Ferris Robert L, Blumenschein George, Fayette Jerome, Guigay Joel, Colevas A Dimitrios, Licitra Lisa, Harrington Kevin, Kasper Stefan, Vokes Everett E, Even Caroline, Worden Francis, Saba Nabil F, Iglesias Docampo Lara C, Haddad Robert, Rordorf Tamara, Kiyota Naomi, Tahara Makoto, Monga Manish, Lynch Mark, Geese William J, Kopit Justin, Shaw James W, Gillison Maura L
From the University of Pittsburgh Medical Center and Cancer Institute, Pittsburgh (R.L.F.); the Department of Thoracic-Head and Neck Medical Oncology, University of Texas M.D. Anderson Cancer Center, Houston (G.B.); Centre Leon Berard, Lyon (J.F.), Centre Antoine Lacassagne, Nice (J.G.), and Institut Gustave Roussy, Villejuif (C.E.) - all in France; Stanford Cancer Institute, Stanford, CA (A.D.C.); Fondazione Istituto di Ricovero e Cura a Carattere Scientifico, Istituto Nazionale Tumori, Milan (L.L.); Institute of Cancer Research-Royal Marsden National Institute for Health Research Biomedical Research Centre, London (K.H.); University Hospital Essen, Essen, Germany (S.K.); University of Chicago, Chicago (E.E.V.); University of Michigan, Ann Arbor (F.W.); Winship Cancer Institute of Emory University, Atlanta (N.F.S.); Hospital Universitario 12 de Octubre, Madrid (L.C.I.D.); Dana-Farber Cancer Institute, Boston (R.H.); Universitätsspital Zurich, Zurich, Switzerland (T.R.); Kobe University Hospital, Kobe (N.K.), and National Cancer Center Hospital East, Kashiwa (M.T.) - both in Japan; Bristol-Myers Squibb, Princeton, NJ (M.M., M.L., W.J.G., J.K., J.W.S.); and Ohio State University, Columbus (M.L.G.).
N Engl J Med. 2016 Nov 10;375(19):1856-1867. doi: 10.1056/NEJMoa1602252. Epub 2016 Oct 8.
BACKGROUND: Patients with recurrent or metastatic squamous-cell carcinoma of the head and neck after platinum chemotherapy have a very poor prognosis and limited therapeutic options. Nivolumab, an anti-programmed death 1 (PD-1) monoclonal antibody, was assessed as treatment for this condition. METHODS: In this randomized, open-label, phase 3 trial, we assigned, in a 2:1 ratio, 361 patients with recurrent squamous-cell carcinoma of the head and neck whose disease had progressed within 6 months after platinum-based chemotherapy to receive nivolumab (at a dose of 3 mg per kilogram of body weight) every 2 weeks or standard, single-agent systemic therapy (methotrexate, docetaxel, or cetuximab). The primary end point was overall survival. Additional end points included progression-free survival, rate of objective response, safety, and patient-reported quality of life. RESULTS: The median overall survival was 7.5 months (95% confidence interval [CI], 5.5 to 9.1) in the nivolumab group versus 5.1 months (95% CI, 4.0 to 6.0) in the group that received standard therapy. Overall survival was significantly longer with nivolumab than with standard therapy (hazard ratio for death, 0.70; 97.73% CI, 0.51 to 0.96; P=0.01), and the estimates of the 1-year survival rate were approximately 19 percentage points higher with nivolumab than with standard therapy (36.0% vs. 16.6%). The median progression-free survival was 2.0 months (95% CI, 1.9 to 2.1) with nivolumab versus 2.3 months (95% CI, 1.9 to 3.1) with standard therapy (hazard ratio for disease progression or death, 0.89; 95% CI, 0.70 to 1.13; P=0.32). The rate of progression-free survival at 6 months was 19.7% with nivolumab versus 9.9% with standard therapy. The response rate was 13.3% in the nivolumab group versus 5.8% in the standard-therapy group. Treatment-related adverse events of grade 3 or 4 occurred in 13.1% of the patients in the nivolumab group versus 35.1% of those in the standard-therapy group. Physical, role, and social functioning was stable in the nivolumab group, whereas it was meaningfully worse in the standard-therapy group. CONCLUSIONS: Among patients with platinum-refractory, recurrent squamous-cell carcinoma of the head and neck, treatment with nivolumab resulted in longer overall survival than treatment with standard, single-agent therapy. (Funded by Bristol-Myers Squibb; CheckMate 141 ClinicalTrials.gov number, NCT02105636 .).
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