Publication:
Pembrolizumab plus Chemotherapy for Squamous Non-Small-Cell Lung Cancer.

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2018-09-25

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Paz-Ares, Luis
Luft, Alexander
Vicente, David
Tafreshi, Ali
Gümüş, Mahmut
Mazières, Julien
Hermes, Barbara
Çay Şenler, Filiz
Csőszi, Tibor
Fülöp, Andrea

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Abstract

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. 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. 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 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 .).

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Adult
Aged
Aged, 80 and over
Antibodies, Monoclonal, Humanized
Antineoplastic Combined Chemotherapy Protocols
Carboplatin
Carcinoma, Non-Small-Cell Lung
Double-Blind Method
Female
Humans
Intention to Treat Analysis
Lung Neoplasms
Male
Middle Aged
Paclitaxel
Programmed Cell Death 1 Receptor
Progression-Free Survival
Survival Analysis

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