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Nivolumab combined with induction chemotherapy and radiotherapy in nasopharyngeal carcinoma: A multicenter phase 2 PLATINUM trial

作者:Cheng Xu, Guan-Qun Zhou, Wen-Fei Li, Desheng Hu, Xiaozhong Chen, Shaojun Lin, Feng Jin, Xinqiong Huang, Gang Peng, Jing Huang, Yuan Wu, Changjuan Tao, Ji-Bin Li, Aihua Lin, Hongyun Zhao, Shubin Hong, Hui-Ling Huang, Ling Tang, Yinglin Peng, Ke-Fu Shi, Chen Liu, Liping Qi, Kun-Yu Yang, Liangfang Shen, Ying Sun, Jun Ma · 发表于:Cancer Cell · 年份:2025 · DOI:10.1016/j.ccell.2025.01.014 · 被引用次数:41 · 研究领域:Cancer Immunotherapy and Biomarkers、Head and Neck Cancer Studies、Lung Cancer Research Studies

Severe toxicities caused by concurrent cisplatin are a critical problem in nasopharyngeal carcinoma (NPC) treatment. In this phase 2 multicenter PLATINUM trial (NCT03984357), we recruited 152 NPC patients who received 12-cycle nivolumab plus induction chemotherapy and radiotherapy without concurrent cisplatin. After a median follow-up of 43 months, the 3-year failure-free survival (FFS) was 88.5% (95% confidence interval [CI], 83.4%-93.8%) and the 3-year overall survival was 97.9%. An early clearance of Epstein-Barr virus (EBV) DNA after induction-phase treatment was associated with FFS benefit. Sixty (40.2%) and eight (5.2%) patients had acute and late grade 3-4 adverse events (AEs), respectively. Most patients had good tolerance to AE-associated frequency (68.0%-96.7%), severity (56.0%-98.6%), and interference (58.0%-98.0%); 86.7%-100.0% of quality-of-life domains showed either no clinically meaningful deterioration or a rapid recovery. Nivolumab plus induction chemotherapy and radiotherapy demonstrated efficacious anti-tumor activity, low toxicity, and favorable tolerability and quality-of-life for NPC patients.