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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

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.
   
citation Schneeweiss A, Ettl J, Lüftner D, Beckmann M W, Belleville E, Fasching P A, Fehm T N, Geberth M, Häberle L, Hadji P, Hartkopf A D, Hielscher C, Huober J, Ruckhäberle E, Janni W, Kolberg H C, Kurbacher C M, Klein E, Lux M P, Müller V, Nabieva N, Overkamp F, Tesch H, Laakmann E, Taran F A, Seitz J, Thomssen C, Untch M, Wimberger P, Wuerstlein R, Volz B, Wallwiener D, Wallwiener M, Brucker S Y. 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. Breast 2020; 54:88-95.
   
type journal paper/review (English)
date of publishing 29-08-2020
journal title Breast (54)
ISSN electronic 1532-3080
pages 88-95
PubMed 32956934
DOI 10.1016/j.breast.2020.08.011