Polymeric Micellar Paclitaxel Plus Cisplatin Combined With Tislelizumab as the First-Line Treatment of Advanced Unresectable Esophageal Squamous Cell Carcinoma: A Phase II Study.
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引用次数: 0
Abstract
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.
期刊介绍：
Thoracic Cancer aims to facilitate international collaboration and exchange of comprehensive and cutting-edge information on basic, translational, and applied clinical research in lung cancer, esophageal cancer, mediastinal cancer, breast cancer and other thoracic malignancies. Prevention, treatment and research relevant to Asia-Pacific is a focus area, but submissions from all regions are welcomed. The editors encourage contributions relevant to prevention, general thoracic surgery, medical oncology, radiology, radiation medicine, pathology, basic cancer research, as well as epidemiological and translational studies in thoracic cancer. Thoracic Cancer is the official publication of the Chinese Society of Lung Cancer, International Chinese Society of Thoracic Surgery and is endorsed by the Korean Association for the Study of Lung Cancer and the Hong Kong Cancer Therapy Society.
The Journal publishes a range of article types including: Editorials, Invited Reviews, Mini Reviews, Original Articles, Clinical Guidelines, Technological Notes, Imaging in thoracic cancer, Meeting Reports, Case Reports, Letters to the Editor, Commentaries, and Brief Reports.
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