J Clin Oncol. 1991 Feb;9(2):305-12. doi: 10.1200/JCO.1991.9.2.305.
The French Epirubicin Study Group carried out a randomized trial comparing epirubicin alone 75 mg/m2 with fluorouracil (5FU) 500 mg/m2, cyclophosphamide 500 mg/m2, and epirubicin 50 mg/m2 (FEC 50) and 5FU 500 mg/m2, cyclophosphamide 500 mg/m2, and epirubicin 75 mg/m2 (FEC 75) as first treatment for advanced breast cancer patients. Patients were stratified according to whether or not there were bone metastases only. Four hundred twelve patients entered this trial; 378 were assessable for tolerability and 365 for efficacy. The overall response rates were comparable between FEC 50 (44.6%) and FEC 75 (44.7%), but both were better than the epirubicin alone (30.6%) (P = .04 and P = .0006, respectively). The complete response rate was better in FEC 75 (15.5%) than in FEC 50 (7%) (P = .025) or epirubicin (4%) (P = .002). Similar results were obtained in the group of patients without bone-only metastases. No difference in the three treatments was observed in the patients with bone metastases only. Mean durations of response were similar in the three groups, being 412 days, 440 days, and 350 days for FEC 50, FEC 75, and epirubicin, respectively. Patients without previous adjuvant chemotherapy fared better than those with previous treatment (without anthracyclines). Tolerability was fair in the three groups. Overall, the epirubicin-alone group showed better tolerance than the two other groups, which did not differ significantly. Time to progression and survival were not different among the three groups, but more early relapses occurred in the epirubicin and FEC 50 groups; survival seemed to be better during the first 8 months in the FEC 75 group, and the survival difference between the epirubicin group and the FEC 75 group was of borderline significance. No difference in survival was observed between epirubicin- and FEC 50-group patients, even though the response rate was significantly worse in the monochemotherapy group.
法国表柔比星研究小组开展了一项随机试验，比较单独使用表柔比星75mg/m²与氟尿嘧啶（5FU）500mg/m²、环磷酰胺500mg/m²和表柔比星50mg/m²（FEC 50）以及5FU 500mg/m²、环磷酰胺500mg/m²和表柔比星75mg/m²（FEC 75）作为晚期乳腺癌患者的一线治疗方案。患者根据是否仅存在骨转移进行分层。412例患者进入该试验；378例可评估耐受性，365例可评估疗效。FEC 50组（44.6%）和FEC 75组（44.7%）的总缓解率相当，但均优于单独使用表柔比星组（30.6%）（P值分别为0.04和0.0006）。FEC 75组的完全缓解率（15.5%）高于FEC 50组（7%）（P = 0.025）或表柔比星组（4%）（P = 0.002）。在仅无骨转移的患者组中也获得了类似结果。在仅存在骨转移的患者中，三种治疗方法未观察到差异。三组的平均缓解持续时间相似，FEC 50组、FEC 75组和表柔比星组分别为412天、440天和350天。未接受过辅助化疗的患者比接受过先前治疗（不含蒽环类药物）的患者预后更好。三组的耐受性尚可。总体而言，单独使用表柔比星组的耐受性优于其他两组，而其他两组之间无显著差异。三组之间的疾病进展时间和生存率无差异，但表柔比星组和FEC 50组出现更多早期复发；FEC 75组在前8个月的生存率似乎更好，表柔比星组和FEC 75组之间的生存差异具有临界显著性。表柔比星组和FEC 50组患者的生存率无差异，尽管单药化疗组的缓解率明显更差。
