RANDOMIZED PHASE-III TRIAL EVALUATING THE ROLE OF ERYTHROPOIETIN IN THE PREVENTION OF CHEMOTHERAPY-INDUCED ANEMIA

Purpose: Although erythropoietin (EPO) is known to be useful in treati ng chemotherapy-induced anemia, few data are available on its potentia l preventive role. The aim of this study was to evaluate the ability o f EPO in preventing the development of clinically significant anemia i n patients treated with chemotherapy. Patients and Methods: Sixty-two early-stage breast cancer patients undergoing accelerated adjuvant che motherapy were randomized to receive EPO 150 U/kg three times a week o r no additional treatment. Chemotherapy consisted of six cycles of cyc lophosphamide 600 mg/m(2), epirubicin 60 mg/m(2), and fluorouracil 600 mg/m(2) (CEF) intravenously on day 1, every 2 weeks with the support of granulocyte colony-stimulating factor (G-CSF), 5 mu g/kg subcutaneo usly from day 4 to day 11, Results: Throughout the six cycles of chemo therapy, 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 gr oup 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), Cl inically significant anemia (hemoglobin less than or equal to 10 g/dL) occurred in 16 patients (52%; 95% CI, 33 to 69) in the control arm an d in no patient (0%; 95% CI, 0 to 14) in the EPO arm (P = .00001), Con clusion: EPO prevents anemia in patients undergoing chemotherapy. Furt her trials are required to identify subsets of patients in which the p reventive use of this drug could be cost-effective. (C) 1997 by Americ an Society of Clinical Oncology.