Breast (Dec 2020)
Initial experience with CDK4/6 inhibitor-based therapies compared to antihormone monotherapies in routine clinical use in patients with hormone receptor positive, HER2 negative breast cancer — Data from the PRAEGNANT research network for the first 2 years of drug availability in Germany
- Andreas Schneeweiss,
- Johannes Ettl,
- Diana Lüftner,
- Matthias W. Beckmann,
- Erik Belleville,
- Peter A. Fasching,
- Tanja N. Fehm,
- Matthias Geberth,
- Lothar Häberle,
- Peyman Hadji,
- Andreas D. Hartkopf,
- Carsten Hielscher,
- Jens Huober,
- Eugen Ruckhäberle,
- Wolfgang Janni,
- Hans Christian Kolberg,
- Christian M. Kurbacher,
- Evelyn Klein,
- Michael P. Lux,
- Volkmar Müller,
- Naiba Nabieva,
- Friedrich Overkamp,
- Hans Tesch,
- Elena Laakmann,
- Florin-Andrei Taran,
- Julia Seitz,
- Christoph Thomssen,
- Michael Untch,
- Pauline Wimberger,
- Rachel Wuerstlein,
- Bernhard Volz,
- Diethelm Wallwiener,
- Markus Wallwiener,
- Sara Y. Brucker
Affiliations
- Andreas Schneeweiss
- National Center for Tumor Diseases, Heidelberg University Hospital, German Cancer Research Center (DKFZ), Heidelberg, Germany
- Johannes Ettl
- Department of Obstetrics and Gynecology, Klinikum Rechts der Isar, Technical University of Munich, Munich, Germany
- Diana Lüftner
- Charité University Hospital, Berlin, Campus Benjamin Franklin, Department of Hematology, Oncolo0gy and Tumour Immunology, Berlin, Germany
- Matthias W. Beckmann
- Erlangen University Hospital, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-EMN, Friedrich Alexander University of Erlangen-Nuremberg, Germany
- Erik Belleville
- ClinSol GmbH & Co KG, Würzburg, Germany
- Peter A. Fasching
- Erlangen University Hospital, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-EMN, Friedrich Alexander University of Erlangen-Nuremberg, Germany; Corresponding author. Erlangen University Hospital, Department of Gynecology and Obstetrics; Comprehensive Cancer Center Erlangen EMN; Friedrich Alexander University of Erlangen–Nuremberg Universitätsstrasse 21–23, 91054 Erlangen, Germany; Tel.: +49 (0)9131-85-33553; fax: +49 (0)9131-85-33938;
- Tanja N. Fehm
- Department of Gynecology and Obstetrics, Düsseldorf University Hospital, Germany
- Matthias Geberth
- Gynäkologische Praxisklinik Am Rosengarten, Mannheim, Germany
- Lothar Häberle
- Erlangen University Hospital, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-EMN, Friedrich Alexander University of Erlangen-Nuremberg, Germany; Biostatistics Unit, Erlangen University Hospital, Department of Gynecology and Obstetrics, Erlangen, Germany
- Peyman Hadji
- Frankfurt Center of Bone Health Frankfurt, Germany
- Andreas D. Hartkopf
- Department of Obstetrics and Gynecology, University of Tuebingen, Tuebingen, Germany
- Carsten Hielscher
- GSUND Gynäkologie Kompetenzzentrum Stralsund, Stralsund, Germany
- Jens Huober
- Department of Gynecology and Obstetrics, Ulm University Hospital, Ulm, Germany
- Eugen Ruckhäberle
- Department of Gynecology and Obstetrics, Düsseldorf University Hospital, Germany
- Wolfgang Janni
- Department of Gynecology and Obstetrics, Ulm University Hospital, Ulm, Germany
- Hans Christian Kolberg
- Marienhospital Bottrop, Bottrop, Germany
- Christian M. Kurbacher
- Gynecology I (Gynecologic Oncology), Gynäkologisches Zentrum Bonn Friedensplatz, Bonn, Germany
- Evelyn Klein
- Department of Obstetrics and Gynecology, Klinikum Rechts der Isar, Technical University of Munich, Munich, Germany
- Michael P. Lux
- Erlangen University Hospital, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-EMN, Friedrich Alexander University of Erlangen-Nuremberg, Germany
- Volkmar Müller
- Department of Gynecology, Hamburg-Eppendorf University Medical Center, Hamburg, Germany
- Naiba Nabieva
