SCI
8 October 2018
Paz-Ares L, Luft A, Vicente D, et al. Pembrolizumab plus Chemotherapy for Squamous Non–Small-Cell Lung Cancer. New England Journal of Medicine 2018.
Address reprint requests to Dr. Paz-Ares at the Department of Medical Oncology, Hospital Universitario 12 de Octubre, Avenida de Córdoba, Madrid 28041, Spain, or at lpazaresr@seom.org.
BACKGROUND 背景
Standard 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.
对于转移性的、鳞状的非小细胞肺癌（NSCLC）的标准一线治疗是基于铂类的化疗或pembrolizumab（用于有超过50%的肿瘤细胞表达PD-L1的患者）。近年来，pembrolizumab加化疗被证明可以显著延长非鳞状NSLC患者的整体生存期。
METHODS 方法
In 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.
在这个双盲的第三阶段试验中，我们将559例未经治疗的转移性的，鳞状的NSCLC患者随机按1:1的比例分配，接受200 mg的pembrolizumab治疗或生理盐水安慰剂，时间达到35个周期; 在前4个周期中，所有的病人也都接受了卡铂，或者是紫杉醇或纳米颗粒的白蛋白-紫杉醇。主要终点是总体生存和无进展生存。
After 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<>
在平均随访时间为7.8个月后，在pembrolizumab组合组中，平均存活时间为15.9个月（95%CI，13.2到未测及），在安慰剂组合组11.3个月（95%CI，9.5到14.8）。（死亡风险比为0，0.64；95%CI，0.49到0.85;P <>
The overall survival benefit was consistent regardless of the level of PD-L1 expression. The median progression-free survival was 6.4 months (95% CI, 6.2 to 8.3) in the pembrolizumab-combination group and 4.8 months (95% CI, 4.3 to 5.7) in the placebo-combination group (hazard ratio for disease progression or death, 0.56; 95% CI, 0.45 to 0.70; P<>
无论PD-L1的表达水平如何，总体的生存期的获益是一致的。在pembrolizumab组合组中，无进展生存期的中值为6.4个月（95%CI，6.2至8.3），在安慰剂组合组为4.8个月（95%CI，4.3到5.7） （疾病进展或死亡的危险比为0.56， 95%C, 0.45到0.70;P <>
Adverse events of grade 3 or higher occurred in 69.8% of the patients in the pembrolizumab-combination group and in 68.2% of the patients in the placebo-combination group. Discontinuation of treatment because of adverse events was more frequent in the pembrolizumab-combination group than in the placebo-combination group (13.3% vs. 6.4%).
3级或以上的不良事件发生在pembrolizumab组合组中69.8%的患者中，在安慰剂组的患者中有68.2%。与安慰剂组合组相比，在pembrolizumab组合组中，因不良反应而停止治疗的频率更高（13.3%比6.4%）。
In patients with previously untreated metastatic, squamous NSCLC, the addition of pembrolizumab to chemotherapy with carboplatin plus paclitaxel or nab-paclitaxel resulted in significantly longer overall survival and progression-free survival than chemotherapy alone. (Funded by Merck Sharp & Dohme; KEYNOTE-407 ClinicalTrials.gov number, NCT02775435.)
在以前未经治疗的转移性的鳞状细胞NSCLC患者中，使用卡铂和紫杉醇或nab-紫杉醇的化疗再加上pembrolizumab，可以使其在整体存活率和无进展生存期比单纯的化疗要长得多。
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