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

作者：Ray Coquard I^*; Dussart S; Goillot C; Mayeur D; Debourdeau P; Ghesquieres H; Bachelot T; Le Cesne A; Anglaret B; Agostini C; Guastalla J P; Lancry L; Biron P; Desseigne F; Blay J Y

来源：Annals of Oncology, 2009, 20(6): 1105-1112.

DOI：10.1093/annonc/mdn750

• cancer patients
• chemotherapy
• epoetin
• survival

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/mu l, 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/mu l 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.

• 出版日期2009-6