局部晚期口腔鳞状细胞癌新辅助免疫治疗联合或不联合化疗：随机、双臂、2期试验

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

作者信息

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

机构信息

State Key Laboratory of Oral & Maxillofacial Reconstruction and Regeneration, Key Laboratory of Oral Biomedicine Ministry of Education, Hubei Key Laboratory of Stomatology, School & Hospital of Stomatology, Wuhan University, Wuhan 430079, China; Department of Oral and Maxillofacial Surgery, School and Hospital of Stomatology, Wuhan University, Wuhan 430079, China.

出版信息

Cell Rep Med. 2025 Feb 18;6(2):101930. doi: 10.1016/j.xcrm.2025.101930. Epub 2025 Jan 30.

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).

局部晚期口腔鳞状细胞癌（OSCC）患者接受标准治疗的预后较差。新辅助治疗已被证明对这些患者有效。在这项随机、双臂、2期、非对照试验中，我们研究了新辅助程序性细胞死亡1（PD-1）抑制剂卡瑞利珠单抗联合或不联合多西他赛-顺铂-5-氟尿嘧啶（TPF）化疗在可切除的局部晚期OSCC患者中的疗效和安全性。III-IVA期OSCC患者接受新辅助治疗，使用三个周期的卡瑞利珠单抗（卡瑞利珠单抗组）联合或不联合两个周期的TPF化疗（卡瑞利珠单抗+TPF组），随后进行手术和辅助治疗。卡瑞利珠单抗组（5/34，14.7%）和卡瑞利珠单抗+TPF组（26/34，76.4%）均达到主要病理缓解（MPR）。中位随访32个月时，卡瑞利珠单抗组和卡瑞利珠单抗+TPF组的2年无事件生存率（EFS）分别为52.9%和91.2%。这项研究证明了免疫化疗在OSCC新辅助治疗中的可行性和安全性。本研究已在ClinicalTrials.gov（NCT04649476）注册。