Paclitaxel plus bevacizumab versus paclitaxel alone for metastatic breast cancer
Paclitaxel plus bevacizumab versus paclitaxel alone for metastatic breast cancer
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DOI：
10.1056/nejmoa072113
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发表时间：
2007-12-27
影响因子：
158.5
通讯作者：
Davidson, Nancy E.
中科院分区：
文献类型：
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作者：
Miller, Kathy;Wang, Molin;Davidson, Nancy E.
背景：在一项开放标签、随机、3 期试验中，我们比较了紫杉醇与紫杉醇加贝伐单抗（一种抗血管内皮生长因子的单克隆抗体）作为转移性乳腺癌初始治疗的疗效和安全性。方法：我们随机分配患者在每 4 周第 1、8 和 15 天接受每平方米体表面积 90 mg 的紫杉醇治疗，单独治疗或联合 10 mg 治疗第 1 天和第 15 天每公斤体重的贝伐珠单抗。主要终点是无进展生存期；总生存期是次要终点。结果：从2001年12月到2004年5月，共有722名患者入组。与单独使用紫杉醇相比，紫杉醇联合贝伐单抗显着延长无进展生存期（中位时间为 11.8 个月与 5.9 个月；进展风险比为 0.60；P
Background: In an open-label, randomized, phase 3 trial, we compared the efficacy and safety of paclitaxel with that of paclitaxel plus bevacizumab, a monoclonal antibody against vascular endothelial growth factor, as initial treatment for metastatic breast cancer.Methods: We randomly assigned patients to receive 90 mg of paclitaxel per square meter of body-surface area on days 1, 8, and 15 every 4 weeks, either alone or with 10 mg of bevacizumab per kilogram of body weight on days 1 and 15. The primary end point was progression-free survival; overall survival was a secondary end point.Results: From December 2001 through May 2004, a total of 722 patients were enrolled. Paclitaxel plus bevacizumab significantly prolonged progression-free survival as compared with paclitaxel alone (median, 11.8 vs. 5.9 months; hazard ratio for progression, 0.60; P