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20. Deutscher Kongress für Versorgungsforschung

Deutsches Netzwerk Versorgungsforschung e. V.

06. - 08.10.2021, digital

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Prospective precision oncology registries PRAEGNANT and CATCH improve outcome of patients with metastatic breast cancer in Germany

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  • Andreas Schneeweiss - National Center for Tumor Diseases, University of Heidelberg and German Cancer Research Center (DKFZ), Heidelberg, Germany
  • Mario Hlevnjak - National Center for Tumor Diseases, University of Heidelberg and German Cancer Research Center (DKFZ), Heidelberg, Germany; Division of Molecular Genetics, German Cancer Research Center, Heidelberg, Germany
  • Markus Schulze - National Center for Tumor Diseases, University of Heidelberg and German Cancer Research Center (DKFZ), Heidelberg, Germany; Division of Molecular Genetics, German Cancer Research Center, Heidelberg, Germany
  • Andreas Hartkopf - Department of Gynecology and Obstetrics, University of Tübingen, Tübingen, Germany
  • Volkmar Mueller - Department of Gynecology and Obstetrics, University of Hamburg-Eppendorf, Hamburg, Germany
  • Tanja Fehm - Department of Gynecology and Obstetrics, University of Düsseldorf, Düsseldorf, Germany
  • Johannes Ettl - Department of Gynecology and Obstertics, Technical University of Munich, Munich, Germany
  • Pauline Wimberger - Department of Gynecology and Obstetrics, Technische Universität Dresden, Dresden, Germany; National Center for Tumor Diseases (NCT/UCC), Dresden, Germany; German Cancer Research Center (DKFZ), Heidelberg, Germany; Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany; Helmholtz-Zentrum Dresden - Rossendorf (HZDR), Dresden, Germany
  • Carlo Fremd - National Center for Tumor Diseases, University of Heidelberg and German Cancer Research Center (DKFZ), Heidelberg, Germany
  • Laura Michel - National Center for Tumor Diseases, University of Heidelberg and German Cancer Research Center (DKFZ), Heidelberg, Germany
  • Laura Gieldon - Institute of Human Genetics, University Hospital Heidelberg, Heidelberg, Germany
  • Katharina Smetanay - National Center for Tumor Diseases, University of Heidelberg and German Cancer Research Center (DKFZ), Heidelberg, Germany
  • Hans-Peter Sinn - Institute of Pathology, University Hospital Heidelberg, Heidelberg, Germany
  • Dirk Jäger - National Center for Tumor Diseases, University of Heidelberg and German Cancer Research Center (DKFZ), Heidelberg, Germany
  • Marc Zapatka - Division of Molecular Genetics, German Cancer Research Center, Heidelberg, Germany
  • Sara Brucker - Department of Gynecology and Obstetrics, University of Tübingen, Tübingen, Germany
  • Verena Thewes - National Center for Tumor Diseases, University of Heidelberg and German Cancer Research Center (DKFZ), Heidelberg, Germany
  • Erik Belleville - ClinSol GmbH, Würzburg, Germany
  • Peter Lichter - Division of Molecular Genetics, German Cancer Research Center, Heidelberg, Germany
  • Peter A. Fasching - Department of Gynecology and Obstetrics, University of Erlangen, Erlangen, Germany

20. Deutscher Kongress für Versorgungsforschung (DKVF). sine loco [digital], 06.-08.10.2021. Düsseldorf: German Medical Science GMS Publishing House; 2021. Doc21dkvf229

doi: 10.3205/21dkvf229, urn:nbn:de:0183-21dkvf2296

Published: September 27, 2021

© 2021 Schneeweiss et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution 4.0 License. See license information at http://creativecommons.org/licenses/by/4.0/.

Outline

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Purpose: PRAEGNANT (PRospective AcadEmic translational research network for the optimization of the oncoloGical health care quality iN the AdvaNced therapeutic seTting) and CATCH (Comprehensive Assessment of clinical feaTures and biomarkers to identify patients with advanced or metastatic breast Cancer for marker driven trials in Humans) are two linked prospective multicentric breast cancer registries that aim to implement precision oncology in daily practice in order to improve outcome of patients with metastatic breast cancer (mBC).

Patients and methods: Since April 2014 more than 4,200 patients from 60 German centers have been documented within the PRAEGNANT database. Besides documentation of breast cancer risk factors, pedigree information, demographics and tumor characteristics, therapies, adverse events, quality of life and outcome, key function of this registry is to utilize molecular and clinical information to screen patients for ongoing precision oncology programs like CATCH. From June 2017 to March 2021, 495 patients with progressive mBC prospectively documented in PRAEGNANT and treated at the National Center for Tumor Diseases (NCT) in Heidelberg with at least one metastatic site accessible to biopsy were enrolled in CATCH. DNA and RNA from tumor tissue and corresponding blood-derived non-tumor DNA were profiled using whole-genome and transcriptome sequencing. Identified actionable alterations were brought into clinical context in a multidisciplinary molecular tumor board (MTB) with the aim of prioritizing personalized treatment recommendations.

Results: PRAEGNANT has been established as the data source for multiple analyses with a clinical and/or molecular objective. The most comprehensive analysis concerning biomaterials was done with more than 2595 breast cancer patients who were genotyped for germline breast cancer susceptibility genes. Germline mutations in 12 established BC predisposition genes were found in 271 Patients (10.4%) (Fasching et al. J Clin Oncol 2021). Results were utilized under study conditions to identify patients for respective treatments. Another project centered around the identification of heregulin overexpression for a prospective study. Out of 2769 patients at that time 129 could be identified for the study. 37% were HRG positive (Huebner et al. BMC Cancer 2020). In addition, PRAEGNANT has been proven to be an ideal feeder registry for the CATCH program. Among the first 200 patients enrolled in CATCH, 128 were discussed in the MTB, of which 64 were subsequently treated according to MTB recommendation. Of 53 evaluable patients as of September 2019, 21 (40%) achieved either stable disease (n=13, 25%) or partial response (n=8, 15%). Furthermore, 16 (30%) of those patients showed improvement in progression-free survival (PFS) of at least 30% while on MTB-recommended treatment compared to the PFS of the previous treatment line (PFS2/PFS1 ratio > 1.3) (Hlevnjak et al. JCO Precis Oncol 2021).

Conclusion: The prospective multicentric registries PRAEGNANT and CATCH are successful in building on each other to provide deep molecular analysis of tumor tissue in daily practice as the basis of personalized treatment approaches. The initial phase of the CATCH program demonstrates that such approaches provide clinical benefit to a substantial proportion of patients with mBC.