Del Mastro L, Venturini M, Lionetto R, Garrone O, Melioli G, Pasquetti W, Sertoli M R, Bertelli G, Canavese G, Costantini M, Rosso R
Divisione di Oncologia Medica I, Istituto Nazionale per la Ricerca sul Cancro, Genova, Italy.
J Clin Oncol. 1997 Jul;15(7):2715-21. doi: 10.1200/JCO.1997.15.7.2715.
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.
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.
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).
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.
尽管已知促红细胞生成素（EPO）可用于治疗化疗引起的贫血，但其潜在预防作用的数据却很少。本研究的目的是评估EPO预防接受化疗患者发生具有临床意义贫血的能力。
62例接受加速辅助化疗的早期乳腺癌患者被随机分为两组，一组每周三次接受150 U/kg的EPO治疗，另一组不接受额外治疗。化疗方案为每2周的第1天静脉注射环磷酰胺600 mg/m²、表柔比星60 mg/m²和氟尿嘧啶600 mg/m²（CEF），共六个周期，并从第4天至第11天皮下注射粒细胞集落刺激因子（G-CSF），剂量为5 μg/kg。
在整个六个化疗周期中，接受EPO治疗的患者血红蛋白值保持稳定，而对照组患者出现进行性贫血。化疗结束时，对照组血红蛋白平均（±标准差）下降3.05 g/dL（±1.0；95%置信区间[CI]，2.6至3.5），而EPO组为0.8（±1.4；95%CI，0.3至1.4）。对照组有16例患者（52%；95%CI，33至69）发生具有临床意义的贫血（血红蛋白≤10 g/dL），而EPO组无患者发生（0%；95%CI，0至14）（P = 0.00001）。
EPO可预防接受化疗患者的贫血。需要进一步试验以确定预防性使用该药可能具有成本效益的患者亚组。
