Toripalimab Plus Chemotherapy for Recurrent or Metastatic Nasopharyngeal Carcinoma

作者：Hai‐Qiang Mai, Qiuyan Chen, Dongping Chen, Chaosu Hu, Kunyu Yang, Jiyu Wen, Jingao Li, Yingrui Shi, Feng Jin, Ruilian Xu, Jianji Pan, Shenhong Qu, Ping Li, Chunhong Hu, Yi‐Chun Liu, Yi Jiang, Xia He, Hung‐Ming Wang, Wan‐Teck Lim, Wangjun Liao, Xiaohui He, Xiaozhong Chen, Siyang Wang, Xianglin Yuan, Qi Li, Xiaoyan Lin, Shanghua Jing, Yanju Chen, Lu Yin, Ching-Yun Hsieh, Muh‐Hwa Yang, Chia‐Jui Yen, Jens Samol, Xianming Luo, Xiaojun Wang, Xiongwen Tang, Hui Feng, Sheng Yao, Patricia Keegan, Rui‐Hua Xu · 发表于：JAMA · 年份：2023 · DOI：10.1001/jama.2023.20181 · 被引用次数：250 · 研究领域：Head and Neck Cancer Studies、Protein Degradation and Inhibitors、Oral Health Pathology and Treatment

Importance: There are currently no therapies approved by the US Food and Drug Administration for nasopharyngeal carcinoma (NPC). Gemcitabine-cisplatin is the current standard of care for the first-line treatment of recurrent or metastatic NPC (RM-NPC). Objective: To determine whether toripalimab in combination with gemcitabine-cisplatin will significantly improve progression-free survival and overall survival as first-line treatment for RM-NPC, compared with gemcitabine-cisplatin alone. Design, Setting, and Participants: JUPITER-02 is an international, multicenter, randomized, double-blind phase 3 study conducted in NPC-endemic regions, including mainland China, Taiwan, and Singapore. From November 10, 2018, to October 20, 2019, 289 patients with RM-NPC with no prior systemic chemotherapy in the RM setting were enrolled from 35 participating centers. Interventions: Patients were randomized (1:1) to receive toripalimab (240 mg [n = 146]) or placebo (n = 143) in combination with gemcitabine-cisplatin for up to 6 cycles, followed by maintenance with toripalimab or placebo until disease progression, intolerable toxicity, or completion of 2 years of treatment. Main Outcome: Progression-free survival as assessed by a blinded independent central review. Secondary end points included objective response rate, overall survival, progression-free survival assessed by investigator, duration of response, and safety. Results: Among the 289 patients enrolled (median age, 46 [IQR, 38-53 years...