Neoadjuvant sintilimab and platinum-doublet chemotherapy followed by transoral robotic surgery for HPV-associated resectable oropharyngeal cancer: Single-arm, phase II trial.

作者：Shida Yan, Shu-Wei Chen, Xing Zhang, Wanming Hu, Hui Li, Yanmei Ma, Lili Han, Shiting Zhang, Jun Wang, Jianwei Zhang, Guodong Man, Quan Zhang, Ankui Yang, Ming Song · 发表于：Journal of Clinical Oncology · 年份：2024 · DOI：10.1200/jco.2024.42.16_suppl.6011 · 被引用次数：5 · 研究领域：Head and Neck Cancer Studies、Head and Neck Surgical Oncology、Lung Cancer Research Studies

6011 Background: De-escalation treatments for HPV-associated (HPV+) oropharyngeal cancer (OPC) have been well discussed. Meanwhile, the combination of anti-PD-1 therapy and chemotherapy (immunochemotherapy, ICT) and transoral robotic surgery (TORS) shows promising results in OPC, especially in HPV+ ones. This study aims to investigate the efficacy and safety of neoadjuvant ICT and sequential TORS to reduce functional impairments and omit adjuvant radiotherapy for resectable HPV+ OPC. Methods: In the single-arm, phase II trial, patients with resectable HPV+OPC (cT2-4N0-3M0, AJCC 8.0) were recruited and received neoadjuvant sintilimab (200mg), platinum (cisplatin 60mg/m 2 , or carboplatin AUC=5), and paclitaxel (nab-paclitaxel 260mg/m 2 , or docetaxel 75mg/m 2 ) every 3 weeks for 2 cycles, followed by radical surgery (with TORS as an option). The primary endpoint was major pathological response (MPR; defined as residual viable tumor of less than or equal to 10%) in the primary lesion. The secondary endpoints include pathologically complete response (pCR) of all resected lesions, objective response rate (ORR) according to RECIST 1.1, disease-free survival (DFS) rate and overall survival (OS) rate at 1 and 3 years, quality of life (QoL) by EORTC QLQ-H&N35 questionnaire. Results: From February 1, 2022 to November 30, 2023, 27 patients were enrolled and received 2 cycles of neoadjuvant ICT. After neoadjuvant therapy, all 27 cases achieved partial response (PR), the ORR was 100%...