TY - JOUR
T1 - Randomized phase III trial evaluating the role of erythropoietin in the prevention of chemotherapy-induced anemia
AU - Del Mastro, Lucia
AU - Venturini, Marco
AU - Lionetto, Rita
AU - Garrone, Ornella
AU - Melioli, Giovanni
AU - Pasquetti, Wanda
AU - Sertoli, Mario Roberto
AU - Bertelli, Gianfilippo
AU - Canavese, Giuseppe
AU - Costantini, Massimo
AU - Rosso, Riccardo
PY - 1997/7
Y1 - 1997/7
N2 - Purpose: 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. Patients and 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 fluorauraci1 600 mg/m2 (CEF) intravenously on day 1, every 2 weeks with the support of granulocyte colony-stimulating factor (G-CSF), 5 μg/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 ≤ 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). Conclusion: 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.
AB - Purpose: 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. Patients and 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 fluorauraci1 600 mg/m2 (CEF) intravenously on day 1, every 2 weeks with the support of granulocyte colony-stimulating factor (G-CSF), 5 μg/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 ≤ 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). Conclusion: 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.
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M3 - Article
C2 - 9215845
AN - SCOPUS:17144459940
VL - 15
SP - 2715
EP - 2721
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
SN - 0732-183X
IS - 7
ER -