Five-Year Survival Outcomes With Nivolumab Plus Ipilimumab Versus Chemotherapy as First-Line Treatment for Metastatic Non–Small-Cell Lung Cancer in CheckMate 227

作者：Julie R. Brahmer, Jong-Seok Lee, Tudor–Eliade Ciuleanu, Reyes Bernabe Caro, Makoto Nishio, László Urbán, Clarisse Audigier-Valette, Lorena Lupinacci, Randeep Sangha, Adam Płużański, Jacobus A. Burgers, Mauricio Mahave, Samreen Ahmed, Adam J. Schoenfeld, Luis Paz‐Ares, Martin Reck, Hossein Borghaei, Kenneth J. O’Byrne, Ravi G. Gupta, Judith Bushong, Li Li, Steven I. Blum, Laura J. Eccles, Suresh S. Ramalingam · 发表于：Journal of Clinical Oncology · 年份：2022 · DOI：10.1200/jco.22.01503 · 被引用次数：407 · 研究领域：Cancer Immunotherapy and Biomarkers、Lung Cancer Diagnosis and Treatment、Radiomics and Machine Learning in Medical Imaging

PURPOSE: We present 5-year results from CheckMate 227 Part 1, in which nivolumab plus ipilimumab improved overall survival (OS) versus chemotherapy in patients with metastatic non-small-cell lung cancer, regardless of tumor programmed death ligand 1 (PD-L1) status. METHODS: alterations and with tumor PD-L1 ≥ 1% or < 1% (n = 1739) were randomly assigned. Patients with tumor PD-L1 ≥ 1% were randomly assigned to first-line nivolumab plus ipilimumab, nivolumab alone, or chemotherapy. Patients with tumor PD-L1 < 1% were randomly assigned to nivolumab plus ipilimumab, nivolumab plus chemotherapy, or chemotherapy. End points included exploratory 5-year results for efficacy, safety, and quality of life. RESULTS: At a minimum follow-up of 61.3 months, 5-year OS rates were 24% versus 14% for nivolumab plus ipilimumab versus chemotherapy (PD-L1 ≥ 1%) and 19% versus 7% (PD-L1 < 1%). The median duration of response was 24.5 versus 6.7 months (PD-L1 ≥ 1%) and 19.4 versus 4.8 months (PD-L1 < 1%). Among patients surviving 5 years, 66% (PD-L1 ≥ 1%) and 64% (PD-L1 < 1%) were off nivolumab plus ipilimumab without initiating subsequent systemic anticancer treatment by the 5-year time point. Survival benefit continued after nivolumab plus ipilimumab discontinuation because of treatment-related adverse events, with a 5-year OS rate of 39% (combined PD-L1 ≥ 1% and < 1% populations). Quality of life in 5-year survivors treated with nivolumab plus ipilimumab was similar to that in the general US popu...