Neoadjuvant sintilimab and chemotherapy followed by transoral surgery for HPV-positive resectable oropharyngeal cancer: a single-arm, two-centre, phase 2 trial

作者：Shida Yan, Xing Zhang, Fengjiao Li, Ankui Yang, Hui Li, Wanming Hu, Qiaohong Lin, Xiyuan Li, Mingyuan Du, Jingtao Chen, Guodong Man, Jianwei Zhang, Xuemei Fang, Ning Li, Shiting Zhang, Lili Han, Yanmei Ma, Jun Wang, Shu-Wei Chen, Ming Song · 发表于：EClinicalMedicine · 年份：2025 · DOI：10.1016/j.eclinm.2025.103393 · 被引用次数：4 · 研究领域：Head and Neck Cancer Studies、Esophageal Cancer Research and Treatment、Colorectal and Anal Carcinomas

Background Treatment deintensification, such as neoadjuvant immunochemotherapy and transoral surgery, has shown promise but remains under investigation in human papillomavirus-associated oropharyngeal squamous cell carcinoma (HPV + OPSCC). We aimed to explore the efficacy and safety of neoadjuvant immunochemotherapy and the feasibility of sequential transoral surgery in patients with resectable HPV + OPSCC. Methods In this single-arm, two-centre, phase 2 trial, patients with resectable HPV + OPSCC (clinical stage T2-4N0-3M0) were recruited and received two cycles of neoadjuvant sintilimab, cisplatin, and nab-paclitaxel every three weeks, followed by transoral surgery, including transoral robotic surgery (TORS). The primary endpoint was major pathological response (MPR), defined as the residual viable tumor of less than or equal to 10% in the primary lesion. The study is registered with Chinese Clinical Trial Registry (ChiCTR2200058650) and is ongoing. Findings Between April 13, 2022 and November 17, 2023, 27 patients were enrolled and all received two cycles of neoadjuvant immunochemotherapy, which all achieved partial responses. Among them, 25 patients received radical surgery (21 TORSs and 4 transoral surgeries). MPR was achieved in 24 patients (24/25, 96.0%), including 17 (17/25, 68.0%) with pathological complete response (pCR). Grade 1–2 treatment-related adverse events (TRAE) occurred in 24 of 27 patients (88.9%), including skin rash (12/27, 44.4%), alopecia (10/27, 37.0...