中山大学孙莹研究组近日取得一项新成果。经过不懈努力，他们报道了卡马利珠单抗辅助PD-1阻断治疗鼻咽癌。相关论文于2025年3月13日发表于国际顶尖学术期刊《美国医学会杂志》上。

重要性:大约20%至30%的局部晚期鼻咽癌（NPC）患者尽管接受了明确的放化疗，但仍会复发。程序性细胞死亡1 （PD-1）阻滞剂camrelizumab在复发性或转移性鼻咽癌中显示出相当大的价值，但其在局部区域晚期鼻咽癌中的作用尚不清楚。

目的:评价辅助camrelizumab治疗局部区域晚期鼻咽癌患者的疗效和安全性。

设计、设置和参与者：随机、开放标签、多中心、3期临床试验于2018年8月至2021年11月在中国11个中心进行，纳入了450例完成诱导同步放化疗的T4N1M0或T1-4N2-3M0 NPC患者。追踪的最后日期是2024年3月20日。

干预措施:患者随机（1:1）接受辅助camrelizumab (200 mg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)。

主要成果和措施：主要终点为无事件生存期（无远处转移、局部复发或任何原因导致的死亡）。次要终点包括远端无转移生存期、局部无复发生存期、总生存期、安全性和健康相关生活质量。

结果:450名参与者(平均年龄45 [SD， 10]岁；中位随访39个月（IQR, 33-50）后，camrelizumab组的3年无事件生存率为86.9%，而标准治疗组的3年无事件生存率为77.3%(分层风险比，0.56；95% ci, 0.36-0.89；P = . 01)。camrelizumab组有23例（11.2%）患者报告了3级或4级不良事件，标准治疗组有7例（3.2%）。反应性毛细血管内皮增生是与camrelizumab相关的最常见不良事件，发生在85.8%的1级或2级患者中，而2%的患者发生3级或4级事件。camrelizumab治疗没有显著的生活质量恶化。

研究结果表明，camrelizumab辅助PD-1阻断显著提高了无事件生存期和可控的毒性，突出了其在局部区域晚期鼻咽癌管理中的潜在作用。

附：英文原文

Title: Adjuvant PD-1 Blockade With Camrelizumab for Nasopharyngeal Carcinoma: The DIPPER Randomized Clinical Trial

Author: Ye-Lin Liang, Xu Liu, Liang-Fang Shen, Guang-Yuan Hu, Guo-Rong Zou, Ning Zhang, Chuan-Ben Chen, Xiao-Zhong Chen, Xiao-Dong Zhu, Ya-Wei Yuan, Kun-Yu Yang, Feng Jin, Wei-Han Hu, Fang-Yun Xie, Ying Huang, Fei Han, Ling-Long Tang, Yan-Ping Mao, Li-Xia Lu, Rui Sun, Yu-Xiang He, Yang-Ying Zhou, Guo-Xian Long, Jie Tang, Lu-Si Chen, Jing-Feng Zong, Ting Jin, Ling Li, Jie Lin, Jing Huang, Xiu-Yun Gong, Guan-Qun Zhou, Lei Chen, Wen-Fei Li, Yu-Pei Chen, Cheng Xu, Li Lin, Shao-Hui Huang, Sai-Wei Huang, Ya-Qin Wang, Cheng-Long Huang, Hui-Xia Feng, Min Hou, Chun-Hua Chen, Su-Fen Zheng, Ying-Qing Li, Shu-Bin Hong, Yu-Sheng Jie, Hao Li, Jing-Ping Yun, Sheng-Bing Zang, Song-Ran Liu, Qing-Guang Lin, Hao-Jiang Li, Li Tian, Li-Zhi Liu, Hong-Yun Zhao, Ji-Bin Li, Ai-Hua Lin, Na Liu, Yuan Zhang, Rui Guo, Jun Ma, Ying Sun

Issue&Volume: 2025-03-13

Abstract: Importance  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.

Objective  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.

Interventions  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).

Main Outcomes and Measures  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.

Results  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.

Conclusions and Relevance  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.

DOI: 10.1001/jama.2025.1132

Source: https://jamanetwork.com/journals/jama/fullarticle/2831625