNCTION FOLLOWING RADIOCHEMOTHERAPY OR RADIOTHERAPY ALONE OF TUMORS OF THE FLOOR OF THE MOUTH – PHARYNX WITH OR WITHOUT LARYNX INVOLVEMENT. Wuttge-Hannig A.C.(1), Prosiegel M.(3), Hannig C.E.M.(2) (1) Gemeinschaftspraxis für Radiologie, Strahlentherapie und Nuklearmedizin Dres. Wuttge-Hannig-Schepp-Sindelar, München; (2) Institut für Röntgendiagnostik des Klinikums rechts der Isar der Technischen Universität München; (3) Neurologisches Krankenhaus München Swallowing disorders are a well known side-effect after radiotherapy. In the long course of disease they are sometimes more limitating live quality than speech disorders. Purpose: We assessed which therapeutic modality (radiation alone, radio-chemotherapy, postoperative radiation therapy) caused which sort or severity of side effects. We also tried to evaluate an early onset of logopedic and antiphlogistic therapy in some patients. Material and Methods: We examined 194 patients with a T3 or T4 tumor of the floor of the mouth of the pharynx. With a nodal stage N0-2 and in 42 with an infiltration of the larynx. 38% of them had a tracheostomy. 112 patients underwent a combined radio-chemotherapy (70,2 Gy Gy ZVD, acellerated, hyperfractionated with chemotherapy Mitomycin/5FU, Cisplatin/5FU respectively), 65 patients underwent a postoperative (mainly longitudinal Hemopharyngetomy) Radiotherapy (66GyZVD) and 17 patients underwent just a radiotherapy alone (66–70,2 GyZVD). The evaluation of the swallowing disorders was done by means of dynamic videofluoroscopy. 25–50 frames/s, which allow an analysis of 25 muscle groups triggered bs 5 pairs of cranial nerves during the 0,7 sec of the pharyngeal swallow, thus transporting the bolus from the oral cavity to the upper esophageal sphincter. Results: The trigger of the swallowing reflex is affected by all modalities of therapy. The more severe cases we observed in radio-chemotherapy, followed by post-surgical radiotherapy. Resulting fibrosis is due to dosage and inflammatory reaction and is less affected by chemotherapy then by surgical intervention. Edema and enoral swellings worsen fibrosis of the subcutaneaus tissue. Anatomic deficits are more often seen due to surgery but may also happen after a high-dosage radiotherapy, specially when combined with chemotherapy. Discussion: The early post-interventional analysis of the oro-pharyngo-laryngealmotoric and sensoric affections enables an adequate functional therapeutic onset. The learning of compensatory mechanisms turned out to be very decisive as well in early rehabilitation for improving the nutritional stage of the patient as in the prevention of fibrosis hindering the relative laryngeal anterior and upward movement during deglutition. A reflexstimulation-therapy of those patients accelerates the awareness for sensibility deficiencies in the pharynx and thus acellerates to learn anti-aspiration strategies. The rehabilitative therapy should be started very early, if possible before radiation therapy. Additional therapy for lymphedema, antiphlogistic therapy and lymphatic drainage may be important supportive procedures.

A-77 PATIENT INFORMATION ABOUT FATIGUE – HOW PATIENTS FEEL ABOUT IT *Glaus Agnes1, Knipping Cornelia1, Frei Irena-Anna1, Ream Emma2, Brown Natasha2 1) Centre for Tumordetection and Prevention, St.Gallen, Switzerland ”2) Kings College, London, UK In the course of a cancer trajectory, many patients suffer from distressing fatigue. Current research suggests that care givers tend to underestimate or even to ignore this frequent phenomenon. De-

spite increasing knowledge, fatigue seems to remain an orphan topic in symptom education and management. Aim: A qualitative research strategy was used to evaluate the usefulness of currently available information materials about fatigue and to explore how patients’ needs regarding information were met. Methods: The expert-opinion of cancer patients in Switzerland and England was analysed. Convenient sampling guided the selection process of seven patients in each country. A tape-recorded focus-group interview served as method to collect and transcribe data. Data were analysed according to the framework analyses by Richie & Spencer. Results: Results were very similar in both countries. Patients stated a great need for more information regarding fatigue. They felt that care givers were not sufficiently aware of it and that a specific support was not part of current standard practice. The information material was well received and mostly judged as very helpful. Conclusions: Communication barriers between professionals and patients and vice versa continue to exist. Patients wish to be better informed by care givers and to receive information material systematically. Brochures and videos challenge communication, open the dialog and provide words for the still rather unknown phenomenon. Key words: Fatigue, patient-needs, information-material, evaluation, communication-barriers.

A-78 QUALITY OF LIFE IN LUNG CANCER PATIENTS: DOES SOCIOECONOMIC STATUS MATTER? *Ali Montazeri, David Hole, Robert Milroy, James McEwen, Charles Gillis Iranian Institute for Health Sciences Research, Tehran, Iran; Public Health & Health Policy, Division of Community Based Sciences, University of Glasgow, Glasgow, UK. As part of a prospective study on quality of life in newly diagnosed lung cancer patients an investigation was carried out to examine whether there were differences among patients’ quality of life scores and their socioeconomic status. Quality of life was measured at two points in time (baseline and three months after initial treatment) using three standard instruments; the Nottingham Health Profile (NHP), the EORTC QLQ-C30 and its lung cancer supplement (QLQ-LC13). Socioeconomic status for each individual patient was derived using Carstairs and Morris Deprivation Category ranging from 1 (least deprived) to 7 (most deprived) on the basis of the postcode sector of their address. In all, 129 lung cancer patients entered into the study. Of these data for 82 patients were complete (at baseline and follow-up). 57% of patients were of lower socioeconomic status and they had more health problems, less functioning, and more symptoms as compared to affluent patients. Of these, physical mobility (P=0.05), energy (P=0.01), role functioning (P=0.04), physical functioning (P=0.03), and breathlessness (P=0.02) were significant at baseline. However, at followup assessment there was no significant difference between patient groups nor did any consistent pattern emerge. Although the results were not conclosive, in general the findings suggest that quality of life is not only the outcome of the disease and its treatment, but is also highly dependent on each patients’ socioeconomic characteristics.

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REGIONAL PALLIATIVE CARE PROGRAM IN EXTREMADURA: TOWARDS A TAILORED INTEGRATED PALLIATIVE CARE REAL SOLUTION. Emilio Herrera Co-ordinator, Regional Palliative Care Program in Extremadura, Servicio Extremeño de Salud

‘ESPERANTO’ IN PALLIATIVE CARE: A COMMON LANGUAGE FOR DESCRIBING PALLIATIVE POPULATIONS. Currow DC1,2, Abernethy AP1,2,3, and Glare P4 1 Flinders University Department of Palliative and Supportive Services, Adelaide, Australia; 2 Southern Adelaide Palliative Services, Adelaide, Australia; 3 Duke University Medical Centre, Durham, North Carolina, USA; 4 Royal Prince Alfred Hospital, Sydney, Australia

Introduction: In February 2002, Extremadura had not Palliative Care (PC) resources to attend more than 2500 dying cancer patients a year. The 1.100.000 people of this wide region (41.602 km2), and its eight hospitals impelled the new Extremenian Health Service to deal with this situation designing and implementing a regional program that was integrated in the public health system. Objective: to describe the process to design, create and implement a Regional Palliative Care Program tailored to provide quality PC to the whole population of terminal patients in a Spanish region. Methods: After a technical leader was designated and the local needs were analysed, professionals agreed the PC framework document based in local reality, specific professional selection for PC was done, 15 doctors and 15 nurses were selected, which received advanced training in PC. Results: 8 PC support teams working in both acute hospitals and in the community were implemented, one in every health area (8), in January 2003. Since then, they have been offering a well co-ordinated and integrated support regional resource for patients, as well as for their families and their head doctors, in order to alleviate the physical and emotional suffering of dying patients. The first month, more than 150 patients were attended, 360 hospitals and home visits were done, and more than 390 recommendations were given. Conclusion: In only eleven months a well-tailored Regional PC Program was fully implemented. It offers 100% cover to all terminally ill patients, whatever is the place or the sanitary level to be attended. A well-structured plan based in real local needs, as well as government involvement is mandatory to get these early and impressive results.

A-80 DOES THE PALLIATIVE PROGNOSTIC (PAP) SCORE WORK FOR ONCOLOGISTS? Paul Glare, Patrick McMahon, Steffen Eychmueller Royal Prince Alfred Hospital, Camperdown, NSW 2050 Australia The PaP score combines symptoms, performance status (PS), and lymphocyte counts with the physician’s survival estimate (PSE) to reliably predict the short term survival of patients with advanced cancer referred to palliative care services. Its usefulness in other patient populations has not yet been determined. The study aim was to test the predicitive power of the PaP score in the hands of Medical and Radiation Oncologists when applied to 100 consecutive hospitalised patients with advanced cancer prior to palliative care referral. 52 were still receiving systemic anti-cancer treatment. 62 reported anorexia, 36 dyspnea. Karnofsky PS score was >50 in 64. The PSE was >3 months in 55, <1 month in 10. Severe lymphopenia (<12% total white cell count) occurred in 73. By February 15 2003, 41 had reached the end of the study (180 days post recruitment); the PaP score distinguished three distinct groups (log rank 50.90, P<0.0001) with median survival 84 (n=22), 22 (n=9) and 2 (n=3) days respectively. To date, PaP appears to perform well for Oncologists.

Introduction: Palliative services are generally referral based; local factors greatly impact on the population seen and the model of service delivery. The palliative care literature lacks routine thorough descriptions of the study population and setting, and this is especially true for case series and retrospective studies. Evidencebased practice requires critical review of the study participants and setting to determine if the work is adequately generalisable to the local setting. An adequate description of the palliative study population and their setting is imperative. Results: We argue that the following are important to adequately describe a palliative care patient population: ● Health system (e.g. universal healthcare, fee-for-service, insurers) ● Philosophy of palliative care (‘What is trying to be achieved by the service?’) ● Access to service (e.g. referral by anyone, referral by any health professional, referral only by doctor) ● Disciplines represented in the interdisciplinary team (e.g. medical, nursing, social work, psychology) ● Medical involvement (e.g. all or selected patients seen by palliative care doctor) ● Who does the assessment on referral (e.g. nurse only, doctor only, interdisciplinary team, referrer can choose) ● The role of the service in continued care (e.g. consultation only, direct care around the clock, interaction with primary carers) ● Location of care and death (e.g. home, hospital, hospice) ● Services available (e.g. day care, complimentary care, bereavement) ● Reason for referral (e.g. crisis, symptom control, access to services) ● Profile of the population seen (disease profile including cancer versus non-cancer, phase of illness, functional status, and median plus average time from referral to death) Conclusions: A common language will facilitate evidence-based practice in palliative care and the conduct of confirmatory studies by accommodating for the diversity in palliative care service delivery.

A-82 SYMPTOM CONTROL AND PALLIATIVE CARE CONTENT OF ABSTRACTS PRESENTED AT THE CANADIAN ASSOCIATION OF RADIATION ONCOLOGISTS ANNUAL MEETINGS *Elizabeth A. Barnes and Edward Chow Department of Radiation Oncology, Toronto Sunnybrook Regional Cancer Center, Toronto, Ontario, Canada Purpose: Forty percent of all patients referred for radiotherapy are treated with palliative intent. Recent emphasis has been placed on the importance of symptom control and palliative care (SCPC) in the radiation oncology community. The purpose of this study was to determine the number of abstracts relating to SCPC presented at the annual Canadian Association of Radiation Oncologists (CARO) meetings, and whether this number has increased over the time period examined. Methods and Materials: SCPC abstracts presented at CARO from 1992-2002 were counted. Abstracts were included if they de-

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scribed a patient population with metastatic or advanced cancer treated with palliative intent. Abstracts were then categorized as reporting treatment outcomes, health services research, descriptive studies or literature reviews. Radiation treatment sites were recorded. Results: An average of 6.7% (60/892) (range 0-16.2%) of all abstracts presented at CARO from 1992-2002 pertained to SCPC. The proportion of SCPC abstracts did not increase significantly during this time. Descriptive studies accounted for 46.7%, treatment outcomes 31.7%, health services research 13.3% and literature reviews 8.3% of the SCPC abstracts. Bone metastases (48.3%), primary lung tumors (11.7%) and brain metastases (10.0%) were the most common treatment sites. Forty five percent of the SCPC abstracts came from dedicated palliative radiotherapy clinics. Conclusions: SCPC research is poorly represented at the annual CARO meetings. Research in this field should be promoted as the palliative patient population represents a large component of our clinical practice. The recent emergence of dedicated palliative radiotherapy clinics should continue to increase palliative radiotherapy research.

A-83 RELATIONSHIP BETWEEN BONE MARKERS AND BONE EVENTS IN BREAST CANCER I. Mancini, F. Renard, J.J. Body* Supportive Care Clinic, Institut J. Bordet, ULB, Brussels, Belgium Biochemical markers of bone resorption (BRM) and bone formation (BFM) are increased in patients(pts) with bone metastases.We have looked for a relationship between markers and different types of skeletal-related events (SREs).78 breast cancer pts were included in this retrospective study. Of these, 64 had an SRE [bone fracture and/or surgery (BFS), need for radiotherapy (Rxther), spinal cord compression (Sp.c.comp.), change of treatment for bone progression (Ch. trt), hypercalcemia (HyCa)] during follow up (mean 21.4 m, median 19.4, 3.3-52.8 m). Evaluated BRM were the collagen crosslinks (PYD, DPD), and BFM were Bone Alk Phos(BAP) and Bone gla protein(BGP). Interestingly, pts without SREs had normal PYD and DPD values. All markers were significantly elevated in pts with SREs (P<0.001) (See tabl; all). PYD and DPD were the highest in pts with BFS or HyCA up to 3 to 6 times the median values of pts without SREs. Similarly, PYD was increased in 78% in pts with BFS and in 65% of hyCa pts, as compared to the 97.5 percentile. BRM are especially high in pts with severe SREs and their predicitve values deserves to be investigated. BFM were less increased than BRM suggesting uncoupling in bone turnover. Median values

PYD

DPYD

BAP

BGP

No SREs SREs Fract; Surg RXther SP.c.comp. Ch.trt HyCA

58 137* 211* 138* 135* 129* 211*

7.3 22.4* 44.4* 21.4* 21.2* 21.0* 39.9*

7.7 14.8* 21.7* 19.9* 22.0* 17.4* 11.4*

5.7 13.6* 17* 11.5* 14.3* 13.6* 13.5*

A-84 THE NEXT GENERATION OF CLINICAL TRIALS IN BONE METASTASES – PERSPECTIVE OF CANADIAN RADIATION ONCOLOGISTS *A. Bezjak1, J.S.Y. Wu2, R. K. S. Wong2, E. Chow3, P. Cross4, E. Fitzgibbon4, P. Genest4, N. Grant5, I. Roy6, T. Whelan2, P. Kirkbride7 Princess Margaret Hospital, Toronto Canada1, Hamilton Regional Cancer Centre, Hamilton Canada2, Toronto Regional Sunnybrook Cancer Centre, Toronto Canada3, Ottawa Regional Cancer Centre, Ottawa Canada4, St. John Regional Hospital, St. John New Brunswick5, Centre Hospitalier Universitaire, Montreal Canada6, Weston Park Hospital NHS Trust, Sheffield England7 We have conducted a one-day national workshop of Canadian radiation oncologists and clinical trials methodologists to review existing evidence from randomized trials on bone metastases management, and to identify priority research questions that could be answered through clinical trials through our national cancer cooperative organization. Abstracts of clinical studies, published 1996–2002, related to palliative management of bone metastases were searched, reviewed and summarized. Examples of outstanding questions related to RT management of bone metastases were identified. Workshop participants deliberated on scientific merits, required methodology and clinical context of these research questions. A list of prioritized clinical studies was proposed. The question of single versus multi-fraction re-irradiation for symptomatic bone metastases was identified as most pertinent to Canadian radiation oncologists present. For patients with intermediate prognosis, the question of an alternative dose-schedule of 17 Gy/ 2 fractions/ 1 week apart was proposed. For good-prognosis patients with early or mild symptoms of bone metastases, the question of early referral for RT assessment and/or use of RT was of interest. The former trial is about to commence, and the latter two require methodological development.

A-85 GPS AND DOMICILIARY PALLIATIVE CASE SERVICES *Emanuela Porta Giuditta Minutiello, Gabriella Monolo, Milan Italy Premise. The Milan 1 Local Health Authority has promoted various models of domiciliary palliative care. In the three districts (Corsico-Magenta-Abbiategrasso) a partnership has been formed between the local health authority and Vidas, a non-profit making organisation. The organisational model includes an interprofessional team made up of a GP, who calls a service operating in his or her district, and the Vidas team (doctor, nurse, psychologist, social worker, physiotherapist, health worker), expert in domiciliary palliative care. We examined what percentage of GPs called in the domiciliary palliative care service working in their area. In 2001 65% of GPs were using the palliative care service in the three districts considered: respectively 74% Corsico, 56% Magenta and 63% Abbiategrasso. In 2002, 72% of GPs were using the service: 71% in Corsico, 71% in Magenta and 75% in Abbiategrasso. In Corsico, where the project is more established as it began from long time, we found GPs readily contacted the domiciliary palliative care service in both 2001 and 2002. In Abbiategrasso and Magenta we found a high percentage of GPs were using the palliative care service in 2002 even if the project is recent. The patients in this study were at a very advanced stage of their terminal illness and average length of survival was 41.1-37.9-43.7 days. The level of awareness of the service and the percentage of GPs using the service is satisfactory, given the fact the service has only recently been organised.

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A-86 GASTROINTESTINAL CANCERS-ASSESSMENT OF PAIN IN ELDERLY PATIENTS R. Dobrila-Dintinjana, A. Ruzic, M. Dintinjana, I. Djipalo Gastroenterology dpt, Internal Clinic, University Hospital Rijeka, Croatia, EU Introduction: Patients (pts) with gastrointestinal cancers suffer from many symptoms during their disease; range symptoms 1-25. Pain is the most prevalent symptom and occurs in 70-90% of pts with advanced disease. Aim and methods: The aim of this study is to compare the pain prevalence in elderly cancer pts versus younger cancer pts. We took age 70 years as border for ederly. Results:During four years period on our department 676 pts with cancer of the gastrointestinal site was cured. The most common tumor sites were pancreas, colon and stomach. In group of ederly there was 172 men and 120 women with mean age of 77,4+3,2 years. In the comparative group there was 242 men and 142 women with mean age of 63,2+4,1 years.We specially examined pain which we tought is related to cancer. 230 (78,77%) of ederly pts experienced pain compared with 253 (65,88%) of pts in comparative group. In ederly group 88 (30,14%) of pts expressed mild pain, 128 (43,84%) moderate and 76 (26,02%) severe pain versus 98 (25,52%) mild pain, 174 (45,31%) moderate pain and 112 (29,17%) severe pain in comparative group, respectivelly. To all pts with pain we prescribed analgetic therapy according “three ladder step”-WHO. 165 (56,51%) of ederly and 291 (75,78%) of others respected pain therapy. Pain therapy “respectors” lived longer than “nonrespectors” (11 to 6,4 months respectivelly). Pts prefered phentanyl patch (Durogesic TSS) for pain therapy, expecially ederly (257-88% versus 292-76% respectivelly). Conclusions: There is no difference in Pain expression according to age, gender and tumor site. There is no difference between severity of pain among this two groups. There is statistically significant difference in respecting pain therapy; younger pts respect pain therapy statistically significant more than ederly. Pts who respect pain therapy live statistically significant longer (almost twice) than “nonrespectors” . Pts prefered transdermal opioid therapy, expecially in ederly group.