- Erlangen University Hospital, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-EMN, Friedrich Alexander University of Erlangen-Nuremberg, Germany
- Friedrich Overkamp
- Oncologianova GmbH, Recklinghausen, Germany
- Hans Tesch
- Oncology Practice at Bethanien Hospital, Frankfurt, Germany
- Elena Laakmann
- Department of Gynecology, Hamburg-Eppendorf University Medical Center, Hamburg, Germany
- Florin-Andrei Taran
- Department of Obstetrics and Gynecology, University of Tuebingen, Tuebingen, Germany
- Julia Seitz
- National Center for Tumor Diseases, Heidelberg University Hospital, German Cancer Research Center (DKFZ), Heidelberg, Germany; Department of Obstetrics and Gynecology, University of Heidelberg, Heidelberg, Germany
- Christoph Thomssen
- Department of Gynecology, Martin Luther University of Halle-Wittenberg, Halle (Saale), Germany
- Michael Untch
- Department of Gynecology and Obstetrics, Helios Clinics Berlin Buch, Berlin, Germany
- Pauline Wimberger
- National Center for Tumor Diseases (NCT), Dresden, Germany; German Cancer Research Center (DKFZ), Heidelberg, Germany; Carl Gustav Carus Faculty of Medicine and University Hospital, Technical University of Dresden, Dresden, Germany; Helmholtz-Zentrum Dresden-Rossendorf (HZDR), Dresden, Germany; German Cancer Consortium (DKTK), Dresden and German Cancer Research Center (DKFZ), Heidelberg, Germany
- Rachel Wuerstlein
- Department of Gynecology and Obstetrics, Breast Center, and CCC Munich, Munich University Hospital, Germany
- Bernhard Volz
- Erlangen University Hospital, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-EMN, Friedrich Alexander University of Erlangen-Nuremberg, Germany
- Diethelm Wallwiener
- Department of Obstetrics and Gynecology, University of Tuebingen, Tuebingen, Germany
- Markus Wallwiener
- Department of Obstetrics and Gynecology, University of Heidelberg, Heidelberg, Germany
- Sara Y. Brucker
- Department of Obstetrics and Gynecology, University of Tuebingen, Tuebingen, Germany
- Journal volume & issue
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Vol. 54
pp. 88 – 95
Abstract
Purpose: Treatment with CDK4/6 inhibitors and endocrine therapy (CDK4/6i + ET) is a standard for patients with advanced hormone receptor–positive, HER2-negative (HR + HER2–) breast cancer (BC). However, real-world data on the implementation of therapy usage, efficacy, and toxicity have not yet been reported. Methods: The PRAEGNANT registry was used to identify advanced HR + HER2– BC patients (n = 1136). The use of chemotherapy, ET, everolimus + ET, and CDK4/6i + ET was analyzed for first-line, second-line, and third-line therapy. Progression-free survival (PFS) and overall survival (OS) were also compared between patients treated with CDK4/6i + ET and ET monotherapy. Also toxicity was assessed. Results: CDK4/6i + ET use increased from 38.5% to 62.7% in the first 2 years after CDK4/6i treatment became available (November 2016). Chemotherapy and ET monotherapy use decreased from 2015 to 2018 from 42.2% to 27.2% and from 53% to 9.5%, respectively. In this early analysis no statistically significant differences were found comparing CDK4/6i + ET and ET monotherapy patients with regard to PFS and OS. Leukopenia was was seen in 11.3% of patients under CDK4/6i + ET and 0.5% under ET monotherapy. Conclusions: In clinical practice, CDK4/6i + ET has been rapidly implemented. A group of patients with a more unfavorable prognosis was possibly treated in the real-world setting than in the reported randomized clinical trials. The available data suggest that longer follow-up times and a larger sample size are required in order to identify differences in survival outcomes. Studies should be supported that investigate whether chemotherapy can be avoided or delayed in this patient population by using CDK4/6i + ET.
