Overall Survival with Durvalumab after Chemoradiotherapy in Stage III NSCLC

作者：Scott Antonia, Augusto Villegas, Davey B. Daniel, David Vicente, Shuji Murakami, Rina Hui, Takayasu Kurata, Alberto Chiappori, Ki Hyeong Lee, Maike de Wit, Byoung Chul Cho, Maryam Bourhaba, Xavier Quantin, Takaaki Tokito, Tarek Mekhail, David Planchard, Young‐Chul Kim, Christos S. Karapetis, Sandrine Hiret, Gyula Ostoros, Kaoru Kubota, Jhanelle E. Gray, Luis Paz‐Ares, Javier de Castro, Corinne Faivre‐Finn, Martin Reck, Johan Vansteenkiste, David R. Spigel, Catherine Wadsworth, Giovanni Melillo, Maria Taboada, Phillip A. Dennis, Mustafa Özgüroğlu · 发表于：New England Journal of Medicine · 年份：2018 · DOI：10.1056/nejmoa1809697 · 被引用次数：2831 · 研究领域：Cancer Immunotherapy and Biomarkers、Lung Cancer Diagnosis and Treatment、Lung Cancer Treatments and Mutations

BACKGROUND: An earlier analysis in this phase 3 trial showed that durvalumab significantly prolonged progression-free survival, as compared with placebo, among patients with stage III, unresectable non-small-cell lung cancer (NSCLC) who did not have disease progression after concurrent chemoradiotherapy. Here we report the results for the second primary end point of overall survival. METHODS: We randomly assigned patients, in a 2:1 ratio, to receive durvalumab intravenously, at a dose of 10 mg per kilogram of body weight, or matching placebo every 2 weeks for up to 12 months. Randomization occurred 1 to 42 days after the patients had received chemoradiotherapy and was stratified according to age, sex, and smoking history. The primary end points were progression-free survival (as assessed by blinded independent central review) and overall survival. Secondary end points included the time to death or distant metastasis, the time to second progression, and safety. RESULTS: Of the 713 patients who underwent randomization, 709 received the assigned intervention (473 patients received durvalumab and 236 received placebo). As of March 22, 2018, the median follow-up was 25.2 months. The 24-month overall survival rate was 66.3% (95% confidence interval [CI], 61.7 to 70.4) in the durvalumab group, as compared with 55.6% (95% CI, 48.9 to 61.8) in the placebo group (two-sided P=0.005). Durvalumab significantly prolonged overall survival, as compared with placebo (stratified hazard ratio f...