J Clin Oncol. 1988 Apr;6(4):679-88. doi: 10.1200/JCO.1988.6.4.679.
Two hundred sixty-three patients with advanced breast cancer were randomized to two treatment regimens consisting of fluorouracil, 500 mg/m2; cyclophosphamide, 500 mg/m2; and either epirubicin (Farmorubicin, Farmitalia Carlo Erba SpA, Italy), 50 mg/m2 (FEC); or doxorubicin (Adriamycin, Adria Laboratories, Columbus, OH), 50 mg/m2 (FAC), administered intravenously (IV) every 3 weeks. Two hundred thirty patients (FAC, 113; FEC, 117) were evaluable for response, and 244 patients for toxicity (FAC, 120; FEC, 124). The two groups were comparable with respect to age, menopausal status, disease-free interval to first recurrence, time from initial diagnosis to protocol activation, indicator lesions, performance status, and prior adjuvant therapy. Of 117 evaluable patients treated with FEC, 59 (50.4%) had a partial response (PR) or complete response (CR), 40 showed no change (NC), and 18 had progressive disease. Of 113 evaluable patients treated with FAC, 54 (52%) showed a remission, 30 NC, and 18 progression. There was no statistical difference between the two regimens in overall response rate, response rate according to tumor site, time to response, or duration of response. Median survival was 15 months for FEC and 18.2 months for FAC (not significant). In the 120 patients evaluable for toxicity treated with FAC, three episodes of congestive heart failure (CHF) were observed after 225, 350, and 550 mg/m2 of doxorubicin, respectively. Of the 124 evaluable patients treated with FEC, 25 received greater than 600 mg/m2 of epirubicin and no CHF was recorded. FEC induced significantly less neutropenia (P = .01), less nausea and vomiting (P less than .01), and less complete alopecia (P less than 10(-3) than did FAC. The results of this study demonstrate that FEC is as effective a regimen as FAC for the therapy of advanced breast cancer. Moreover, FEC was better tolerated than FAC in this patient population.
263例晚期乳腺癌患者被随机分为两种治疗方案组，治疗方案包括氟尿嘧啶500mg/m²、环磷酰胺500mg/m²，以及表柔比星（法玛新，意大利法玛西亚普强公司）50mg/m²（FEC方案）或多柔比星（阿霉素，美国俄亥俄州哥伦布市阿德里亚实验室）50mg/m²（FAC方案），每3周静脉注射一次。230例患者（FAC方案组113例，FEC方案组117例）可评估疗效，244例患者（FAC方案组120例，FEC方案组124例）可评估毒性。两组在年龄、绝经状态、首次复发的无病间期、从初始诊断到进入研究方案的时间、指示性病灶、体能状态以及既往辅助治疗方面具有可比性。在117例接受FEC方案治疗的可评估患者中，59例（50.4%）有部分缓解（PR）或完全缓解（CR），40例无变化（NC），18例病情进展。在113例接受FAC方案治疗的可评估患者中，54例（52%）缓解，30例NC，18例病情进展。两种方案在总缓解率、根据肿瘤部位的缓解率、缓解时间或缓解持续时间方面无统计学差异。FEC方案组的中位生存期为15个月，FAC方案组为18.2个月（无显著性差异）。在120例接受FAC方案治疗且可评估毒性的患者中，分别在给予多柔比星225mg/m²、350mg/m²和550mg/m²后观察到3例充血性心力衰竭（CHF）发作。在124例接受FEC方案治疗的可评估患者中，25例接受了超过600mg/m²的表柔比星治疗，未记录到CHF。与FAC方案相比，FEC方案引起的中性粒细胞减少明显较少（P = 0.01）、恶心和呕吐较少（P < 0.01）、完全脱发较少（P < 10⁻³）。本研究结果表明，FEC方案在治疗晚期乳腺癌方面与FAC方案同样有效。此外，在该患者群体中，FEC方案的耐受性优于FAC方案。
