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.
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 (EPOalpha) administration according to our risk model on the basis of three clinical parameters: hemoglobin (Hb) <12 g/dl, lymphocytes <or=700/microl, and/or performance status (PS) >1.


METHODS
Patients >or=18 years with chemotherapy-treated solid or hematologic tumors were randomized to 150 UI/kg/TIW s.c. EPOalpha (arm 1) or no EPOalpha (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 <or=700/microl 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.


CONCLUSIONS
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.
Ray-Coquard
I
I
Department of Medical Oncology, Léon Bérard Comprehensive Cancer Center, University of Lyon, and EA 4128 SIS Individu Santé, Société, Lyon, France. ray@lyon.fnclcc.fr
Dussart
S
S
Goillot
C
C
Mayeur
D
D
Debourdeau
P
P
Ghesquieres
H
H
Bachelot
T
T
Le Cesne
A
A
Anglaret
B
B
Agostini
C
C
Guastalla
J-P
JP
Lancry
L
L
Biron
P
P
Desseigne
F
F
Blay
J-Y
JY
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000740:Anemia / Q000188:drug therapy* / Q000209:etiology; D018890:Chemoprevention; D000068817:Epoetin Alfa; D004921:Erythropoietin / Q000008:administration & dosage*; D005260:Female; D006397:Hematinics / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D008875:Middle Aged; D008954:Models, Biological; D009369:Neoplasms / Q000150:complications*; D011446:Prospective Studies; D011994:Recombinant Proteins; D012307:Risk Factors
D006397:Hematinics; D011994:Recombinant Proteins; D004921:Erythropoietin; D000068817:Epoetin Alfa