新辅助tislelizumab联合化疗治疗局部晚期口腔和口咽鳞状细胞癌：单臂II期临床试验

IF 4 2区医学 Q1 DENTISTRY, ORAL SURGERY & MEDICINE

Oral oncology Pub Date : 2026-01-01 Epub Date: 2025-12-05 DOI:10.1016/j.oraloncology.2025.107809

Wen-Jie Wu , Pu-Gen An , Zi-Qi Zhang , Li-Hang Shen , Jian-Yun Zhang , Yan Chen , Ming-Wei Huang , Shu-Ming Liu , Jie Yao , Jie Zhang

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引用次数: 0

摘要

本研究旨在评估新辅助化疗联合tislelizumab（一种程序性死亡-1抑制剂）治疗可切除的局部晚期口腔或口咽鳞状细胞癌（LAOOPSCC）的抗肿瘤效果和安全性。方法符合条件的III-IV期laopscc患者接受2个周期的替利单抗（200 mg）、白蛋白结合紫杉醇（260 mg/m2）和顺铂（60-75 mg/m2）治疗，每个周期间隔3周；这种治疗之后是手术和辅助放疗或同步放化疗。主要终点是主要病理反应（MPR）率和安全性。结果在2022年3月至2023年6月期间，共有82例患者符合条件并完成了2个周期的新辅助治疗；影像学评价78例，手术及病理反应评价73例。40例患者接受原发肿瘤降级手术。1例患者避免了眶底切除术，5例患者避免了下颌切除术，32例患者避免了近全舌切除术或全舌切除术。客观缓解率为67.9%，MPR为60.3%，34.2%的患者达到病理完全缓解。中位随访时间为24个月，2年总生存率为84.4%，2年无事件生存率为76.7%。11例患者（13.4%）在新辅助治疗期间发生了3级或4级治疗相关不良事件。结论：tislelizumab联合化疗治疗laopscc获得了较高的病理反应率和良好的生存指标，安全性可接受。

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Neoadjuvant tislelizumab plus chemotherapy in locally advanced oral and oropharyngeal squamous cell carcinoma: A single-arm phase II clinical trial

Background

This study aimed to evaluate the antitumor effect and safety of neoadjuvant chemotherapy plus tislelizumab (a programmed death-1 inhibitor) for the treatment of resectable locally advanced oral or oropharyngeal squamous cell carcinoma (LAOOPSCC).

Methods

Eligible patients with stage III-IV LAOOPSCC were treated with two cycles of tislelizumab (200 mg), albumin-bound paclitaxel (260 mg/m²), and cisplatin (60–75 mg/m²) with a three-week interval between each cycle; this treatment was followed by surgery and adjuvant radiotherapy or concurrent chemoradiotherapy. The primary endpoints were the major pathological response (MPR) rate and safety.

Results

Between March 2022 and June 2023, a total of 82 patients were eligible and completed two cycles of neoadjuvant therapy; 78 patients underwent imaging evaluation, and 73 underwent surgery and pathological response evaluation. Forty patients underwent de-escalation surgery for the primary tumor. Orbital floor resection was avoided in 1 patient, mandibulectomy was avoided in 5 patients, and near-total glossectomy or total glossectomy was avoided in 32 patients. An objective response rate of 67.9 % and an MPR rate of 60.3 % were achieved, with 34.2 % of patients achieving a pathological complete response. With a median follow-up time of 24 months, the two-year overall survival rate was 84.4 %, and the two-year event-free survival rate was 76.7 %. Treatment-related adverse events of grade 3 or 4 occurred in 11 patients (13.4 %) during the neoadjuvant therapy.

Conclusions

Neoadjuvant tislelizumab plus chemotherapy for LAOOPSCC achieved a high pathological response rate and favorable survival metrics with an acceptable safety profile.

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来源期刊

Oral oncology 医学-牙科与口腔外科

CiteScore

8.70

自引率

10.40%

发文量

505

审稿时长

20 days

期刊介绍： Oral Oncology is an international interdisciplinary journal which publishes high quality original research, clinical trials and review articles, editorials, and commentaries relating to the etiopathogenesis, epidemiology, prevention, clinical features, diagnosis, treatment and management of patients with neoplasms in the head and neck. Oral Oncology is of interest to head and neck surgeons, radiation and medical oncologists, maxillo-facial surgeons, oto-rhino-laryngologists, plastic surgeons, pathologists, scientists, oral medical specialists, special care dentists, dental care professionals, general dental practitioners, public health physicians, palliative care physicians, nurses, radiologists, radiographers, dieticians, occupational therapists, speech and language therapists, nutritionists, clinical and health psychologists and counselors, professionals in end of life care, as well as others interested in these fields.