Five Year Survival Update From KEYNOTE-010: Pembrolizumab Versus Docetaxel for Previously Treated, Programmed Death-Ligand 1-Positive Advanced NSCLC.

Autor:	Herbst RS; Section of Medical Oncology, Yale Comprehensive Cancer Center, Yale University School of Medicine, New Haven, Connecticut. Electronic address: roy.herbst@yale.edu., Garon EB; David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California., Kim DW; Seoul National University Hospital, Seoul National University College of Medicine, Seoul, South Korea., Cho BC; Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea., Gervais R; Centre François Baclesse, Caen, France., Perez-Gracia JL; Clinica Universidad de Navarra, Pamplona, Spain., Han JY; Center for Lung Cancer, National Cancer Center, Goyang, South Korea., Majem M; Hospital de la Santa Creu i Sant Pau, Barcelona, Spain., Forster MD; UCL Cancer Institute/University College London Hospitals, London, United Kingdom., Monnet I; Centre Hospitalier Intercommunal de Créteil, Créteil, France., Novello S; Department of Oncology, University of Turin, Azienda Ospedaliero Universitaria San Luigi, Turin, Italy., Gubens MA; University of California, San Francisco, San Francisco, California., Boyer M; Chris O'Brien Lifehouse, Camperdown, Australia., Su WC; National Cheng Kung University Hospital, Tainan, Taiwan., Samkari A; Merck & Co., Inc., Kenilworth, New Jersey., Jensen EH; Merck & Co., Inc., Kenilworth, New Jersey., Kobie J; Merck & Co., Inc., Kenilworth, New Jersey., Piperdi B; Merck & Co., Inc., Kenilworth, New Jersey., Baas P; The Netherlands Cancer Institute, Amsterdam, the Netherlands.
Jazyk:	angličtina
Zdroj:	Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer [J Thorac Oncol] 2021 Oct; Vol. 16 (10), pp. 1718-1732. Date of Electronic Publication: 2021 May 26.
DOI:	10.1016/j.jtho.2021.05.001
Abstrakt:	Introduction: In the KEYNOTE-010 study, pembrolizumab improved overall survival (OS) versus docetaxel in patients with previously treated, advanced NSCLC with programmed death-ligand 1 (PD-L1) tumor proportion score (TPS) ≥50% and ≥1%. We report 5-year efficacy and safety follow-up for the KEYNOTE-010 study. Methods: Patients were randomized to pembrolizumab 2 mg/kg or 10 mg/kg once every 3 weeks or docetaxel 75 mg/m 2 once every 3 weeks for up to 35 cycles (2 y). Patients who completed pembrolizumab treatment and subsequently had recurrence could receive second-course pembrolizumab for up to 17 cycles (1 y). Pembrolizumab doses were pooled in this analysis. Results: A total of 1034 patients were randomized (pembrolizumab, n = 691; docetaxel, n = 343). Median study follow-up was 67.4 months (range: 60.0‒77.9). The hazard ratio (95% confidence interval) for OS was 0.55 (0.44‒0.69) for patients with PD-L1 TPS ≥50% and 0.70 (0.61‒0.80) with PD-L1 TPS ≥1%. The 5-year OS rates for pembrolizumab versus docetaxel were 25.0% versus 8.2% in patients with PD-L1 TPS ≥50% and 15.6% versus 6.5% with PD-L1 TPS ≥1%. Among 79 patients who completed 35 cycles/2 years of pembrolizumab, the OS rate 3 years after completion (∼5 y from randomization) was 83.0%. A total of 21 patients received second-course pembrolizumab; 11 (52.4%) had an objective response after starting the second course and 15 (71.4%) were alive at data cutoff. Exploratory biomarker analysis revealed that higher tissue tumor mutational burden (≥175 mutations per exome) was associated with improved outcomes with pembrolizumab. Conclusions: Pembrolizumab continued to provide long-term benefit than docetaxel in patients with previously treated advanced NSCLC with PD-L1 TPS ≥50% and ≥1%. Our findings confirm pembrolizumab as a standard-of-care treatment in the second-line or later setting. (Copyright © 2021. Published by Elsevier Inc.)
Databáze:	MEDLINE
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