Neoadjuvant immunotherapy with or without chemotherapy in locally advanced oral squamous cell carcinoma: Randomized, two-arm, phase 2 trial

局部晚期口腔鳞状细胞癌联合或不联合化疗的新辅助免疫治疗:随机、双组、 2 期试验

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作者:Hai-Ming Liu, Xue-Peng Xiong, Zi-Li Yu, Zhe Shao, Gai-Li Chen, Yu-Tong Liu, Xin-Xin Wang, Qiu-Yun Fu, Xiao-Xia Cheng, Jing Li, Jia-Li Zhang, Bo Li, Hong-Yun Gong, Ya-Hua Zhong, Wei Zhang, Jun Jia, Bing Liu, Gang Chen1

Abstract

Patients with locally advanced oral squamous cell carcinoma (OSCC) have poor outcomes with standard care. Neoadjuvant therapy is shown to be effective for these patients. In the randomized, two-arm, phase 2, non-comparative trial, we investigate the efficacy and safety of the neoadjuvant programmed cell death 1 (PD-1) inhibitor camrelizumab with or without docetaxel-cisplatin-5-fluorouracil (TPF) chemotherapy in patients with resectable locally advanced OSCC. Patients with stage III-IVA OSCC receive neoadjuvant therapy with three cycles of camrelizumab (arm Cam) with or without two cycles of TPF chemotherapy (arm Cam+TPF), followed by surgery and adjuvant therapy. Major pathological response (MPR) is achieved in both arm Cam (5/34, 14.7%) and arm Cam+TPF (26/34, 76.4%). With a median follow-up of 32 months, the 2-year event-free survival (EFS) rate of arm Cam and Cam+TPF is 52.9% and 91.2%, respectively. This work demonstrates feasibility and safety for immunochemotherapy in the neoadjuvant setting for OSCC. This study was registered at ClinicalTrials.gov (NCT04649476).

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