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http://hdl.handle.net/10553/73944
Título: | Pembrolizumab or Placebo Plus Etoposide and Platinum as First-Line Therapy for Extensive-Stage Small-Cell Lung Cancer: Randomized, Double-Blind, Phase III KEYNOTE-604 Study | Autores/as: | Rudin, Charles M. Awad, Mark M. Navarro, Alejandro Gottfried, Maya Peters, Solange Csőszi, Tibor Cheema, Parneet K. Rodríguez Abreu, Delvys Wollner, Mirjana Yang, James Chih Hsin Mazieres, Julien Orlandi, Francisco J. Luft, Alexander Gümüş, Mahmut Kato, Terufumi Kalemkerian, Gregory P. Luo, Yiwen Ebiana, Victoria Pietanza, M. Catherine Kim, Hye Ryun |
Clasificación UNESCO: | 320101 Oncología | Fecha de publicación: | 2020 | Publicación seriada: | Journal of Clinical Oncology | Resumen: | Pembrolizumab monotherapy has shown antitumor activity in patients with small-cell lung cancer (SCLC). The randomized, double-blind, phase III KEYNOTE-604 study compared pembrolizumab plus etoposide and platinum (EP) with placebo plus EP for patients with previously untreated extensive-stage (ES) SCLC. METHODS: Eligible patients were randomly assigned 1:1 to pembrolizumab 200 mg once every 3 weeks or saline placebo for up to 35 cycles plus 4 cycles of EP. Primary end points were progression-free survival (PFS; RECIST version 1.1, blinded central review) and overall survival (OS) in the intention-to-treat population. Objective response rate (ORR) and duration of response were secondary end points. Prespecified efficacy boundaries were one-sided P = .0048 for PFS and .0128 for OS. RESULTS: Of the 453 participants, 228 were randomly assigned to pembrolizumab plus EP and 225 to placebo plus EP. Pembrolizumab plus EP significantly improved PFS (hazard ratio [HR], 0.75; 95% CI, 0.61 to 0.91; P = .0023). Twelve-month PFS estimates were 13.6% with pembrolizumab plus EP and 3.1% with placebo plus EP. Although pembrolizumab plus EP prolonged OS, the significance threshold was not met (HR, 0.80; 95% CI, 0.64 to 0.98; P = .0164). Twenty-four-month OS estimates were 22.5% and 11.2%, respectively. ORR was 70.6% in the pembrolizumab plus EP group and 61.8% in the placebo plus EP group; the estimated proportion of responders remaining in response at 12 months was 19.3% and 3.3%, respectively. In the pembrolizumab plus EP and placebo plus EP groups, respectively, any-cause adverse events were grade 3-4 in 76.7% and 74.9%, grade 5 in 6.3% and 5.4%, and led to discontinuation of any drug in 14.8% and 6.3%. CONCLUSION: Pembrolizumab plus EP significantly improved PFS compared with placebo plus EP as first-line therapy for patients with ES-SCLC. No unexpected toxicities were seen with pembrolizumab plus EP. These data support the benefit of pembrolizumab in ES-SCLC. | URI: | http://hdl.handle.net/10553/73944 | ISSN: | 1527-7755 | DOI: | 10.1200/JCO.20.00793 | Fuente: | Journal of Clinical Oncology [EISSN 1527-7755], v. 38 (21), p. 2369-2379, (Julio 2020) |
Colección: | Artículos |
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