新辅助托瑞帕利单抗联合化疗治疗局部晚期头颈部鳞状细胞癌

Neoadjuvant toripalimab combined with chemotherapy in locally advanced HNSCC.

作者信息

Wang Zhaoyang, Yang Sheng, Yan Dangui, Zhang Ye, Zhang Xiwei, Zhang Fa, Zhao Xiaohui, Zhang Zongmin, Liu Shaoyan, Gui Lin, An Changming

机构信息

Department of Head and Neck Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.

Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.

出版信息

Front Oncol. 2025 May 19;15:1571776. doi: 10.3389/fonc.2025.1571776. eCollection 2025.

INTRODUCTION

To determine the safety and efficacy of neoadjuvant toripalimab combined with chemotherapy in locally advanced head and neck squamous cell carcinoma (LA-HNSCC).

PATIENTS AND METHODS

This single-arm investigator-initiated trial was conducted at a tertiary cancer hospital in China. The untreated LA-HNSCC patients received two cycles of neoadjuvant paclitaxel and cisplatin (TP) + toripalimab regimen (paclitaxel 175 mg/m d1, cisplatin 75 mg/m d1, and toripalimab 240 mg d1, every 3 weeks). Surgery or chemoradiotherapy (CRT) was determined via the patient-doctor consensus. The primary endpoints were objective response rate (ORR) and safety.

RESULTS

The study enrolled a total of 23 patients. All the patients completed the entire treatment course with an ORR of 78.3% (18/23). Any grades of treatment-related adverse events (TRAEs) were reported in 12 patients (52.2%), and three patients experienced grade 3-4- TRAEs. No delay for curative treatment was observed. Twelve patients underwent radical surgery, and six patients developed pathological complete response (pCR), with a pCR rate of 50%. With a median follow-up of 15 months, 12 surgery patients maintained event-free survival; however, three out of 11 who received CRT suffered from local recurrence or metastases.

CONCLUSIONS

Neoadjuvant TP + toripalimab for LA-HNSCC showed high ORR and pCR rates with a good safety profile.

CLINICAL TRIAL REGISTRATION

https://www.chictr.org.cn/showproj.html?proj=231832, identifier ChiCTR2400091148.

引言

确定新辅助托瑞帕利单抗联合化疗治疗局部晚期头颈部鳞状细胞癌（LA-HNSCC）的安全性和有效性。

患者与方法

本单臂研究者发起的试验在中国一家三级癌症医院进行。未经治疗的LA-HNSCC患者接受两个周期的新辅助紫杉醇和顺铂（TP）+托瑞帕利单抗方案（紫杉醇175mg/m² d1，顺铂75mg/m² d1，托瑞帕利单抗240mg d1，每3周一次）。通过医患共同决策确定手术或放化疗（CRT）。主要终点为客观缓解率（ORR）和安全性。

结果

该研究共纳入23例患者。所有患者均完成了整个治疗过程，ORR为78.3%（18/23）。12例患者（52.2%）报告了任何级别的治疗相关不良事件（TRAEs），3例患者发生3-4级TRAEs。未观察到根治性治疗延迟。12例患者接受了根治性手术，6例患者达到病理完全缓解（pCR），pCR率为50%。中位随访15个月，12例手术患者维持无事件生存；然而，11例接受CRT的患者中有3例出现局部复发或转移。