Long-term survival advantage for women treated with pegylated liposomal doxorubicin compared with topotecan in a phase 3 randomized study of recurrent and refractory epithelial ovarian cancer

拓扑替康 医学 内科学 危险系数 化疗 胃肠病学 阿霉素 随机对照试验 肿瘤科 药理学 外科 置信区间
作者
Alan N. Gordon,Margaret Tonda,Steven Sun,Wayne Rackoff
出处
期刊:Gynecologic Oncology [Elsevier]
卷期号:95 (1): 1-8 被引量:415
标识
DOI:10.1016/j.ygyno.2004.07.011
摘要

Abstract Objective Provide long-term follow-up data for women treated in a randomized multicenter study of pegylated liposomal doxorubicin compared with topotecan. Methods Patients with epithelial ovarian cancer that recurred after or failed to respond to first-line platinum-based chemotherapy were randomized to receive pegylated liposomal doxorubicin 50 mg/m 2 every 28 days ( n = 239) or topotecan 1.5 mg/m 2 per day for 5 days every 21 days ( n = 235). Patients were stratified prospectively based on response to initial platinum-based chemotherapy as well as the presence or absence of bulky disease. Most patients had been previously treated with platinum and taxanes (74% in the pegylated liposomal doxorubicin group and 72% in the topotecan group). Survival data are mature: 87% of patients have died ( n = 413). Results There was an 18% reduction in the risk of death for patients treated with pegylated liposomal doxorubicin (median survival 62.7 weeks for pegylated liposomal doxorubicin and 59.7 weeks for topotecan-treated patients; HR=1.216; 95% confidence interval (CI) 1.000–1.478; P = 0.050). The hazard ratio for all randomized subjects (includes those randomized, but never treated; n = 481) was 1.23 (median survival 63.6 weeks for pegylated liposomal doxorubicin and 57.0 weeks for topotecan-treated patients; 95% CI 1.01–1.50; P = 0.038). For patients with platinum-sensitive disease, there was a 30% reduction in the risk of death for the pegylated liposomal doxorubicin-treated group (median survival 107.9 weeks for pegylated liposomal doxorubicin and 70.1 weeks for topotecan-treated patients; HR=1.432; 95% CI 1.066–1.923; P = 0.017). In patients with platinum-refractory disease, survival was similar between treatment groups. Conclusion Long-term follow-up demonstrates that treatment with pegylated liposomal doxorubicin significantly prolongs survival compared with topotecan in patients with recurrent and refractory epithelial ovarian cancer. The survival benefit is pronounced in patients with platinum-sensitive disease.
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