Pembrolizumab plus Chemotherapy for Squamous Non-Small-Cell Lung Cancer
Pembrolizumab plus Chemotherapy for Squamous Non-Small-Cell Lung Cancer
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DOI：
10.1056/nejmoa1810865
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发表时间：
2018-11-22
影响因子：
158.5
通讯作者：
Kowalski, D. M.
中科院分区：
文献类型：
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作者：
Paz-Ares, L.;Luft, A.;Kowalski, D. M.
背景：转移性鳞状非小细胞肺癌(NSCLC)的标准一线治疗是以铂为基础的化疗或培溴利珠单抗(适用于程序性死亡配体1[PD-L1]表达在50%的肿瘤细胞上的患者)。在这项3期双盲试验中，我们以1：1的比例随机分配了559名未经治疗的转移性鳞状非小细胞肺癌患者，接受200毫克的培布罗珠单抗或生理盐水安慰剂治疗，疗程长达35个周期；所有患者还接受卡铂和紫杉醇或纳米白蛋白结合[NAB]-紫杉醇治疗前4个周期。结果经过7.8个月的中位随访，培溴利珠单抗联合组的中位总生存期为15.9个月(95%可信区间，13.2个月未达)，安慰剂联合组的中位总生存期为11.3个月(95%可信区间，9.5~14.8)(死亡风险比0.64；95%可信区间0.49~0.85；P
BACKGROUNDStandard first-line therapy for metastatic, squamous non-small-cell lung cancer (NSCLC) is platinum-based chemotherapy or pembrolizumab (for patients with programmed death ligand 1 [PD-L1] expression on >= 50% of tumor cells). More recently, pembrolizumab plus chemotherapy was shown to significantly prolong overall survival among patients with nonsquamous NSCLC.METHODSIn this double-blind, phase 3 trial, we randomly assigned, in a 1:1 ratio, 559 patients with untreated metastatic, squamous NSCLC to receive 200 mg of pembrolizumab or saline placebo for up to 35 cycles; all the patients also received carboplatin and either paclitaxel or nanoparticle albumin-bound [nab]-paclitaxel for the first 4 cycles. Primary end points were overall survival and progression-free survival.RESULTSAfter a median follow-up of 7.8 months, the median overall survival was 15.9 months (95% confidence interval [CI], 13.2 to not reached) in the pembrolizumab-combination group and 11.3 months (95% CI, 9.5 to 14.8) in the placebo-combination group (hazard ratio for death, 0.64; 95% CI, 0.49 to 0.85; P