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Medline ® Abstract for Reference 159

of 'Principles of cancer immunotherapy'

Nivolumab versus Docetaxel in Advanced Squamous-Cell Non-Small-Cell Lung Cancer.
Brahmer J, Reckamp KL, Baas P, CrinòL, Eberhardt WE, Poddubskaya E, Antonia S, Pluzanski A, Vokes EE, Holgado E, Waterhouse D, Ready N, Gainor J, Arén Frontera O, Havel L, Steins M, Garassino MC, Aerts JG, Domine M, Paz-Ares L, Reck M, Baudelet C, Harbison CT, Lestini B, Spigel DR
N Engl J Med. 2015;373(2):123. Epub 2015 May 31.
BACKGROUND: 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 efficacyand safety of nivolumab, a fully human IgG4 programmed death 1 (PD-1) immune-checkpoint-inhibitor antibody, as compared with docetaxel in this patient population.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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 ClinicalTrials.gov number, NCT01642004.).
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,