Ipilimumab in Combination With Paclitaxel and Carboplatin As First-Line Treatment in Stage IIIB/IV Non-Small-Cell Lung Cancer: Results From a Randomized, Double-Blind, Multicenter Phase II Study
Ipilimumab in Combination With Paclitaxel and Carboplatin As First-Line Treatment in Stage IIIB/IV Non-Small-Cell Lung Cancer: Results From a Randomized, Double-Blind, Multicenter Phase II Study
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DOI：
10.1200/jco.2011.38.4032
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发表时间：
2012-06-10
影响因子：
45.3
通讯作者：
Reck, Martin
中科院分区：
文献类型：
--
作者：
Lynch, Thomas J.;Bondarenko, Igor;Reck, Martin
目的
伊匹木单抗是一种抗细胞毒性T细胞淋巴细胞相关抗原4单克隆抗体，在按照方案规定的指南处理不良事件（AE）的情况下，对黑色素瘤显示出生存获益。一项针对肺癌的Ⅱ期研究评估了伊匹木单抗联合紫杉醇和卡铂的活性。
患者与方法
初治的非小细胞肺癌（NSCLC）患者（N = 204）按1∶1∶1随机分组，接受紫杉醇（175 mg/m²）和卡铂（曲线下面积为6），同时联合以下两种方案之一的安慰剂（对照组）或伊匹木单抗：同步伊匹木单抗组（4剂伊匹木单抗联合紫杉醇和卡铂，随后2剂安慰剂联合紫杉醇和卡铂）或序贯伊匹木单抗组（2剂安慰剂联合紫杉醇和卡铂，随后4剂伊匹木单抗联合紫杉醇和卡铂）。治疗每3周静脉给药一次，持续……
PurposeIpilimumab, which is an anti-cytotoxic T-cell lymphocyte-4 monoclonal antibody, showed a survival benefit in melanoma with adverse events (AEs) managed by protocol-defined guidelines. A phase II study in lung cancer assessed the activity of ipilimumab plus paclitaxel and carboplatin.Patients and MethodsPatients (N = 204) with chemotherapy-naive non-small-cell lung cancer (NSCLC) were randomly assigned 1:1:1 to receive paclitaxel (175 mg/m(2)) and carboplatin (area under the curve, 6) with either placebo (control) or ipilimumab in one of the following two regimens: concurrent ipilimumab (four doses of ipilimumab plus paclitaxel and carboplatin followed by two doses of placebo plus paclitaxel and carboplatin) or phased ipilimumab (two doses of placebo plus paclitaxel and carboplatin followed by four doses of ipilimumab plus paclitaxel and carboplatin). Treatment was administered intravenously every 3 weeks for