RT Journal Article
T1 Nivolumab plus Ipilimumab in Advanced Non-Small-Cell Lung Cancer.
A1 Hellmann, Matthew D
A1 Paz-Ares, Luis
A1 Bernabe Caro, Reyes
A1 Zurawski, Bogdan
A1 Kim, Sang-We
A1 Carcereny Costa, Enric
A1 Park, Keunchil
A1 Alexandru, Aurelia
A1 Lupinacci, Lorena
A1 de la Mora Jimenez, Emmanuel
A1 Sakai, Hiroshi
A1 Albert, Istvan
A1 Vergnenegre, Alain
A1 Peters, Solange
A1 Syrigos, Konstantinos
A1 Barlesi, Fabrice
A1 Reck, Martin
A1 Borghaei, Hossein
A1 Brahmer, Julie R
A1 O'Byrne, Kenneth J
A1 Geese, William J
A1 Bhagavatheeswaran, Prabhu
A1 Rabindran, Sridhar K
A1 Kasinathan, Ravi S
A1 Nathan, Faith E
A1 Ramalingam, Suresh S
AB In an early-phase study involving patients with advanced non-small-cell lung cancer (NSCLC), the response rate was better with nivolumab plus ipilimumab than with nivolumab monotherapy, particularly among patients with tumors that expressed programmed death ligand 1 (PD-L1). Data are needed to assess the long-term benefit of nivolumab plus ipilimumab in patients with NSCLC. In this open-label, phase 3 trial, we randomly assigned patients with stage IV or recurrent NSCLC and a PD-L1 expression level of 1% or more in a 1:1:1 ratio to receive nivolumab plus ipilimumab, nivolumab alone, or chemotherapy. The patients who had a PD-L1 expression level of less than 1% were randomly assigned in a 1:1:1 ratio to receive nivolumab plus ipilimumab, nivolumab plus chemotherapy, or chemotherapy alone. All the patients had received no previous chemotherapy. The primary end point reported here was overall survival with nivolumab plus ipilimumab as compared with chemotherapy in patients with a PD-L1 expression level of 1% or more. Among the patients with a PD-L1 expression level of 1% or more, the median duration of overall survival was 17.1 months (95% confidence interval [CI], 15.0 to 20.1) with nivolumab plus ipilimumab and 14.9 months (95% CI, 12.7 to 16.7) with chemotherapy (P = 0.007), with 2-year overall survival rates of 40.0% and 32.8%, respectively. The median duration of response was 23.2 months with nivolumab plus ipilimumab and 6.2 months with chemotherapy. The overall survival benefit was also observed in patients with a PD-L1 expression level of less than 1%, with a median duration of 17.2 months (95% CI, 12.8 to 22.0) with nivolumab plus ipilimumab and 12.2 months (95% CI, 9.2 to 14.3) with chemotherapy. Among all the patients in the trial, the median duration of overall survival was 17.1 months (95% CI, 15.2 to 19.9) with nivolumab plus ipilimumab and 13.9 months (95% CI, 12.2 to 15.1) with chemotherapy. The percentage of patients with grade 3 or 4 treatment-related adverse events in the overall population was 32.8% with nivolumab plus ipilimumab and 36.0% with chemotherapy. First-line treatment with nivolumab plus ipilimumab resulted in a longer duration of overall survival than did chemotherapy in patients with NSCLC, independent of the PD-L1 expression level. No new safety concerns emerged with longer follow-up. (Funded by Bristol-Myers Squibb and Ono Pharmaceutical; CheckMate 227 ClinicalTrials.gov number, NCT02477826.).
YR 2019
FD 2019-09-28
LK http://hdl.handle.net/10668/14563
UL http://hdl.handle.net/10668/14563
LA en
DS RISalud
RD Apr 8, 2025