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Multicenter Study
. 2025 Jun 18;151(6):191.
doi: 10.1007/s00432-025-06239-1.

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

Florian Gerhardt  1 , Christian Müller  2 , Marino Venerito  2 , Jack Chater  3 , Raphael Mohr  4 , Mara Egerer  4 , Udo Lindig  5 , Aaron Schindler  1 , Sebastian Ebel  6 , Janett Fischer  1 , Maik Schwarz  7 , Sonja Gehring  8 , Thomas Berg  1 , Florian van Bömmel  9
Affiliations
Multicenter Study

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

Florian Gerhardt et al. J Cancer Res Clin Oncol. .

Abstract

Background: Biliary tract cancers (BTCs) are a heterogeneous group of malignant cancers with an overall poor prognosis. For more than a decade, the standard palliative first-line therapy was cytotoxic chemotherapy with gemcitabine/cisplatin. The results of the TOPAZ-1 and KEYNOTE-966 trials have now introduced immune checkpoint inhibitors (ICIs) into first-line therapy.

Methods: Between July 2022 and March 2024, we retrospectively analyzed patients with advanced BTC who were treated with gemcitabine/cisplatin and durvalumab (GCD) at collaborating German university hospitals, tertiary hospitals, and outpatient oncology practices.

Results: A total of 90 patients were enrolled. The median overall survival (mOS) was 16 months, and the median progression-free survival (mPFS) was 5 months. The overall response rate (ORR) was 11.1%, and the disease control rate (DCR) was 41.1%. A perihilar primary tumor was significantly associated with better mPFS, while age group between 70 and 75 years and performance status of ECOG 2 at treatment initiation were significantly associated with poorer mOS. Adverse events (AEs) occurred in a total of 64% of patients. The most common grade 1 and grade 2 AEs included anemia (23%), thrombocytopenia (16%), neutropenia (10%), nausea (14%), and fatigue (16%). Grade 3 and grade 4 AEs included anemia (10%), thrombocytopenia (5%), and neutropenia (11%). Only one case of immune-mediated hypothyroidism (imAE) was documented.

Conclusion: Our real-world data support previously reported findings and further validate ICI based therapy as the standard of care for patients with advanced BTCs.

Keywords: Biliary tract cancer; Cholangiocarcinoma; Immune checkpoint inhibitor; Liver cancer; Real-world data.

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Conflict of interest statement

Declarations. Competing interests: The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Kaplan-Meier Curve of progression-free survival (PFS) after treatment initiation of BTC with gemcitabine/cisplatin and durvalumab. BTC – biliary tract cancer
Fig. 2
Fig. 2
Kaplan-Meier Curve of overall survival (OS) after treatment initiation of BTC with gemcitabine/cisplatin and durvalumab. BTC – biliary tract cancer
Fig. 3
Fig. 3
Progression-free survival in subgroups treated with GCD. GCD – gemcitabine/cisplatin and durvalumab, HR – hazard ratio, 95% CI – 95% confidence interval
Fig. 4
Fig. 4
Overall survival in subgroups treated with GCD. GCD – gemcitabine/cisplatin and durvalumab, HR – hazard ratio, 95% CI – 95% confidence interval
Fig. 5
Fig. 5
Sankey Diagram illustrating subsequent therapy for BTC. FOLFOX - folinic acid, fluorouracil, and oxaliplatin, FOLFIRI - folinic acid, fluorouracil and irinotecan
See this image and copyright information in PMC

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