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N Engl J Med. 2015 Jul 9;373(2):123-35. doi: 10.1056/NEJMoa1504627. Epub 2015 May 31.

Nivolumab versus Docetaxel in Advanced Squamous-Cell Non-Small-Cell Lung Cancer.

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From the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore (J.B.); the City of Hope Comprehensive Cancer Center, Duarte, CA (K.L.R.); the Netherlands Cancer Institute and Antoni van Leeuwenhoek Hospital, Amsterdam (P.B.), Erasmus MC Cancer Institute, Rotterdam (J.G.A.), and Ziekenhuis Amphia, Breda (J.G.A.) - all in the Netherlands; the University Hospital of Perugia, Perugia (L.C.), and the Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (M.C.G.) - both in Italy; the Department of Medical Oncology, West German Cancer Center, Universitätsklinikum Essen, and the Ruhrlandklinik, Universität Duisburg-Essen, Essen (W.E.E.E.), the Thoraxklinik, Heidelberg University Hospital, Heidelberg (M.S.), and the LungenClinic Grosshansdorf, Grosshansdorf (M.R.) - all in Germany; the N.N. Blokhin Russian Cancer Research Center, Moscow (E.P.); the H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL (S.A.); the Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie, Warsaw, Poland (A.P.); the University of Chicago Medicine and Biological Sciences, Chicago (E.E.V.); the Hospital Madrid Norte Sanchinarro (E.H.), the Hospital Universitario Fundación Jiménez Díaz, Madrid (M.D.), and the Hospital Universitario Virgen Del Rocío, Seville (L.P.-A.) - all in Spain; Oncology Hematology Care, Cincinnati (D.W.); the Duke University Medical Center, Durham, NC (N.R.); Massachusetts General Hospital, Boston (J.G.); Centro Internacional de Estudios Clinicos, Santiago, Chile (O.A.F.); Nemocnice Na Bulovce, Prague, Czech Republic (L.H.); Bristol-Myers Squibb, Princeton, NJ (C.B., C.T.H., B.L.); and the Sarah Cannon Research Institute and Tennessee Oncology, Nashville (D.R.S.).



Patients with advanced squamous-cell non-small-cell lung cancer (NSCLC) who have disease progression during or after first-line chemotherapy have limited treatment options. This randomized, open-label, international, phase 3 study evaluated the efficacy and safety of nivolumab, a fully human IgG4 programmed death 1 (PD-1) immune-checkpoint-inhibitor antibody, as compared with docetaxel in this patient population.


We randomly assigned 272 patients to receive nivolumab, at a dose of 3 mg per kilogram of body weight every 2 weeks, or docetaxel, at a dose of 75 mg per square meter of body-surface area every 3 weeks. The primary end point was overall survival.


The median overall survival was 9.2 months (95% confidence interval [CI], 7.3 to 13.3) with nivolumab versus 6.0 months (95% CI, 5.1 to 7.3) with docetaxel. The risk of death was 41% lower with nivolumab than with docetaxel (hazard ratio, 0.59; 95% CI, 0.44 to 0.79; P<0.001). At 1 year, the overall survival rate was 42% (95% CI, 34 to 50) with nivolumab versus 24% (95% CI, 17 to 31) with docetaxel. The response rate was 20% with nivolumab versus 9% with docetaxel (P=0.008). The median progression-free survival was 3.5 months with nivolumab versus 2.8 months with docetaxel (hazard ratio for death or disease progression, 0.62; 95% CI, 0.47 to 0.81; P<0.001). The expression of the PD-1 ligand (PD-L1) was neither prognostic nor predictive of benefit. Treatment-related adverse events of grade 3 or 4 were reported in 7% of the patients in the nivolumab group as compared with 55% of those in the docetaxel group.


Among patients with advanced, previously treated squamous-cell NSCLC, overall survival, response rate, and progression-free survival were significantly better with nivolumab than with docetaxel, regardless of PD-L1 expression level. (Funded by Bristol-Myers Squibb; CheckMate 017 number, NCT01642004.).

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