Evidence map›Paper›PMID 40533571›Full record

ArticleJournal of cancer research and clinical oncology2025

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

Florian Gerhardt, Christian Müller, Marino Venerito, Jack Chater, Raphael Mohr, Mara Egerer, Udo Lindig, Aaron Schindler, Sebastian Ebel, Janett Fischer and 4 more

Abstract readMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of cancer research and clinical oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Florian GerhardtDivision of Hepatology, Department of Medicine II, Leipzig University Medical Center, Leipzig, Germany.
Christian MüllerDepartment of Gastroenterology, Hepatology and Infectious Diseases, Otto von Guericke University Hospital, Magdeburg, Germany.
Marino VeneritoDepartment of Gastroenterology, Hepatology and Infectious Diseases, Otto von Guericke University Hospital, Magdeburg, Germany.
Jack ChaterMedical Clinic III, Klinikum Chemnitz, Chemnitz, Germany.
Raphael MohrDepartment of Hepatology and Gastroenterology, Charité University Medicine Berlin, Berlin, Germany.
Mara EgererDepartment of Hepatology and Gastroenterology, Charité University Medicine Berlin, Berlin, Germany.
Udo LindigMedical Clinic II, University Hospital Jena, Jena, Germany.
Aaron SchindlerDivision of Hepatology, Department of Medicine II, Leipzig University Medical Center, Leipzig, Germany.
Sebastian EbelDepartment of Diagnostic and Interventional Radiology, Leipzig University Medical Center, Leipzig, Germany.
Janett FischerDivision of Hepatology, Department of Medicine II, Leipzig University Medical Center, Leipzig, Germany.
Maik SchwarzMVZ Schöneck, Schöneck, Germany.
Sonja GehringDepartment of Gastroenterology, University Hospital Marburg, Marburg, Germany.
Thomas BergDivision of Hepatology, Department of Medicine II, Leipzig University Medical Center, Leipzig, Germany.
Florian van BömmelDivision of Hepatology, Department of Medicine II, Leipzig University Medical Center, Leipzig, Germany. florian.vanboemmel@medizin.uni-leipzig.de.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBiliary 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.

methodsBetween 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.

resultsA 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.

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

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsBiliary Tract NeoplasmsAdultAgedAged, 80 and overAntibodies, MonoclonalCisplatinDeoxycytidineFemaleGemcitabineGermanyHumansMaleMiddle AgedRetrospective StudiesAntibodies, MonoclonalCisplatinDeoxycytidinedurvalumabGemcitabineBiliary tract cancerCholangiocarcinomaImmune checkpoint inhibitorLiver cancerReal-world data

Identifiers

PMID40533571
PMCPMC12176970

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.