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J Clin Oncol. 2017 Dec 10;35(35):3924-3933. doi: 10.1200/JCO.2017.74.3062. Epub 2017 Oct 12.

Nivolumab Versus Docetaxel in Previously Treated Patients With Advanced Non-Small-Cell Lung Cancer: Two-Year Outcomes From Two Randomized, Open-Label, Phase III Trials (CheckMate 017 and CheckMate 057).

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Leora Horn, Vanderbilt-Ingram Cancer Center; David R. Spigel, Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN; Everett E. Vokes, University of Chicago, Chicago, IL; Esther Holgado, Hospital De Madrid, Norte Sanchinarro, Madrid; Enriqueta Felip, Hospital Universitari Vall d'Hebron, Barcelona; Luis Paz-Ares, Hospital Universitario Virgen Del Rocio, Seville, Spain; Neal Ready, Duke University Medical Center, Durham, NC; Martin Steins, Thoraxklinik-Heidelberg gGmbH, Heidelberg; Martin Kohlhäeufl, Robert-Bosch-Krankenhaus, Stuttgart; Martin Reck, LungenClinic Grosshansdorf, Airway Research Center North, German Center for Lung Research, Grosshansdorf; Wilfried E.E. Eberhardt, University Hospital and Ruhrlandclinic, University of Duisburg-Essen, Essen, Germany; Elena Poddubskaya, N.N. Blokhin Russian Cancer Research Center, Moscow, Russia; Hossein Borghaei, Fox Chase Cancer Center, Philadelphia, PA; Adam Pluzanski, Centrum Onkologii-Instytut Im. Marii Sklodowskiej-Curie, Warsaw, Poland; Karen L. Reckamp, City of Hope, Duarte, CA; Marco A. Burgio and Lucio Crinò, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Istituto Scientifico Romagnolo Per lo Studio e la Cura dei Tumori, Meldola, Italy; David Waterhouse, Oncology Hematology Care (OHC)/US Oncology, Cincinnati, OH; Fabrice Barlesi, Aix-Marseille Université, Assistance Publique Hôpitaux de Marseille, Marseille; Jérôme Fayette, Léon Bérard, Lyon, France; Scott Antonia, H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL; Oscar Arrieta, Instituto Nacional De Cancerologia, Mexico City, Mexico; Naiyer Rizvi and Matthew D. Hellmann, Memorial Sloan Kettering Cancer Center, New York, NY; William J. Geese, Ang Li, Anne Blackwood-Chirchir, and Diane Healey, Bristol-Myers Squibb, Princeton, NJ; and Julie Brahmer, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD.


Purpose Nivolumab, a programmed death-1 inhibitor, prolonged overall survival compared with docetaxel in two independent phase III studies in previously treated patients with advanced squamous (CheckMate 017; identifier: NCT01642004) or nonsquamous (CheckMate 057; identifier: NCT01673867) non-small-cell lung cancer (NSCLC). We report updated results, including a pooled analysis of the two studies. Methods Patients with stage IIIB/IV squamous (N = 272) or nonsquamous (N = 582) NSCLC and disease progression during or after prior platinum-based chemotherapy were randomly assigned 1:1 to nivolumab (3 mg/kg every 2 weeks) or docetaxel (75 mg/m2 every 3 weeks). Minimum follow-up for survival was 24.2 months. Results Two-year overall survival rates with nivolumab versus docetaxel were 23% (95% CI, 16% to 30%) versus 8% (95% CI, 4% to 13%) in squamous NSCLC and 29% (95% CI, 24% to 34%) versus 16% (95% CI, 12% to 20%) in nonsquamous NSCLC; relative reductions in the risk of death with nivolumab versus docetaxel remained similar to those reported in the primary analyses. Durable responses were observed with nivolumab; 10 (37%) of 27 confirmed responders with squamous NSCLC and 19 (34%) of 56 with nonsquamous NSCLC had ongoing responses after 2 years' minimum follow-up. No patient in either docetaxel group had an ongoing response. In the pooled analysis, the relative reduction in the risk of death with nivolumab versus docetaxel was 28% (hazard ratio, 0.72; 95% CI, 0.62 to 0.84), and rates of treatment-related adverse events were lower with nivolumab than with docetaxel (any grade, 68% v 88%; grade 3 to 4, 10% v 55%). Conclusion Nivolumab provides long-term clinical benefit and a favorable tolerability profile compared with docetaxel in previously treated patients with advanced NSCLC.

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