Exploring the impact of first-line durvalumab plus chemotherapy on advanced biliary tract cancer: a systematic review and meta-analysis.

Abstract

<h4>Background</h4>Biliary tract cancer is a rare tumor entity mostly diagnosed at advanced stages with poor prognosis. Since publication of the TOPAZ-1 trial, durvalumab + gemcitabine/cisplatin has become the standard palliative first-line treatment. However, real-world evidence is inconclusive and no systematic review or meta-analysis has yet evaluated the current available literature on this topic.This meta-analysis, therefore, aimed to assess the effectiveness of durvalumab plus gemcitabine/cisplatin as first-line treatment compared to the previous standard and evaluate the existing evidence of this treatment in real-world cohorts.<h4>Methods</h4>Trials investigating durvalumab + gemcitabine/cisplatin as palliative first-line treatment in advanced biliary tract cancer and published in PubMed/Medline databases between January 2020 and December 2024 were included. Studies on second-line treatment or studies investigating other than the standard chemotherapy backbones were excluded. Selection of the trials and quality assessment was conducted independently by two reviewers. Trials with a two-arm design reporting effect measures were included in the meta-analysis.<h4>Results</h4>After screening 190 studies, 10 trials encompassing 2877 patients were included. Evidence was heterogeneous, but results of the meta-analysis demonstrated a statistically significant difference in overall survival and progression-free survival, in favor of patients treated with durvalumab + gemcitabine/cisplatin.<h4>Conclusion</h4>This systematic review and meta-analysis confirm durvalumab + gemcitabine/cisplatin as the best currently available treatment option in patients with advanced biliary tract cancer. Furthermore, multiple real-world cohorts reported similar results even in patients with higher risk factors. However, trials are heterogeneous, and further evidence from real-world cohorts is needed to enhance data quality.