RT Journal Article
T1 Durvalumab after Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer.
A1 Antonia, Scott J
A1 Villegas, Augusto
A1 Daniel, Davey
A1 Vicente, David
A1 Murakami, Shuji
A1 Hui, Rina
A1 Yokoi, Takashi
A1 Chiappori, Alberto
A1 Lee, Ki H
A1 de Wit, Maike
A1 Cho, Byoung C
A1 Bourhaba, Maryam
A1 Quantin, Xavier
A1 Tokito, Takaaki
A1 Mekhail, Tarek
A1 Planchard, David
A1 Kim, Young-Chul
A1 Karapetis, Christos S
A1 Hiret, Sandrine
A1 Ostoros, Gyula
A1 Kubota, Kaoru
A1 Gray, Jhanelle E
A1 Paz-Ares, Luis
A1 de Castro Carpeño, Javier
A1 Wadsworth, Catherine
A1 Melillo, Giovanni
A1 Jiang, Haiyi
A1 Huang, Yifan
A1 Dennis, Phillip A
A1 Özgüroğlu, Mustafa
A1 PACIFIC Investigators, 
AB Most patients with locally advanced, unresectable, non-small-cell lung cancer (NSCLC) have disease progression despite definitive chemoradiotherapy (chemotherapy plus concurrent radiation therapy). This phase 3 study compared the anti-programmed death ligand 1 antibody durvalumab as consolidation therapy with placebo in patients with stage III NSCLC who did not have disease progression after two or more cycles of platinum-based chemoradiotherapy. We randomly assigned patients, in a 2:1 ratio, to receive durvalumab (at a dose of 10 mg per kilogram of body weight intravenously) or placebo every 2 weeks for up to 12 months. The study drug was administered 1 to 42 days after the patients had received chemoradiotherapy. The coprimary end points were progression-free survival (as assessed by means of blinded independent central review) and overall survival (unplanned for the interim analysis). Secondary end points included 12-month and 18-month progression-free survival rates, the objective response rate, the duration of response, the time to death or distant metastasis, and safety. Of 713 patients who underwent randomization, 709 received consolidation therapy (473 received durvalumab and 236 received placebo). The median progression-free survival from randomization was 16.8 months (95% confidence interval [CI], 13.0 to 18.1) with durvalumab versus 5.6 months (95% CI, 4.6 to 7.8) with placebo (stratified hazard ratio for disease progression or death, 0.52; 95% CI, 0.42 to 0.65; P Progression-free survival was significantly longer with durvalumab than with placebo. The secondary end points also favored durvalumab, and safety was similar between the groups. (Funded by AstraZeneca; PACIFIC ClinicalTrials.gov number, NCT02125461 .).
YR 2017
FD 2017-09-08
LK http://hdl.handle.net/10668/11565
UL http://hdl.handle.net/10668/11565
LA en
DS RISalud
RD Apr 19, 2025