Phase III study, V-15-32, of gefitinib versus docetaxel in previously treated Japanese patients with non-small-cell lung cancer
Phase III study, V-15-32, of gefitinib versus docetaxel in previously treated Japanese patients with non-small-cell lung cancer
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DOI：
10.1200/jco.2007.15.0185
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发表时间：
2008-09-10
影响因子：
45.3
通讯作者：
Fukuoka, Masahiro
中科院分区：
文献类型：
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作者：
Maruyama, Riichiroh;Nishiwaki, Yutaka;Fukuoka, Masahiro
目的：这项III期研究（V-15-32）比较了吉非替尼（250 mg/d）和多西他赛（60 mg/m(2)）在1或2个化疗方案失败的晚期/转移性非小细胞肺癌（NSCLC）患者（N = 489）中的疗效。方法：主要目的是比较吉非替尼相对于多西他赛的总生存期。采用未调整的Cox回归模型进行初步分析。结果根据预定义标准（HR上限），总生存期未达到非劣效性（风险比[HR]， 1.12; 95.24% CI, 0.89 ~ 1.40）
PurposeThis phase III study (V-15-32) compared gefitinib (250 mg/d) with docetaxel (60 mg/m(2)) in patients (N = 489) with advanced/metastatic non-small-cell lung cancer (NSCLC) who had failed one or two chemotherapy regimens.MethodsThe primary objective was to compare overall survival to demonstrate noninferiority for gefitinib relative to docetaxel. An unadjusted Cox regression model was used for the primary analysis.ResultsNoninferiority in overall survival was not achieved (hazard ratio [HR], 1.12; 95.24% CI, 0.89 to 1.40) according to the predefined criterion (upper CI limit for HR