Thoracic cancer · 2025
Polymeric Micellar Paclitaxel Plus Cisplatin Combined With Tislelizumab as the First-Line Treatment of Advanced Unresectable Esophageal Squamous Cell Carcinoma: A Phase II Study.
СтатьяКлиническое исследование II фазыНазвание и аннотация: Перевод пока не подготовлен
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Li Xiaoyou, Shi Jiamin, Zhu Jinghua, Zhu Jingni, Yan Fei, Liu Delin, Cao Guochun
Аннотация
BACKGROUND: The current standard treatment for advanced and metastatic esophageal squamous cell carcinoma (ESCC) involves a combination of immunotherapy and chemotherapy, but paclitaxel's hormone preconditioning can reduce immune response and effectiveness. Polymeric micellar paclitaxel (Pm-Pac), a nanoformulation, bypasses this issue, enhancing tumor permeability and retention. While Pm-Pac has shown promise in non-small cell lung cancer, its efficacy in ESCC is yet to be established.
METHODS: This is a prospective phase II trial involving untreated stage IV ESCC receiving two cycles of Pm-Pac, cisplatin, and tislelizumab. If no disease progression was observed, they received two additional cycles followed by a year of tislelizumab maintenance. Each 3-week cycle consisted of Pm-Pac (230 mg/m2), cisplatin (70 mg/m2), and tislelizumab (200 mg) on Day 1. The main objective was ORR. Secondary endpoints encompassed OS, PFS, DCR, and safety.
RESULTS: Between September 1, 2022, and June 30, 2024, 23 patients were included in the study. The median follow-up period was 14.8 months. The ORR stood at 69.6% (95% CI: 0.45-0.84) with a DCR of 100% (95% CI: 0.86-1.00). Out of the patients, 2 experienced complete responses, 14 had partial responses, and 7 maintained stable diseases. The mPFS was 10.8 months (95% CI: 0.26-0.632). The 1-year OS rate was 69.6% (95% CI: 49.1-84.4). Notably, no grade 3 or higher treatment-related adverse events or treatment-linked fatalities were reported.
CONCLUSIONS: The combination of Pm-Pac, cisplatin, and tislelizumab as an initial therapy for advanced ESCC is safe and effective and should be tested on a larger scale in the future.
TRIAL REGISTRATION: Chinese Clinical Trial Registry: ChiCTR2400088576.
METHODS: This is a prospective phase II trial involving untreated stage IV ESCC receiving two cycles of Pm-Pac, cisplatin, and tislelizumab. If no disease progression was observed, they received two additional cycles followed by a year of tislelizumab maintenance. Each 3-week cycle consisted of Pm-Pac (230 mg/m2), cisplatin (70 mg/m2), and tislelizumab (200 mg) on Day 1. The main objective was ORR. Secondary endpoints encompassed OS, PFS, DCR, and safety.
RESULTS: Between September 1, 2022, and June 30, 2024, 23 patients were included in the study. The median follow-up period was 14.8 months. The ORR stood at 69.6% (95% CI: 0.45-0.84) with a DCR of 100% (95% CI: 0.86-1.00). Out of the patients, 2 experienced complete responses, 14 had partial responses, and 7 maintained stable diseases. The mPFS was 10.8 months (95% CI: 0.26-0.632). The 1-year OS rate was 69.6% (95% CI: 49.1-84.4). Notably, no grade 3 or higher treatment-related adverse events or treatment-linked fatalities were reported.
CONCLUSIONS: The combination of Pm-Pac, cisplatin, and tislelizumab as an initial therapy for advanced ESCC is safe and effective and should be tested on a larger scale in the future.
TRIAL REGISTRATION: Chinese Clinical Trial Registry: ChiCTR2400088576.