Year: 2024
Type: conference-abstract
Abstract: 129 Background: Approximately 30% of locoregionally advanced nasopharyngeal carcinoma (NPC) experience disease relapse despite definitive chemoradiotherapy. The programmed death-1 (PD-1) blockade camrelizumab has demonstrated considerable value in recurrent/metastatic NPC, while its role in locoregionally advanced NPC is worth exploring. Methods: We conducted a randomized, open-label, phase 3 trial to evaluate adjuvant camrelizumab in locoregionally advanced NPC after definitive chemoradiotherapy. Patients with T4N1M0 or T1-4N2-3M0 NPC who have undergone induction chemotherapy and concurrent chemoradiotherapy were randomized in a 1:1 ratio to receive adjuvant camrelizumab (200mg intravenously once every 3 weeks for up to 12 cycles; Camrelizumab group) or observation ( Standard-therapy group). The primary endpoint was event-free survival (freedom from randomization to locoregional recurrence, distant metastasis, or death from any cause). The secondary endpoint included locoregional recurrence-free survival, distant metastasis-free survival, overall survival, safety, and quality of life. Results: A total of 226 patients were randomized to the Camrelizumab group and 224 to Standard-therapy group. At a median follow-up of 37 months, the 3-year event-free survival was 86.9% in the Camrelizumab group and 77.4% in the Standard-therapy groups (stratified hazard ratio, 0.61; 95% confidence interval [CI], 0.38 to 0.96; P = 0.03). Grade 3 or 4 adverse events were reported in 11.2% patients in the Camrelizumab group and 3.2% of those in the Standard-therapy group. The most common adverse event of grade 3 or 4 was leukopenia (4.9% and 1.4%, respectively). There was no meaningful deterioration in quality of life associated with the use of adjuvant camrelizumab. Conclusions: Adjuvant PD-1 blockade with camrelizumab significantly improved event-free survival, with mild toxicity, highlighting its compelling role in the management of locoregionally advanced NPC. (DIPPER,ClinicalTrials.gov numberNCT03427827). Clinical trial information: NCT03427827 . [Table: see text]
Source: Journal of Clinical Oncology
Authors: Jun Ma, Ying Sun, Ye-Lin Liang, Xu Liu, Liangfang Shen, Guangyuan Hu, Guorong Zou, Ning Zhang, Chuanben Chen, Xiaozhong Chen, Xiao-Dong Zhu, Yawei Yuan, Kunyu Yang, Feng Jin, Shu-Bin Hong, Hongyun Zhao, Ji-Bin Li
Institutions: Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Central South University, Xiangya Hospital Central South University, Tongji Hospital, Huazhong University of Science and Technology, Panyu District Central Hospital, First People's Hospital of Foshan, Fujian Provincial Cancer Hospital, Zhejiang Cancer Hospital, Guangxi Medical University, Tumor Hospital of Guangxi Medical University, Guangzhou Medical University Cancer Hospital, Wuhan Union Hospital, Guizhou Cancer Hospital, The First Affiliated Hospital, Sun Yat-sen University, Sun Yat-sen University
Language: English
Topic: Head and Neck Cancer Studies
Subfield: Otorhinolaryngology
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W4401514393