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

IF 11.7 1区医学 Q1 CELL BIOLOGY

Cell Reports Medicine Pub Date : 2025-01-28 DOI:10.1016/j.xcrm.2025.101930

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 Chen

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引用次数: 0

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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局部晚期口腔鳞状细胞癌（OSCC）患者的标准治疗效果不佳。事实证明，新辅助治疗对这些患者有效。在这项随机、双臂、2 期、非比较试验中，我们研究了新辅助程序性细胞死亡 1（PD-1）抑制剂坎瑞珠单抗联合或不联合多西他赛-顺铂-5-氟尿嘧啶（TPF）化疗对可切除的局部晚期 OSCC 患者的疗效和安全性。III-IVA期OSCC患者接受三个周期的坎瑞珠单抗（Cam组）联合或不联合两个周期的TPF化疗（Cam+TPF组）的新辅助治疗，然后接受手术和辅助治疗。Cam治疗组（5/34，14.7%）和Cam+TPF治疗组（26/34，76.4%）均获得了主要病理反应（MPR）。中位随访时间为32个月，Cam治疗组和Cam+TPF治疗组的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。该研究已在ClinicalTrials.gov（NCT04649476）上注册。

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来源期刊

Cell Reports Medicine Biochemistry, Genetics and Molecular Biology-Biochemistry, Genetics and Molecular Biology (all)

CiteScore

15.00

自引率

1.40%

发文量

231

审稿时长

40 days

期刊介绍： Cell Reports Medicine is an esteemed open-access journal by Cell Press that publishes groundbreaking research in translational and clinical biomedical sciences, influencing human health and medicine. Our journal ensures wide visibility and accessibility, reaching scientists and clinicians across various medical disciplines. We publish original research that spans from intriguing human biology concepts to all aspects of clinical work. We encourage submissions that introduce innovative ideas, forging new paths in clinical research and practice. We also welcome studies that provide vital information, enhancing our understanding of current standards of care in diagnosis, treatment, and prognosis. This encompasses translational studies, clinical trials (including long-term follow-ups), genomics, biomarker discovery, and technological advancements that contribute to diagnostics, treatment, and healthcare. Additionally, studies based on vertebrate model organisms are within the scope of the journal, as long as they directly relate to human health and disease.