Perioperative Nivolumab and Chemotherapy in Stage III Non–Small-Cell Lung Cancer

作者：Mariano Provencio, Ernest Nadal, J.L. González-Larriba, Alex Martínez‐Martí, Reyes Bernabé, Joaquim Bosch‐Barrera, Joaquín Casal‐Rubio, Virginia Calvo, Amelia Insa, Santiago Ponce, Noemı́ Reguart, Javier de Castro, Joaquín Mosquera, Manuel Cobo, Andrés Aguilar, Guillermo López-Vivanco, Carlos Camps, Rafael López Castro, Teresa Morán, I. Barneto, Delvys Rodríguez‐Abreu, Roberto Serna‐Blasco, Raquel Benítez, Carlos Aguado, Ramón Palmero, Florentino Hernándo, Javier Martín-López, Alberto Cruz‐Bermúdez, Bartomeu Massutí, Atocha Romero · 发表于：New England Journal of Medicine · 年份：2023 · DOI：10.1056/nejmoa2215530 · 被引用次数：471 · 研究领域：Lung Cancer Diagnosis and Treatment、Cancer Immunotherapy and Biomarkers、Cancer, Stress, Anesthesia, and Immune Response

BACKGROUND: Approximately 20% of patients with non-small-cell lung cancer (NSCLC) receive a diagnosis of stage III disease. There is no current consensus regarding the most appropriate treatment for these patients. METHODS: In this open-label, phase 2 trial, we randomly assigned patients with resectable stage IIIA or IIIB NSCLC to receive neoadjuvant nivolumab plus platinum-based chemotherapy (experimental group) or chemotherapy alone (control group), followed by surgery. Patients in the experimental group who had R0 resections received adjuvant treatment with nivolumab for 6 months. The primary end point was a pathological complete response (0% viable tumor in resected lung and lymph nodes). Secondary end points included progression-free survival and overall survival at 24 months and safety. RESULTS: A total of 86 patients underwent randomization; 57 were assigned to the experimental group and 29 were assigned to the control group. A pathological complete response occurred in 37% of the patients in the experimental group and in 7% in the control group (relative risk, 5.34; 95% confidence interval [CI], 1.34 to 21.23; P = 0.02). Surgery was performed in 93% of the patients in the experimental group and in 69% in the control group (relative risk, 1.35; 95% CI, 1.05 to 1.74). Kaplan-Meier estimates of progression-free survival at 24 months were 67.2% in the experimental group and 40.9% in the control group (hazard ratio for disease progression, disease recurrence, or death, 0.4...