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
Standard
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. / Schneeweiss, Andreas; Ettl, Johannes; Lüftner, 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; Kurbacher, Christian M; Klein, Evelyn; 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; Brucker, Sara Y.
in: BREAST, Jahrgang 54, 12.2020, S. 88-95.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
Harvard
APA
Vancouver
Bibtex
}
RIS
TY - JOUR
T1 - 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
AU - Schneeweiss, Andreas
AU - Ettl, Johannes
AU - Lüftner, Diana
AU - Beckmann, Matthias W
AU - Belleville, Erik
AU - Fasching, Peter A
AU - Fehm, Tanja N
AU - Geberth, Matthias
AU - Häberle, Lothar
AU - Hadji, Peyman
AU - Hartkopf, Andreas D
AU - Hielscher, Carsten
AU - Huober, Jens
AU - Ruckhäberle, Eugen
AU - Janni, Wolfgang
AU - Kolberg, Hans Christian
AU - Kurbacher, Christian M
AU - Klein, Evelyn
AU - Lux, Michael P
AU - Müller, Volkmar
AU - Nabieva, Naiba
AU - Overkamp, Friedrich
AU - Tesch, Hans
AU - Laakmann, Elena
AU - Taran, Florin-Andrei
AU - Seitz, Julia
AU - Thomssen, Christoph
AU - Untch, Michael
AU - Wimberger, Pauline
AU - Wuerstlein, Rachel
AU - Volz, Bernhard
AU - Wallwiener, Diethelm
AU - Wallwiener, Markus
AU - Brucker, Sara Y
N1 - Copyright © 2020 The Author(s). Published by Elsevier Ltd.. All rights reserved.
PY - 2020/12
Y1 - 2020/12
N2 - 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.
AB - 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.
U2 - 10.1016/j.breast.2020.08.011
DO - 10.1016/j.breast.2020.08.011
M3 - SCORING: Journal article
C2 - 32956934
VL - 54
SP - 88
EP - 95
JO - BREAST
JF - BREAST
SN - 0960-9776
ER -