Identificador persistente para citar o vincular este elemento: http://hdl.handle.net/10553/41319
Título: Pembrolizumab plus Chemotherapy in Metastatic Non-Small-Cell Lung Cancer
Autores/as: Gandhi, Leena
Rodríguez Abreu, Delvys 
Gadgeel, Shirish M.
Esteban, Emilio
Felip, Enriqueta
De Angelis, Flavia
Dómine, Manuel
Clingan, Phillip R.
Hochmair, Maximilian J.
Powell, Steven F.
Cheng, Susanna Yee Shan
Bischoff, Helge G.
Peled, Nir
Grossi, Francesco
Jennens, Ross R.
Reck, Martin
Hui, Rina
Garon, Edward B.
Boyer, Michael
Rubio-Viqueira, Belén
Novello, Silvia
Kurata, Takayasu
Gray, Jhanelle E.
Vida, John
Wei, Ziwen
Yang, Jing
Raftopoulos, Harry
Pietanza, Maria Catherine
Garassino, Marina Chiara
KEYNOTE
Clasificación UNESCO: 32 Ciencias médicas
320101 Oncología
Palabras clave: Cáncer de pulmón
Metástasis
Fecha de publicación: 2018
Publicación seriada: New England Journal of Medicine 
Resumen: Background. First-line therapy for advanced non–small-cell lung cancer (NSCLC) that lacks targetable mutations is platinum-based chemotherapy. Among patients with a tumor proportion score for programmed death ligand 1 (PD-L1) of 50% or greater, pembrolizumab has replaced cytotoxic chemotherapy as the first-line treatment of choice. The addition of pembrolizumab to chemotherapy resulted in significantly higher rates of response and longer progression-free survival than chemotherapy alone in a phase 2 trial. Methods. In this double-blind, phase 3 trial, we randomly assigned (in a 2:1 ratio) 616 patients with metastatic nonsquamous NSCLC without sensitizing EGFR or ALK mutations who had received no previous treatment for metastatic disease to receive pemetrexed and a platinum-based drug plus either 200 mg of pembrolizumab or placebo every 3 weeks for 4 cycles, followed by pembrolizumab or placebo for up to a total of 35 cycles plus pemetrexed maintenance therapy. Crossover to pembrolizumab monotherapy was permitted among the patients in the placebo-combination group who had verified disease progression. The primary end points were overall survival and progression-free survival, as assessed by blinded, independent central radiologic review. Results. After a median follow-up of 10.5 months, the estimated rate of overall survival at 12 months was 69.2% (95% confidence interval [CI], 64.1 to 73.8) in the pembrolizumab-combination group versus 49.4% (95% CI, 42.1 to 56.2) in the placebo-combination group (hazard ratio for death, 0.49; 95% CI, 0.38 to 0.64; P<0.001). Improvement in overall survival was seen across all PD-L1 categories that were evaluated. Median progression-free survival was 8.8 months (95% CI, 7.6 to 9.2) in the pembrolizumab-combination group and 4.9 months (95% CI, 4.7 to 5.5) in the placebo-combination group (hazard ratio for disease progression or death, 0.52; 95% CI, 0.43 to 0.64; P<0.001). Adverse events of grade 3 or higher occurred in 67.2% of the patients in the pembrolizumab-combination group and in 65.8% of those in the placebo-combination group. Conclusions. In patients with previously untreated metastatic nonsquamous NSCLC without EGFR or ALK mutations, the addition of pembrolizumab to standard chemotherapy of pemetrexed and a platinum-based drug resulted in significantly longer overall survival and progression-free survival than chemotherapy alone.
URI: http://hdl.handle.net/10553/41319
ISSN: 0028-4793
DOI: 10.1056/NEJMoa1801005
Fuente: New England Journal Of Medicine [ISSN 0028-4793], v. 378 (22), p. 2078-2092, (Mayo 2018)
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