Efficacy and safety of tislelizumab in combination with other chemotherapy agents in patients with biliary cancer: Systematic review and meta analysis.

Abstract

e14618 Background: Biliary tract tumors (BTC) are rare but aggressive malignancies with poor prognoses and limited treatment choices. Despite advances in diagnosis and treatment, the prognosis is still poor, with a 5-year survival rate of < 10% in advanced stages. Tislelizumab, an anti-PD-1 antibody, has shown some promise in improving outcomes, particularly when combined with chemotherapy or targeted therapies. Our study aims to evaluate the efficacy and safety of Tislelizumab in BTC, synthesizing data from existing clinical trials to inform future research and clinical application. Methods: Our Study evaluated Tislelizumab combined with chemotherapy in biliary tract cancers by analysis non-randomized trials. Screening and data extraction steps were independently performed by 2 reviewers and conflicts were resolved by a third reviewer. Outcomes included; Disease Control Rate (DCR), Objective Response Rate (ORR), median Progression-Free Survival (mPFS), treatment-related adverse events (TRAEs). Publication bias was assessed using funnel plot and meta-analysis was performed by Comprehensive meta-analysis software 5. Pooled estimates for efficacy and safety outcomes were calculated using a random-effects model and heterogeneity was assessed byI² statistic.Subgroup analyses were conducted based on chemotherapy regimens. Results: Our study showed that Tislelizumab combined with other chemotherapy agents demonstrated good efficacy in biliary cancer management, with a pooled DCR of 81.1% (95% CI: 71.8–87.8 %) showing moderate variability (I² = 51%) but no significant heterogeneity (Q = 10.177, p = 0.070). The ORR of 40.8% (95% CI: 29.7%–53.0%, p = 0.014; I² = 65), indicating a meaningful proportion of patients achieved tumor reduction. The mPFS was 6.877 months (6.88 months (95% CI: 5.099–8.656, p < 0.001; I² = 99%).Safety analysis revealed a moderate increase in TRAEs; 33.4((95% CI: 0.171 to 0.550, p < 0.001; I² = 84%). Subgroup analyses showed that Tislelizumab/Gemcitabine combination therapy had a higher TRAE at 43.2% compared to non-Tislelizumab/Gemcitabine therapy at 21.4 Conclusions: Tislelizumab combined with chemotherapy demonstrates significant efficacy in the treatment of biliary tract cancers, with a high DCR, considerable ORR, and an encouraging median PFS. The study revealed concerns for adverse effects which was seen the Tislelizumab/Gemcitabine combination. While the therapy shows promise, moderate to high heterogeneity across studies highlights the need for further research to optimize patient selection and treatment regimens.