Tislelizumab plus nab-paclitaxel and cisplatin as induction immunochemotherapy for organ preservation of locally advanced hypopharyngeal squamous cell carcinoma: a single-arm phase II trial

作者：L. Gui, Zhijian Xie, Wei Zhang, Xin Chen, Shuli Liu, Xin Wang, Junlin Yi, Chenyi An, Hui Lu, Jia Yao, Hongxia Zhu, Tianyu Xie, Le Tang, Xiaodong He, Yajun Shi · 发表于：ESMO Open · 年份：2025 · DOI：10.1016/j.esmoop.2025.105505 · 被引用次数：8 · 研究领域：Head and Neck Cancer Studies、Esophageal Cancer Research and Treatment、Head and Neck Surgical Oncology

INTRODUCTION: Hypopharyngeal squamous cell carcinoma (HPSCC) has the poorest prognosis among head and neck cancer subtypes. The efficacy, role in organ preservation, safety, and biomarkers of induction immunochemotherapy for HPSCC require further investigation. METHODS: ) i.v. on day 1 of each 3-week cycle for two cycles (ChiCTR2200060094). The primary endpoint was the larynx preservation rate (LPR) at 3 months. Secondary endpoints included objective response rate (ORR), pathological complete response (pCR) rate, disease control rate (DCR), larynx preservation survival (LPS), progression-free survival (PFS), overall survival (OS), disease-free survival (DFS), and safety. Sample size was calculated using Simon's optimal two-stage design, with an expected LPR of 65% for chemotherapy and 85% for immunochemotherapy. Survival analysis was carried out using the Kaplan-Meier method. RESULTS: Between 25 May 2022, and 15 November 2023, 45 patients were enrolled and all completed two cycles of induction immunochemotherapy. At the data cut-off on 15 March 2024, the 3-month LPR was 86.7% [39/45, 95% confidence interval (CI) 0.73% to 0.95%]. The ORR and DCR were 62.2% (28/45) and 100% (45/45), respectively. Twenty-eight patients underwent surgery. The pCR rate was 21.4% (6/28). With a median follow-up of 11.6 months (95% CI 10.1-17.7 months), the median LPS, PFS, DFS, and OS were not reached. The 12-month LPS, PFS, DFS, and OS rates were 66.7% (95% CI 52.2% to 85.2%), 69.8% (95% CI 56.0% ...