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N Engl J Med. 2017 Jun 22;376(25):2415-2426. doi: 10.1056/NEJMoa1613493.

First-Line Nivolumab in Stage IV or Recurrent Non-Small-Cell Lung Cancer.

Collaborators (140)

Lupinacci L, Martin C, Pilnik N, Richardet ME, Varela MS, Adams J, Boyer M, John T, Moore M, O'Byrne K, Eckmayr J, Pirker R, Decoster L, van Meerbeeck J, Vansteenkiste J, Surmont V, Barrios CH, Franke FA, Pinto G, Blais N, Foley MC, Juergens R, Leighl N, Morris DG, Havel L, Kolek V, Krejci J, Reiterer P, Roubec J, Ahvonen J, Jekunen A, Maasilta P, Barlesi F, Dansen E, Fraboulet G, Lena H, Mennecier B, Zalcman G, Frickhofen N, Kohlhaeufl M, Reck M, Repp R, Steins M, Wolf J, Agelaki S, Syrigos K, Albert I, Ostoros G, Szilasi M, Cappuzzo F, Crino L, De Marinis F, Gridelli C, Morabito A, Roila F, Atagi S, Fujita S, Hida T, Hirashima T, Maemondo M, Minato K, Nakagawa K, Nishio M, Nogami N, Ohe Y, Saka H, Sakai H, Satouchi M, Takeda K, Tanaka H, Yamamoto N, Arrieta-Rodriguez O, De la Mora Jimenez E, Flores Wilbert V, Aerts J, Hiltermann TJN, Van Den Heuvel M, Chmielowska E, Czyzewicz G, Gabrys J, Kalinka-Warzocha E, Pluzanski A, Kim HR, Kim SW, Park K, Cainap C, Ciuleanu TE, Ghizdavescu D, Blasco A, Corral Jaime J, De Castro J, Felip E, Paz-Ares L, Rodriguez Abreu D, Trigo J, Kölbeck KG, Lindskog M, Curioni-Fontecedro A, Mark M, Peters S, Chen YM, Karaca H, Chao D, Mulatero C, Summers Y, Arledge S, Badin F, Batus M, Blumenschein G, Borghaei H, Camidge R, Boyd T, Brahmer J, Carbone D, Cetnar J, Chachoua A, Chaft J, Chen H, Creelan B, Gainor J, Gettinger S, Gerber DE, Horn L, Kaywin P, Kessler R, Langer CJ, McCracken J, Nair S, Oyola R, Pillai R, Quddus F, Rangachari D, Ready N, Reynolds C, Rosenberg R, Sharma N, Stinchcombe T, Villaruz L, Wakelee H, Wrangle J.

Author information

1
From the Ohio State University Comprehensive Cancer Center, Columbus (D.P.C.); LungenClinic Grosshansdorf, Airway Research Center North, German Center for Lung Research, Grosshansdorf (M.R.), and Thoraxklinik, Heidelberg University Hospital, Heidelberg (M.S.) - both in Germany; Hospital Universitario Doce de Octubre, Centro Nacional de Investigaciones Oncológicas and Universidad Complutense, Madrid (L.P.-A., J.C.J.), Vall d'Hebron University Hospital, Barcelona (E.F.), and Hospital Universitario Insular de Gran Canaria, Las Palmas (D.R.-A.) - all in Spain; H. Lee Moffitt Cancer Center, Tampa, FL (B.C.); Vanderbilt University Medical Center, Nashville (L. Horn); Antoni van Leeuwenhoek Ziekenhuis, Amsterdam (M.M.H.), and University of Groningen, Universitair Medisch Centrum Groningen, Groningen (T.J.N.H.) - both in the Netherlands; Prof. Dr. Ion Chiricuta Institute of Oncology and University of Medicine and Pharmacy Iuliu Hatieganu, Cluj-Napoca, Romania (T.-E.C.); Baptist Health Lexington, Lexington, KY (F.B.); Duke University, Durham, NC (N.R.); Lehigh Valley Health Network, Allentown (S.N.), Fox Chase Cancer Center, Philadelphia (H.B.), and University of Pittsburgh Medical Center Cancer Center, Pittsburgh (L.C.V., M.A.S.) - all in Pennsylvania; Juravinski Cancer Centre, Hamilton, ON, Canada (R.J.); Oncology Department, Lausanne University Hospital, Lausanne, Switzerland (S.P.); Santa Maria Hospital, Terni, Italy (E.M.); Hollings Cancer Center, Charleston, SC (J.M.W.); Department of Thoracic-Head and Neck Medical Oncology, University of Texas M.D. Anderson Cancer Center, Houston (G.R.B.); Klinika Pneumologie a Hrudní Chirurgie, Nemocnice Na Bulovce, Prague, Czech Republic (L. Havel, J.K.); and Bristol-Myers Squibb, Princeton, NJ (H.C., W.J.G., P.B., A.C.C.).

Abstract

BACKGROUND:

Nivolumab has been associated with longer overall survival than docetaxel among patients with previously treated non-small-cell lung cancer (NSCLC). In an open-label phase 3 trial, we compared first-line nivolumab with chemotherapy in patients with programmed death ligand 1 (PD-L1)-positive NSCLC.

METHODS:

We randomly assigned, in a 1:1 ratio, patients with untreated stage IV or recurrent NSCLC and a PD-L1 tumor-expression level of 1% or more to receive nivolumab (administered intravenously at a dose of 3 mg per kilogram of body weight once every 2 weeks) or platinum-based chemotherapy (administered once every 3 weeks for up to six cycles). Patients receiving chemotherapy could cross over to receive nivolumab at the time of disease progression. The primary end point was progression-free survival, as assessed by means of blinded independent central review, among patients with a PD-L1 expression level of 5% or more.

RESULTS:

Among the 423 patients with a PD-L1 expression level of 5% or more, the median progression-free survival was 4.2 months with nivolumab versus 5.9 months with chemotherapy (hazard ratio for disease progression or death, 1.15; 95% confidence interval [CI], 0.91 to 1.45; P=0.25), and the median overall survival was 14.4 months versus 13.2 months (hazard ratio for death, 1.02; 95% CI, 0.80 to 1.30). A total of 128 of 212 patients (60%) in the chemotherapy group received nivolumab as subsequent therapy. Treatment-related adverse events of any grade occurred in 71% of the patients who received nivolumab and in 92% of those who received chemotherapy. Treatment-related adverse events of grade 3 or 4 occurred in 18% of the patients who received nivolumab and in 51% of those who received chemotherapy.

CONCLUSIONS:

Nivolumab was not associated with significantly longer progression-free survival than chemotherapy among patients with previously untreated stage IV or recurrent NSCLC with a PD-L1 expression level of 5% or more. Overall survival was similar between groups. Nivolumab had a favorable safety profile, as compared with chemotherapy, with no new or unexpected safety signals. (Funded by Bristol-Myers Squibb and others; CheckMate 026 ClinicalTrials.gov number, NCT02041533 .).

PMID:
28636851
PMCID:
PMC6487310
DOI:
10.1056/NEJMoa1613493
[Indexed for MEDLINE]
Free PMC Article

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