1. First-Line Nivolumab in Stage IV or Recurrent Non-Small-Cell Lung Cancer
- Author
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CheckMate 026 Investigators, Carbone, David P, Reck, Martin, Paz-Ares, Luis, Creelan, Benjamin, Horn, Leora, Steins, Martin, Felip, Enriqueta, van den Heuvel, Michel M, Ciuleanu, Tudor-Eliade, Badin, Firas, Ready, Neal, Hiltermann, T Jeroen N, Nair, Suresh, Juergens, Rosalyn, Peters, Solange, Minenza, Elisa, Wrangle, John M, Rodriguez-Abreu, Delvys, Borghaei, Hossein, Blumenschein, George R, Villaruz, Liza C, Havel, Libor, Krejci, Jana, Corral Jaime, Jesus, Chang, Han, Geese, William J, Bhagavatheeswaran, Prabhu, Chen, Allen C, Socinski, Mark A, CheckMate 026 Investigators, 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., Clinical sciences, Medical Oncology, Laboratory for Medical and Molecular Oncology, van Meerbeeck, Jan, et al., and Translational Immunology Groningen (TRIGR)
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0301 basic medicine ,Oncology ,Lung Neoplasms ,medicine.medical_treatment ,THERAPY ,B7-H1 Antigen ,Lung Neoplasms/chemically induced ,0302 clinical medicine ,PACLITAXEL PLUS CARBOPLATIN ,Carcinoma, Non-Small-Cell Lung ,Clinical endpoint ,Carcinoma, Non-Small-Cell Lung/chemically induced ,DOCETAXEL ,General Medicine ,CHEMOTHERAPY ,OPEN-LABEL ,3. Good health ,Docetaxel ,030220 oncology & carcinogenesis ,oncology ,TRIAL ,Nivolumab ,medicine.drug ,B7-H1 Antigen/metabolism ,medicine.medical_specialty ,Antigens, CD274/metabolism ,Antineoplastic Agents ,Disease-Free Survival ,Humans ,Rare cancers Radboud Institute for Molecular Life Sciences [Radboudumc 9] ,Article ,03 medical and health sciences ,CISPLATIN ,MAINTENANCE BEVACIZUMAB ,Internal medicine ,medicine ,Carcinoma ,Lung cancer ,neoplasms ,Cisplatin ,Chemotherapy ,business.industry ,medicine.disease ,PHASE-III ,Gemcitabine ,respiratory tract diseases ,030104 developmental biology ,GEMCITABINE ,Human medicine ,business - Abstract
BACKGROUNDNivolumab 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.METHODSWe 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.RESULTSAmong 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.CONCLUSIONSNivolumab 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.)
- Published
- 2017