Epstein–Barr virus DNA-guided chemoradiotherapy for patients with low-risk locoregionally advanced nasopharyngeal carcinoma: a secondary 5-year follow-up analysis of an open-label, randomised controlled, phase 2 non-inferiority trial

作者：Yu-Chen Li, Xiaoyun Li, Kai‐Qi Lan, Hui Cheng, Jie Chen, Li-Ting Liu, Dong‐Xiang Wen, Li-Wen Gu, Wan‐Ping Guo, Xue-Song Sun, Sai Lan Liu, Jin‐Hao Yang, Su‐Chen Li, Yi-Fu Li, Hao-Xiang Long, Dong-Hua Luo, Ling Guo, Hao‐Yuan Mo, Rui Sun, Shanshan Guo, Pan Wang, Li-Bin Li, Libin Li, Qi Yang, Yu-Jing Liang, Guo-Dong Jia, Jin‐Jie Yan, Chong Zhao, Qiu-Yan Chen, Liang-Ji Li, Liangji Li, Hai‐Qiang Mai, Lin-Quan Tang · 发表于：EClinicalMedicine · 年份：2025 · DOI：10.1016/j.eclinm.2025.103615 · 被引用次数：3 · 研究领域：Head and Neck Cancer Studies、Viral-associated cancers and disorders、Cleft Lip and Palate Research

Background Intensity-modulated radiation therapy (IMRT) with two cycles of concurrent 100 mg/m 2 cisplatin (DDP) presents a potential alternative for low-risk, locoregionally advanced nasopharyngeal carcinoma (LA-NPC). This study assessed its long-term survival outcomes and late toxicities. Methods This is a secondary analysis of an open-label, randomised, controlled, phase 2 non-inferiority trial, which enrolled patients with low-risk LA-NPC (pretreatment plasma Epstein–Barr virus DNA < 4000 copies/mL) at Sun Yat-sen University Cancer Center. Eligible participants were randomly assigned (1:1) to receive either two cycles or three cycles of concurrent cisplatin (100 mg/m 2 every 3 weeks) with intensity-modulated radiation therapy. The primary endpoint was 5-year progression-free survival (PFS); secondary endpoints were 5-year overall survival (OS), locoregional relapse-free survival (LRRFS), distant metastasis-free survival (DMFS), and late toxic effects. The non-inferiority margin was 10%. This secondary analysis of long-term follow-up was prespecified in the study protocol. Analyses of primary and secondary endpoints included intention-to-treat and per-protocol populations. The trial is registered with ClinicalTrials.gov, NCT02871518. Findings Between Sept 28, 2016, to Oct 18, 2018, 332 patients were enrolled and randomly assigned to the two-cycle group (n = 166) or three-cycle group (n = 166). The final follow-up date was Oct 11, 2024. Data were analysed from Oct 11, 2024,...