特瑞普利单抗联合TPF作为诱导化学免疫治疗用于局部晚期下咽癌的前瞻性II期研究
Toripalimab Plus TPF as Induction Chemoimmunotherapy for the Treatment of Locally Advanced Hypopharyngeal Carcinoma: A Prospective Phase II Study.
文献信息
| PMID | 42765138 |
|---|---|
| 原文 | 在 PubMed 查看原文 ↗ |
| 发表日期 | 2026 |
| 作者 | Dan Zhao |
| 作者单位 | Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Radiation Oncology, Peking University Cancer Hospital & Institute, Beijing, China. |
| 期刊 | Head & neck |
| SCI 分区 | Q1 |
| IF | 2.5 |
| 研究类型 | 临床研究 · 临床 |
| 所属专科 | 咽喉科 |
中文摘要
背景： 本研究旨在评估特瑞普利单抗联合TPF在局部晚期下咽鳞状细胞癌（LA HSCC）患者中的疗效及喉功能保留的潜在作用。
方法： 在这项单臂II期研究中，组织学确诊的LA HSCC患者接受三个周期的特瑞普利单抗联合TPF作为诱导化学免疫治疗（I-CI）。主要终点为确定性局部治疗后3个月时的CR率。
结果： 在29例入组患者（62.1%为N3b）中，确定性局部治疗后3个月时，非手术患者的CR率为80.0%（16/20），手术患者100%（9/9）维持无病状态。该队列的CR率为86.2%（25/29）。喉保留率为86.2%（25/29）。I-CI的总体缓解率为81.5%。中位随访38.3个月时，3年无进展生存率、总生存率和喉保留生存率分别为64.0%、76.3%和68.8%。
结论： 在该LA HSCC队列中，特瑞普利单抗联合TPF显示出令人鼓舞的疗效、有前景的喉保留效果和可接受的毒性。
英文摘要
BACKGROUND: This study was aimed to assess the efficacy and potential role of laryngeal function preservation of toripalimab combined with TPF in locally advanced hypopharyngeal squamous cell carcinoma (LA HSCC) patients.
METHODS: Patients with histologically confirmed LA HSCC received three cycles of toripalimab combined with TPF as induction chemoimmunotherapy (I-CI) in this single-arm phase II study. The primary endpoint was the CR rate at 3-months after definitive local treatment.
RESULTS: Of 29 enrolled patients (62.1% N3b), CR rate was 80.0% (16/20) among the non-surgical patients and 100% (9/9) surgical patients maintained disease-free, at 3-month after definitive local treatment. The CR rate for the cohort was 86.2% (25/29). The laryngeal-preservation rate was 86.2% (25/29). Overall response rate of I-CI was 81.5%. With a median follow-up of 38.3 months, the 3-year progression-free survival rate, overall survival, and larynx preservation survival were 64.0%, 76.3%, and 68.8%, respectively.
CONCLUSIONS: Toripalimab combined with TPF showed encouraging efficacy, promising larynx preservation and acceptable toxicity in this cohort of LA HSCC.