First-line nivolumab plus ipilimumab with or without chemotherapy for Japanese patients with non-small cell lung cancer: LIGHT-NING study

作者：Hisao Imai, Takashi Kijima, Koichi Azuma, Kazuma Kishi, Haruhiro Saito, Teppei Yamaguchi, Junko Tanizaki, Yasuto Yoneshima, Kohei Fujita, Satoshi Watanabe, Satoru Kitazono, Tatsuro Fukuhara, Osamu Hataji, Yukihiro Toi, Hideaki Mizutani, Yusuke Hamakawa, Makoto Maemondo, Tomoyuki Ohsugi, Keisuke Suzuki, Hidehito Horinouchi, Yuichiro Ohe · 发表于：Japanese Journal of Clinical Oncology · 年份：2024 · DOI：10.1093/jjco/hyad195 · 被引用次数：10 · 研究领域：Cancer Immunotherapy and Biomarkers、Lung Cancer Diagnosis and Treatment、CAR-T cell therapy research

OBJECTIVE: As first-line treatment for stage IV or recurrent non-small cell lung cancer, combination immunotherapy with nivolumab and ipilimumab, with or without chemotherapy, had demonstrated survival benefits over chemotherapy; however, data on Japanese patients are limited. METHODS: LIGHT-NING was a multicenter, observational study and retrospectively collected data. In this interim analysis, we analyzed patients who received combination immunotherapy between 27 November 2020 and 31 August 2021 for the treatment status, safety objectives (treatment-related adverse events and immune-related adverse events incidences), and effectiveness objectives (objective response rate and progression-free survival) to determine the characteristics and early safety information. RESULTS: We analyzed 353 patients, with a median follow-up of 7.1 (interquartile range, 5.0-9.7) months. Overall, 60.1 and 39.9% received nivolumab plus ipilimumab with and without chemotherapy, respectively. In these cohorts, the median age was 67 and 72 years; 10.8 and 35.5% were aged ≥75 years; 80.2 and 79.4% were male; 5.2 and 13.5% had a performance score ≥ 2; 32.1 and 27.0% developed grade 3-4 immune-related adverse events; treatment-related deaths were observed in 6 (2.8%) and 5 (3.5%) patients, respectively. Grade 3-4 immune-related adverse event incidence was the highest within the first month of treatment in both cohorts, although the immune-related adverse event risk persisted throughout. No new safety s...