Hortobagyi G N, Yap H Y, Kau S W, Fraschini G, Ewer M S, Chawla S P, Benjamin R S
Department of Medical Oncology, University of Texas M.D. Anderson Hospital and Tumor Institute, Houston 77030.
Am J Clin Oncol. 1989 Feb;12(1):57-62. doi: 10.1097/00000421-198902000-00014.
Seventy-seven patients with progressive metastatic breast cancer refractory to prior therapy participated in a prospective randomized trial designed to compare the efficacy and toxicity of doxorubicin and epirubicin administered as single agents. In arm 1, 60 mg/m2 of doxorubicin and, in arm 2, 90 mg/m2 of epirubicin were administered by 48-h continuous i.v. infusion every 3 weeks. In arm 3, 90 mg/m2 of epirubicin was administered by bolus every 3 weeks. Patients in the three groups had similar characteristics, except that in arm 3 more patients were premenopausal, had more extensive disease, and fewer patients had been exposed to doxorubicin. Objective remission rates were 29, 26, and 13%, respectively for the three arms. Median response durations ranged from 4-6 months. No significant differences occurred in response rate, remission duration, or survival among patients in the three arms. The incidence of gastrointestinal toxicity and alopecia was evenly distributed. Hematologic toxicity was more severe in arms 2 and 3, and there was a higher incidence of infectious complications in arms 2 and 3 compared to arm 1 (p = 0.05). Two episodes of congestive heart failure occurred in arm 1, one in arm 2, and three in arm 3. Although the total cumulative anthracycline dosage was highest in the arm 2 group, they had the lowest incidence of cardiac toxicity. Epirubicin by bolus and doxorubicin administered by continuous infusion have similar potential for cardiac toxicity. Epirubicin administered by continuous infusion appears less cardiotoxic than doxorubicin by either method of administration or epirubicin given by bolus. Epirubicin appears equally active and less cardiotoxic than the parent compound doxorubicin in patients with metastatic breast cancer.
77例先前治疗无效的进行性转移性乳腺癌患者参与了一项前瞻性随机试验，该试验旨在比较阿霉素和表阿霉素单药治疗的疗效和毒性。在第1组中，每3周通过48小时持续静脉输注给予60mg/m²阿霉素，在第2组中，每3周通过48小时持续静脉输注给予90mg/m²表阿霉素。在第3组中，每3周推注给予90mg/m²表阿霉素。三组患者具有相似的特征，只是第3组中更多患者为绝经前患者，疾病范围更广，且接触过阿霉素的患者更少。三组的客观缓解率分别为29%、26%和13%。中位缓解持续时间为4 - 6个月。三组患者在缓解率、缓解持续时间或生存率方面无显著差异。胃肠道毒性和脱发的发生率分布均匀。第2组和第3组的血液学毒性更严重，与第1组相比，第2组和第3组感染并发症的发生率更高（p = 0.05）。第1组发生2例充血性心力衰竭，第2组发生1例，第3组发生3例。尽管第2组阿霉素的总累积剂量最高，但他们的心脏毒性发生率最低。推注表阿霉素和持续输注阿霉素具有相似的心脏毒性潜力。持续输注表阿霉素似乎比通过任何一种给药方法给予的阿霉素或推注表阿霉素的心脏毒性更小。在转移性乳腺癌患者中，表阿霉素似乎与母体化合物阿霉素具有同等活性且心脏毒性更小。
