Randomized phase III trial evaluating the role of erythropoietin in the prevention of chemotherapy-induced anemia.
OBJECTIVE
Although erythropoietin (EPO) is known to be useful in treating chemotherapy-induced anemia, few data are available on its potential preventive role. The aim of this study was to evaluate the ability of EPO in preventing the development of clinically significant anemia in patients treated with chemotherapy.


METHODS
Sixty-two early-stage breast cancer patients undergoing accelerated adjuvant chemotherapy were randomized to receive EPO 150 U/kg three times a week or no additional treatment. Chemotherapy consisted of six cycles of cyclophosphamide 600 mg/m2, epirubicin 60 mg/m2, and fluorouracil 600 mg/m2 (CEF) intravenously on day 1, every 2 weeks with the support of granulocyte colony-stimulating factor (G-CSF), 5 microg/kg subcutaneously from day 4 to day 11.


RESULTS
Throughout the six cycles of chemotherapy, EPO-treated patients maintained stable values of hemoglobin, whereas control patients developed a progressive anemia. At the end of chemotherapy, the mean (+/- SD) hemoglobin decrease in the control group was 3.05 g/dL (+/- 1.0; 95% confidence interval [CI], 2.6 to 3.5), whereas in the EPO group it was 0.8 (+/- 1.4; 95% CI, 0.3 to 1.4). Clinically significant anemia (hemoglobin < or = 10 g/dL) occurred in 16 patients (52%; 95% CI, 33 to 69) in the control arm and in no patient (0%; 95% CI, 0 to 14) in the EPO arm (P = .00001).


CONCLUSIONS
EPO prevents anemia in patients undergoing chemotherapy. Further trials are required to identify subsets of patients in which the preventive use of this drug could be cost-effective.
Del Mastro
L
L
Divisione di Oncologia Medica I, Istituto Nazionale per la Ricerca sul Cancro, Genova, Italy. marco.venturini@schering-pl.it
Venturini
M
M
Lionetto
R
R
Garrone
O
O
Melioli
G
G
Pasquetti
W
W
Sertoli
M R
MR
Bertelli
G
G
Canavese
G
G
Costantini
M
M
Rosso
R
R
D000328:Adult; D000368:Aged; D000747:Anemia, Hypochromic / Q000139:chemically induced / Q000517:prevention & control*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects*; D001943:Breast Neoplasms / Q000097:blood / Q000188:drug therapy / Q000523:psychology; D004334:Drug Administration Schedule; D004921:Erythropoietin / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007501:Iron / Q000097:blood; D008875:Middle Aged; D016896:Treatment Outcome
D004921:Erythropoietin; D007501:Iron