A-87 ANALYSIS OF ECONOMIC BURDEN ASSOCIATED WITH SEVEN TUMOR TYPES IN THE US DURING PALLIATIVE CARE *L. Kutikova1, L. Bowman1, S. Chang2, S. Long2 1Eli Lilly and Company, Indianapolis, IN, USA, 2MEDSTAT Group, Washington DC, USA The economic burden measured as direct medical costs of 7 tumors in the US during palliative treatment course was analyzed using claims databases. Patients (pts) diagnosed in 1999-2000 with colorectal, lung, prostate, brain, pancreatic and ovarian cancers and non-Hodgkin’s lymphoma (NHL) were considered to start receiving palliative care when: 1) disease reached advanced stage; 2) start of using nursing facility or hospice care; or 3) death within 12 months after initial cancer diagnosis. Sixty-four percent of 2,844 study pts received treatment prior to palliative care. Mean follow-up period for study pts was 8.3 months. Mean monthly total costs adjusted for demographics, comorbidities and follow-up period were $6,140. Aggressive NHL and lung cancer pts accrued the greatest monthly total cost ($9,836 and $8,744). Use of inpatient services was the most significant contributor to total costs ($4,115). Further analysis is planned to compare costs of palliative treatment course to costs associated with prior treatment courses. Although palliative care treatment goals are intended to provide symptom relief, treatment costs are still substantial and vary by tu-

mor type. Research should be conducted to evaluate reasons for and effectiveness of inpatient service use as well as improving success of earlier interventions.

A-88 USE OF ALTERNATIVE THERAPIES BY WOMEN WITH ADVANCED BREAST CANCER: A LONGITUDINAL STUDY *Eva Grunfeld1,2; Whelan T2; Reyno L2; Craig E1; Coristine M1,2 1Ottawa Regional Cancer Centre, Ottawa 2Supportive Cancer Care Research Unit, Hamilton, Canada Background: Most studies documenting use of complementary and alternative medicines (CAM) by breast cancer patients are cross-sectional. Purpose of the Study: The objective of this study was to measure longitudinally the use of CAM by women with advanced breast cancer. Methods: We conducted a longitudinal study of 130 women with hormone refractory advanced breast cancer. Prospective eligible patients were enrolled within 3 months of diagnosis of advanced disease and followed up until death or completion of the study at 2 years, whichever came first. Description of the patient population was reported previously.1 We report here CAM use and costs. Results: Almost half of patients (55;42.3%) used a wide range of CAMs. Of alternative medicines, herbal mixtures (36;27.7%), multivitamins (25;19.2%, and essiac (21;16.2%) were most frequently used. Costs associated with CAM use ranged from $4 to $1,513CAN. For herbal mixtures, the 36 patients used up to 180 different forms of herbal mixtures. Alternative therapies were less frequently used: naturopathy (8;6.2%), chiropractic medicine (6;4.6%) and acupuncture (5;3.8%) 1. Grunfeld E et al. Supportive Care in Cancer 2002;10(4):381.

A-89 ´ THE DEVELOPMENT OF PALLIATIVE CARE IN ŁODZ PROVINCE IN POLAND Wojciech Leppert*, Jolanta Szamburska**, Krystyna de Cordé***, Zofia Pawlak****, Andrzej Dukowicz*****, Aleksandra Ciałkowska – Rysz****** * Chair and Palliative Care Department, Karol Marcinkowski University of Medical Sciences, Pozna´n, Regional Consultant in Palliative Medicine for Łód´z Province; ** Rafał Chyli´nski Hospice, 4th Nursing Home, Łód´z; *** St. John Hospital, Łód´z; **** Home Care Hospice Team, “Caritas” Archdiocese Łód´z; ***** Palliative Care and Radiotherapy Department, Mikołaj Kopernik Hospital, Łód´z; ****** Palliative Care Department, Chair of Oncology, Medical University, Łód´z, Poland Introduction: Łód´z is a big town in central Poland with near 800 thousand inhabitants and it is the capital of a province which comprise over 2600 thousand inhabitants. Every year in Łód´z province over 6500 patients die from cancer and these patients need palliative care at the advanced stage of the disease. Aim of the study: To assess present stage of palliative care in Łód´z province. Material and methods: Information gathered from heads of all palliative care units in Łód´z province by the questionnaire elaborated by Expert Group of National Consultant in Palliative Medicine in Poland. Results: There are 6 in – patient departments in Łód´z province (3 of them in Łód´z) and 22 home care teams usually with out patient clinics. In most of the towns there are palliative care services; however in 2 bigger towns (Radomsko, Opoczno) there are no such services. After Polish National Conference “10 Years of Pal-

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liative Care in Łód´z” which took place in October 2002 in Łód´z on the initiative of Regional Consultant in Palliative Medicine The Palliative Care Department as part of Chair of Oncology at the Medical University in Łód´z was established. In 2002 a new educational programme for family doctors from Łód´z province was started. It should help family physicians to be better prepared for caring for patients who need palliative care in the community where limits in special palliative care services availability still does exist. In 2003 apart from education for family doctors courses for district nurses working in the community and nurses working in palliative care will be held. These programmes together with continuous education for medical and nursing students at the Palliative Care Department, Chair of Oncology, Medical University in Łód´z should improve patients’ access and quality of care offered by palliative care services in Łód´zprovince. Conclusions: In most of the Łód´z province patients have access to palliative care (at least to home care). However there are some regions where palliative care is not available. Most educational efforts are focused on appropriate training for students, doctors and nurses in order to improve and disseminate palliative care in all Łód´z province.

A-90 PALLIATIVE CARE FOR ONCOLOGI-CAL PATIENTS: THE HOME-CARE MODEL. Ranuzzi M., Palmeri G., Ranaldi P., Sabbi A., Taddei A., Brunetti S., Gentile S., Vercelloni R. Gruppo Ricerca Assistenza Domiciliare Oncologi-ca, Rome (Italy) Purpose: the G.R.A.D.O. Association (Gruppo Ricerca Assistenza Domiciliare Oncologica) providing home care for cancer patients was begun in June 1998. Our aims are: aid, research, study, promote, organize, carry out the home-care for oncological patients, prevalently by voluntary service. Moreover, we aid the public and social structures involved in oncologic care. Patients and methods: this service is provided upon request from the family doctor or directly from the patients who are unable to travel or whose condition need a palliative treatment. Patients are visited at home by an oncologist with the aid of a professional nurse with oncological experience; they together draw up the assistance program. The professional team is also composed of an internist, a physician for pain therapy, a psychologist, a physiotherapist. Assistance is completely free for the patients and their families. Our home-care model is able to guarantee: best supportive care, antalgic therapy, psychological aid, follow-up. The professional team is also supported by a group of trained volunteers who are responsible for the social aspects of the patients’ life. Results: during four years of activity 283 patients, the mean age was 65.3 yrs (38-90), have been followed: they requested 2265 oncological visits, 887 medical visits, 166 thoracentesis, 160 paracentesis, 1516 nurse interventions, 1093 supportive treatments, 35 physioterapeutical interventions and 380 psychological supports. The median follow up were 40 days (3-359). Conclusion: the data regarding our activity showed us that this specifically oriented medical assistance permits education and adaptation of patients and their families with the disease and diminishes the hospitalization of these patients, resulting in an improvement of their quality of life (better preserved in their family environment). During our years of activity we have distributed 19.358 days of medical services and it has certainly helped in saving the expenses of the welfare state. So considering the mean cost of a day in a general hospital aproximately equivalent to 500,00 € and considering a day of medical services=a day of non hospitalization, our work allowed an economical benefit of 9.697.260,00 €.

A-91 WHERE DO CANCER PATIENTS DIE – IMPLICATIONS FOR HOME CARE PROVIDERS *Papke J, Koch R Praxis fuer Innere Medizin, D–01844 Neustadt; Technische Universitaet Dresden, Institut für Medizinische Informatik und Biometrie, D–01307 Dresden, Germany Purpose of the study was to analyse the places of death of cancer patients in the rural district Saechsische Schweiz and to search for consequences for the offering of home care outputs. Description: The data of died cancer patients from 1997 to 2001 were analysed for influences through age, sex, diagnosis and the place of living. For the estimation of age we formed 6 age-groups (<40, 41 to 50, 51 to 60, 61 to 70, 71 to 80, >80 years). Statistical calculations were done with loglinear models using SAS procedure GENMOD. Results and conclusions: From 1997 to 2001 there were 1505 deaths from cancer pts. registered at the health office in the region. People in middle age and elderly people (51–70 y.) mostly die in hospital but the oldest people (>80 y.) die mostly at home. Patients from the countryside also mostly die at home. Elderly pts. with lung cancer more die at home; pts. with breast carcinoma mostly die in hospital. – There are no useful predicting factors for the providing of home care in the terminal phase, so the possibilities of home care should be offered to every cancer patient.

A-92 TOTAL SKIN ELECTRON IRRADIATION IN MYCOSIS FUNGOIDES: COMPARISON BETWEEN A MODIFIED CHRISTIE HOSPITAL RECUMBENT TRANSLATIONAL TECHNIQUE AND THE STANFORD TECHNIQUE. ME Stein, A. Kuten, K. Drumea, E. Rosenblatt, A. Tamir, L. Chetver, R. Bar Deroma Department of Oncology, Rambam Medical Center, Haifa, Israel Between 1979 and 1999, 71 Mycosis Fungoides patients [pts] received Total Skin Electron Irradiation [TSEI], using a modified Christie Hospital recumbent translational technique [1979-92, 44 pts, 62%] or the 6 dual field Stanford technique [1992-99, 27 pts, 38%]. The following total doses and doses/fraction were given: Modified Christie Hospital technique: Total dose – median 32 Gy, range 16-44 Gy; dose/fraction: median 4 Gy, range 1.5-4 Gy; fractions/month 2-8. Stanford technique: Total dose – median 30 Gy, range 15-36 Gy; dose/fraction: median 2.5 Gy, range 1.2-3.3 Gy; fractions/month 5-28. Results: 64 [90%] pts achieved CR and 4 [5.5%] PR, with no difference in RR between the two techniques. With a median follow-up of 61 months, 43 pts developed recurrence. The 5-year OS and DSF were 63% and 25% with the modified Christie Hospital technique and 25% and 18% with the Stanford technique [p=0.88; 0.87]. Total dose and fractionation parameters did not influence DSF. Moderate/severe skin reactions appeared in 26 [41.5%] pts. Severe skin toxicity was uncommon with the Stanford technique [p=0.026] dose/fraction
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A-93 A DOSE TITRATION STUDY OF THALIDOMIDE IN CANCER ANOREXIA Fade Mahmoud, Declan Walsh, Mellar Davis, Susan LeGrand, Ruth Lagman, Tarek Mekhail, David Peereboom The Harry R. Horvitz Center for Palliative Medicine. The Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio Introduction: The anorexia-cachexia syndrome is the leading cause of cancer death. Thalidomide (TH) may increase appetite (Ap) and weight (W) by lowering TNF-α. We studied TH safety and efficacy in cancer anorexia. W, performance status (PS), bioimpedance (BEI), early satiety, insomnia, sweating, and quality of life (QOL) were assessed. Methods: Patients with cancer were screened using an appetite numerical analogue scale (Ap-NAS, 0: worst -10: normal). Patients on current anti-anorexia or anti-tumor therapy were excluded. Patients with an Ap-NAS ≤8 were eligible. TH 50 mg/d was the starting dose. Both patients and staff complied with the System for TH Education and Prescribing Safety STEPS (Celgene Corporation). ≥2-point increase in Ap-NAS was a response. Evaluable patients must complete 2 weeks of TH 50 mg/d. Non-responders were titrated to 100 mg. QOL was measured using a categorical scale. Other symptoms were assessed by a NAS (0: None, 10: the worst) Results: Fifteen patients enrolled. There were seven males and eight females; median age 66 (R 5380). Lung cancer was the commonest diagnosis (N=3). Five were withdrawn early (non-evaluable); severe drowsiness (N=3), death (N=1), and refusal (N=1). Ten were evaluable for efficacy. Nine patients had an AP response (7 at 50 mg, 2 at 100 mg). The median/range Ap-NAS was 2 (1-6) baseline, 5 (3-8) day 7, 6 (4-9) day 14. The QOL at baseline was okay (N=6) and bad (N=3). This improved to good (N=6) after three days. Most (N=8) noted improved sleep. Early satiety (N=5) also improved (N=3). W and BEI results are available in six. Of those, five gained W. W (median/range Kg) was 48.4 (42.4-61.6) day 1; 54.9 (43.9-63.8) day 21. W gain was both fat and LBM (N=2), LBM alone (N=2), and fat alone (N=1). Two had sweating which improved after 3 days. Conclusion: 1) Most had sustained improved Ap 2) Sweating and early satiety improved 3) Some gained significant W 4) QOL improved first.

A-94 CONSULTATIVE PALLIATIVE MEDICINE IN USA CANCER CENTER Declan Walsh, John Cowan, Jade Homsi The Harry R. Horvitz Center for Palliative Medicine, The Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio Purpose: a) To report the medical complexity of cancer and noncancer patients receiving palliative medicine (PM) consultation at a tertiary medical center and, b) to describe the consult recommendations made for this group. Methods: Prospective data collection was performed on all consultations (Cancer, n=175; non-cancer, n=35). A computer database was used to query for demographics, complexity of medical problems, current medications, mortality, symptoms, nursing problems, and consult recommendations. Results: A median of three (range, 0-12) acute medical problems and three (range, 0-16) chronic medical problems were identified for each patient. Patients were taking a median of six medications (range, 0-20). They had a median of five symptoms (range, 0-13) with pain (73%) being most common, followed by weakness (40%) and shortness of breath (40%). Cancer patients were twice as likely to have more than five symptoms (48% versus 23%)(P=0.006). The most common nursing problems were ambulation or fall risk (15%) and skin integrity (11%). A median of five (range, 1-11) management recommendations were made as part of each consultation. These included med-

ication changes in (81%), non-medication changes in (53%), and follow-up services in (100%). The median survival from the time of consultation for the known dead was 29 days with 65 percent living more than 14 days. Conclusion: Multiple recommendations were made with most patients surviving long enough potentially to benefit. Consultation in palliative medicine is a sophisticated intervention involving considerable acuity and complexity of care.

A-95 PROSPECTIVE STUDY OF SERUM PRO INFLAMMATORY CYTOKINE-AND ACUTE PHASE REACTANTS IN CANCER PATIENTS WITH FN. B L Rapoport,(1) A Uys(1), R Anderson(2) Johannesburg, (2) Pretoria, South Africa Febrile neutropenia (fn) remains a potentially life-threatening complication in cancer patients (pts) undergoing chemotherapy. MASCC developed a scoring system, based on clinical predictive factors to identify pts at low risk for development of serious medical complications. The purpose of this study was to validate the MASCC risk-index score in order to predict which pts will have a favorable outcome and which are at risk to develop complications. The dependant variable of primary interest was the final outcome of each febrile neutropenic episode: a) fever resolution for five consecutive days, allowing change in antibiotic treatment, b) fever resolution with occurrence of a serious medical complication, c) death before resolution of fever. Data from 80 episodes of fn was collected prospectively. The MASCC score was calculated on each patient. Pts with a score of ≥21 were low risk and pts with a score of <21 high risk. There were 19 males and 61 females. Sixty pts were younger than 60 years. Twenty four pts had a PS 0-1. Twenty four pts were inpatients. Fifty six pts had solid tumours and 24 hematological malignancies. Twenty six pts received G-CSF.Fifty eight pts (72,5%) were low risk (≥21) and twenty two (27,5%) high risk (<21). Among the 58 low risk pts, 57 (98,2%) were treated successfully. One pt developed a fungal infection. Among the 22 high risk pts, 10 (45,5%) developed complications: admission to intensive care (4 pts), fungal and viral infections (4 pts), hypotension (3 pts). Eight high risk pts (36,3%) died before fever resolution. Three high risk pts were treated successfully. Microbiological infections were documented in 30% of all patients. When applying the MASCC risk-index score in this study the positive predictive value was 95% (76/80). We confirm that the MASCC model is accurate and useful to predict low and high risk pts.

A-96 PALLIATIVE MEDICINE: HOW DO WE COMPARECHEAP OR EXPENSIVE? M Davis, D Walsh, S Legrand, R Lagman, B Harrison, F Mahmoud Cleveland Clinic Foundation; Cleveland, Ohio USA The DRG is an organ-system based disease classification system used by Medicare for healthcare reimbursement. Economic comparisons between conventional and palliative medicine are problematic due to differences in case mix, illness severity and treatments. Comparisons are possible using an All Patient Refined (APR) Drug Related Group (DRG). The APR-DRG adds subclasses based on illness severity and mortality risk. This can be further refined to compare primary, secondary and tertiary hospitals. We examined actual and predicted charges for Cleveland Clinic palliative medicine patients similar to patients at other hospitals. METHOD: APR-DRG data was obtained using 3M Healthcare Software (Wallingford, CT USA). We compared 1,189 APR-DRG

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Palliative Medicine admissions to national data (June 2000–January 2003). Predicted national costs including laboratory, nursing, pharmacy, radiology and total charges from 136,344 year 2000 records were compared to our palliative patients. Charges were also compared to peer institutions. (Baylor University, Brigham and Women’s Hosp., Cedar Sinai Med Center, Duke Univ., John Hopkin’s Hosp., Scott and White Memorial Hosp., Stanford Univ., Vanderbilt Med Center, Thomas Jefferson Univ. Hosp., New York Presbyterian Hosp., Loma Linda Univ. Med Center). RESULTS: Compared to the national APR-DRG (including the peer APR-DRG) laboratory costs were 36% and pharmacy costs 34% lower. Radiology and nursing charges were 30% and 3% higher respectively compared to APR-DRG year 2000. Total palliative medicine charges compared to the national APR-DRG were 9% higher than expected. Compared to peer APR-DRG (similar tertiary centers) our total charges were 27% lower (0.0001 paired T test); range 5,000 – 10,540 dollars saved per patient. DISCUSSION: This is the first time a palliative medicine program within a tertiary medical center has demonstrated dramatic inpatient cost savings compared to peer institutions with a similar patient mix defined by APR-DRG. Goals of care when transitioning to palliative medicine alters cost. Palliative medicine programs in cancer centers may incur additional charges due to collaboration with oncology. CONCLUSION: Palliative medicine programs within tertiary medical centers are cost effective.

A-97 IBANDRONATE IN THE PALLIATIVE MANAGEMENT OF UROLOGICAL MALIGNANCIES WITH COMPENSATED RENAL INSUFFICIENCY C. Ohlmann, A. Heidenreich* Department of Urology, Philipps University Marburg, Germany Up to 20% of all urological malignancies are complicated by paraneoplastic hypercalcemia due to increased bone resorption and enhanced renal tubular reabsorption. Increased bone resorption is associated with osteolytic bone metastases and severe bone pain. Since both hyperclacemia and bone pain,might be managed by the application of bisphosphonates, we investigated the safety and tolerability of ibandronate in tumor-associated hypercalcemia. 21 cancer patients with either hypercalcemia (n=6) or severe bone pain (n=15) were included in this study. All patients had a serum creatinine level greater than 2.0 mg/dl; group A had serum calcium levels greater than 2.8 mmol/l and group B patients had a mean pain score of 6.8 using a VAS from 1-10. After fluid repletion, ibandronate was given at 6 mg i.v. daily until serum calcium levels had normalized. Patients with bone pain were ibandronate was given at 6 mg i.v. for 3 consecutive days, followed by 3weekly intervals. Serum calcium values fell progressively from day 2, reaching a nadir on day 4 and normocalcemia was maintained for 28 days. Bone pain was significantly improved in 12/15 (75%) of the patients starting on day 2; the main pain score on day 3 was 2.5 (p<0.001). None of the patients demonstrated an increase in serum creatinine or serum urea nitrogen concentrations. Ibandronate was well tolerated with only 2 patients (9.5%) developing slightly increased temperatures. Ibandronate can be safely administered to treat paraneoplastic hypercalcemia and bone pain in patients with compensated renal insufficiency.

