Characteristics of immunotherapy trials for nasopharyngeal carcinoma over a 15-year period

Frontiers in Immunology

Immunology

Xinyi Deng¹  Le Yu²  Huangming Hong²  Xiaojie Fang³  Zegeng Chen³  Zhao Wang³  He Huang³  Huageng Huang³  Huawei Weng³  Yuyi Yao³  Tongyu Lin⁴ 

[1] Department of Dermatology, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China;Department of Oncology, Senior Ward and Phase I Clinical Trial Ward, Sichuan Cancer Hospital and Institute, Sichuan Cancer Center, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China;Department of Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, China;Department of Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, China;Department of Oncology, Senior Ward and Phase I Clinical Trial Ward, Sichuan Cancer Hospital and Institute, Sichuan Cancer Center, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China;

关键词: nasopharyngeal carcinoma;    immunotherapy;    Clinicaltrials.gov;    clinical trial;    immune checkpoint inhibitor;   

DOI  :  10.3389/fimmu.2023.1195659

 received in 2023-03-28, accepted in 2023-07-24,  发布年份 2023

来源: Frontiers

【 摘 要 】

BackgroundImmunotherapy has been a hotspot in nasopharyngeal carcinoma (NPC) in recent years. This study aimed to provide a comprehensive landscape of the characteristics of immunotherapy clinical trials in NPC and to determine whether contemporary studies are of sufficient quality to demonstrate therapeutic value.MethodsThis is a cross-sectional analysis of NPC trials registered on ClinicalTrials.gov in the last 15 years (Jan 1, 2008-Nov 20, 2022). Only interventional trials with a primary purpose of treatment were included in the final analysis. Characteristics of immunotherapy trials were compared with those of other NPC trials. Chronological shifts in NPC immunotherapy trials were also analyzed.ResultsOf the 440 NPC studies selected, 161 (36.6%) were immunotherapy trials and 279 (63.4%) were other NPC trials. NPC immunotherapy trials were more likely than other NPC trials to be phase 1-2 (82.6% vs. 66.7%, P < 0.001), single-arm (51.3% vs. 39.6%, P = 0.020), non-randomized (64.8% vs. 44.4%, P < 0.001), and enroll fewer than 50 participants (46.3% vs. 34.4%, P = 0.015). Blinding was used in 8.8% of NPC immunotherapy trials. Also, 90.7% of NPC immunotherapy trials were recruited nationally and 82.6% were Asia-centric. Although academic institutions and governments (72.7%) were the major sponsors of NPC trials, immunotherapy trials were more likely to be industry-funded than other NPC trials (34.2% vs. 11.5%, P < 0.001). The number of NPC immunotherapy trials increased exponentially after 2017, attributed to the exploration of immune checkpoint inhibitors. Immunotherapy combined with chemotherapy was the most commonly investigated regimen.ConclusionNPC immunotherapy trials over a 15-year period were predominantly exploratory. To generate high-quality evidence and advance the clinical application of immunotherapy in NPC, more attention and concerted efforts are needed.

【 授权许可】

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Copyright © 2023 Huang, Yao, Deng, Weng, Chen, Yu, Wang, Fang, Hong, Huang and Lin