Assessment of efficacy, safety and survival of tislelizumab as neoadjuvant therapy for locally advanced esophageal squamous cell carcinoma: a real-world data study.

Background: Tislelizumab, an immune checkpoint inhibitor, has made significant advancements in the neoadjuvant therapy of esophageal squamous cell carcinoma (ESCC). However, the clinical benefits of neoadjuvant immunotherapy for resectable ESCC remain uncertain. This study aims to provide robust and precise evidence for the clinical application of tislelizumab in neoadjuvant therapy for ESCC by analyzing real-world data. Methods: We conducted a retrospective analysis of patients with locally advanced patients (stage IIA-IVA) with pathologically confirmed ESCC who were treated at the First Affiliated Hospital of Fujian Medical University from August 2022 to April 2024. Following evaluations by thoracic surgeons and oncologists, these patients received neoadjuvant therapy combined with surgical resection. The primary endpoints were the pCR rate and the safety assessment of neoadjuvant therapy. Secondary endpoints included the R0 resection rate, tumor regression grade, objective response rate (ORR), postoperative complications, overall survival (OS), and disease-free survival (DFS). Results: A total of 59 patients were enrolled, with a pCR rate of 22%. During the neoadjuvant immunochemotherapy (nICT) period, the most common adverse events (AEs) included anemia (56%). The incidence of grade ≥3 AEs was 10%. The R0 resection rate was 100%, and the most common postoperative complications included pulmonary infection (13/50, 26%). The 1-year OS rate was 93.9%, while the 1-year DFS rate was 73.5%. Conclusions: In real-world data, tislelizumab as a neoadjuvant therapy for patients with locally advanced ESCC patients demonstrated excellent safety and feasibility. However, further investigation is needed to assess its long-term survival outcomes.