A-98 MORPHINE AND MIDAZOLAM IN PALLIATION OF SEVERE DYSPNEA DURING THE LAST WEEK OF LIFE IN PATIENTS WITH ADVANCED CANCER Navigante A, Cerchietti L, *Castro M, Lutteral M and Cabalar M. Supportive Care Division. Angel H. Roffo Cancer Institute. University of Buenos Aires. Argentina Introduction: Dyspnea remains one of the most challenging symptoms to manage in the setting of advanced malignancy. After appropriate interventions to control the underlying disease, the first line palliative measure is morphine. Anxiolytics are commonly prescribed for anxiety related to dyspnea. The recommendation for anxiolytic medications is based on the clinical observation of anxiety in these people. The present trial was designed to assess the role of midazolam as adjunct therapy to morphine in the alleviation of severe dyspnea during last week of life in patients with advanced cancer. Patients and Methods: 101 advanced cancer patients with severe dyspnea (at rest) were randomized to received either around-theclock morphine (2.5 mg q4h) with midazolam rescues (7.5 mg) in case of exacerbation (Group Mo), or around-the-clock midazolam (7.5 mg q4h) with morphine rescues (2.5 mg) in case of exacerbation (Group Mi), or around-the-clock morphine plus midazolam (2.5 mg and 7.5 mg q4h, respectively) with morphine rescues (2.4 mg) in case of exacerbation (Group MM). All drugs were given subcutaneously. The principal end points were dyspnea intensity (modified 10-point Borg scale) and dyspnea relief (yes-no) The assessment were effected at baseline, 24 and 48 hours. All patients were treated in our hospital and received the same psychological approach. Results: Thirty-five patients entered in Group Mo, 33 in Mi, and 33 in MM. Twenty-one patients died before the first evaluation (6, 7 and 8 in each group respectively), and 10 pts died before the second evaluation (5, 3 and 2 respectively). Analysis was performed with an intent-to-treat basis. At the time of the first assessment, the percentage of patients who experienced dyspnea relief were 69%, 46% and 92% (p= 0.0004 and p=0.03 for MM vs. Mi and Mo respectively) and those who required rescues were 41%, 46% and 28%; in Mo, Mi and MM respectively (p=NS). The median (interquartile range) of dyspnea intensity were 3 (2-5.5), 4 (26.2) and 3 (2-5) respectively. This value were statistically different from the baseline for each group (p=0.002, p=0.018 and p=0.003 for Mo, Mi and MM, Wilcoxon Signed Rank Test) At the time of the second assessment (48 hs), the median (interquartile range) of dyspnea intensity were 2 (0-4.7), 2 (0-7) and 2 (1-5) respectively (p=NS), those who required rescues were 45.8%, 43.5% and 26% (p=NS); and those with dyspnea intensity more or equal than 7 were 12.5%, 26% and 4% (p=0.04 for MM vs. Mi), for Mo, Mi and MM respectively. Forty-five side effects were recorded. Of those only 16 were clinically relevant (grade 2 or more). The most frequent toxicity was somnolence (56%). Conclusion: Patients who received both drugs from the beginning showed better control of dyspnea compared with those who received either drug alone. Our data also support the conclusion that benzodiazepines alone should not be first-line therapy for dyspnea.

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A-99 EFFECTS OF EICOSAPENTAENOIC AND DOCOSAHEXAENOIC N-3 FATTY ACIDS FROM FISH OIL ON CANCER-CACHEXIA SYNDROME (CCS) IN PATIENTS WITH ADVANCED LUNG ADENOCARCINOMA Cerchietti L, *Castro M, Navigante A, Lutteral M and Cabalar M. Supportive Care Division. Angel H. Roffo Cancer Institute. University of Buenos Aires. Argentina Introduction: CCS in advanced cancer patients produces an environment that prevents the appropriate use of supplied nutrition. This may be due to profound and persistent metabolic changes mediated in part by proinflamatory cytokines. Fish oil supplements have shown benefit in pancreatic cancer patients. We and others have used non-steroidal anti-inflammatories as adjuvant therapy to control the systemic inflammatory response which characterizes the CCS. The aim of this study was to assess the role of fish oil concentrate in amelioration of CCS in a homogeneous group of lung-adenocarcinoma patients receiving celecoxib plus nutritional supplements in the setting of a multi-targeted therapy. Patients and Methods: Twenty patients with lung adenocarcinoma and evidence of CCS were studied. CCS was defined as the presence of weight loss >10%, anorexia and performance status ≥2. Patients were randomized in two groups. Group FO received fishoil capsules (2g t.i.d.) whereas Group PL received placebo. Both groups also received celecoxib (200 mg b.i.d.) and oral food supplementation for 6 weeks. Baseline and weekly determination of performance status, appetite, fatigue, hand grip, caloric intake, bioelectrical impedance analysis and blood chemistry were performed. Results: Ten patients received fish-oil capsules and other ten patients received placebo. After 6 wks of treatment, patients in the FO group showed significantly more weight gain and fat mass gain compared with those in the PL Group (p=0.023 and 0.041 respectively, T Test). Both groups showed equal appetite, caloric intake and fatigue improvements compared to baseline levels (p=0.0018, p=0.012, p=0.0019 respectively, Wilcoxon Signed Rank Test). PS and Hand Grip showed a tendency to improve in both groups (p=0.062 and p=0.065 respectively). There were no significant differences for the inter and intragroup comparison in lean mass, protein and albumin measurements. Conclusion: Fish oil in addition to an anti-inflammatory agent such as celecoxib in combination with nutritional supplementation may reverse aspects of cachexia in advanced patients with lung cancer.

a useful tool. 22 out of 23 patients in stage 2 agreed the QPL was helpful, contained useful questions, was easy to understand & would be useful in the future. Anxiety decreased after receiving the QPL & seeing the doctor in 16 of 19 patients. Both patient & HP participants in stage 2 endorsed the inclusion of end-of-life issues in the QPL despite some initial reservations expressed about this by HPs in stage 1. Conclusions We have identified a specific set of questions that might facilitate useful dialogue between PC patients & their doctor. The concept has strong support from PC patients, their carers & relevant HPs.

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Α ANTIBODY REMIPHASE II STUDY OF ANTI-TNFΑ CADE (INFLIXIMAB) IN PANCREATIC CANCER CACHEXIA Mark Anderson, Mark DeWitte; *Stefan Rosewicz; Giovanni Mantovani Centocor, Inc. Malvern PA USA 19355; Campus Virchow Klinikum Berlin, BE 13353 Germany; Policlinico Univ di Cagliari, Monserrato CA 09042 Italy TNFα is an inflammatory cytokine causally associated with wasting conditions. It was originally termed “cachectin” when identified as a circulating mediator of weight loss in parasite infected animals. It produces cachexia in a TNFα transgenic rodent model and in various TNFα producing tumor models. TNFα may be a critical mediator of the catabolic syndrome of cancer cachexia. Therefore TNFα blockade is a potentially beneficial intervention for this debilitating syndrome. We will test this hypothesis in a blinded, placebo-controlled, 3-arm Phase II clinical trial in 90 cachectic pancreatic cancer patients. Safety and efficacy of 2 dose levels (3 mg/kg; 5 mg/kg) of infliximab will be evaluated when administered concomitantly with standard gemcitabine chemotherapy. The primary endpoint is change in lean body mass measured by bioelectrical impedance. Secondary endpoints include toxicity, functional performance (six-minute walk test), Karnofsky performance status, time to disease progression, tumor response, patientreported Quality of Life, effects on chemotherapy, pharmacokinetics, and survival. Centocor is awaiting approval from the two clinical investigators conducting this study in Europe, to include their names as authors.

A-102 A-100 ASKING QUESTIONS CAN HELP: DEVELOPMENT & PRELIMINARY EVALUATION OF A QUESTION PROMPT LIST FOR PALLIATIVE CARE PATIENTS. Josephine Clayton1, 3, MHN Tattersall2, P Butow1, R Chye3, M Noel4, JM Davis5, P Glare6 Medical Psychology Research Unit1& Department of Cancer Medicine2, University of Sydney; Sacred Heart3; Nepean4, Calvary5 & Royal Prince Alfred6 Hospital Palliative Care Services, Sydney Objectives To develop a question prompt list (QPL) for palliative care (PC) patients’ use in gaining information from their doctor & to pilot this in clinical practice. Design Stage 1: Qualitative study based on focus groups & individual interviews; Stage 2: pilot provision of QPL Setting 3 PC services in Sydney & health professionals (HPs) around Australia. Participants 19 PC patients, 24 carers & 22 PC HPs took part in stage 1. A further 21 HPs, from various disciplines, reviewed the draft document. 23 patients seeing one of 3 doctors, from 3 PC services, took part in stage 2. Results 103 questions were identified & grouped into 8 categories. All participants in stage 1 felt the QPL, in booklet form, could be

PALLIATIVE ROLE OF CHEMOTHERAPY IN PATIENTS WITH NONRESECTABLE CANCER OF THE BILIARY SYSTEM OR ADVANCED GALLBLADER CANCER R. Dobrila-Dintinjana, D. Stimac, A. Ruzic, M. Dintinjana Gastroenterology dtp, Internal Clinic, University Hospital Rijeka, Croatia Introduction: Adenocarcinomas of the bile ducts (BSCa) and gallblader (GBCa) are higly malignant neoplasms with a very poor prognosis. Chemotherapy (cht) often plays only a palliative role and responses are transient without prolonged survival. Aim of the study: to evaluate effectiveness of gemcitabine (G) and cisplatin (CP) combination protocol in achieving Clinical Benefit Response (CBR) for patients (pts) with nonresectable BSCa and with advanced GBCa. Results: during four years period we cured 30 pts with BSCa and GBCa with mean age of 50,4+5,4 years. There was 18 females with mean age of 48,2+4,6 years, and 12 men with mean age 52,6+4,6 years. 20 pts (66,7%) had locally advanced disease and 10 pts (33,3%) metastatic disease. Pts achieved G 1000 mg/m2 intravenous once per week for seven times. CP l00 mg/m2 iv was administered at day 1,15,29 and 43. Number of applicated cycles was 1-10 (median 4 cycles). Global

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response rate achieved 18 pts (60%), also as partial response rate (18 pts-60%). All pts (100%) achieved CBR. Pain measured at VAS scale before cht was 4,8; and after 1st cht cycle 1,6. Karnofsky Performance Status (KPS) before cht was 60%, and after 1st cht cycle 80%. Median duraion Clinical Benefit was 22 weeks. Conclusion: This results indicate that the treatment of GBCa and BSCa with Gemcitabine and Cisplatinum is effective, well tolerated and leads to Clinical Benefit. We can also confirm that the role of cht is not only prolonging survival time but also palliation and achieving better Quality of Life.

A-103 PHALLUS IMPUDICUS IN NUTRITION FOR CANCER PAIN ADJUVANT CONTROL AFTER PALLIATIVE RADIOTHERAPY *Sergejs Kuznecovs, Galina Kuznecova Cancer Unit,Public Health Foundation, Riga, Latvia The present study aimes to assess the efficacy of additional use of Phallus impudicus (PhI), an edible fungus from the order of Gasteromycets. as alternative remedy for cancer pain control. During the period of 1991-2002, 3152 patients with moderate to severe chronic cancer pain, defined as a value >4 in a visual analogue scale (VAS) from 0-10 (0:no pain; 10: worst pain) were folowed for 1 to 12 months (m) to assess pain control. The standart juice from PhI fresh fruiting bodies was used by all pts in the dose of 10 grams three times daily. It was found that after radiotherapy with PhI pain disappeared or decreased in 85% of pts at 1 m, 74% of pts at three m, 62% of pts at 6 m and 25% of patients at 12 m. 56% of pts have less need for analgesics and psychotropic drugs. PhI has showed to be a good choice for cancer pain treatment in all groups of patients The clinical results include a decrease of pain in the majority of pts with breast cancer and prostate cancer with bone metastases. Considered it a safe and efective approach that increases survival and improves the quality of life of patients with advanced prostatic carcinoma. This mushroom has been a Latvian folk remedy for bone and abdomen pain. It is possible that PhI longterm consumption stops the breakdown of enkephalins. We find it encouraging to study analgesic action of this remedy as a nutrient for palliative pain contol.

A-104 PHARMACOKINETIC AND DOSE PROPORTIONALITY OF EXTENDED-RELEASE OXYMORPHONE AND ITS METABOLITES Michael Adams1 and *Harry Ahdieh2 1SFBC-New Drug Services, Kennett Square, PA, US; 2Endo Pharmaceuticals Inc., Chadds Ford, PA, US The pharmacokinetics and dose proportionality of oxymorphone extended release (ER) and its metabolites following single- and multiple-dose administration were evaluated in a randomized, 3period, crossover study of 4 doses (5, 10, 20, and 40 mg) in normal volunteers. During each 8-day treatment period, subjects received a single dose on day 1; the same dosage every 12 hours days 3 to 7; and a single dose on day 8, with a 7-day washout period between treatments. During each treatment, naltrexone was given to prevent opioid side effects Plasma was collected up to 48 hours after day-1 dosing and out to 12 hours after the day-8 dose to determine single-dose and steady-state pharmacokinetics. Twenty-one subjects (11 men, 10 women) completed the study. Following a single dose of 5, 10, 20, or 40 mg, the oxymorphone mean AUC (4.54, 8.94, 17.80, and 37.90 ng · h/mL, respectively) and Cmax (0.27, 0.65, 1.21, and 2.59 ng/mL, respectively) confirmed dose proportionality. The metabolites also increased in a

linear fashion. Similar results were obtained at steady state. The pharmacokinetic profile of oxymorphone ER demonstrates linearity and dose proportionality under single-dose and steady-state conditions for oxymorphone and its metabolites from doses of 5 mg to 40 mg administered every 12 hours.

A-105 ORAL IBANDRONATE: AN EFFECTIVE, CONVENIENT AND WELL-TOLERATED THERAPY FOR METASTATIC BONE DISEASE Bell R*, Tripathy D, Body JJ, Pecherstorfer M, Diel I, Bergstrom B Although intravenous (i.v.) bisphosphonates are currently considered standard therapy for metastatic bone disease (MBD), the need to visit the hospital, coupled with lengthy infusion times, impact on the ability of the patient to lead a normal life. The availability of an effective and well-tolerated oral bisphosphonate would allow chronic at-home administration in patients who are not receiving intravenous chemotherapy (e.g. in conjunction with oral hormone therapy). Ibandronate, a new, highly-potent bisphosphonate, has been developed in both oral and i.v. formulations and these have equivalent efficacy. Ibandronate is currently being evaluated in clinical trials for the treatment of patients with MBD. In two phase III, randomised, multicenter studies (n=846), patients with MBD from breast cancer were treated with a simple, once-daily regimen of 50mg oral ibandronate. Oral ibandronate provided a significant (38%) reduction in the risk of new skeletal events, alleviated bone pain below baseline levels and improved patient quality of life (p<0.05). Oral ibandronate was well-tolerated, with few gastrointestinal side effects and no renal toxicity. These results suggest that oral ibandronate is as effective as existing i.v. bisphosphonates in patients with MBD from breast cancer, with a favourable tolerability profile. Oral dosing of ibandronate eliminates the need for time-consuming hospital visits. This oral treatment option increases access to this important palliative modality for patients with impaired mobility and pain due to reduced skeletal integrity, and for those with poor performance status.

A-106 RENAL SAFETY OF ORAL AND INTRAVENOUS IBANDRONATE IN METASTATIC BONE DISEASE: PHASE III CLINICAL TRIAL RESULTS Diel I*, Bell R, Tripathy D, Body JJ, Bergstrom B Institut for Gynecological Oncology, CGG-Clinic, Mannheim The safety of therapy is an important issue in patients with metastatic bone disease (MBD), because of the high morbidity burden of disease and the toxicity associated with the treatment of their underlying malignancy. Although effective against skeletal complications, currently available bisphosphonates are associated with renal toxicity, which may have serious and potentially life-threatening consequences. The renal safety of ibandronate, a third-generation bisphosphonate, has recently been evaluated in three Phase III clinical trials of patients with MBD from breast cancer (n=1312). Patients received treatment with oral ibandronate (50 mg/day) or intravenous (i.v.) ibandronate (6mg infused over 12 hours every 3-4 weeks) for 96 weeks. Very few renal adverse events were reported, and the number of patients experiencing these events with ibandronate was similar to placebo (50 mg oral dose: 13 events vs 11 events with placebo; 6mg i.v. dose: 5 events vs 4 events with placebo). None of the events in the ibandronate group were graded serious, or led to withdrawal from treatment. These results suggest that, unlike other currently available bisphosphonates, ibandronate has a favourable renal safety profile in the treatment of patients with MBD.

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LONG-TERM TREATMENT WITH INTRAVENOUS IBANDRONATE DOES NOT EFFECT RENAL FUNCTION IN BREAST CANCER PATIENTS WITH METASTATIC BONE DISEASE Lyubimova NV*, Kushlinsky NE, Lichinitser MR Laboratory of Clinical Biochemistry, NN Blokhin Cancer Research Centre, Moscow

INFLUENCE OF ACETYLCYSTEIN TREATMENT ON ELECTROLYTE HOMEOSTASIS IN PATIENTS RECEIVING CISPLATIN RADIO-CHEMOTHERAPY FOR ADVANCED HEAD/NECK CANCERS Oliver Micke1, Fritz Matzkies2, Klaus Kisters3, Uta Hillebrand4, Agnes David4, Manfred Fobker5, Normann Willich1 of Radiotherapy, University Hospital Münster, 2Praxisklinik Haus Sentmaring, Münster 3Internal Medicine I, St. Anna Hospital Herne, 4Medical Clinic D and 5Central Laboratory, University Hospital Münster, Germany

1Dpt.

Renal adverse events are a troublesome complication of bisphosphonate therapy. This placebo-controlled study investigated the effect of intravenous ibandronate treatment on renal function in breast cancer patients with metastatic bone disease. Twenty-eight patients received 6 mg 1-hour infusions of ibandronate every 3–4 weeks for 96 weeks. Measurements of urinary excretion of total protein, albumin, α1-microglobulin, N-acetyl-■ ■ -D-glucosaminidase, haematuria and serum creatinine were performed before, during and after treatment. The results showed that 6mg ibandronate was not associated with impairment of renal function. Assessments of proteinuria, haematuria, enzymuria and serum creatinine indicated that there were no statistically significant changes between patients receiving 6 mg ibandronate and placebo. Urine parameters varied during treatment in the same range with approximately similar frequency in the ibandronate and placebo groups. These results suggest that intravenous administration of 6 mg ibandronate does not impair renal function in breast cancer patients with metastatic bone disease. Because tolerability profiles vary between bisphosphonates, the lack of renal toxicity with intravenous ibandronate makes this formulation an attractive treatment option for metastatic bone disease.

