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Annals of Oncology Advance Access originally published online on January 27, 2009
Annals of Oncology 2009 20(6):1105-1112; doi:10.1093/annonc/mdn750
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© The Author 2009. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oxfordjournals.org

quality of life/supportive care/palliative care

A risk model for severe anemia to select cancer patients for primary prophylaxis with epoetin {alpha}: a prospective randomized controlled trial of the ELYPSE study group

I. Ray-Coquard1,*, S. Dussart1, C. Goillot2, D. Mayeur3, P. Debourdeau4, H. Ghesquieres1, T. Bachelot1, A. Le Cesne6, B. Anglaret7, C. Agostini8, J.-P. Guastalla1, L. Lancry1, P. Biron1, F. Desseigne1 and J.-Y. Blay1,5

1 Department of Medical Oncology, Léon Bérard Comprehensive Cancer Center, University of Lyon, and EA 4128 SIS Individu Santé, Société
2 Oncology–Hematology Department, Eugène André Clinics, Lyon
3 Medical Oncology Department, Foch Hospital, Versailles
4 Internal Medicine Department, Desgenettes Military Hospital, Lyon
5 Adult Medical Oncology Department, Gustave Roussy Institute, Villejuif
6 Oncology Department, General Hospital of Valence, Valence
7 Medical Oncology Department, General Hospital of Chambéry, Chambéry
8 Medical Oncology Department, Edouard Herriot University Hospital, Lyon, France

* Correspondence to: Dr I. Ray-Coquard, Centre Léon Bérard, 28 rue Laennec, 69008 Lyon, France. Tel: +33-478782888; Fax: +33-478782716; E-mail: ray{at}lyon.fnclcc.fr

Background: Epoetin (EPO) administration reduces the need for transfusion. Identifying patients at high risk of anemia requiring red blood cell (RBC) transfusion is needed. This multicentric phase III trial tested epoetin {alpha} (EPO{alpha}) administration according to our risk model on the basis of three clinical parameters: hemoglobin (Hb) <12 g/dl, lymphocytes ≤700/µl, and/or performance status (PS) >1.

Patients and methods: Patients ≥18 years with chemotherapy-treated solid or hematologic tumors were randomized to 150 UI/kg/TIW s.c. EPO{alpha} (arm 1) or no EPO{alpha} (arm 2) and stratified on Hb level at day 0, lymphocyte count, and PS. The primary end point was transfusion rate; secondary end points included overall survival (OS), safety, and quality of life.

Results: From September 2000 to January 2005, 218 patients (median age 64 years, 42.7% males) with principally breast cancer, sarcoma, or lung carcinoma were included. In total, 93% patients had PS >1 and 35% had ≤700/µl lymphocytes. Baseline Hb levels were 10.1 g/dl (range 6.9–11.9). Two hundred and thirteen patients were assessable for the primary end point: 36% received RBC in arm 1 and 58% in arm 2 (P = 0.0012). Median OS was 7.6 [95% confidence interval (CI): 5–12] and 6 (95% CI: 5–8) months in arms 1 and 2, respectively. Median OS was significantly worse for patients with three prognostic factors (3.6 months) compared with two factors (8.3 months) (P < 0.001). No difference in toxicity (47% versus 41%) or thrombovascular events (4.5% versus 3.7%) was observed.

Conclusion: Patients at high risk for RBC transfusion according to the ELYPSE model could be given prophylactic EPO with significantly reduced RBC transfusions and no significant impact on side-effects, progression-free survival, and OS.

Key words: cancer patients, chemotherapy, epoetin, survival

Received for publication August 12, 2008. Revision received September 13, 2008. Accepted for publication September 19, 2008.


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