Reduced cardiotoxicity and comparable efficacy in a phase III trial of pegylated liposomal doxorubicin HCl (CAELYX™/Doxil®) versus conventional doxorubicin for first-line treatment of metastatic breast cancer
Reduced cardiotoxicity and comparable efficacy in a phase III trial of pegylated liposomal doxorubicin HCl (CAELYX™/Doxil®) versus conventional doxorubicin for first-line treatment of metastatic breast cancer
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DOI：
10.1093/annonc/mdh097
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发表时间：
2004-03-01
影响因子：
50.5
通讯作者：
Tendler, C
中科院分区：
文献类型：
--
作者：
O'Brien, MER;Wigler, N;Tendler, C
背景资料：本研究旨在证明CAELYX（TM）[聚乙二醇化脂质体盐酸多柔比星（PLD）]的疗效[无进展生存期（PFS）]不劣于多柔比星，在转移性乳腺癌（MBC）女性的一线治疗中具有显著更低的心脏毒性。患有MBC且心功能正常的女性（n = 509）被随机分配接受PLD 50 mg/m2（每4周）或阿霉素60 mg/m2（每3周）。心脏事件发生率的基础上减少左心室射血分数作为一个功能的累积anthracycline dose.Results：PLD和阿霉素是可比的PFS [6.9与7.8个月，分别;风险比（HR）= 1.00; 95%置信区间（CI）0.82-1.22]。亚组结果一致。多柔比星组的心脏毒性总体风险显著高于PLD组（HR = 3.16; 95%CI 1.58-6.31; P
Background: This study was designed to demonstrate that efficacy [progression-free survival (PFS)] of CAELYX(TM) [pegylated liposomal doxorubicin HCl (PLD)] is non-inferior to doxorubicin with significantly less cardiotoxicity in first-line treatment of women with metastatic breast cancer (MBC).Patients and methods: Women (n = 509) with MBC and normal cardiac function were randomized to receive either PLD 50 mg/m(2) (every 4 weeks) or doxorubicin 60 mg/m(2) (every 3 weeks). Cardiac event rates were based on reductions in left ventricular ejection fraction as a function of cumulative anthracycline dose.Results: PLD and doxorubicin were comparable with respect to PFS [6.9 versus 7.8 months, respectively; hazard ratio (HR) = 1.00; 95% confidence interval (CI) 0.82-1.22]. Subgroup results were consistent. Overall risk of cardiotoxicity was significantly higher with doxorubicin than PLD (HR = 3.16; 95%CI 1.58-6.31; P