A-108 COMBINATION OF IBANDRONATE AND RADIOTHERAPY IN METASTATIC BONE DISEASE – FINAL RESULTS OF A RANDOMIZED TRIAL *Oliver Micke, Ulrich Schäfer, Dorothee Berning, Frank Bruns, Normann Willich Klinik und Poliklinik für Strahlentherapie, Universitätsklinikum Münster, 48129 Münster, Germany A potential synergistic effects of local radiotherapy (RT) with Ibandronate was investigated. 52 patients with lytic bone metastases were included in the study. Total dose of RT: 36-40 Gy. Median follow-up: 12 months. Group A received 4 mg Ibandronate i.v. on the first day of RT plus 3 mg every 28 days for one year. Group B received 1 mg Ibandronate on day 1, 8, 15, 22 of RT and 3 mg i.v. every 28 days for one year. The median pain intensity at the baseline measured by visual analog scale (VAS) was 8. 8 later median VAS was 1. At the time of data analysis median VAS was 0. Group A: 7/26 patients had a complete, 13/26 had a partial and 6/26 a beginning recalcification. Group B: CR: 9, PR: 11, NC: and 6/26. There was no significant difference between both groups. Combination of local RT and intravenously applied Ibandronate leads to a fast and substantial pain relief with long term effect.

Cisplatin chemotherapy causes acute renal insufficiency with tubular necrosis and electrolyte disorders. Recently acetylcystein (ACC) proved to prevent acute renal failure in patients with preexisting renal insufficiency after contrast medium exposure. We compared two groups of patients (10 patients) receiving radiochemotherapy. One group received additionally 1.2 g acetylcystein orally during the entire follow up of six days starting the day before cisplatin application. All patients were followed for three cycles of chemotherapy. Both groups showed an acute renal failure with reduction of creatinine clearance, increase in fractional sodium clearance (FeNa) and increase in fractional magnesium clearance. Creatinine clearance and FeNa returned to normal at day 6 after cisplatin, the increase in magnesium excretion persisted throughout the three cycles. There was no significant difference between the both groups. Acetylcystein could not prevent acute renal failure after cisplatin chemotherapy.

A-110 RAPID INFUSION OF INTRAVENOUS IBANDRONATE: SAFETY AND TOLERABILITY Pecherstorfer M*, Body JJ, Diel I, Tripathy D, Bergstrom B First Department of Medicine and Oncology, Wilhelminenspital, Vienna Intravenous bisphosphonates are currently standard therapy for the treatment of metastatic bone disease (MBD) and its complications. However, existing treatments can be associated with an increased incidence of renal adverse events. Clinical trials have shown that intravenous infusion of 6mg ibandronate over 1 hour is effective, safe and well tolerated in patients with MBD. Bolus intravenous (i.v.) injections of 2 mg ibandronate given monthly have been shown to be safe for up to 2 years in patients with breast cancer and multiple myeloma, while a single bolus dose of 3 mg ibandronate i.v. has also been shown to be safe in breast cancer patients. Here we review the results of recent investigations that have assessed the safety of intravenous ibandronate by rapid infusion. In a study of healthy male (n=27) and female (n=30) volunteers, shortening the infusion time of 6 mg ibandronate from 60 to 15 minutes did not result in any renal adverse effects (as assessed by creatinine clearance, serum creatinine, and urinary excretion of microalbumin, α1-microglobulin or N-acetyl-β-D-glucosaminidase). In a study of newly diagnosed cancer patients (11 males, 19 females) with bone metastases, intravenous infusion of 4 mg ibandronate over 30 minutes every 3-4 weeks (198 infusions received in total) did not result in any immediate or long-term side effects. In conclusion, rapid infusion of ibandronate is generally well tolerated, and does not compromise renal safety. Shorter infusion times could allow administration in outpatient or hospice settings, thus improving the convenience of therapy for the patient.

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BLOCKING INTERLEUKIN 6 WITH A MONOCLONAL ANTIBODY INHIBITS CANCER CACHEXIA IN NUDE MICE *Mohit Trikha, Ph.D and Mohamed Zaki, M.D., Ph.D. Oncology Research, Centocor, Inc., Malvern, PA 19355 USA

THE CLINICAL PHARMACIST; AN ESSENTIAL MEMBER OF THE MULTIDISCIPLINARY TEAM IN CHILDRENS CANCER CARE Rachel Hollis, Senior Sister, Paediatric and Adolescent Oncology Leeds Teaching Hospitals Trust, England, United Kingdom

Interleukin 6 (IL-6) is a pleitropic cytokine that is implicated in a variety of cancers. IL-6 is a growth factor for certain tumors, contributes to drug resistance, cachexia and bone resorption. Cancer cachexia is a metabolic state that is seen in several malignant disorders, it is commonly recognized as progressive weight loss with depletion of host reserves of adipose tissue and skeletal muscle. We have developed a human-mouse chimeric antibody to human IL-6 (Kd of ~10-12 M) designated, CNTO 328 or cCLB8, that completely blocks IL-6 function. A dose escalating Phase I study with CNTO 328 in patients with advanced multiple myeloma demonstrated that the antibody was safe, non-immunogenic, and had a half-life of 17.8 days. (Van Zannen et al., Br J Hematol. 102, 783790, 1998). Since IL-6 is implicated in cachexia, we hypothesized that CNTO 328 could inhibit tumor-induced cachexia. In this report, two human tumor-induced cachexia models were established in mice. In the first model, human melanoma cells were inoculated in female nude mice. Control animals (n=7) lost 19% (+/-7.7%) body weight in 31 days where as CNTO 328 (10 mg/kg, 12 doses over 4 weeks) treated animals (n=9) lost 1.5 % (+/- 1.3%) (P=0.009). In the second cachexia model, human prostate tumor cells were injected into male nude mice. Control animals (n=7) lost 6% (+/- 3.5%) body weight, where as the CNTO 328 (10 mg/kg, 6 doses over 4 weeks) treated animals (n=5) gained 7% (+/-4%) body weight (P=0.0005). Since CNTO 328 blocks human IL-6 but not mouse IL-6, the data indicate that tumor-secreted IL-6 is a mediator of body weight loss and highlight the potential efficacy of CNTO 328 in the treatment of cachexia.

Cancer in childhood is rare, affecting 1:600 children under the age of fifteen. Significant improvements in outcomes for cancer care have been associated with the development of specialist treatment centres for children and young people. It is one of the factors behind the continuing improvement in the survival rates of children with cancer, now around 70%. The development of expert multidisciplinary teams in the regional treatment centres of the United Kingdom Childhood Cancer Study Group (UKCCSG) and the subsequent development of clinical expertise in the management of critically ill children has been an important factor in this improved survival. In the delivery of cancer treatment and supportive care the clinical pharmacist has a vital role to play and must be seen as a key member of that multidisciplinary team. At the local level, our pharmacists work alongside medical, nursing and other colleagues in developing unit protocols, e.g. for antiemetic, antibiotic or antifungal treatment. They play a key role at every stage of the medication pathway, from prescription, through dispensing, to administration. Nationally, there is in the UK a group of paediatric oncology pharmacists, who work in close collaboration with medical and nursing colleagues in developments within the speciality.

A-112 PHARMACEUTICAL CARE AT A PAEDIATRIC WARD Elvira Ahlke, Pharmacist Münster, Germany The integration of a pharmacist into the staff structure of the paediatric oncology ward was initiated in 1991. This step was taken to establish an additional qualified supervisory position for improved drug safety. Regular participation in daily rounds ensures the constant exchange of information between pharmacist, physicians and nurses. Issues regarding dosage, dose intervals, side effects and drug cross reactions, incompatibilities with supportive medication, selection of the suitable route of administration, and transfer into a suitable formulation are regularly discussed. Frequently, the pharmacist will be asked to assist in tailoring chemotherapy treatment plans and supportive measures to the individual patient’s needs (standards of care of oral mucosa, guidelines for care of indwelling venous catheters) and to supervise appropriate handling immediately prior to their preparation. The pharmacist who maintains close contact with the patient also provides an important link between day hospital, general practitioners, and public pharmacies.

A-114 INTRODUCTION OF GUIDELINES IN SUPPORTIVE CANCER CARE – CONTRIBUTION OF THE PHARMACIST Annette Freidank, Pharmacist Fulda, Germany Supportive therapy has become an essential part of cancer treatment. Side effects such as diarrhoea, leucopoenia, emesis and nausea should be well controlled to ensure the effective treatment of cancer. As in Germany the pharmacy has established the central cytotoxic service with quality control of the chemotherapy protocols, the next step might to ensure the effective supportive therapy together with the medical staff. The pharmacist knows the side effects of the cytotoxic drugs and has access to the individual patient data, therefore his contribution might be: Introduction of guidelines by the drugs and therapeutics committee, adoption of the supportive guidelines according to the individual patients’ need, and dispensing the supportive therapy together with the chemotherapy. Since 1997 guidelines for antiemetic therapy are established in our hospital, the antiemetic drugs are dispensed with the cytotoxic therapy. To improve the antiemetic protocol in collaboration with patients, doctors, nurses and pharmacists, the patients should report the effect of the therapy with the help of record-sheets. This example can be extended to further supportive regimens.

A-115 SUPPORTIVE CARE AS PART OF PHARMACEUTICAL CARE IN AMBULATORY CHEMOTHERAPY Michael Höckel, Pharmacist Kassel, Germany “Simple interventions such as medication calendars, individualized counseling, and carefully selected educational materials are routinely offered and keep many problems from occuring at our institution.” (1) Cancer patients require our attention and our professional knowledge in many respects.

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On one hand, there is the centralised aseptic preparation of chemotherapy drugs with respective to individual requirements. On other hand, there are the monitoring of therapy including supportive medication, reduce the risk of chemotherapy errors and drug related problems, safe drug handling, pharmaco-economics etc.. All of these require our professional engagement. In order to provide care to cancer patients in community pharmacies, it is required to establish a structural procedure. Individualized counseling and personal care of the patient should be a part of pharmaceutical services. The services include counselling patient on their supportive care medication to prevent and manage drug-releated problems. Developing a constructive relevant relation between patient and pharmacist has to be cultivated and begins with issue of the first prescription. (1) Parker P.E., Finkbiner K.L. The Expanding Role of the Oncology Pharmacist. Oncology Issue. 2002; 17(6):34-36.

A-116 PHASE II TRIAL OF TEMOZOLOMIDE AND CONCURRENT RADIOTHERAPY IN PATIENTS WITH BRAIN METASTASES. *Ginopoulos V. P.1, Sougleri M.1, Christopoulou A.1, Sgoura V.1, Macridou A.2, Tsoni E.3, Alivizatos V.4 1Dept of Clinical Oncology, 2Dept of Neurology, 3Dept of Radiotherapy, 4Dept. of Surgery, General Hospital of St Andreas, Tsertidou 1, Patras, PC 26335, Greece Our study was designed to determine the safety, efficacy and quality of life of concurrent Temozolomide and radiotherapy in patients with previously untreated brain metastases.26 pts with brain metastases from solid tumors were enrolled in our study. The primary tumors type included 8 pts (33.3%) with NSCLC, 10 pts (41.6%) breast cancer, 2 pts (8.3%) SCLC, 2 pts (8.3%) ovarian cancer, 2 pts (8.3%) rectal cancer. All pts received oral Temozolomide 75mg/m2 daily concurrent with 70-Gy fractionated conventional external-beam radiotherapy (2-Gy, 5 days/week). Concomitant administration of methylprednisolone 16mg twice daily was given in pts with brain edema. The endpoints were radiologic response, neurologic symptoms and quality of life evaluation as well. Among 26 pts enrolled in the study, 24 pts (92.3%) were assessable for response. 6 pts (25%) presented CR, 12 pts (50%) PR, 3 pts SD (12.5%) and 3 pts (12.5%) PD. All pts even those with PD presented improvement of quality of life during chemoradiation and 45 days after. The hematologic toxicity was significantly absent or predictable and reversible. Only 14 pts (58.3%) presented Grade >or=II nausea and 8 pts (33.3%) presented vomiting. The chemoradiation in pts with systemic disease and brain metastases previous untreated, showed high response rate and essential improvement of quality of life with good tolerance and no toxicity

A-117 THE JOURNEY TO C.D.U. SUPPORTING THOSE WHO SUPPORT. *Jane Connolly In order to enrich nursing and move to true therapeutic practice, our unit began the journey towards becoming a Clinical Development Unit in July 2002. When one of the most critical issues in nursing today is retention, any strategy which promotes the creation of a unit in which nurses feel truly challenged, valued and able to provide excellence in their care will be worthy of consideration. Our 19 bed palliative care unit has been since July 2002 a site for introduction of C.D.U. In my presentation I will describe how we

managed the process towards becoming a C.D.U., the achievements and the disappointments. I will discuss the nature and purpose of C.D.U.s and how, with educative leadership, we have committed to the systematic development of nursing staff in the unit. I will speak to the experience of reflective practice and clinical supervision in the unit, its strengths and weaknesses. Has mentoring become more important in this climate? Lastly I will briefly review the projects which have grown from increased nursing strength and confidence and review their inception and results.

A-118 ASSESSMENT OF THE EFFECT OF EDUCATIONAL PROGRAM ON INDIVIDUAL’S KNOWLEDGE CONCERNING COLORECTAL CANCER Farahnaz.Abdollahzadeh , Sima .Moghaddasian , Naser Ghorbanian Faculty of Nursing & Midwifery, Tabriz University of Medical Sciences,Shariati-e-Djunubi Ave., P.O. Box 51745-347, Tabriz, Iran Background and objectives: In spite of recent progression in med0 icine, mortality rate of colorectal cancer throughout the world has remained unchanged .This research was attempted in view of high incidence of colorectal cancer and its mortality rate in Iran. The purpose of this study was to assess the effect of an educational program on the level of individual’s knowledge toward colorectal cancer. Materials and methods: In this study, 80 parents (aged over 50 years)of students studying in female high school were selected as samples. Data were collected through a questionnaire consisted of two parts: demographic data and knowledge of samples concerning colorectal cancer. Data were collected and analyzed in two phases, before and 10 days following the educational program. Results634: In terms of knowledge of the nature of colorectal cancer and its screening method by fecal occult blood test(FOBT), the finding of the research showed that the samples had low or moderate level of knowledge about colorectal cancer before educational program. However, the mean scores increased after the educational program. The results with 99% confidentiality showed that education was effective on the level of subjects’ knowledge. Conclusion: It is recommended that education should be given to all individuals in order to increase the level of knowledge about risk factors, screening and preventional methods of this cancer.

A-119 EDUATIONAL DIFFERENCES IN THE EXPERIENCE OF CANCER PATIENT AT A HOSPITAL IN ARGENINE De Toma Veronica (*) (Buenos Aires), Cassini Jorge (Buenos Aires), Moro Francisco (Buenos Aires), Rao Francisco (Buenos Aires) Hospital Aeronautico Central Buenos Aires Argentine The purpose of this study was to evaluate the relation of education in the perception, assessment and management of pain in two educational related different poblation (military and civil pts) treated at our hospital. Methods: Between Apri-Nov 2002 81pts (42 civils/40 militars) with cancer stage 4 (TNM) and pain related tumor were evaluated. Average age 48 yrs (18–86). Media formal education militars 23 yrs/civils 18 yrs. Pain intensity, pleasantness, responsiveness and impact on function evaluated by numeric rating scale. Perception by descriptive scale. Performance Status (PS)(ECOG). Adherence rate to treatment by pts self report. Results: Military group demonstrate not significantly difference in pain intensity and PS (P=NS) but higher level of tolerance (P<0,01), respensiveness (P=0,01) and pleasant to treatment

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(P<0,01). Higher adherence to medical treatment with lower adherence to opiod (P<0,01). Higher impact of pain function (P<0,01) and significantly less requirement of opiods. Civil pts perceive more fear, depression and anxiety while militars refer frustration, anger and depression. Conclusion: Education is an important variable and should be taken into account for assessment and pain management.

and 97% in a realistic way. Expertise, access to latest treatment, working as a team and humour were regarded as most hope giving of 30 doctor behaviours. Conclusions: After negotiation, most patients want prognostic information that is given with sensitivity and allows for hope.

A-122 A-120 INFORMATION ON CANCER TREATMENT – DO WE MEET PATIENTS’ NEEDS? Andrea Liekweg, Pharmacist Bonn, Germany Cancer patients form a group with particular needs. Information about cancer treatment plays a decisive role in terms of coping strategies, initiation of self-care behaviour and quality of life. Recent care strategies advocate the patients’ active participation in the therapeutic process. The competent patient should be well informed and thus be able to make informed decisions regarding the treatment. With a measure for patient satisfaction with cancer treatment education (PS-CaTE) developed by the BC Cancer Agency, Vancouver, Canada, which has been translated to German and verified regarding its test quality criteria, 232 cancer patients over Germany were surveyed. Patients seem to be content with the information regarding their cancer treatment. However, the information about side effects and complementary treatment options could be improved. These findings address physicians, nurses and pharmacists to optimize their care strategies for the patients. The main sources of information are oncologists and GPs whereas pharmacists still seem to play a minor role as a source of information for cancer patients. Pharmacists are appealed to increasingly offer information to cancer patients and take on a more active part in the health care team.

A-121 DISCUSSING PROGNOSIS AND TREATMENT GOALS WITH PATIENTS WITH METASTATIC CANCER Hagerty, R.G.1*, Tattersall, M.H.N.1,2,3, Butow, P.N.1, Ellis, P.E.1, Pendlebury, S.4, Lobb, E.A.1 Medical Psychology Research Unit1, and Dept of Cancer Medicine2, University of Sydney, Dept of Medical Oncology3, Dept of Radiation Oncology4, Royal Prince Alfred Hospital, N.S.W., Australia Aim: To explore preferences for prognostic information among patients with incurable metastatic cancer. Participants:(N=125). 54% female; diagnosed 6 weeks to 6 months ago; attending follow-up appointments with one of 25 oncologists at outpatient clinics (n=12). 25% had primary diagnosis of breast cancer, 18% colorectal, 15% prostate, 10% lung cancer. Method: Patients completed a survey eliciting pref-erences for prognostic information including: type, quantity, mode and manner of presentation, timing, and what type and manner of presentation they would find most and least hope giving.Results:Over 95% wanted details of side effects, symptoms and treatment options. The least desired facts included one-year survival rates (72%) and shortest (74%) and longest survival (78%) without treatment. More patients wanted to know longest survival time with treatment (84%), 5-year survival rates (81%) and average survival (81%). 1/3 wanted information about rare symptoms or side effects (<5/1000). Words and numbers were preferred over pie charts or graphs.36% and 42% wanted to negotiate when prognosis and dying respectively were discussed. 78% wanted their prognosis given in an optimistic way

THE IMPACT OF PSYCHOSOCIAL SUPPORT ON REHABILITATION OUTCOMES OF TWO PATIENTS AFTER EXTERNAL HEMIPELVECTOMY Beth Young*, Leday-Jacobs, Connie Department of Physical Medicine and Rehabilitation, MD Anderson Cancer Centre Background: Despite major advances in chemotherapy and limb sparing surgery, external hemipelvectomy remains the optimal surgical intervention for high grade and metastatic sarcomas of the upper thigh and buttock. Post-operatively, patients who undergo this procedure most often require a comprehensive inpatient rehabilitation course to improve strength, preserve range of motion, optimize pain management, and control lymphedema. Although much research has been reported on post-operative complications and long-term survival rates of individuals after external hemipelvectomy, little have noted the impact of psychosocial support in predicting functional outcomes. In this case report, we present contrasting rehabilitation courses of two external hemipelvectomy female patients with similar demographics, but varying degrees of psychosocial support contributing to dramatically different functional outcomes. Result: Both patients (AA, BB), ages 32 and 28 underwent external hemipelvectomy secondary to high-grade metastatic sarcoma of the pelvis. AA and BB were both transferred to the rehabilitation unit medically stable with intact muscle strength in the 3 remaining extremities. Four identified psychosocial variables which greatly influenced the functional outcomes of these 2 patients included: (1) extent of patient’s social support system, (2) effective use of effective coping strategies, (3) patient’s overall sense of well-being/quality of life, and (4) management of physiological symptoms. AA who had extensive support from family, church and friends, as well as, a positive attitude regarding her rehabilitation and recovery, made exceptional functional gains during her 14-day rehabilitation course. At the time of discharge, she was able to ambulate 200 feet with minimal assistance with a Functional Independence Measure (FIM) gain of 36. BB had limited support and experienced multiple grief/loss issues related to her hemipelvectomy. Throughout her rehabilitation program, BB was unmotivated and participated minimally in physical and occupational therapy. After her 14-day rehabilitation course, she still required total assistance with ambulation and had a FIM score gain of only 18. Conclusion: These 2 cases illustrate the significant influence of psychosocial factors on functional outcomes. Rehabilitation programs should integrate psychological and social support, and intervene with pharmacological measures when necessary. 1. Malawer, M. & Henshaw, R. (2001). Posterior flap hemipelvectomy. In Malawer, M. & P. Sugarbaker (Eds), Musculoskeletal Cancer Surgery, p. 359. Dordrecht. Kluwer Publishing. Malawer, M. & Henshaw, R. (2001). Posterior flap hemipelvectomy. In Malawer, M. & P. Sugarbaker (Eds), Musculoskeletal Cancer Surgery, p.359. Dordrecht. Kluwer Publishing.

