Phase III trial of liposomal doxorubicin and cyclophosphamide compared with epirubicin and cyclophosphamide as first-line therapy for metastatic breast cancer
Phase III trial of liposomal doxorubicin and cyclophosphamide compared with epirubicin and cyclophosphamide as first-line therapy for metastatic breast cancer
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DOI：
10.1093/annonc/mdh393
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发表时间：
2004-10-01
影响因子：
50.5
通讯作者：
Lee, LW
中科院分区：
文献类型：
--
作者：
Chan, S;Davidson, N;Lee, LW
目的：确定非聚乙二醇化脂质体阿霉素（Myocet(TM)）和表阿霉素联合环磷酰胺一线治疗转移性乳腺癌患者的疗效和耐受性。方法：160 名未接受过蒽环类药物治疗的转移性乳腺癌患者随机接受 Myocet（M；75 mg/m(2)）或表阿霉素（E；75）治疗。 mg/m(2)) 与环磷酰胺 (C; 600 mg/m(2)) 联用，每 3 周一次，最多 8 个周期。结果指标：缓解（总体缓解 = 完全缓解 + 部分缓解率）、疾病进展时间、总体生存率和心功能（左心室射血分数）。结果：MC 和 EC 治疗的总体缓解率分别为 46% 和 39%（P=0.42）。就治疗失败中位时间（5.7 个月与 4.4 个月；P=0.01）和疾病进展中位时间（7.7 个月与 5.6 个月；P=0.02）而言，MC 优于 EC。 MC 和 EC 的中位生存时间分别为 18.3 个月和 16.0 个月（P=0.504）。毫不奇怪，进行等摩尔比较后，接受 MC 治疗的患者中中性粒细胞减少症和口腔炎/粘膜炎明显更常见。然而，MC 的注射部位毒性较小。两种治疗方法均显示出较低的心脏毒性发生率。结论：Myocet 似乎是表柔比星的可接受替代品，作为转移性乳腺癌患者的一线治疗药物，因为它结合了阿霉素的剂量效应可靠性和表柔比星提供的安全水平。
Objective: To ascertain the efficacy and tolerability of non-pegylated liposomal doxorubicin (Myocet(TM)) and epirubicin combined with cyclophosphamide in the first-line treatment of patients with metastatic breast cancer.Methods: One hundred and sixty anthracycline-naive metastatic breast cancer patients were randomised to receive Myocet (M; 75 mg/m(2)) or epirubicin (E; 75 mg/m(2)) in combination with cyclophosphamide (C; 600 mg/m(2)), every 3 weeks for up to eight cycles.Outcome measures: Response (overall response = complete + partial response rates), time to disease progression, overall survival and cardiac function (left ventricular ejection fraction).Results: Overall response rates were 46% and 39% for MC and EC treatment, respectively (P=0.42). MC was superior to EC with respect to median time to treatment failure (5.7 versus 4.4 months; P=0.01) and median time to disease progression (7.7 versus 5.6 months; P=0.02). Median survival times were 18.3 and 16.0 months for MC and EC, respectively (P=0.504). Unsurprisingly, given an equimolar comparison, neutropenia and stomatitis/mucositis were significantly more common in patients who received MC. However, there was less injection site toxicity with MC. Both treatments showed a low incidence of cardiotoxicity.Conclusion: Myocet appears to be an acceptable alternative to epirubicin as a first-line treatment for patients with metastatic breast cancer because it combines the dose-effect reliability of doxorubicin with the level of safety provided by epirubicin.