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 |
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| Institution: | 1. National Center for Tumor Diseases, Heidelberg University Hospital, German Cancer Research Center (DKFZ), Heidelberg, Germany;2. Department of Obstetrics and Gynecology, Klinikum Rechts der Isar, Technical University of Munich, Munich, Germany;3. Charité University Hospital, Berlin, Campus Benjamin Franklin, Department of Hematology, Oncolo0gy and Tumour Immunology, Berlin, Germany;4. Erlangen University Hospital, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-EMN, Friedrich Alexander University of Erlangen-Nuremberg, Germany;5. ClinSol GmbH & Co KG, Würzburg, Germany;6. Department of Gynecology and Obstetrics, Düsseldorf University Hospital, Germany;7. Gynäkologische Praxisklinik Am Rosengarten, Mannheim, Germany;8. Biostatistics Unit, Erlangen University Hospital, Department of Gynecology and Obstetrics, Erlangen, Germany;9. Frankfurt Center of Bone Health Frankfurt, Germany;10. Department of Obstetrics and Gynecology, University of Tuebingen, Tuebingen, Germany;11. GSUND Gynäkologie Kompetenzzentrum Stralsund, Stralsund, Germany;12. Department of Gynecology and Obstetrics, Ulm University Hospital, Ulm, Germany;13. Marienhospital Bottrop, Bottrop, Germany;14. Gynecology I (Gynecologic Oncology), Gynäkologisches Zentrum Bonn Friedensplatz, Bonn, Germany;15. Department of Gynecology, Hamburg-Eppendorf University Medical Center, Hamburg, Germany;p. Oncologianova GmbH, Recklinghausen, Germany;q. Oncology Practice at Bethanien Hospital, Frankfurt, Germany;r. Department of Obstetrics and Gynecology, University of Heidelberg, Heidelberg, Germany;s. Department of Gynecology, Martin Luther University of Halle-Wittenberg, Halle (Saale), Germany;t. Department of Gynecology and Obstetrics, Helios Clinics Berlin Buch, Berlin, Germany;u. National Center for Tumor Diseases (NCT), Dresden, Germany;v. German Cancer Research Center (DKFZ), Heidelberg, Germany;w. Carl Gustav Carus Faculty of Medicine and University Hospital, Technical University of Dresden, Dresden, Germany;x. Helmholtz-Zentrum Dresden-Rossendorf (HZDR), Dresden, Germany;y. German Cancer Consortium (DKTK), Dresden and German Cancer Research Center (DKFZ), Heidelberg, Germany;z. Department of Gynecology and Obstetrics, Breast Center, and CCC Munich, Munich University Hospital, Germany |
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| Abstract: | PurposeTreatment 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.MethodsThe 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.ResultsCDK4/6i + 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.ConclusionsIn 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. |
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| Keywords: | Advanced breast cancer Metastatic Chemotherapy Endocrine therapy CDK4/6 Ribociclib Palbociclib Abemaciclib |
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