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FROM GIVING DATA TO SUPPORTIVE COMMUNICATION Herbert Kappauf1, Susanne Gutberlet2, Wolfgang Soellner2, Martin Wilhelm1; 1Dept. of Medical Oncology & Haematology, 2Dept. of Psychosomatic & Psychotherapeutic Medicine, Nuremberg Hospital, D90340 Nuremberg, Germany

THE BEARS (BONE MARROW, EDUCATION, AWARENESS, RESOURCE, SUPPORT) FAMILY SUPPORT PROGRAM *Wolff L; Olson C, Metz J, Helmold D, Brady K, Moore T Doernbecher Childrens Hospital, Portland, Oregon, 97239, USA

Problem: Advances in modern oncology paradoxically entail new problems in patient-oncologist relationship. A common incongruence of disease and illness experience is prologed by multimodal therapy and advances in palliative treatment and may empede coping with disease and illness adaptation. Ambuigity becomes immanent in the patient-oncologist realtionship when therapy is experienced as illness. Data access and broad availability of unbalanced information does not necessarily improve understanding and may add to patients distress particularly in patients with psychosocial premorbidity (about 20 % of the general population!). Project and conclusions: Background, conception and results of highly appreciated communication training programs for experienced clinicians by clinicians will be presented. Communication skills can be learnt and taught and prove crucial for doctors’ professional satisfaction, their burnn-out prevention and for providing state of the art curative and palliative care.

A-124 THE HERFORD MODEL – EXAMPLES OF MULTIDISCIPLINARY NETWORK IN SUPPORTIVE CARE Dipl.-Psych. Irmela Nelle Klinikum Kreis Herford, Germany In 1995 the department of psychooncology was founded at the Herford Community Hospital. Psychooncology as a discipline focussing on psychological support is an important constituent of comprehensive cancer therapy. Psychooncological supportive care accompanies a patient and his relatives at all stages including the terminal phase. At every stage each patient has different problems and needs which psychooncologists have to identify, treat and meet to evaluate. For this goal it is mandatory to cooperate intensively with the other sections of the hospital and with other healthcare structures following and supporting the patient on his way through all these institutions. Examples of this cooperation are: – Psychooncological liaison-service and consultation – Staff-education and supervision – Patient-education – Meetings and lectures for professionals – Counselling-center – Self-help-groups – Homecare-and hospice-services Each year 3 fulltime psychologists have an average of 3.3 contacts to 700 patients. Intensive adherence to documentation and quality standards and scientific evaluation have granted Herford model high patient satisfaction rates.

Families of children who receive hematopoietic stem cell transplants (HSCT), are often overwhelmed. Realizing the many issues, families of HSCT patients face, the BEARS program was started as a support association of families, who experienced the journey of HSCT, volunteers, and health professionals. The BEARS program helps with patient and family education. Public education and awareness is implemented via blood drives, HSCT donor registry recruitment and speaking to public and private groups. Besides educational and emotional help, financial assistance for food, housing, transplantation, and other emergencies are met. A team provides one on one support and family to family support. Hosting BEARS’s dinners semimonthly at the hospital has been a significant comfort and support for HSCT families. The BEARS group maintains an ongoing grief recovery program. An annual reunion celebration for HSCT patients and their families is held. This event and other initiatives of support demonstrates a family, volunteer support group can help meet the many needs of patients and families undergoing HSCT.

A-126 TELEHOSPICE: USING TELECOMMUNICATION TECHNOLOGIES TO PROVIDE END-OF-LIFE CARE Pamela Whitten, Ph.D. Michigan State University Introduction: Michigan State University (with Hospice of Michigan) conducted a telehospice research project funded by the US Department of Commerce, Technology Opportunities Program. The overall purpose of the project was to evaluate the use of videophone technologies in the delivery of end-of-life care. Methodology: Nurses’ notes on patient visits were coded and entered onto a database where summary statistics and content analyses were performed. Hospice patients/caregivers participated in open-ended telephone interviews that included Likert-style and open-ended questions. Hospice providers completed pre-perception and postperception surveys. Patients choosing not to receive the service completed a decline survey to document the reasons for their decision. Finally, activity logs and patient charts yielded utilization data. Results: The nurse-patient communication appears unaltered for telehospice interactions. Patients and family caregivers proved to be extremely enthusiastic about this service and wished to see increased utilization within their own care plans. Providers, primarly nurses, emerged as the most signifcant barrier for telehospice. Certain providers embraced telehospice and identified immediate benefits for their patients, whereas other providers had no desire to employ this technology. Exposure and experience with telehospice did not appear to mitigate providers’ attitudes toward telehospice. The vast majority of patient decline forms resulted from project ineligibility rather than patient lack of desire. Those patients that did decline the service expressed feeling overwhelmed. Discussion: There is tremendous potential for telehospice as evidenced by interview data collected from providers and patients. This augmentation to traditional hospice care could reduce expenses incurred by hospice organizations to pay providers to travel great distances to care for patients, particularly those in the rural sector. However, we must further examine why nurse and provider surveys reflected more potential barriers when compared to the patient/caregiver surveys. Adoption at the nursing level is essential to the livelihood and sustainability of telehospice.

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COORDINATION OF SUPPORTIVE CANCER CARE BY NON-ONCOLOGIST PHYSICIANS: A PROSPECTIVE STUDY Sussman J1,2, Whelan T1,2, Brazil K1,2, O’Brien MA1,2, Bainbridge D1, Pyette N1 1Supportive Cancer Care Research Unit, Hamilton, Canada 2McMaster University Hamilton, Canada

INTERNET USE AMONG 1015 CANCER PATIENTS ASSESSED IN COMMUNITY PRACTICES: A URCC CCOP STUDY S.L. Ranson, G.R. Morrow, J.A. Roscoe, A.R. Shelke, J.J. Griggs, J.T. Hickok James P. Wilmot Cancer Center, Rochester, NY, USA

Purpose: To study non-oncologist physicians practices specific to coordination of supportive cancer care in the community. Methods: A mailed survey was sent to all non-oncologist physicians working within a typical health care region in Canada in May 2002. The survey instrument was pilot tested and the Dilman procedure was used. Results: The unadjusted response rate was 52% (111/212). Respondents included primary care physicians (93) and surgeons (18). Median practice size was 2000 patients with a median of 35 cancer patients. Assessment and provision of supportive care was higher in the physical domains of care (pain and symptom support) than in the psychological domain (78% vs. 58%). 57% of physicians indicated that they addressed supportive care informational needs. Referrals for physical supports were higher than for psychological supports (70% vs. 43%). Only 25% of respondents indicated that they saw their role as being primarily responsible for coordinating supportive care and most (85%) were satisfied with current role. Conclusions: We have identified gaps in community coordination of supportive care by non-oncologist physicians. They tend not to see themselves as primarily responsible for coordination of supportive cancer care.

The URCC CCOP Research Base conducted a survey of 1015 cancer patients following diagnosis and referral to a CCOP treatment facility. Patients ranged in age from 20 to 92, with a mean age of 60.6 years. When asked if they used the Internet as an information source, 418 (41.2%) answered “Yes”, with 5 patients (1.2%) saying that it was “Not at all” helpful, 176 (42.1%) responding that it was “A little” helpful, and 237 patients (56.7%) indicating that it was “Very” helpful as an information source. When asked how they used the Internet, 13 patients (3.1%) said that they participated in on-line support groups, 217 patients (51.9%) researched information about their diagnosis, 88 respondents (21.1%) used it to learned about people who have survived cancer, and 56 patients (13.4%) were able to order merchandise on-line. When asked about the accuracy of information received, 288 patients responded. Of those, 105 respondents (36.5%) said they believed that the information was “very reliable,” 171 respondents (59.4%) said that it was “usually reliable”, and 12 respondents (4.2%) said that it was “not reliable.” Supported by grant U10CA 37420 from the National Cancer Institute.

A-130 A-128 EVALUATION AND PSYCHOLOGICAL SUPPORT IN ONCOHEMATOLOGIC-AL PATIENTS IN A BONE MARROW TRANSPLANTATION UNIT E. Terruzzi, A. Amà, R. Montesano, M. Parma, I. Miccolis, E. Todisco, M. Carraro, F. Rossini, E.M. Pogliani Hematology. S. Gerardo Hospital. MONZA (IT) Recovery from allogeneic and autologous stem cell transplantations requires a long-term course, often accompanied by acute morbidity, which includes various distressing physical symptoms. The assessment and procedures performed by medical equipment includes: 1)Patient’s clinical and psychological assessment using a psycho-diagnostic interview (defensive attitude and/or adaptation to disease and treatment protocol; interior and interpersonal resources; fears and aspirations about hospitalization and outcome); 2)Implementing plan of psychological support (individual weekly interview taking about 30 minutes) during hospitalisation 3)Analysis of quality of life with a questionnaire EORTC-QlQC-30 and compilation of a clinical and psychological record with observations obtained during multidisciplinar (physicians, nurses and psyco-oncologists) evaluation of patient. We have identified three areas of psychosocial morbidity: a) psychological problems (fears about the future, sense of loss of control, anxiety and depression); b) physical problems; c) community reintegration problems.. In our experience we have obtained: a) more integration among patient’s needs; b) more sharing, into the equipe, of the emotional experience related to the care role; c) more stimulus and/or exchange between different professional roles.

COMMUNICATING WITH CANCER PATIENTS. Ranuzzi M. and Russo F. Medicine Department, Monterotondo Hospital; Monterotondo (Rome), Italy Central to patients making healthcare decisions is the adequacy of information provided by their physicians. The “oncologist-cancer patient” relationship constitutes a most complex problem, one of the most difficult aspects of which is sincere communication with the patient. Among the main dilemmas is whether the patient should be told the truth. The American model is willing to inform the patient first, the European model is in favor of telling the family first. Should the cancer patient be told the whole truth even when the disease is advanced and there is no chance of cure, or should the patient be cheated, the seriousness of the situation be minimized, while telling the truth to the family? Is it possible to separate truth and honesty respecting the patient (who trusts us and listens with hope to our every word)? We all need to learn how to become better truth-tellers, able to tailor the information that individual patients tell us they exactly want, rather than relying on our, often faulty, assumptions about what people want. Patients are within their rights in knowing what they got and what they underwent (we have to enable everyone to reorganize the own life). Before entering into discussion with patients or family it is prudent to establish the level of knowledge amongst the parties; the patient often has a detailed knowledge of their illness, it does not necessary follow that the family has the same degree of awareness and vice versa. In communicating bad news it is important to be positive as there is always something useful to do even in patients with hours to live; emphasizing the positive it is always important to express regret for negative news. Knowing what to say and what not to say is an important skill: it presuppose that oncologist listen to patient in active form about his history, imaginations, fears and defensive processes. Oncologists should be able to deeper understand the patients’ psychological condition to better evaluate their own choices regarding communication. Anyway, we absolutely need more research directed to identifying ways to train oncologists how to im-

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part difficult information in a way to help the patients and doesn’t compromise the physicians’ emotional survival. Criticizing is easy, but the training in communication and management of these situations is not sufficiently developed. Despite most patients’ satisfaction with the information received, oncologists and patients often differ in their views about how much detailed information should be provided to patients. Physicians need to change their assumption about how much information patients want.

A-131 EDUCATION AND CANCER Ranuzzi M. , Taddei A. Gruppo Ricerca Assistenza Domiciliare Oncologica (Rome), Italy The steady increase of the cultural level, also due to the availability of informative resources from several media (books, magazines, television, computers), has now made irreversible a process that makes the patient more and more informed about his disease and therapies. Notwithstanding this cancer incidence arises in the western countries. Where have we got to people education? Are we doing everything possible about cancer educational programs? Education of the public about cancer might go hand in hand with education about other health problems, the basic premise being that the individual, not the doctor, not the government, has the greatest responsibility for his own health. But people need more education. People must understand the direct consequences of their actions (smoking, drinking, eating, polluting). A proper attention to these matters by the individual would result in much greater improvement in the public health than any other action. In terms of altering lifestyles, which is what health education should really try to do, we must begin at any early age: at home (the importance of the family’s responsibility) and in the early school years (the importance of the educational programs’ responsibility). Above all, children and young adults must learn the consequences of inappropriate health behavior and must be motivated to accept responsibility for their own health care. If we wait until adult life to begin effective health education, it is too late. The above implies a much more important role for health education in our schools than in the past. Health education should not be a secondary or tertiary role of the physical education instructor, the biology teacher, or the school nurse. The importance of the health educator’s role demands a complete changes in concept and a completely new generation of health educator possibly trained in university departments of health sciences alongside those other health professionals (oncologists, doctors) with whom they must work and interact. It would be desiderable a greater involvement of the oncologists in the health educational programs.

A-132 IMPROVEMENT OF QUALITY OF CARE THROUGH THE USE OF A BEDSIDE COMPUTER SYSTEM: EXPERIENCES IN AN INPATIENT PEDIATRIC ONCOLOGY WARD Leland, Christopher; Robertson, Lauren, BA; Roberts, Stephen, MD; Howell, Debra, BA, Jones, Gary R., MD Division of Pediatric Hematology/Oncology, Department of Pediatrics, Doernbecher Children’s Hospital, Oregon Health & Science University, Portland, Oregon 97239 Prolonged hospitalization of children with cancer for diagnostic evaluation and intensive treatments including chemotherapy and hematopoietic stem cell transplantation can adversely affect patient and family by isolation from normal activities and contacts, therapy induced toxicities such as nausea and lack of access to pertinent medical information. Based on a study by the Pew Re-

search Center in 2002, 60 percent of Americans have regular internet access and 97 percent of these users expect to find information on health care, government agencies, news, and/or shopping online. Access to computer and internet resources by patients and families should have a significant impact on improving adverse impacts of hospitalization. With the recent move of the Doernbecher Children’s Hospital into a new facility, all inpatient rooms on the dedicated oncology unit were outfitted with in-room, bed-side computers. Supervised by a dedicated technician, the project was implemented to provide patients and families with a technological resource for communication via email and instant messaging, videoconferencing links using analog telephone or internet connection, entertainment through access to games and interactive sites, education related to current school work and informational web pages related to the patient’s illness. Recognizing that a patient’s illness affects the entire family, the system was designed for broad use through installation of the monitor on a movable arm and a wireless mouse and keyboard allowing use by other persons without interfering with the patient’s comfort and care. The ability to maintain communication with employers and family, participate in classroom video conferencing, and to have access to round-theclock entertainment and information have been very positive based on feedback from families, significantly improving the quality of care, facilitating communication, increasing tolerance to noxious therapies, and building medical knowledge base. Consequently, our current study proposes the administration of quality assurance questionnaires to families to identify: utilization rates of the current system correlated to home, business and school computer and internet use, family satisfaction with current resources, and future areas of enhancement and development. Implementation of this type of system in other hospital and outpatient settings could significantly empower patients and families by improving the quality of communication and education.

A-133 HOW HELPFUL IS PROMPT COMMUNICATION ABOUT A PALLIATIVE RADIOTHERAPY VISIT? A SURVEY ON OUR INTERIM CONSULTATION REPORT Peiman Haddad, Freidele Soban, Diane Williams, *Rebecca Wong, Wilfred Levin, Michael McLean, Andrea Bezjak Palliative Radiation Oncology Program, Department of Radiation Oncology, Princess Margaret Hospital, University Health Network, Toronto, Ontario, Canada After each consult in our Palliative Radiation Oncology Program (PROP), an interim consultation report summarizing the patient condition, key recommendations and the radiation treatment selected is faxed on the same day to the patient’s physicians. A survey was undertaken to assess the satisfaction and information needs of physicians receiving our reports. A survey sheet was faxed to each physician receiving a PROP consultation report in July-October 2002. It was sent 206 times to 170 physicians, of whom 73 (43%) responded. The response rate was significantly more for medical oncologists (58%, p=0.03). 70 physicians (96%) stated that they always read the PROP consultation reports; 61 (84%) would read the report the same day. 67 (92%) thought the length of the report was just right. Only 4 (5%) found unnecessary information in the report, but 11 (15%) considered some important information (mostly the rationale underlying treatment decisions) missing from it. Also 68 (93%) found our suggestions helpful for further care. Overall, 68 (93%) considered our consultation report necessary; the remaining 5 physicians did not answer this question. There were no significant differences between the responses of medical oncologists, family physicians and other physicians. In conclusion, our interim consultation report was helpful and well received, and was considered generally successful in communicating the required data to the patients’ physicians on the same day of

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consultations. Clinically relevant and prompt communication between the various health care providers can be achieved, but requires a feedback loop to meet the needs of the physicians and ultimately help provide quality care to the patients.

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The diagnosis of cancer and its treatment have more than a physical impact upon an individual. Social, emotional, psychological, spiritual, and practical consequences also emerge for individuals living with this illness. As the disease progresses and symptoms appear and become more pronounced, patients may experience difficulties in managing day-to-day activities and in coping with the situation. Access to supportive care services becomes very important for these individuals. Three studies will be highlighted in this presentation. All were undertaken to identify the type of supportive care needs (physical, social, emotional, psychological, informational, practical) experienced by cancer patients. One focused on lung cancer patients (N=89), one on gynecological cancer patients (N=100) and one on patients receiving palliative radiation therapy (N=78). The data provides clear evidence that 1) patients experience a range of needs that are not always met within the cancer care system and 2) unmet needs elicit distress for patients. The intriguing aspect of this work that looks beyond the identification of needs and distress is the determination of whether or not the patients received help or wanted help with a particular need. Despite our expectations as cancer care providers, some patients do not wish for our assistance in meeting some needs.

TELEHOSPICE: USING TECHNOLOGY TO ENHANCE SUPPORT TO CAREGIVERS *Jennifer L. Gregg; Pamela Whitten Department of Communication, University of Louisville, Louisville, KY 40292, USA; Department of Telecommunication, Michigan State University, East Lansing, MI 48824, USA Hospice caregivers, typically family members, neighbors, and friends, deal with a wide range of stresses every day, both physical and emotional. Telemedicine, the use of telecommunication technologies to deliver health services over a distance, may be one means of potentially alleviating the stress on caregivers. Pilot projects with hospice patients have shown that patients and providers feel telehospice, an application of telemedicine whereby hospice care is delivered directly to the patient’s home, is a beneficial service (Doolittle et al., 1998; Whitten & Doolittle, 2002). The purpose of this study was to investigate opportunities for expanding current applications of telehospice to include services for caregivers. Methodology: Using a framework of social support theory, researchers conducted telephone interviews with caregivers of hospice patients in rural Michigan, USA. Results: Caregivers expressed a lack of understanding of the possibilities created by technology. While they felt telehospice would be beneficial for patients, they could not envision using telehospice equipment to meet their own needs. Implications: While hospice caregivers mentioned the need for support in their caregiving role and expressed a myriad of service needs, they were unable to imagine how telehealth technologies could be used to enable them to receive these support services. This has important educational and policy implications for hospice providers.

