First-Line Nivolumab in Stage IV or Recurrent Non-Small-Cell Lung Cancer.
Details
State: Public
Version: Final published version
Serval ID
serval:BIB_5A4A2E2F4748
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
First-Line Nivolumab in Stage IV or Recurrent Non-Small-Cell Lung Cancer.
Journal
The New England journal of medicine
Working group(s)
CheckMate 026 Investigators
Contributor(s)
Lupinacci L., Martin C., Pilnik N., Richardet M.E., Varela M.S., Adams J., Boyer M., John T., Moore M., OByrne K., Eckmayr J., Pirker R., Decoster L., van Meerbeeck J., Vansteenkiste J., Surmont V., Barrios C.H., Franke F.A., Pinto G., Blais N., Foley M.C., Juergens R., Leighl N., Morris D.G., 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 H.R., Kim S.W., Park K., Cainap C., Ciuleanu T.E., Ghizdavescu D., Blasco A., Corral Jaime J., De Castro J., Felip E., Paz-Ares L., Rodriguez Abreu D., Trigo J., Kölbeck K.G., Lindskog M., Curioni-Fontecedro A., Mark M., Peters S., Chen Y.M., 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 D.E., Horn L., Kaywin P., Kessler R., Langer C.J., 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.
ISSN
1533-4406 (Electronic)
ISSN-L
0028-4793
Publication state
Published
Issued date
22/06/2017
Peer-reviewed
Oui
Volume
376
Number
25
Pages
2415-2426
Language
english
Notes
Publication types: Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't ; Comment
Publication Status: ppublish
Publication Status: ppublish
Abstract
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.
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.
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.
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 .).
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.
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.
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 .).
Keywords
Antigens, CD274/metabolism, Antineoplastic Agents, Carcinoma, Non-Small-Cell Lung/chemically induced, Disease-Free Survival, Humans, Lung Neoplasms/chemically induced
Pubmed
Web of science
Create date
22/06/2017 21:12
Last modification date
20/08/2019 15:13
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