Sequential vs Induction Plus Concurrent Chemoradiotherapy in Nasopharyngeal Carcinoma

作者：Fen Xue, Dan Ou, Congying Xie, Shaojun Lin, Jingao Li, Xiaozhong Chen, Fuzheng Zhang, Hongmei Ying, Xueguan Lu, Chunying Shen, Tingting Xu, Xiaomin Ou, Weiwei Li, Xin Zhou, Chengrun Du, Changming Zhou, Chaosu Hu, Xiayun He · 发表于：JAMA Oncology · 年份：2025 · DOI：10.1001/jamaoncol.2025.2191 · 被引用次数：8 · 研究领域：Head and Neck Cancer Studies、Head and Neck Surgical Oncology、Advanced Drug Delivery Systems

Importance: Induction chemotherapy (IC) plus concurrent chemoradiotherapy (CCRT) has been a standard treatment for locoregionally advanced nasopharyngeal carcinoma (LA-NPC) but with high acute toxic effects in CCRT phase. Whether CCRT can be safely replaced by radiation therapy with adjuvant chemotherapy (AC) is unknown. Objective: To assess if sequential chemoradiotherapy (SCRT; IC, followed by radiotherapy alone, followed by AC) is noninferior to IC plus CCRT for LA-NPC in terms of efficacy, with less acute toxic effects. Design, Setting, and Participants: This multicenter, open-label, phase 3 noninferiority randomized clinical trial was conducted from January 2018 to September 2021 in 6 centers in China. Patients aged 18 to 65 years with newly diagnosed stage III/IVA NPC were enrolled. The data cutoff date was June 30, 2024. Interventions: Patients were randomly assigned 1:1 to receive 2 cycles of IC with a gemcitabine and cisplatin (GP) regimen (gemcitabine, 1000 mg/m2, on days 1 and 8 plus cisplatin, 25 mg/m2, on days 1, 2, and 3, repeated every 3 weeks) plus radiotherapy alone, followed by 2 cycles of AC with a GP regimen (SCRT group) or 2 cycles IC (GP regimen) followed by radiotherapy concurrent with weekly cisplatin, 30 mg/m2 (IC plus CCRT group). Main Outcomes and Measures: The primary end points were 3-year failure-free survival (FFS) with a noninferiority margin of 10% (hazard ratio [HR] less than 1.6) and the incidence of grade 3 or higher acute mucositis during ...