A-135 UNDERSTANDING SUPPORTIVE CARE NEEDS OF PATIENTS WITH LUNG CANCER Rose Steele, RN PhD, *Margaret I. Fitch, RN PhD Toronto Sunnybrook Regional Cancer Centre The diagnosis of cancer and its treatment have more than a physical impact on an individual. Social, emotional, psychological, spiritual and practical consequences also emerge for individuals living with this illness. As the disease progresses and symptoms appear and become more pronounced, patients may experience difficulties in managing day-to-day activities and in coping with the situation. Access to supportive care services becomes important to these individuals. Earlier work in documenting the supportive care needs of lung cancer patients led to the discovery that, although individuals had needs and were distressed by unmet needs, not all patients wanted assistance for their unmet needs. This finding was contrary to expectations and warranted further investigation. The study to be reported in this presentation was undertaken to explore patients’ expectations about supportive care services and, in particular, their desire for assistance regarding their unmet needs. In-depth interviews were conducted with 89 lung cancer patients following their completion of a standardized supportive care needs tool. Content and thematic analysis was performed on the verbatim transcripts. This presentation will describe lung cancer patients’ perspectives on whether or not they wanted help with issues such as fatigue, shortness of breath, fear of recurrence, uncertainty about the future and pain.

SUPPORTIVE CARE NEEDS OF CANCER PATIENTS: LOOKING BEYOND THE OBVIOUS *Margaret I. Fitch, RN PhD, Rose Steele, RN PhD Toronto Sunnybrook Regional Cancer Centre, Toronto, Canada

A-137 INFORMATION NEEDS OF WOMEN WITH OVARIAN CANCER *Margaret I. Fitch, RN PhD, Fran Turner, RN MScN Toronto Sunnybrook Regional Cancer Centre, Toronto, Canada The impact of a diagnosis of ovarian cancer has profound effects not only on the physical health of a woman, but also on the social, psychological and spiritual aspects of her life and that of her family. How she copes with the changes and challenges that emerge during and following the diagnosis and treatment of ovarian cancer depends to a large extent on her access to relevant information. The Ovarian Cancer Information Project is a 3-year Canada-wide initiative aimed at enhancing the access women have to relevant information about ovarian cancer, its treatment, and managing with the illness. As an initial step a needs assessment was conducted. This assessment made use of in-depth interview (N=43) and survey methods (N=315) with women living with ovarian cancer across Canada. This presentation will describe the topic areas women consider important for them to have information about, the difficulties they experienced accessing the information and the suggestions they offered to overcome the existing barriers. Throughout their experience with ovarian cancer women faced barriers accessing relevant information.

A-138 VOLUNTEERS’ APPROACH TO SUPPORTIVE CARE IN BREAST CANCER: NATIONAL CUSTOMS E. Demin Petrov Research Institute of Oncology, St. Petersburg, Russia The purpose of the study: In a lot of countries the involvement of volunteers in supportive care for breast cancer patients has proved its benefit by improving the quality of sufferers’ life. The program, called Reach to Recovery, has been running in Russia for 14 years and needed to be evaluated in the light of our own customs.

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A summarized description of the project: We wanted to know how well our local mentality in this way agreed with the American Cancer Society’s Reach to Recovery that had been taken as a model. It was necessary to adapt this Program to national psychosocial traditions. Results and conclusions: It was the unique experience to turn an approach “to get” into “to give”. Volunteers realized their main role: public awareness of breast cancer. They provided visits, practical and emotional advice, holding annual city conferences. However some rather significant obstacles were evident. Often new candidates refused to be involved because of an inability to serve free of charge. It was hard to persuade some activists to advance training in interactive skills that destroyed world standards. Nevertheless, due to volunteers’ activities, breast cancer patients felt less distressed by the fact that they had cancer and were positive on reaching recovery.

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ONGOING PLACEBO-CONTROLLED STUDY OF OXANDROLONE IN WEIGHT LOSS OF CANCER S Tchekmedyian J Thropay, L Price, FD Ottery* Pacific Shores Medical Group, Long Beach, CA; Beverly Oncology / Clinical Trials and Research Associates, Montebello CA; Decatur General Oncology, Decatur, AL; Bio-Technology General Corp, East Brunswick, NJ USA

IMMUNE REHABILITATION WITH PHYSICAL FACTORS: SCENAR-TECHNOLOGY B. Zaidiner*, Ya. Grinberg, Ye. Vorozheikina Cancer Hospital, Rostov-on-Don; Design Bureau, Taganrog; Blood Research Centre of RAMS, Moscow, Russia

Purpose Open label study with oxandrolone therapy in weight-losing cancer pts showed a 2.1% gain in wt and 5.3% gain in lean wt in 4 mos, p<0.02 and p<0.006, respectively. Wt gain was associated with improved scores for QOL and activity. Design Blinded placebo-controlled study in pts with aerodigestive tract cancer (last pt in 1/03) compares efficacy and safety of oxandrolone, 20 mg/d, vs placebo x 4 mos. Demographics 43 men, 21 women, mean age 62 yrs (47-86). Baseline Data See table. Mean wt loss was 4% and 12% in the 1 mo and 6 mos prior to enrollment, respectively. Wt losses as great as 16% in 1 mo and 30% at 6 mos were seen.

Women Men

Wt (lb)

% Ideal wt

BCM as % Ideal wt*

117 (77-160) 139 (82-195)

104 (77-142) 89 (60-123)

35 (20-48) 33 (27-40)

*normal men: 40-45%, women: 30-35% Labs: 98% had elevation of the catabolic marker C reactive protein, 33% had low albumin (2.2-3.4 g/dl), 37% had low transferrin (104-199 mg/dl). Testosterone, known to be low in cachexia, was low in 28%, many <100 ng/dl. Summary Previous open label study of oxandrolone in cancer pts was associated with gain in wt and lean tissue and improved scores for QOL and activity. Enrollment has closed in a placebo-controlled study in pts with aerodigestive tract cancers, elevated catabolic markers, significant loss of wt and lean tissue. Data analysis, to be completed in June, compares efficacy of these variables and safety of therapy with oxandrolone vs placebo.

THE USE OF THE FAMILY TREE IN ONCOLOGY Diricq Catherine The family tree or genogram has been used for a long time as a media in the family therapy. Nowadays, it is becoming, through new knowledge in onco-genetics, a thinking tool for doctors and psychotherapists treating people suffering from a cancer. But, since the cases of deaths and illnesses in the patient’s family are now being taken into account, this tree becomes more significant. On the basis of clinical example(s) of women suffering from mammary or ovarian cancer, we will tackle the interest of such a methodology for the patient and the team doctor/psychotherapist, not only at the real scientific level but also at the symbolical and imaginary levels.

Background: SCENAR is the device for electric therapy (US Patent № 5257623), its activity was presented in previous works. The purpose of the study: to present data of the pilot study on SCENAR efficacy for immune restoration in the supportive care. A summarized description of the project. 21 patients (pts) (mean age 57,6 years, range 41–82 yrs) were enrolled in this study; all pts had morphologically proved neoplasms in far-advanced stages. We’ve assessed the levels of CD3, CD4, CD8, CD16, CD20, CD25, CD95, IgA, IgM, IgG and circulating immune complexes (CIC) with routine methods before and after SCENAR-therapy (S-t). Its procedures were conducted daily, their technique was described earlier, every patient 15 procedures were done. Before this course 20 of 21 pts were received immune rehabilitation therapy with “classical” drugs, S-t wasn’t accompanied with any immune medications. Results and conclusion: in all pts we’ve observed the disorders of baseline values: CD8, CD16, CD25 and especially CD95 were reduced; in many pts of CD20, CD4 and IgM was reduced too, whereas CIC value was elevated, both IgA & G and CD3, CD4 were remained in “physiologic range”. After SCENAR course CD16 , CD25, ,CIC values were significantly (p <0.01) improved, while CD8, CD95 and IgM didn’t ameliorated. SCENAR-therapy seems to be effective for immune rehabilitation in the supportive care. However, results from studies with larger number of pts (including placebo-controlled group) are warranted.

A-142 FORMULA OF HOPE:TEST FOR CANCER NURSES *Galina Kuznecova, Sergejs Kuznecovs Public Health Research Foundation, Cancer Unit, Riga, Latvia The present study was designed to assess personal cancer nurses’ aptitude to be a carrier of hope for cancer patients and their families. 456 cancer nurses from 5 countries of the former Soviet Union during 1996-2002 were requested to design the formula of hope for cancer patients. The completed task were subjected to statistic handling with the focus on the mnemonic device. Of the 201 (44%) returned questionnaires 68 (15%) was completed The task was awoken by 44 (9,6%) of nurses to the sence of duty to be a carrier of hope. Respondents have defined the prioritaties of can-

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cer nursing as follows:Education about cancer, its disease course, and individual implications; information about treatment options side effects, and patient and family implications; appropriate literature to support acquired knowledge.Adaptation: Adjusting to physical changes; modifying life style according to physical function; setting priorities and conserving energy; incorporating self care and healthcare activities into activities of daily living. Support: counseling for the patient and family; affiliating with support groups; obtaining needed entitlements. Enhancement: enhancement of self-care skills, facilitation of communication about needs and concerns. Cancer nursing is an avocation. About 10% of nurses have an aptitude to be a carrier of hope.This can be obtained by acronymic formula: HOPE=E(Education)+A(Adaptation)+S(Support)+E(Enhancement.

A-143 Towards A European Standard For Supportive Care In Cancer Patients Lübbe AS, Ahmedzai SH, van den Eynden B, Tuca A, Small N, Curran D, Lacombe D, on behalf of the EORTC Task Force and Pain and Symptom Control Rationale: Best supportive care (BSC) is being used increasingly as a comparative arm of randomised clinical trials (RCTs). Typically, the BSC is not defined. This undermines the scientific basis of such RCTs. A coordinated activity formed by the EU DGV program seeked consensus among European experts about what constitutes BSC and to establish minimum European standards for research and education priorities and to propose a patients charter of choices in supportive care. Methods: Via Delphi exercises, round table discussions and a steering group derived questionnaires defined elements of BSC and eligible patients and barriers to implementing BSC. EORTC Data Center in Brussels did simple frequency and correlation statistics. Results and Discussion: The second round table led to of the following proposed definition “BSC for cancer patients is the multidisciplinary attention to the individual’s overall needs and should be available at all stages of the illness, for patients of all ages and regardless of the current intention of any anti-cancer treatment”. Characteristics of BSC which are considered “essential” include attention to individual needs, availability of enough staff to give adequate time to each patient, patients should have access to information about the disease and treatment and pain should be scored regularly. BSC was “essential” with unrelieved pain and other symptoms and in terminal stage and symptom monitoring is crucial. “Best” was omitted to lead to “supportive care” (SC). A proposed “patient charter” formulates various possibilities and supportive care measures that patients should be handed out in doctor’s offices and hospital wards. We propose therefore the use the term “supportive care” instead of BSC and to implement rigorous standards for clinical trials, which include a SC arm. Also the patient charter should be translated into European languages and distributed to the national Cancer leagues.

A-144 SELENIUM IN THE TREATMENT OF RADIATION-ASSOCIATED LYMPHEDEMA – FINAL RESULTS OF A PHASEII STUDY *Frank Bruns1, Jens Büntzel2, Ralph Mücke3, Michael Glatzel4, Klaus Schönekaes5, Klaus Kisters6, Oliver Micke7 1Dpt. of Radiotherapy, Medical University,-Hannover, 2Dpt. of Otolaryngology, Südharz-Hospital Nordhausen, 3Dpt. of Radiotherapy, Weiden Municipal Hospital, 4Dpt. of Radiotherapy, Suhl Central Hospital, 5German Working Group Trace Elements and Electrolytes in Radiation Oncology, 6Dpt. of Internal Medicine, St. Anna Hospital Herne, 7Dpt. of Radiotherapy, University Hospital Münster, Germany Twelve patients with arm and 36 with edema of the head and neck region were treated with selenium for therapy-related lymphedema. 20/36 patients had endolaryngeal edema associated with stridor and dyspnea. All patients received sodium selenite over four to six weeks. Self-assessment by visual analogue scale showed a reduction of 4.3 points when comparing pre- and posttreatment values. Of 20 patients with endolaryngeal edema 13 underwent no, 5 a temporary and only 2 a permanent tracheostomy. 10 of 12 patients with arm edema showed a circumference reduction of the edematous limb and improvement in the Skin-Fold Index by 23.3 points. An improvement of one stage or more was shown by the Földi or the Miller score. Conclusion: Sodium selenite has a positive effect on secondary developing lymphedema.

A-145 USE OF COMPLEMENTARY AND ALTERNATIVE MEDICINE (CAM) IN RADIOTHERAPY PATIENTS – RESULTS OF A GERMAN MULTICENTER STUDY *Oliver Micke1, Jens Büntzel2, Michael Glatzel3, Klaus Schönekaes4, Dorothea Riesenbeck1, Ralph Mücke5, Frank Bruns6, Klaus Kisters7 1Dpt. of Radiotherapy, University Hospital Münster, 2Dpt. of Otolaryngology, Hospital Nordhausen, 3Dpt. of Radiotherapy, Suhl Central Hospital, 4German Working Group Trace Elements and Electrolytes in Radiation Oncology, 5Dpt. of Radiotherapy, Weiden Hospital 6Dpt. of Radiotherapy, University Hannover 7Internal Medicine I, St. Anna Hospital Herne, Germany Use of CAM is a frequent phenomenon in cancer patients wanting to support conventional treatment and to lesson treatment-related side effects. Therefore a multicenter study in Germany was performed to evaluate the use of CAM in cancer patients in addition to radiotherapy. A total of 1013 patients were interviewed using a structured questionnaire. CAM use was most frequent in breast cancer patients followed by patients with Hodgkin’s disease and other gynecologic malignancies. The most frequently used CAM were Vitamin combinations, treatment with mistle toe preparations, and selenium. The most cited reasons for CAM use were: “Supporting the conventional treatment“ and “a better feeling”. 32% reported an improvement of their subjective general condition, in 37% it was unchanged. Conclusion: CAM use should be documented and taken into account especially in clinical studies.

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A-146 ERYTHROPOETIN AND IRON STATUS IN ADVANCED CANCER PATIENTS Oliver Micke1, Fritz Matzkies2, Ulrich Schäfer1, Klaus Kisters3, Uta Hillebrand4, Normann Willich1 1Dpt. of Radiotherapy, University Hospital Münster, 2 Praxisklinik Haus Sentmaring, Münster 3Internal Medicine I, St. Anna Hospital Herne, 4Medical Clinic D, University Hospital Münster, Germany In our study we therefore investigated the response of erythropoesis to a single dose of 10,000 IU erythropoetin in patients with anemia due to advanced tumor disease to detect markers for iron deficient erythropoesis. Besides conventional markers as transferrin saturation and ferritin we measured percentage of hypochromic erythrocytes and zinc protoporphyrin. 10 Patients of advanced malignant diseases were treated with a single dose of 10,000 IU. Parameters were measured at baseline and on five following days. Similar to anemia of chronic disease we found enlarged ferritin values 642±102 µg/l and slightly diminished transferrin saturation 17±4%. Hemoglobin values slightly increased from 9.8±0.6 to 10.1±0.7 g/dl. Percentage of hypochromic red cells increased from 11±4.3% to 15.2±5.1% and zinc protoporphyrin also increased. Additional markers as zinc protoporphyrine and hypochromic red cells reflect a profound iron deficient erythropoeisis in the presence of elevated ferritin values, detecting patients, who may benefit from iron substitution.

A-147 REIRRADIATION WITH CONCOMITANT APPLICATION OF AMIFOSTINE IN RECURRENT PELVIC TUMORS – RESULTS OF A PROSPECTIVE PHASE II TRIAL *Oliver Micke, Ulrich Schäfer, Kirsten Horn, Normann Willich Klinik und Poliklinik für Strahlentherapie, Universitätsklinikum Münster, 48129 Münster, Germany This prospective phase II study evaluated the feasibility of pelvic high dose reirradiation with concomitant application of Amifostine. Patients with a recurrent pelvic malignancy and a history of prior radiotherapy (RT) in the pelvic region received a reirradiation of the gross disease, that cumulative dose including prior RT did not exceed 100 Gy. Additionally 500 mg Amifostine (Ethyol) were infused 20 minutes prior to RT. 16 patients were included into study. Primary treatment: 45-60 Gy (Median: 50.4 Gy); recurrent treatment: 30.6-50.4 Gy (Median: 45 Gy). No interruption of therapy was necessary. No acute grade III/IV toxicities, but some episodes of moderate nausea and hypotension due to amifostine infusion were noted. During follow-up of 11 months no serious chronic toxicities occurred. Median actuarial survival of all patients was 11.4 months. Our results suggest that the high dose reirradiation with concomitant application of Amifostine of recurrent pelvic malignancies is feasible and effective.

A-148 SUPPORTIVE CARE NEEDS OF PEOPLE WITH CANCER: A SYSTEMATIC REVIEW *M.A. O’Brien, S. Dimitry, T.J. Whelan, J. Sussman, K. Brazil, N. Pyette, D. Bainbridge Supportive Cancer Care Research Centre, Hamilton Regional Research Centre, and McMaster University, Hamilton, ON, CA Purpose: Recently, there has been an increased effort to identify and address non-medical needs of cancer patients. We conducted a systematic review to assess patients’ supportive care needs and to determine how needs change along the care continuum.

Methods: Multiple databases were searched for primary studies, published in English, from 1991-2001. Reviewers assessed fulltext articles for quality on the basis of sampling strategy, and measurement validity and reliability. Data from 30 studies were extracted and double-checked. Results: The median for patients with information needs ranged from 24% to 100% in mixed cancer studies, 14% to 76% in breast cancer studies, and 53% in ovarian cancer studies. Needs were related to the type of information and the method of delivery. The median for psychological support needs ranged from 17% to 67% in mixed cancer studies, 18% to 74% in breast cancer studies, and 28% to 59% for specific cancer studies. Help with coping was the main psychological need. The median for daily living support needs ranged from 19% to 62% in mixed cancer studies and was 28% for breast cancer patients. Substantial support needs related to sexuality or other issues were infrequent. Many patients had unmet support needs which may result from a lack of assessment of patients’ needs across the cancer continuum, lack of referral to appropriate services, and/or lack of services to meet needs.

A-149 EPOETIN (EPO) IN PATIENTS WITH SMALL CELL LUNG CANCER (SCLC). IS BONE MARROW EXAMINATION IMPORTANT? Kell Østerlind Herlev University Hospital. Herlev. Denmark 20% of SCLC pts have bone marrow metastases (bmm) and 24% have a hemoglobin (hgb) conc. <12 g/dL – being a negative prognostic factor in multivariate analyses. Epo during chemo might improve prognosis in pts with hgb<12 g/dL but is it efficacious in pts with bmm? The potential for epo was estimated on data on 1411 SCLC pts from Cph. Lung Cancer Grp trials. 1401 pts had bone marrow exams. and 307 pts (22%) had bmm. Relations between bmm, sex and pretreatment hgb were as follows: Males: 991 bmm: 23% Females: 410 bmm: 20% Hgb

Pts

Bmm

Hgb

Pts

Bmm

<14 g/dL <13– <12– <11– <10–

64% 41– 20– 8– 2–

25% 28– 33– 46– 61–

<14 g/dL <13– <12– <11– <10–

79% 57– 32– 14– 4–

21% 23– 22– 25– 35–

Prevalence of bmm was inverse related to hgb in males but less so in females. Log. reg. analyses proved that S-LDH and alk. phosph. were strong predictors of bmm in both sex. Poor PS (>1) and hgb<11 g/dL (but not <12 g/dL) contributed to the ‘risk’ in males but not in females. 75% of the males and 70% of females had >1 risk factor. Conclusion: Until efficacy of epo in SCLC pts with bmm is proven, we recommend bone marrow exam. in pts with increased S-LDH or alk. phosph. and in male pts with hgb<11 g/dL or PS>1.

