Effect of Radiotherapy Alone vs Radiotherapy With Concurrent Chemoradiotherapy on Survival Without Disease Relapse in Patients With Low-risk Nasopharyngeal Carcinoma

作者：Ling‐Long Tang, Rui Guo, Ning Zhang, Bin Deng, Lei Chen, Zhibin Cheng, Jing Huang, Wei‐Han Hu, Shao Hui Huang, Weijun Luo, Jinhui Liang, Yuming Zheng, Fan Zhang, Yan‐Ping Mao, Wen‐Fei Li, Guan‐Qun Zhou, Xu Liu, Yu‐Pei Chen, Cheng Xu, Li Lin, Qing Liu, Xiaojing Du, Yuan Zhang, Ying Sun, Jun Ma · 发表于：JAMA · 年份：2022 · DOI：10.1001/jama.2022.13997 · 被引用次数：183 · 研究领域：Head and Neck Cancer Studies、Head and Neck Surgical Oncology、Advanced Radiotherapy Techniques

Importance: Concurrent chemoradiotherapy has been the standard treatment for stage II nasopharyngeal carcinoma (NPC) based on data using 2-dimensional conventional radiotherapy. There is limited evidence for the role of chemotherapy with use of intensity-modulated radiation therapy (IMRT). Objective: To assess whether concurrent chemotherapy can be safely omitted for patients with low-risk stage II/T3N0 NPC treated with IMRT. Design, Setting, and Participants: This multicenter, open-label, randomized, phase 3, noninferiority clinical trial was conducted at 5 Chinese hospitals, including 341 adult patients with low-risk NPC, defined as stage II/T3N0M0 without adverse features (all nodes <3 cm, no level IV/Vb nodes; no extranodal extension; Epstein-Barr virus DNA <4000 copies/mL), with enrollment between November 2015 and August 2020. The final date of follow-up was March 15, 2022. Interventions: Patients were randomly assigned to receive IMRT alone (n = 172) or concurrent chemoradiotherapy (IMRT with cisplatin, 100 mg/m2 every 3 weeks for 3 cycles [n = 169]). Main Outcomes and Measures: The primary end point was 3-year failure-free survival (time from randomization to any disease relapse or death), with a noninferiority margin of 10%. Secondary end points comprised overall survival, locoregional relapse-free survival, distant metastasis-free survival, adverse events, and health-related quality of life (QOL) measured by the European Organisation for Research and Treatment of Ca...