Perioperative Durvalumab for Resectable Non–Small-Cell Lung Cancer

作者：John V. Heymach, David H. Harpole, Tetsuya Mitsudomi, Janis M. Taube, Gabriella Gálffy, Maximilian J. Hochmair, Thomas Winder, Р. А. Зуков, Gabriel Garbaos, Shugeng Gao, Hiroaki Kuroda, Gyula Ostoros, Tho V. Tran, Jian You, Kang‐Yun Lee, Lorenzo Antonuzzo, Zsolt Pápai-Székely, Hiroaki Akamatsu, Bivas Biswas, Alexander I. Spira, Jeffrey Crawford, Ha Le, Mike Aperghis, Gary J. Doherty, Helen Mann, Tamer M. Fouad, Martin Reck · 发表于：New England Journal of Medicine · 年份：2023 · DOI：10.1056/nejmoa2304875 · 被引用次数：731 · 研究领域：Cancer, Stress, Anesthesia, and Immune Response、Lung Cancer Diagnosis and Treatment、Cancer Immunotherapy and Biomarkers

Neoadjuvant or adjuvant immunotherapy can improve outcomes in patients with resectable non–small-cell lung cancer (NSCLC). Perioperative regimens may combine benefits of both to improve long-term outcomes. Download a PDF of the Research Summary. We randomly assigned patients with resectable NSCLC (stage II to IIIB [N2 node stage] according to the eighth edition of the AJCC Cancer Staging Manual) to receive platinum-based chemotherapy plus durvalumab or placebo administered intravenously every 3 weeks for 4 cycles before surgery, followed by adjuvant durvalumab or placebo intravenously every 4 weeks for 12 cycles. Randomization was stratified according to disease stage (II or III) and programmed death ligand 1 (PD-L1) expression (≥1% or <1%). Primary end points were event-free survival (defined as the time to the earliest occurrence of progressive disease that precluded surgery or prevented completion of surgery, disease recurrence [assessed in a blinded fashion by independent central review], or death from any cause) and pathological complete response (evaluated centrally). A total of 802 patients were randomly assigned to receive durvalumab (400 patients) or placebo (402 patients). The duration of event-free survival was significantly longer with durvalumab than with placebo; the stratified hazard ratio for disease progression, recurrence, or death was 0.68 (95% confidence interval [CI], 0.53 to 0.88; P=0.004) at the first interim analysis. At the 12-month landmark analysis,...