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INTEGRATED APPROACH TO CANCER WEIGHT LOSS WITH OXANDROLONE S. Tchekmedyian, L. Petersen; J. Thropay, D. Sunga; F.D. Ottery* Pacific Shores Medical Group, Long Beach, CA; Beverly Oncology/Clinical Trials and Research Associates, Montebello CA; BioTechnology General Corp, East Brunswick, NJ USA

REDUCTION IN RISK OF SKELETAL EVENTS WITH IBANDRONATE IN THE TREATMENT OF METASTATIC BREAST CANCER Tripathy D*, Pecherstorfer M, Bartl R, Bell R, Diel I, Bergstrom B University of Texas Southwestern Medical Centre, Dallas

Purpose To study effect of an integrated approach of the anabolic agent oxandrolone with nutrition and resistance exercise on weight, lean tissue, quality of life (QOL) and activity in cancer pts. Weight loss is common in patients with cancer, consists of disproportionate loss of lean tissue, and adversely effects quality of life (QOL), performance status, treatment toxicity, and survival. Nutritional intervention alone or with appetite stimulants may result in weight gain that is predominantly fat, with little or no effect on lean tissue. Open label oxandrolone 20 mg/d x 4 mos, with nutrition and resistance exercise Demographics: N=131 (71 men, 60 women). Mean age 67.8±11.1yr. Cancers: aerodigestive tract (52), other GI (29), GU/gyn (16), hematologic (16), other (18). Results 79% of weight-losing pts gained or maintained weight during the 4 month study. Mean wt increased by 3.1 lbs in total wt and 3.6 lbs lean wt, p<0.05 Mean ECOG function score improved from 1.6 to 1.2, p<0.05. Mean QOL score increased from 90.8 to 107.5, p <0.001. (max=156) Conclusions Use of the anabolic agent oxandrolone was associated with weight gain, mainly as lean wt, and improved scores for QOL and performance status. The integrated approach was designed to optimize wt gain and body composition and to empower patient participation in cancer care.

A-151 DO NOT RESUSCITATE (DNR) ORDERS IN CHILDREN WITH SOLID MALIGNANT TUMORS Sergey Postovsky*, M.D. Anna Levenzon, R.N, Myriam Weyl Ben Arush Department of Pediatric Oncology/Hematology; Rambam Medical Center Aim of the study: to evaluate the frequency and timing of DNR orders among pediatric oncology patients (pts) with progressive solid tumors. Patients and methods: retrospective evaluation of medical charts of 37 pts who died at our department during the last four years. There were 21 males and 16 females with mean age of 10 years (range, 1-22 years). Fifteen pts were with brain tumors, 12 pts – sarcomas, 5 pts – lymphomas, 4 pts – neuroblastomas and one suffered from hepatocellular carcinoma. Results: DNR order was registered in medical charts of 22 pts (59.5%); no reports on DNR order were found in 15 cases (40.5%). In 5 cases DNR was ordered within less than 24 hours of death. The mean time from DNR order till death was 9 days (range, 0.25-82 days). Place of death: home – 6 pts (16.2%, three pts had DNR order), pediatric oncology ward – 28 pts (75.7%, 19 pts had DNR order), ICU – three pts (8.1%, none with DNR order). Mean time from the last day of anticancer treatment till death was 63 days in the group of pts with DNR order and 56.5 days in the group of pts without DNR order (p=NS). Conclusions: 1. DNR order was registered in only approximately half of all pts with progressive cancer. 2. In several cases DNR order was given to the immediate proximity of death. 3. Advanced discussion of DNR with parents of an ill child is needed in order to reduce parental and medical stuff’s stress accompanying death of a child and optimizing management of terminal phase of his disease.

Bisphosphonates treat the underlying cause of metastatic bone disease (MBD) by inhibiting pathological processes of bone resorption. The aim of the present study was to assess the impact of ibandronate, a third-generation amino-bisphosphonate, on skeletal complications from breast cancer. A multivariate Poisson regression analysis was conducted on data from three 96-week, randomised, placebo-controlled studies of oral ibandronate (50 mg/day) or intravenous (i.v.) ibandronate (6 mg infused over 1-2 hours every 4 weeks) (n=846). Compared with placebo, the analysis demonstrated significant and comparable risk reductions (RRs) in the number of new bone events with oral and i.v. ibandronate (38% and 40% respectively, p<0.05). The RR of the i.v. formulation was greater than reported in clinical trials of clodronate (16%) and pamidronate (23%), and at least as effective as i.v. zoledronate (37%). The RR of oral ibandronate appears to be more efficacious than i.v. pamidronate and at least as effective as i.v. zoledronate. The similar efficacy of oral ibandronate to the most effective i.v. amino bisphosphonates (ibandronate and zoledronate) suggests that this formulation may offer a convenient alternative for prescribers and patients. In conclusion, ibandronate provides significant clinical benefits that appear to be at least as efficacious, and may be more convenient than, alternative bisphosphonate therapies in MBD from breast cancer. The suggested RR benefits of ibandronate merit further consideration and investigation in direct comparative trials.

A-153 A SYSTEMATIC REVIEW ON THE MANAGEMENT OF LYMPHEDEMA *Wong KSR1,2, Kligman L3, Laetsch N4 & The Supportive Care Guidelines Group of CCO Practice Guidelines Initiative4 Princess Margaret Hospital1, University of Toronto2, London Regional Cancer Center3, Cancer Care Ontario Program in Evidence Based Care4. Canada. Purpose: To address the question “What treatment options are effective for women with treatment related lymphedema?” Methods: A systematic review followed by a structured practitioner feedback process was used. The literature search employed MeSH headings and keywords for breast cancer, lymphedema, and clinical trials. Practitioner feedback was requested from Ontario oncologists, nurses and physiotherapists. Results & Conclusions: Six RCTs addressing physical therapies (compression garments, massage therapy, manual lymphatic drainage (MLD), pneumatic compression pumps and electrically stimulated lymphatic drainage) and four on medical therapies (benzopyrones and Daflon) were included. There was limited evidence to suggest that physical therapies such as compression therapy and MLD may improve established lymphedema. There was no evidence to support to use of medical therapies. Additional effort to define relevant clinical outcomes for the assessment of patients with lymphedema would be valuable. 95% of the oncologists, and 78% of allied health care professionals strongly agreed or agreed with the overall interpretation of the evidence.

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A-154 NATURAL KILLER CELL ACTIVITY (NKCA) IN CHILDREN WITH BRAIN TUMOR (BT) T. Hajnžić1, M. Kaštelan2, and T. F. Hajnžić1* Departments of 1Pediatrics and 2Nuclear Medicine and Oncology, University Hospital “Sestre milosrdnice”, Zagreb, Croatia NKca represent the first defence mechanism against development and spreading of malignant tumors. 31 BT patients (pts) aged 3-18 years entered in this study. NKca was measured by 51-Cr release assay using K-526 cell line as target cells. The NKca and CD 16+ cells have been determined in 14/31 nontreated pts with benign BT and compared with the same parameters in malignant BT pts. Prior to neurosurgery, chemotherapy and irradiation treatment, the NKca and number of CD 16+ cells were significantly lower in 17/31 malignant BT pts (Table). The pts with initial and permanent decrease of NKca had poorer prognosis. NKca

Benign BT pts

Malignant BT pts

Effector : target cells

N

x

N

x

12.5 : 1 25.0 : 1 50.0 : 1 CD 16+ (x109/L)

14 14 14 14

12 18 26 0.30

17 17 17 17

6 11 15 0.13

A-155 PORT–A–CATH (PAC) USE IN A COHORT OF LEBANESE PATIENTS AT HAMOUD HOSPITAL *Fadi Sami Farhat, Elie Ghafari Hammoud Hospital, Sidon, Lebanon Purpose: PaC are implanted sc to provide access to the peritoneal cavity or the vascular, or epidural system. The use of implantable ports has grown tremendously since their first use in 1981. Oncology patients were the first recipient of PaC. Objectives and materials: The aim of our study is to clarify the advantages and complications that may affect cancer patients using PaC. Moreover, it provides accurate information about patients’ knowledge and their adaptation with such device. To fulfill the above aim, we carried out from January 2000 to June 2002 our statistics at Hammoud Hospital by questioning 64 cancer patients who have a PaC. These questioners were offered in 2 different types: The first type, in English language, filled from the patients’ medical chart. It consists of general information about the patient, the function of the PaC and the actual state of the patient device. The second, in local language, filled by direct interview with the patient himself and consists of general information about him, his acceptability and adaptability with this device. Questioners for patients younger than 14 years were filled by the help of their parents. Results: PaC is been used in all age, mostly in patients from 40 to 60 years and in both genders. The educational level has no major effect on implanting the port since 64% are of median educational level. The financial state does not prevent patients from implanting this port. Most of the doctors educate the patients about PaC before implanting it. Nevertheless most of them (76%) want to know more about PaC and 54% doesn’t know the complications. Most of the patients don’t come for recurrent heparinisation (78%). The majority of PaC is implanted after receiving one or more cycles of chemotherapy and only 16% was convinced to implant PaC before the first cycle. 96% of the patients have a positive reaction toward

implanting the PaC. 52% where having moderate pain and 40% were painless. PaC has no negative effect on life style for 78% of patients and for them it is more comfortable than peripheral insertion. Finally 96% of patients will advice other patients to put PaC. Among 64 patients 28% where having complications. 16% of the patients removed there PaC and this ranges between stopping treatment and having complications (infection- 36%, occlusion36%, pain- 14%, malposition- 14%). Conclusion: Based on our study, the following concluding points are reached: PaC can be used by both gender and all ages, PaC has fewer complications than peripheral line, and has no negative impact on the patient life style, whenever patients are well educated complications are less and most of the patients wants and needs to know more about PaC, and finally, implanting a PaC is cost affordable.

A-156 EVALUATION THE QUALITY OF CARE DURING THE PROCESS OF CHEMOTHERAPY IN CHEMOTHERAPY CENTERS AFFILIATED TO UNIVERSITIES OF MEDICAL SCIENCES OF MOH NATIONWIDE IN IRAN YEAR 2000 Z. Parsa Yekta This research is a descriptive study carried out in order to evaluate the quality of care during the process of chemotherapy in chemotherapy centres affiliated to universities of Medical Sciences of MOH Nationwide in Iran. The samples were 208 cases of chemotherapy done by all involved personnel which were observed 2 times approximately. The methods of data gathering were: observation and interview. The instruments were: one demographic questionnaire of chemotherapy personnel, four check lists consisted of the chemotherapy agents preparation, the drugs administration discarding the antineoplastic injection equipment and finally method of recording the process of chemotherapy. The validit of the tools were determined by content.

A-157 EFFICACY OF DARBEPOETIN ALFA IN CHEMOTHERAPY-AND CANCER RELATED ANEMIA Bernardo M*, Nunes O, Sousa MO, Moreira P Cancer patients (pts) experience frequently fatigue, as a consequence of the malignancy or treatment. This complaint is sometimes overlooked by clinicians, and undertreated. Anemia, even moderate or mild, is an important contributing factor to the fatigue. The causes of anemia in cancer have been extensively reviewed, and include chemotherapy or radiotherapy, anemia of chronic disease, deficient endogenous erythropoietin or resistance to erythropoietin, among others. Recombinant human erythropoietin is effective for treating anemia in cancer patients under chemotherapy, as was demonstrated in randomised trials. Darbepoetin alfa is the recombinant product of a gene produced by mutagenesis of the erythropoietin gene that increases the glycosylation of the protein. The mechanism of erythropoiesis stimulation is the same of endogenous or recombinant erythropoietin, but with increased potency. Since June 2001, 16 pts with solid malignancies were treated with darbepoetin alfa, 2.25 m.c.g.kg-1 weekly. Median age was 64, limits 54–75. 9 pts (56%) were male, Performance Status was 1 in 6 (38%) and 2 in 10 (62%). 6 pts (38%) had gastrointestinal cancer, 4 (25%), lung , and 3 (19%), ovarian cancer. The others had laryngeal, breast and pancreatic malignancies. 12 (75%) had metastatic or locally advanced disease. 7 pts (44%), had platinum-based therapies, and 8 pts (50%), were in second-line treatment.. Median baseline Hb was 9.6 (8.7–11.2).

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Response was assessed each 4 weeks. Hemoglobin response, defined as an increase of at least 2 g/dl, without transfusions, occurred in 6 pts (38%) at four weeks, and 9 (56%) at 8 weeks. 3 pts (19%) achieved Hemoglobin correction, defined as Hb >12 g/dL. Baseline Hb in this pts was 9.1, 9.7 and 10.2 g/dl. Only 2 pts needed red cell transfusions, after treatment with darbepoetin. No side effects from darbepoetin were detected. Fatigue was reduced in all but one of the pts that responded to therapy. In our small population, darbepoetin alfa was a safe and active treatment to increase Hb concentration in cancer pts under chemotherapy.

A-158 BENCHMARKING OF SUPPORTIVE CARE IN RADIATION ONCOLOGY Störring Kai (1), Haun Peter (2), Seegenschmiedt Michael Heinrich (1) (1) Department of Radiation Oncology & (2) Controlling, Alfried Krupp Krankenhaus, Essen Background: Radiation oncology in-house patients require not only specific tumour therapy but also additional supportive care. We analysed the costs (total expenses versus supportive care expenses) of our patients related to various factors, e.g. type of therapy, type of tumour and individual patient and disease parameters. Material & Methods: For all 870 in-house patients in the year 1999 the treatment type (radiotherapy =RT, chemotherapy =CT; radiochemotherapy =RCT; supportive care =S; follow-up exams =F), tumour diagnosis, age, Karnofsky-Score and individual costs per patient were documented. Hospital costs were fully calculated on the basis of a disease specific clinical pathway and work flow (for staff, procedures and medication). Results: Total costs for all patients were 1.299.343,16€. 829 of 861 (96,3%) patients required additional supportive care with total costs of 75.930,78€ (5,84%) and average costs of 88,09€2 for a total in-house stay. The average stay was 9.1 day. The type of treatment resulted in the following mean overall costs and mean costs per day: patients with RT=154,69€/10,32€, with RCT=121,12€/9,98€, with CT= 35,37€/6,44€; with F=8,43€/2,23€; and with S=59,94€/12,48€. The different tumours required the following mean overall costs for supportive care: prostate-cancer: 134,38€ (per stay)/14,89€ (per stay per day), ENT-tumours: 126,05€ (per stay)/15,07€ (per stay per day), and upper GI-tumours: 72,78€ (per stay)/7,02€ (per stay per day); the highest relative costs for supportive care occured for breast carcinoma patients with 14,18€ ( per stay per day (14,1% of all costs). Age and costs for supportive care per case were positively correlated and highly significant [p<0.001]. Karnofsky-Score and costs for supportive care per case were negatively correlated and also highly significant [p<0.001]. For patients with supportive care alone the relative costs of supportive medication was 10% of the total costs; in contrast, for specific tumour treatments relative costs of supportive medication was only 5–6%. Conclusions: Supportive care causes only 5,8% of the total inhouse costs in radiation oncology, while specific tumour therapy accounts for about 34% (RT 30%, CT 3,7%); the remainder of the costs is required for staff (nursing, medical care & administration). Optimized supportive care reduces the in-house stay of patients thereby reducing the overall costs per individual patient’s stay and per treatment and tumour type. 2 Costs only for supportive care

A-159 TUMOR LYSIS SYNDROME IN SOLID TUMORS *Bæksgaard L1, Sørensen JB1 1Dept.of Oncology, National Univ. Hosp., Copenhagen, Denmark Introduction: Tumor lysis syndrome (TLS) is an oncologic emergency characterized by hyperuricemia, hyperkalemia, hyperphosphatemia, hypocalcemia and acute renal failure due to massive lysis of malignant cells. TLS occurs rarely in adult patients with solid tumors. We report the second case of TLS during chemotherapy in a patient with metastatic medulloblastoma. We review the literature regarding the prevalence of TLS in patients with solid tumors. Methods: Data regarding clinical and biochemical parameters were extracted from the actual patient’s file. Reports of TLS in the English-language literature up till year 2002 were identified by searching MEDLINE. Results: A 23-year old male with metastatic medulloblastoma received chemotherapy with cisplatin and etoposide and developed signs of TLS, including acute renal failure. The patient was treated with hydration, allopurinol, repeated hemodialysis and cardiac monitoring and recovered completely from TLS. Reviewing the literature, a total of 45 patients with solid tumors having developed TLS have been reported. Most of the patients present with metastatic, therapy-sensitive disease. Risk factors include increased LDH, hyperuricemia and pretreatment azotemia. In this material the mortality rate is 1/3. Conclusion: TLS is a potentially fatal condition and high awareness is required in patients with bulky disease, sensitive tumor types and pretreatment risk factors.

A-160 STATUS OF TRACE ELEMENTS IN UNTREATED HEAD AND NECK CANCER PATIENTS Jens Büntzel (1), Michael Glatzel (2), Dietmar Fröhlich (2), Ralph Mücke (3), Oliver Micke (4), Klaus G. Schönekaes 1 Dept. of Otolaryngology Nordhausen; 2 Dept. of Radiotherapy Suhl; 3 Dept of Radiotherapy Weiden; 4 Dept. of Radiotherapy Münster Background: The changed mineral status is well known in different tumor types. This phenomenon has influenced the redox potential of patients suffering from solid cancers. A prospective trial was conducted to evaluate the specifics for untreated head and neck cancer patients. Material and methods: We included 100 patients with advanced squamous cell carcinoma of the head and neck region before each kind of treatment. Following serum-concentrations were measured by atom aborption spectrometry: selenium, copper, zinc, and ferrum. Additionally we evaluated the activity of glutathion peroxidase and the concentration of malondialdehyde of the serum. Results: 66% of all patients have shown a decreased serum-concentration of selenium. These patients were additionally characterized by decreased activities of endogenous glutathionperoxiase. A third of all patients had decreased zinc and iron levels. Copper was found enhanced in 30 %. In trend the malondialdehyde was increasing due to decreasing selenium levels. Conclusions: Head neck cancer patients show the same characteristic trace element status as other solid tumors: decreased selenium, zinc and iron, increased copper. The therapeutic consequences of these observations are still unclear.

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A-161 REFERRAL FOR, AND UPTAKE OF, POST-SURGICAL CANCER THERAPY *Stan Lindsay and Kingsley Simmons Kings College London and the University of Hertfordshire, United Kingdom Certain psychosocial characteristics are said to help patients survive cancer. Many fail to complete therapy. Do those characteristics affect that? 330 consecutive patients with different cancers were divided at random into two groups to complete, shortly after surgery and before histological analysis, published questionnaires about their psychological characteristics or their attitudes to consultations and cancer. Demographic and clinical data were available for all. Then, independent of the questionnaires, they were chosen by their surgeons for the oncologists, according to histology. However, shown by multivariable logistic regression, patients were most likely (p<0.01) to be chosen if they did not have gastrointestinal cancer, were young, well-educated, depressed, dissatisfied, had advanced cancer and believed their health was others’ responsibility. They were most likely to complete chemotherapy etc. if they had breast cancer or had been referred to the nearest hospital. Clinical audit may reduce such inequalities and improve survival.

