Liang Ye-Lin, Liu Xu, Shen Liang-Fang, Hu Guang-Yuan, Zou Guo-Rong, Zhang Ning, Chen Chuan-Ben, Chen Xiao-Zhong, Zhu Xiao-Dong, Yuan Ya-Wei, Yang Kun-Yu, Jin Feng, Hu Wei-Han, Xie Fang-Yun, Huang Ying, Han Fei, Tang Ling-Long, Mao Yan-Ping, Lu Li-Xia, Sun Rui, He Yu-Xiang, Zhou Yang-Ying, Long Guo-Xian, Tang Jie, Chen Lu-Si, Zong Jing-Feng, Jin Ting, Li Ling, Lin Jie, Huang Jing, Gong Xiu-Yun, Zhou Guan-Qun, Chen Lei, Li Wen-Fei, Chen Yu-Pei, Xu Cheng, Lin Li, Huang Shao-Hui, Huang Sai-Wei, Wang Ya-Qin, Huang Cheng-Long, Feng Hui-Xia, Hou Min, Chen Chun-Hua, Zheng Su-Fen, Li Ying-Qing, Hong Shu-Bin, Jie Yu-Sheng, Li Hao, Yun Jing-Ping, Zang Sheng-Bing, Liu Song-Ran, Lin Qing-Guang, Li Hao-Jiang, Tian Li, Liu Li-Zhi, Zhao Hong-Yun, Li Ji-Bin, Lin Ai-Hua, Liu Na, Zhang Yuan, Guo Rui, Ma Jun, Sun Ying
Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangdong Provincial Clinical Research Center for Cancer, Guangzhou, China.
Chinese Society of Clinical Oncology, Beijing, China.
JAMA. 2025 May 13;333(18):1589-1598. doi: 10.1001/jama.2025.1132.
Approximately 20% to 30% of patients with locoregionally advanced nasopharyngeal carcinoma (NPC) experience disease relapse despite definitive chemoradiotherapy. The programmed cell death 1 (PD-1) blockade camrelizumab has demonstrated considerable value in recurrent or metastatic NPC, while its role in locoregionally advanced NPC is unclear.
To evaluate the efficacy and safety of adjuvant camrelizumab for patients with locoregionally advanced NPC.
DESIGN, SETTING, AND PARTICIPANTS: Randomized, open-label, multicenter, phase 3 clinical trial conducted from August 2018 to November 2021 at 11 centers in China and enrolling 450 patients with T4N1M0 or T1-4N2-3M0 NPC who had completed induction-concurrent chemoradiotherapy. The final date of follow-up was March 20, 2024.
Patients were randomized (1:1) to receive adjuvant camrelizumab (200 mg intravenously once every 3 weeks for 12 cycles; n = 226) or observation (standard therapy group; n = 224).
The primary end point was event-free survival (freedom from distant metastasis, locoregional relapse, or death due to any cause). Secondary end points included distant metastasis-free survival, locoregional relapse-free survival, overall survival, safety, and health-related quality of life.
Among the 450 participants (mean age, 45 [SD, 10] years; 24% women), after a median follow-up of 39 (IQR, 33-50) months, the camrelizumab group had a 3-year event-free survival rate of 86.9%, whereas the standard therapy group had a rate of 77.3% (stratified hazard ratio, 0.56; 95% CI, 0.36-0.89; P = .01). Grade 3 or 4 adverse events were reported in 23 patients (11.2%) in the camrelizumab and 7 (3.2%) in the standard therapy group. Reactive capillary endothelial proliferation was the most common adverse event related to camrelizumab, occurring in 85.8% of patients at grade 1 or 2, while 2% of patients had grade 3 or 4 events. There was no significant deterioration in quality of life associated with camrelizumab treatment.
Adjuvant PD-1 blockade with camrelizumab significantly improved event-free survival with manageable toxicities, highlighting its potential role in the management of locoregionally advanced NPC.
ClinicalTrials.gov Identifier: NCT03427827.
尽管接受了确定性放化疗，但约20%至30%的局部晚期鼻咽癌（NPC）患者仍会出现疾病复发。程序性细胞死亡1（PD-1）阻断剂卡瑞利珠单抗在复发或转移性NPC中已显示出相当大的价值，但其在局部晚期NPC中的作用尚不清楚。
评估辅助性卡瑞利珠单抗治疗局部晚期NPC患者的疗效和安全性。
设计、地点和参与者：2018年8月至2021年11月在中国11个中心进行的随机、开放标签、多中心3期临床试验，纳入450例T4N1M0或T1-4N2-3M0的NPC患者，这些患者已完成诱导同步放化疗。最终随访日期为2024年3月20日。
患者按1:1随机分组，接受辅助性卡瑞利珠单抗治疗（200mg静脉注射，每3周1次，共12个周期；n = 226）或观察（标准治疗组；n = 224）。
主要终点是无事件生存期（无远处转移、局部区域复发或因任何原因死亡）。次要终点包括无远处转移生存期、无局部区域复发生存期、总生存期、安全性以及与健康相关的生活质量。
在450名参与者中（平均年龄45岁[标准差，10岁]；24%为女性），中位随访39个月（四分位间距，33 - 50个月）后，卡瑞利珠单抗组的3年无事件生存率为86.9%，而标准治疗组为77.3%（分层风险比，0.56；95%置信区间，0.36 - 0.89；P = 0.01）。卡瑞利珠单抗组有23名患者（11.2%）报告了3级或4级不良事件，标准治疗组有7名患者（3.2%）报告了此类事件。反应性毛细血管内皮增生是与卡瑞利珠单抗相关的最常见不良事件，1级或2级事件发生在85.8%的患者中，而2%的患者发生了3级或4级事件。卡瑞利珠单抗治疗未导致生活质量显著下降。
辅助性PD-1阻断剂卡瑞利珠单抗显著提高了无事件生存期，且毒性可控，凸显了其在局部晚期NPC治疗中的潜在作用。
ClinicalTrials.gov标识符：NCT03427827。
