What type of study is this?

This is a Meta-Analysis study (also classified as: Systematic Review).

August 24, 2025Open Access

Efficacy and safety of tislelizumab in patients with advanced esophageal squamous cell carcinoma: a systematic review and meta-analysis

Key Points

Tislelizumab improves overall survival in advanced esophageal squamous cell carcinoma, achieving a median OS of 8.6 months.
Patients receiving tislelizumab had a progression-free survival of 4.75 months and an overall response rate of 40%.
This systematic review involved evaluating pooled clinical data from four studies focusing on esophageal squamous cell carcinoma.
Adverse events observed were manageable, with no significant differences compared to standard chemotherapy, highlighting tislelizumab's safety profile.

Abstract

Abstract Background Tislelizumab, a PD-1-targeting monoclonal antibody, can potentially treat advanced esophageal squamous cell carcinoma (ESCC). Using pooled clinical data, this study evaluates Tislelizumab's efficacy and safety in advanced ESCC. Methods This review followed PRISMA guidelines, with a comprehensive search conducted across PubMed, ProQuest, EBSCOhost, and Google Scholar for clinical trials involving ESCC patients treated with Tislelizumab. Primary endpoints included overall survival (OS), progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and adverse events (AEs). We evaluated the study quality using the Cochrane Risk of Bias and ROBINS-I tools. Data extraction and pooling were performed using R for single-arm studies and RevMan 5.4 for RCTs. Outcomes were analyzed using pooled medians, hazard ratios for OS and PFS, and relative risks for ORR, DCR, and adverse events. Results Four studies with 1,202 patients met inclusion criteria. The risk of bias was low to moderate. Pooled data indicate a median OS of 8.6 months and PFS of 4.75 months in the Tislelizumab group, with an overall ORR of 0.40 (95% CI: 0.20–0.61) and DCR of 0.64 (95% CI: 0.36–0.88). Tislelizumab significantly improved OS (HR 0.68, 95% CI: 0.59–0.78, p < 0.0001), PFS (HR 0.71, 95% CI: 0.54–0.93, p = 0.01), ORR (RR 1.65, 95% CI: 1.22–2.24, p = 0.001), and DCR (RR 1.11, 95% CI: 1.04–1.18, p = 0.001) compared to standard chemotherapy. Pooled rates of grade 3 or more AEs and serious AEs were 0.56 (95% CI: 0.17–0.92) and 0.28 (95% CI: 0.10–0.50), respectively. There were no significant differences in grade 3 and serious AEs between Tislelizumab and standard chemotherapy. The most common AEs reported included hematologic toxicities, gastrointestinal issues, metabolic disturbances, and biochemical abnormalities. Conclusion Tislelizumab improves survival and response in advanced ESCC patients, particularly when combined with chemotherapy, with an acceptable safety profile. These findings support its continued use in ESCC, though further investigation is warranted due to the limited number of studies. Trial registration CRD42024564367.

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