A-162 INCIDENCE OF INFECTION IN LEVAMISOLE (LE) TREATED IMMUNOCOMPROMISSED CHILDREN WITH BRAIN TUMOR (BT) T. Hajnžić1, M. Kaštelan 2, and T. F. Hajnžić1* Departments of 1Pediatrics and 2Nuclear Medicine and Oncology, University Hospital “Sestre milosrdnice”, Zagreb, Croatia The aim of this study was to determine the incidence of intercurrent infection and the influence of LE on some parameters of cellular immunity in 35 patients (pts) with malignant BT. 14/35 pts aged 3-18 years, treated with chemotherapy and irradiation (HIT-MED-91) received LE 2.5 mg/kg body weight p.o. for 3 consecutive days, every two weeks 6-12 months. Reactivity of lymphocytes (Ly) to mitogens (ConA), proportion of all Ly, number of CD 3+, sIg+ and CD 16+ cells were significantly lower in 21/35 LE non-treated BT pts. During the oncologic therapy the incidence by infection in LE treated pts was 30% lower (Table). Conclusion: LE used as immunomodulating drug during the therapy improves immunocompetence in pts with BT. BT-pts/infection

N

N of attacks

N of attacks per pts

LE non-treated LE treated

21 14

96 42

4-5 3

A-163 MUCOSITIS:PREDICTOR OF OUTPATIENT FAILURE IN FEBRILE NEUTROPENIA *Manzullo E, Rolston K, Escalante C The University of Texas M. D. Anderson Cancer Center, Houston, TX, USA Background: Outpatient(op) treatment(tx) of febrile neutropenia in low risk cancer patients(pts) has been the standard of care at our institution since 1998. Op criteria and standard op antibiotic regimens have previously been established. Based on eligibility criteria pts are required to take adequate oral intake prior to discharge. Method: 257 febrile episodes in 191 pts were treated on these regi-

mens from 3/98-2/00. Pts were evaluated and followed in a standard fashion. Results: 205 (80%) febrile episodes responded to op tx and 52 (20%) were hospitalized. 8 of 10(80%) pts with mucositis>grade(gr) 2 required hospitalization. All of the pts had been treated with standard oral antibiotic therapy. Ages ranged 21-77yrs (median 32), 63% female. Cancer diagnosis: 5 sarcoma, 2 breast, 1 testicular. 6 pts received chemotherapy including adriamycin. The pt’s absolute neutrophil count ranged from 0-0.27 (median 0.01) at the start of tx.The average length of stay was 5 days (range 3-11) and all pts received either antifungal and/or antiviral tx plus I.V. antibiotics. Pts with mucositis >gr 2 had a 15-x rate of hospital admission compared to pts with mucositis ≤gr 2 Mucositis >gr 2 affects success of op tx.Mucositis in these pts progressed while receiving op tx. It will be important to identify ways to characterize these pts prior to the development of mucositis.

A-164 EMERGENCY DEPARTMENT (ED) INTERVENTION FOR CANCER PATIENTS (PTS) WITH FEBRILE NEUTROPENIA (FN) *A.Nirenberg, L. Mulhearn, S. Lin, C. Siefert, N. Flomenbaum & E. Larson Columbia University School of Nursing & New York PresbyterianWeill Cornell Medical Center. NY, NY. USA Purpose: To examine length of time from ED admission to definitive FN treatment during nights, week-ends and holidays. Methods: Patients after receiving cancer chemotherapy in the Faculty Practice of the Division of Hematology/Oncology who called with complaints of fever and presumed neutropenia were instructed to go to the ED. Pts were seen by ED staff or on-call Oncology Nurse Practitioners (ONP). Pts received standardized treatment including PE, VS, CBC with differential, chemistry profile, cultures and initiation of broad spectrum intravenous (IV) antibiotics. Times between ED triage and physical assessment/exam, triage to initiation of antibiotic therapy, triage and inpatient admission and FN resolution were recorded. Data were collected from medical records after informed consent was obtained. Risk of complications from FN was evaluated using Talcott’s risk assessment model. Results: There were 23 eligible patient encounters of 33 cancer pt visits with FN (70%), who presented to the ED during 8 months of study period. All pts were hospitalized for FN. Out of 23 encounters, 12 pts had extensive cancer and 6 had significant comorbidities. 18 pts received growth factors. Cancer therapy that resulted in FN included high dose cyclophosphamide alone for stem cell mobilization (n=7) and in combination with other agents (n=11). Of 23 encounters, 40% of pts had multiple myeloma and 17% had non-Hodgkin’s lymphoma . Pts waited a mean of 90 minutes from triage to assessment, 242 minutes from triage to IV antibiotic therapy, 361 minutes from triage to inpatient admission, and had a mean of 4 days from ED triage to recovery. There were 3 positive blood cultures. No pts developed sepsis nor were there ICU admissions. Pts were febrile an average of 21 hours prior to calling the health care provider. Conclusion: Patients with FN seen in the ED waited hours before initiation of treatment or hospital admission. This study provides descriptive information which may provide baseline data for future interventions and education for this population.

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A-165 FEBRILE NEUTROPENIA : PROSPECTIVE STUDY TO VALIDATE THE MASCC (MULTINATIONAL ASSOCIATION FOR SUPPORTIVE CARE IN CANCER) RISK–INDEX SCORE. B L Rapoport,(1) A Uys(1), R Anderson(2) Johannesburg, (2) Pretoria, South Africa Febrile neutropenia (fn) remains a potentially life-threatening complication in cancer patients (pts) undergoing chemotherapy. MASCC developed a scoring system, based on clinical predictive factors to identify pts at low risk for development of serious medical complications. The purpose of this study was to validate the MASCC risk-index score in order to predict which pts will have a favorable outcome and which are at risk to develop complications. The dependant variable of primary interest was the final outcome of each febrile neutropenic episode: a) fever resolution for five consecutive days, allowing change in antibiotic treatment, b) fever resolution with occurrence of a serious medical complication, c) death before resolution of fever. Data from 80 episodes of fn was collected prospectively. The MASCC score was calculated on each patient. Pts with a score of ≥21 were low risk and pts with a score of <21 high risk. There were 19 males and 61 females. Sixty pts were younger than 60 years. Twenty four pts had a PS 0-1. Twenty four pts were inpatients. Fifty six pts had solid tumours and 24 hematological malignancies. Twenty six pts received GCSF.Fifty eight pts (72,5%) were low risk (≥21) and twenty two (27,5%) high risk (<21). Among the 58 low risk pts, 57 (98,2%) were treated successfully. One pt developed a fungal infection. Among the 22 high risk pts, 10 (45,5%) developed complications : admission to intensive care (4 pts), fungal and viral infections (4 pts), hypotension (3 pts). Eight high risk pts (36,3%) died before fever resolution. Three high risk pts were treated successfully. Microbiological infections were documented in 30% of all patients. When applying the MASCC risk-index score in this study the positive predictive value was 95% (76/80). We confirm that the MASCC model is accurate and useful to predict low and high risk pts.

A-166 ONCE DAILY, ORAL, OUTPATIENT THERAPY FOR LOW-RISK FEBRILE NEUTROPENIC PATIENTS *K. Rolston, S. Frisbee-Hume, E. Manzullo, R. Theriault, S. Patel, R. Benjamin The University of Texas M. D. Anderson Cancer Center, Houston, Texas USA We treated 30, low-risk, febrile neutropenic patients in a pilot study, with once-daily, outpatient, oral gatifloxacin. The median age was 44 yrs. (range 20-71 y), male/female ratio was 14/16. Sarcoma (77%) and breast cancer (23%) were the underlying tumors. Twenty-eight patients (93%) were severely neutropenic (≤100 PMN/mm3). Fifteen patients (50%) had unexplained fever – all responded to therapy. The rest (50%) had documented infections, with an 87% response rate (13/15). Organisms isolated were staphylococci, streptococci, enterococci, Enterobacteriaceae, P. aeruginosa, and S. maltophilia Details are listed below: INFECTION

NO. (% response)

Bacteremia UTI URI Pneumonia Cellulitis

8 (88) 1 (100) 4 (100) 1 (100) 1 (0)

Median time to defervescence was 2 days, and median duration of therapy was 7 days (range 3-14 d). There were no superinfections, drug related toxicity, ICU admissions, or deaths. Once daily, oral, outpatient therapy with gatifloxacin appears safe and effective in low-risk febrile neutropenic patients.

A-167 PEGFILGRASTIM ONCE-PER-CHEMOTHERAPY-CYCLE REDUCES THE INCIDENCE AND DURATION OF FEBRILE NEUTROPENIA (FN) COMPARED WITH DAILY FILGRASTIM: A META-ANALYSIS Salvatore Siena1, Martine J Piccart2, Frankie A Holmes3, John Glaspy4, James Hackett5, Jennifer Renwick5 1Divisione Oncologia Medica Falck, Ospedale Niguarda Ca’ Granda, Milan, Italy; 2Institut Jules Bordet, Brussels, Belgium; 3Texas Oncology, PA, Dallas, TX; 4UCLA Medical Ctr, Los Angeles, CA; 5Amgen Inc, Thousand Oaks, CA Filgrastim (Neupogen®) reduces the risk of chemotherapy-induced neutropenia enabling delivery of planned doses of chemotherapy on time. Pegfilgrastim (Neulasta™) is a sustained duration growth factor. Two pivotal trials in breast cancer pts receiving doxorubicin/docetaxel demonstrated that pegfilgrastim (6mg fixed dose [N=77] or 100µg/kg [N=149]), given once-per-cycle is as effective at reducing the duration of grade IV neutropenia as daily filgrastim injections (5µg/kg [N=222]). Pegfilgrastim was observed to be as safe and well tolerated as filgrastim. No statistically significant or otherwise meaningful differences in treatment effects were observed over the range of body weights, so data were pooled to enable more robust comparisons including high-risk subgroups. The risk of FN (grade IV neutropenia with temperature ≥38.2°C) was significantly lower (11% vs 19%, respectively; relative risk=0.56, 95% CI=0.35, 0.89 P<0.05), the duration of FN was significantly shorter (P<0.05) and there were trends towards lower risk of hospitalisation and IV anti-infective use in pts receiving pegfilgrastim than for those receiving filgrastim. These effects were consistent across all risk strata tested. A single dose of pegfilgrastim was observed to be more effective at reducing the overall incidence and duration of FN than daily filgrastim injections. Pegfilgrastim offers pts protection against neutropenic chemotherapy complications with fewer injections and less disruption to their lives.

A-168 NON NEUTROPENIC FEVER IN CANCER PATIENTS (PTS) ADMIT TO ONCOLOGY DIVISION *Silvia Toso, Milena Gusella, Luisa Merlo, Tiziana Passarotto, Paola Ferri, Annalisa Ferrarese§, Antonio Bononi, Giorgio Crepaldi, Daniela Menon and Eros Ferrazzi Oncology Dep. Gen. Hospital Rovigo, § Pharmacy Service Gen. Hospital Rovigo, ITALY Introduction: We observe the approach to fever in non neutropenic patients admitted to an Oncology ward.Methods Sex, age, KPS, fever characteristics, chest X-ray, and biological fluids cultures were collected.Results The pts. were 82,a median age was 63, PS 60. Median lenght of fever was 4 days, median maximum temperature was 38.9°C(38-40.5). A significant positve correlation between fever more than 39°C and lenght of stay longer than three days (CHI test 0.0009) was observed.Chest X-ray was made in 48 pts. and was useful in 13 (32%).Among 72 urine cultures obtained, 26 (36%) were positive for:Enterococcus(46%), for Staphylococcus(23%), for Escherichia coli(23%), Pseudomonas aeruginosa (19%), Morganella morganii (11%), Candida(7.6%),others (7.6%).Among 127 blood cultures 27 (21%) were positive for:Staphylococcus in 37%, Pseudomonas ae.in 26%, Escherichia

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coli in 15%, Candida in 11%, Acinetobacter in 7.4%, Enterococcus in 7.4%, Bacillus in 3,7%, Salmonella C1 in 3.7%. Microbical etiology was not ascertained for 48 pts. and only suspected in 25. A sure infection cause was found in nine patients (11%).Conclusions Non neutropenic fever was very frequently associated to stay in hospital, and that etiological definition can be found in a minority of cases.

A-169 PROSPECTIVE STUDY OF SERUM PRO INFLAMMATORY CYTOKINE-AND ACUTE PHASE REACTANTS IN CANCER PATIENTS WITH FEBRILE NEUTROPENIA. A Uys(1),B L Rapoport,(1)H Fickle(2),P Meyer(2),R Anderson(2) (1)Johannesburg, (2)Pretoria, South Africa (MASCC) has developed a risk scoring system, based on clinical predictive factors to identify patients (pts) at low risk (LR) for development of serious medical complications. Little is known about the relationship between cytokines, acute phase reactants and FN. To determine the differences between cytokines and acute phase reactants in LR and high risk (HR) pts with FN. Serum IL-1, IL-6, IL-8, IL10, C reactive protein (CRP) and serum amyloid A (SAA) levels were determined on 80 pts with FN, at four intervals; at onset of FN (baseline), 72 hours later, at resolution of fever and at a follow up visit within 4 weeks of the FN episode. The MASCC score was calculated on each pt. Pts were divided in LR and HR. There were 19 males and 61 females. Sixty pts were younger than 60 years. Fifty six pts had solid tumors and 24 hematological malignancies. Fifty eight pts (72,5%) were low risk LH and twenty two (27,5%) HR. Eight pts (10%) died during the FN episode (median MASCC score 17). Interval

IL-1 (pg/ml) LR/HR

Baseline 12/7 72 hour 3/3 Resolution 3/8 4 weeks 4/33 P Value 0.1397

IL-6 (pg/ml) LR/HR

IL-8 (pg/ml) LR/HR

88/263 274/423 72/147 272/403 46/101 225/336 15/67 55/245 0.0002 0.0031

IL-10 (pg/ml) LR/HR

CRP (mg/l) LR/HR

SAA (mg/l) LR/HR

12/137 6/55 5/48 5/10 0.0001

58/100 194/349 40/91 187/385 30/57 115/177 13/45 31/160 0.0010 0.0006

Pts who developed serious medical conditions and or died, had the highest baseline values. Additionally there was a statistically significant difference for IL-6 (p=0.0012), IL-8 (p=0.05), CRP (p=0.015), SAA (p=0.015) between responders and non-responders to empiric antibiotic therapy. This study showed that LR and HR pts have different cytokine patterns. This difference could form the basis of further studies to increase the sensitivity and specificity of the MASCC risk scoring system.

A-170 5.2-DAYS-TREATMENT OF LENO-GRASTIM 34MU IS THE STANDARD SCHEDULE FOR CONVENTIONAL CHEMOTHERAPY IN GERMAN CANCER PATIENTS – RESULTS OF A MULTICENTRE TRIAL J. Zahner1, Wolf H-H2 1 Heinrich-Heine-University, Düsseldorf; 2 Martin-Luther-University, Halle, Germany Aim of the Study: Dose intensity is a major point in chemotherapy. Whereas for curative treatment its value is well established, in palliative treatment the value of dose intensity needs further investi-gation. Optimal scheduling of G-CSF treatment to maintain planned dose intensity is not known so far.

Methods: We performed an open label trial with lenograstim 34 MU in 644 cancer patients undergoing chemotherapy to evaluate the dosing schedule of G-CSF. Patients had a median age of 59 years, median body surface area of 1.83m2 and derived from four tumor groups. Breast and ovarian cancer (n=225), Hodgkin’s disease and non-Hodgkin’s lymphoma (n=217), small cell lung cancer and non small cell lung cancer (n=55) and others (n=147). Results: During a mean treatment of 4.3 chemo- therapeutic cycles 21.7 injections of lenograstim 34 MU, corresponding to 5.2 injections per cycle, were given. In comparison to other tumor groups in Hodgkin’s disease and non-Hodgkin’s lymphoma lenograstim 34 MU was given more frequently (28.5 days corresponding to 5.9 injections per cycle). In 84.9% out of 644 patients the planned interval was kept and the calculated dose was fully applied. Conclusion: On average 5.2 injections of lenograstim 34 MU per chemotherapy cycle allow application of planned dose intensity in nearly 85% of tumor patients undergoing conventional chemotherapy. Further clinical trials on the value of dose intensity are warranted.

A-171 CSF TREATMENT OF CHEMOTHERAPY-INDUCED FEBRILE NEUTROPENIA (FN): A META-ANALYSIS Otavio Clark, Benjamin Djulbegovic, David Dale, *Jeffrey Crawford, Gary H Lyman, for the ANC Study Group Instituto Radium de Campinas, Brazil, H Lee Moffitt Cancer Center, Tampa, FL; University of Washington Medical Center, Seattle, WA; Duke University Medical Center, Durham, NC; University of Rochester Medical Center, Rochester, NY FN is a life-threatening event in cancer patients treated with chemotherapy. RCTs of CSFs for the treatment of established FN have shown reduced duration of neutropenia but variable effects on the duration of hospitalization and mortality. We report here a systematic review of the literature with a formal meta-analysis of CSF treatment of established FN. RCTs that compared CSF plus antibiotics with antibiotics alone in the treatment of established FN were identified and retrieved. Thirteen original reports (n=1518 patients) met the eligibility criteria for the meta-analysis. Patients treated with CSF and antibiotics had shorter hospitalizations (OR=0.63; 95% CI, 0.49–0.82; P=0.0006; 8 trials, n=1221) and a shorter time to neutrophil recovery (OR=0.32; 95% CI, 0.23–0.46; P<0.00001; 5 trials, n=794). We also observed a possible reduction in infection-related mortality with CSF treatment (OR=0.51; 95% CI, 0.26–1.00; P=0.05; 9 trials, n=872). A subgroup analysis of overall mortality and infectionrelated mortality found that patients with hematologic malignancies fared better when treated with CSF (OR=0.32; 95% CI, 0.13–0.78; P=0.01). Patients treated with CSF had more bone pain, joint pain, and flu-like symptoms than controls (OR=2.05; 95% CI, 1.22–3.46; P=0.007, 6 trials, n=622). Patients treated with G-CSF had significantly fewer symptoms than patients treated with GM-CSF (OR=6.27; 95% CI, 2.15–18.28; P=0.0008). CSF combined with antibiotics in patients with established FN results in improved outcomes, including shorter hospital stays and, possibly, lower infection-related mortality.

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A-172 PREDICTING BACTEREMIA IN CHILDREN WITH CHEMOTHERAPY-INDUCED FEBRILE NEUTROPENIA *Roland A. Ammann, Andreas Hirt, Annette Ridolfi Lüthy, Christoph Aebi Department of Pediatrics, University of Bern, Switzerland Background. Estimating the risk of bacteremia in pediatric febrile neutropenia (FN) remains a challenge. The purpose of this study was to define an algorithm predicting the risk of bacteremia and gram-negative bacteremia in FN in the emergency situation. Methods. Information available within two hours of presentation with FN, and on outcome, was collected from all pediatric cancer patients presenting with FN from 1993 to 2001 in a retrospective single-center cohort study. Multivariate decision tree models were

constructed and their performance evaluated by crossvalidation. Results. Bacteremia was detected in 87 (24%) and gram-negative bacteremia in 30 (8%) of 364 episodes of FN. At the predetermined sensitivity level ≥95%, the decision tree models predicted bacteremia and gram-negative bacteremia with crossvalidated specificities of 37% and 43%, and negative predictive values of 96% and 99%, respectively. Anticipated long duration of neutropenia, comorbidity requiring hospitalization, absence of a clinically or radiologically evident infection, and individually high susceptibility for fever and bacterial infection in neutropenia were defined as four newly described factors associated with bacteremia. Conclusions. Combining selected information available at presentation, bacteremia in FN can be predicted with clinically useful specificity at a high level of sensitivity. The results of this study require confirmation and refinement in prospective studies.