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

Patrick Reimann; Eva-Maria Schneider; Angela Djanani; Sylvia Mink; Thomas Winder; Magdalena Benda

doi:10.1093/oncolo/oyaf224

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

Oncologist. 2025 Sep 1;30(9):oyaf224. doi: 10.1093/oncolo/oyaf224.

Authors

Patrick Reimann^{1

2}, Eva-Maria Schneider¹, Angela Djanani³, Sylvia Mink^{2

4}, Thomas Winder^{1

5}, Magdalena Benda^{1

2}

Affiliations

¹ Department of Internal Medicine II, Academic Teaching Hospital Feldkirch, Feldkirch 6800, Austria.
² Department of Medical Sciences,Private University of the Principality of Liechtenstein, Triesen 9495, Liechtenstein.
³ Department of Internal Medicine, Medical University of Innsbruck, Innsbruck 6020, Austria.
⁴ Central Medical Laboratories, Feldkirch 6800, Austria.
⁵ University of Zurich, Zurich 8006, Switzerland.

Abstract

Background: 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.

Methods: 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.

Results: 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.

Conclusion: 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.

Keywords: biliary tract cancer; durvalumab; immunotherapy; meta-analysis; systematic review.

Publication types

Systematic Review
Meta-Analysis

MeSH terms

Antibodies, Monoclonal* / pharmacology
Antibodies, Monoclonal* / therapeutic use
Antineoplastic Combined Chemotherapy Protocols* / pharmacology
Antineoplastic Combined Chemotherapy Protocols* / therapeutic use
Biliary Tract Neoplasms* / drug therapy
Biliary Tract Neoplasms* / mortality
Biliary Tract Neoplasms* / pathology
Cisplatin / therapeutic use
Deoxycytidine / analogs & derivatives
Gemcitabine
Humans

Substances

durvalumab
Antibodies, Monoclonal
Gemcitabine
Deoxycytidine
Cisplatin