Effect of Concurrent Chemoradiotherapy With Nedaplatin vs Cisplatin on the Long-term Outcomes of Survival and Toxic Effects Among Patients With Stage II to IVB Nasopharyngeal Carcinoma

作者：Qing‐Nan Tang, Li‐Ting Liu, Bin Qi, Shanshan Guo, Dong–Hua Luo, Rui Sun, Xue-Song Sun, Dongping Chen, Ling Guo, Hao‐Yuan Mo, Pan Wang, Sai‐Lan Liu, Yu-Jing Liang, Xiaoyun Li, Zhen‐Chong Yang, Qiuyan Chen, Hai‐Qiang Mai, Lin‐Quan Tang · 发表于：JAMA Network Open · 年份：2021 · DOI：10.1001/jamanetworkopen.2021.38470 · 被引用次数：32 · 研究领域：Head and Neck Cancer Studies、Head and Neck Surgical Oncology、Advanced Drug Delivery Systems

Importance: Nedaplatin-based concurrent chemoradiotherapy (CCRT) regimen at 2 years was noninferior to cisplatin-based regimen in patients with locoregional, stage II to IVB nasopharyngeal carcinoma (NPC) and was associated with fewer late adverse events, but longer-term outcomes and toxicity are unclear. Objective: To evaluate the 5-year outcomes and late toxicity profile of nedaplatin-based CCRT in patients with locoregional, stage II to IVB NPC. Design, Settings, and Participants: This 5-year follow-up secondary analysis of an open-label, noninferiority, multicenter randomized clinical trial enrolled patients with nonkeratinizing stage II to IVB NPC between January 16, 2012, and July 16, 2014, with a median follow-up duration of 78 months (IQR, 3-99 months). Data analysis was conducted from November 10, 2020, to July 8, 2021. Interventions: Patients were randomly assigned (1:1) to receive nedaplatin (100 mg/m2)- or cisplatin (100 mg/m2)-based chemotherapy every 3 weeks for 3 cycles concurrently with intensity-modulated radiotherapy. Main Outcomes and Measures: The primary end point was progression-free survival (PFS). Secondary end points were overall survival, distant metastasis-free survival, and locoregional relapse-free survival. Results: A total of 402 eligible participants were enrolled (median [IQR] age, 45 [18-65] years; 302 [75.1%] male). Patients were randomly assigned to receive nedaplatin- or cisplatin-based CCRT (n = 201 for each): 196 patients (97.5%) started...