Clinical practice and implications of biomarker testing in biliary tract cancer: An observational study

Genomic profiling is recommended in patients with biliary tract cancers (BTC) but lacks harmonization across platforms and centers. By retrospectively analyzing genomic and clinical information from 1,521 patients with BTC diagnosed and treated at 18 centers in Germany and Austria, we provide real-world insights into the implementation of molecular profiling in BTC, highlighting variability in next generation sequencing-based testing and its impact on the detection of genomic alterations. Standardized molecular testing strategies will be key to enable the integration of more consistent and comparable genomic datasets across studies. Further, by elucidating the prognostic relevance of individual genomic alterations, our insights carry significant implications for interpreting single-arm clinical trials within genomically stratified patient cohorts and underscore the importance of randomized studies to delineate the benefit of targeted therapies.

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Publication Details

Journal
JHEP Reports
Published
2025-11-05
DOI
https://doi.org/10.1016/j.jhepr.2025.101635
Primary Topic
Cholangiocarcinoma and Gallbladder Cancer Studies
Type
article
Field-Weighted Citation Impact
0.00

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article

Clinical practice and implications of biomarker testing in biliary tract cancer: An observational study

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JHEP Reports
Cholangiocarcinoma and Gallbladder Cancer Studies
article

Clinical practice and implications of biomarker testing in biliary tract cancer: An observational study

Thomas Wirth, Arndt Weinmann, Stefan Kasper, Bernhard Doleschal, Hossein Taghizadeh, Stephan Bartels, Christoph Springfeld, Maria Pangerl, Carolin Zimpel, Anna Lena Saborowski, Thomas Gruenberger, Michael T. Dill, Alexander Scheiter, Maria Angeles Gonzalez-Carmona, Gerald W. Prager, Sabrina Welland, Sebastian Lange, Michael Quante, Aurelie Tomczak, Florian Lüke, Thomas Longerich, Maryam Barsch, Nicole Pfarr, Danmei Zhang, Felix Keil, Marino Venerito, Christian Müller, Sophia Petschnak, Arndt Vogel, Dirk Walter, Henning Schulze‐Bergkamen, Maximilian N. Kinzler, Julius Keyl, Angela Djanani, Ilektra A. Mavroeidi, A Zöller, Kateryna Shmanko, Yawen Dong, Jens U. Marquardt, Taotao Zhou, Rainer Günther, Stefan Böck
article en

Abstract

Genomic profiling is recommended in patients with biliary tract cancers (BTC) but lacks harmonization across platforms and centers. By retrospectively analyzing genomic and clinical information from 1,521 patients with BTC diagnosed and treated at 18 centers in Germany and Austria, we provide real-world insights into the implementation of molecular profiling in BTC, highlighting variability in next generation sequencing-based testing and its impact on the detection of genomic alterations. Standardized molecular testing strategies will be key to enable the integration of more consistent and comparable genomic datasets across studies. Further, by elucidating the prognostic relevance of individual genomic alterations, our insights carry significant implications for interpreting single-arm clinical trials within genomically stratified patient cohorts and underscore the importance of randomized studies to delineate the benefit of targeted therapies.

JHEP ReportsVol. 8(1)
Sigmund Freud Privatuniversität Wien (AT), Goethe University Frankfurt (DE), Johannes Kepler University of Linz (AT), Research Institute of Molecular Pathology (AT), Johannes Gutenberg University Mainz (DE), Heidelberg University (DE), University Hospital Bonn (DE), University Medical Center Freiburg (DE), Toronto General Hospital (CA), University Hospital Heidelberg (DE), Princess Margaret Cancer Centre (CA), University Hospital Regensburg (DE), Medizinische Hochschule Hannover (DE), University Medical Center of the Johannes Gutenberg University Mainz (DE), Marien Hospital Wesel (DE), University Hospital Schleswig-Holstein (DE), Universitätsklinikum St. Pölten (AT), Essen University Hospital (DE), University Hospital Frankfurt (DE), University Hospital Magdeburg (DE), AGO Austria (AT), Karl Landsteiner University of Health Sciences (AT), München Klinik Neuperlach (DE), West German Heart and Vascular Center Essen (DE), University Hospital Innsbruck (AT), University of Regensburg (DE), Technical University of Munich (DE), Ludwig-Maximilians-Universität München (DE), University of Lübeck (DE)
Amgen, Eli Lilly and Company, AstraZeneca, Sanofi, Celgene, Les Laboratories Pierre Fabre, Incyte, Eisai, Servier, Ipsen, LEO Pharma, Daiichi Sankyo Europe, Cilag
Openalex Percentile: Top 49%
Cholangiocarcinoma and Gallbladder Cancer Studies
DOIOpen Access PDFOpenAlex
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