Toripalimab Combination Therapy Without Concurrent Cisplatin for Nasopharyngeal Carcinoma

作者：The DIAMOND Study Group, Cheng Xu, Xiaoyu Liang, Xinqiong Huang, Feng Jin, Kunyu Yang, Guangyuan Hu, Xiaodong Zhu, Ying Wang, Ying Huang, Ning Zhang, Desheng Hu, Ling Guo, Guorong Zou, Xiaozhong Chen, Shaowen Xiao, Jingao Li, Liangfang Shen, Yuanyuan Li, Jing Huang, Guoxian Long, Ling Li, Luo Huang, Longjiang She, Yuan Wu, Weihua Zeng, Meng-Yun Qiang, Wei-Xin Liu, Yong Su, Ling Tang, Fang-Yun Xie, Fei Han, Li-Xia Lu, Yan-Qun Xiang, Yan-Ping Mao, Wen‐Fei Li, Xu Liu, Qi Yang, Guan-Qun Zhou, Rui Guo, Pu‐Yun OuYang, Xiaohui Wang, Lei Chen, Li‐Ting Liu, Li Lin, Jibin Li, Aihua Lin, Hong-Yun Zhao, Shubin Hong, Yusheng Jie, Hui-Ling Huang, Xuhua Tang, Yue-Can Zeng, Jing‐Ping Yun, Sheng-Bing Zang, Zi-Ming Du, Zu‐Lu Ye, Lizhi Liu, Li Tian, Hao-Jiang Li, Yinglin Peng, Na Liu, Ying‐Qin Li, Ye‐Lin Liang, Han-Miao Wei, Yu‐Pei Chen, Yuan Zhang, Xiaojing Du, Jia‐Wei Lv, Ying Sun, Jun Ma · 发表于：JAMA · 年份：2025 · DOI：10.1001/jama.2025.13205 · 被引用次数：33 · 研究领域：Head and Neck Cancer Studies、Head and Neck Surgical Oncology、Viral-associated cancers and disorders

Importance: With the programmed cell death protein 1 (PD-1) blockade toripalimab, omitting highly toxic concurrent cisplatin may be feasible for nasopharyngeal carcinoma (NPC) without compromising survival. Objective: To evaluate the efficacy and safety of toripalimab incorporated into induction chemotherapy and radiotherapy, without concurrent cisplatin, for locoregionally advanced NPC. Design, Setting, and Participants: Open-label, multicenter, randomized phase 3 clinical trial conducted from August 2021 to July 2022 at 13 hospitals in China, enrolling 532 patients with T4N1M0 or T1-4N2-3M0 NPC; 400 (75.2%) completed the trial per protocol. The final date of follow-up was March 21, 2025. Interventions: Patients were randomly assigned to either the standard therapy group (n = 266), receiving toripalimab with gemcitabine-cisplatin induction chemotherapy and concurrent cisplatin-radiotherapy (100 mg/m2 triweekly for 2 cycles), or the concurrent cisplatin-sparing group (n = 266), receiving the same regimen without concurrent cisplatin. The 17 cycles of toripalimab (240 mg triweekly) were distributed across the induction, radiotherapy, and adjuvant phases as 3, 3, and 11 cycles, respectively. Main Outcomes and Measures: Coprimary end points were failure-free survival (noninferiority margin, 8%) and incidence of all-grade vomiting (superiority design). Secondary end points included overall survival, locoregional recurrence-free survival, distant metastasis-free survival, safety, ...