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 - Publication

Publication

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

Journal Paper/Review - Aug 29, 2020

Schneeweiss Andreas, Lux Michael P, Müller Volkmar, Nabieva Naiba, Overkamp Friedrich, Tesch Hans, Laakmann Elena, Taran Florin-Andrei, Seitz Julia, Thomssen Christoph, Untch Michael, Wimberger Pauline, Wuerstlein Rachel, Volz Bernhard, Wallwiener Diethelm, Wallwiener Markus, Klein Evelyn, Kurbacher Christian M, Ettl Johannes, Luftner Diana, Beckmann Matthias W, Belleville Erik, Fasching Peter A, Fehm Tanja N, Geberth Matthias, Häberle Lothar, Hadji Peyman, Hartkopf Andreas D, Hielscher Carsten, Huober Jens, Ruckhäberle Eugen, Janni Wolfgang, Kolberg Hans Christian, Brucker Sara Y

Citation

Schneeweiss A, Lux M, Müller V, Nabieva N, Overkamp F, Tesch H, Laakmann E, Taran F, Seitz J, Thomssen C, Untch M, Wimberger P, Wuerstlein R, Volz B, Wallwiener D, Wallwiener M, Klein E, Kurbacher C, Ettl J, Luftner D, Beckmann M, Belleville E, Fasching P, Fehm T, Geberth M, Häberle L, Hadji P, Hartkopf A, Hielscher C, Huober J, Ruckhäberle E, Janni W, Kolberg H, Brucker S. 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)

Journal

Breast 2020; 54

Publication Date

Aug 29, 2020

Issn Electronic

1532-3080

Pages

88-95

Brief description/objective

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.