Erlotinib in previously treated non-small-cell lung cancer
Erlotinib in previously treated non-small-cell lung cancer
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DOI：
10.1056/nejmoa050753
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发表时间：
2005-07-14
影响因子：
158.5
通讯作者：
Seymour, L
中科院分区：
文献类型：
--
作者：
Shepherd, FA;Pereira, JR;Seymour, L
我们进行了一项随机，安慰剂对照，双盲试验，以确定是否表皮生长因子受体抑制剂厄洛替尼在非小细胞肺癌一线或二线化疗失败后的生存率。方法IIIB或IV期非小细胞肺癌患者，从0到3的性能状态，如果他们接受了一个或两个先前的化疗方案。根据中心、体力状态、对先前化疗的反应、先前方案的数量和先前基于铂的治疗对患者进行分层，并以2：1的比例随机分配接受口服厄洛替尼，剂量为每日150 mg，或安慰剂。49%的患者接受过两种化疗方案，93%的患者接受过铂类化疗。厄洛替尼组的反应率为8.9%，安慰剂组的反应率低于1%（P< 0.001）;反应的中位持续时间分别为7.9个月和3.7个月。无进展生存期分别为2.2个月和1.8个月（风险比为0.61，经分层分类调整; P< 0.001）。总生存期分别为6.7个月和4.7个月（风险比，0.70; P< 0.001），厄洛替尼更有利。百分之五的患者停止厄洛替尼，因为毒性effects.CONCLUSIONSErlotinib可以延长一线或二线化疗后的非小细胞肺癌患者的生存期。
BACKGROUNDWe conducted a randomized, placebo-controlled, double-blind trial to determine whether the epidermal growth factor receptor inhibitor erlotinib prolongs survival in non - small-cell lung cancer after the failure of first-line or second-line chemotherapy.METHODSPatients with stage IIIB or IV non - small-cell lung cancer, with performance status from 0 to 3, were eligible if they had received one or two prior chemotherapy regimens. The patients were stratified according to center, performance status, response to prior chemotherapy, number of prior regimens, and prior platinum-based therapy and were randomly assigned in a 2: 1 ratio to receive oral erlotinib, at a dose of 150 mg daily, or placebo.RESULTSThe median age of the 731 patients who underwent randomization was 61.4 years; 49 percent had received two prior chemotherapy regimens, and 93 percent had received platinum-based chemotherapy. The response rate was 8.9 percent in the erlotinib group and less than 1 percent in the placebo group (P< 0.001); the median duration of the response was 7.9 months and 3.7 months, respectively. Progression-free survival was 2.2 months and 1.8 months, respectively ( hazard ratio, 0.61, adjusted for stratification categories; P< 0.001). Overall survival was 6.7 months and 4.7 months, respectively ( hazard ratio, 0.70; P< 0.001), in favor of erlotinib. Five percent of patients discontinued erlotinib because of toxic effects.CONCLUSIONSErlotinib can prolong survival in patients with non - small-cell lung cancer after first-line or second-line chemotherapy.