Adjuvant PD-1 Blockade With Camrelizumab for Nasopharyngeal Carcinoma: The DIPPER Randomized Clinical Trial.
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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
Аннотация
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.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03427827.