Perioperative Nivolumab in Resectable Lung Cancer

作者：Tina Cascone, Mark M. Awad, Jonathan Spicer, Jie He, Shun Lü, Boris Sepesi, Fumihiro Tanaka, Janis M. Taube, Robin Cornelissen, Libor Havel, Nina Karaseva, Jarosław Kużdżał, Luboš Petruželka, Lin Wu, Jean-Louis Pujol, Hiroyuki Ito, Tudor–Eliade Ciuleanu, Ludmila de Oliveira Muniz Koch, Annelies Janssens, Aurelia Alexandru, Sabine Bohnet, Fedor V. Moiseyenko, Yang Gao, Yasutaka Watanabe, Cinthya Coronado Erdmann, Padma Sathyanarayana, S. Meadows–Shropshire, Steven I. Blum, Mariano Provencio · 发表于：New England Journal of Medicine · 年份：2024 · DOI：10.1056/nejmoa2311926 · 被引用次数：485 · 研究领域：Lung Cancer Diagnosis and Treatment、Cancer Immunotherapy and Biomarkers、Cancer, Stress, Anesthesia, and Immune Response

BACKGROUND: Standard treatment with neoadjuvant nivolumab plus chemotherapy significantly improves outcomes in patients with resectable non-small-cell lung cancer (NSCLC). Perioperative treatment (i.e., neoadjuvant therapy followed by surgery and adjuvant therapy) with nivolumab may further improve clinical outcomes. METHODS: In this phase 3, randomized, double-blind trial, we assigned adults with resectable stage IIA to IIIB NSCLC to receive neoadjuvant nivolumab plus chemotherapy or neoadjuvant chemotherapy plus placebo every 3 weeks for 4 cycles, followed by surgery and adjuvant nivolumab or placebo every 4 weeks for 1 year. The primary outcome was event-free survival according to blinded independent review. Secondary outcomes were pathological complete response and major pathological response according to blinded independent review, overall survival, and safety. RESULTS: At this prespecified interim analysis (median follow-up, 25.4 months), the percentage of patients with 18-month event-free survival was 70.2% in the nivolumab group and 50.0% in the chemotherapy group (hazard ratio for disease progression or recurrence, abandoned surgery, or death, 0.58; 97.36% confidence interval [CI], 0.42 to 0.81; P<0.001). A pathological complete response occurred in 25.3% of the patients in the nivolumab group and in 4.7% of those in the chemotherapy group (odds ratio, 6.64; 95% CI, 3.40 to 12.97); a major pathological response occurred in 35.4% and 12.1%, respectively (odds ratio, 4...