Treatment with gemcitabine/cisplatin and durvalumab for advanced biliary tract cancer – real-world data from a multicenter German patient population

PMCID: PMC12176970

PMID: 40533571

DOI: 10.1007/s00432-025-06239-1

Journal: Journal of cancer research and clinical oncology

Publication Date: 2025-6-18

Authors: Gerhardt F, Müller C, Venerito M, Chater J, Mohr R, et al.

Key Points

• First real-world validation of ICI-based therapy for advanced biliary tract cancers using gemcitabine/cisplatin and durvalumab
• Overall response rate of 11.1% with median overall survival of 16 months
• Supports emerging paradigm of immunotherapy as a standard treatment approach for advanced biliary tract malignancies

Summary

This retrospective study evaluated the efficacy and safety of gemcitabine/cisplatin combined with durvalumab (GCD) in advanced biliary tract cancers (BTCs), building on recent landmark trials that introduced immune checkpoint inhibitors (ICIs) into first-line therapy. Analyzing 90 patients across German medical centers, the research provides real-world insights into the emerging standard of care for this challenging malignancy.

The study revealed a median overall survival of 16 months and median progression-free survival of 5 months, with an overall response rate of 11.1% and disease control rate of 41.1%. Notably, perihilar primary tumors were associated with better progression-free survival, while patients aged 70-75 years and those with ECOG performance status 2 experienced poorer overall survival. Adverse events occurred in 64% of patients, predominantly mild to moderate, with the most common being anemia, thrombocytopenia, neutropenia, nausea, and fatigue.