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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

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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. / 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, Vol. 54, 12.2020, p. 88-95.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Schneeweiss, A, Ettl, J, Lüftner, D, Beckmann, MW, Belleville, E, Fasching, PA, Fehm, TN, Geberth, M, Häberle, L, Hadji, P, Hartkopf, AD, Hielscher, C, Huober, J, Ruckhäberle, E, Janni, W, Kolberg, HC, Kurbacher, CM, Klein, E, Lux, MP, 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, SY 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', BREAST, vol. 54, pp. 88-95. https://doi.org/10.1016/j.breast.2020.08.011

APA

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., ... Brucker, S. Y. (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. BREAST, 54, 88-95. https://doi.org/10.1016/j.breast.2020.08.011

Vancouver

Schneeweiss A, Ettl J, Lüftner D, Beckmann MW, Belleville E, Fasching PA et al. 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 Dec;54:88-95. https://doi.org/10.1016/j.breast.2020.08.011

Bibtex

@article{0cf1cd3ff93a49139748d002ecb6bfa9,
title = "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",
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.",
author = "Andreas Schneeweiss and Johannes Ettl and Diana L{\"u}ftner and Beckmann, {Matthias W} and Erik Belleville and Fasching, {Peter A} and Fehm, {Tanja N} and Matthias Geberth and Lothar H{\"a}berle and Peyman Hadji and Hartkopf, {Andreas D} and Carsten Hielscher and Jens Huober and Eugen Ruckh{\"a}berle and Wolfgang Janni and Kolberg, {Hans Christian} and Kurbacher, {Christian M} and Evelyn Klein and Lux, {Michael P} and Volkmar M{\"u}ller and Naiba Nabieva and Friedrich Overkamp and Hans Tesch and Elena Laakmann and Florin-Andrei Taran and Julia Seitz and Christoph Thomssen and Michael Untch and Pauline Wimberger and Rachel Wuerstlein and Bernhard Volz and Diethelm Wallwiener and Markus Wallwiener and Brucker, {Sara Y}",
note = "Copyright {\textcopyright} 2020 The Author(s). Published by Elsevier Ltd.. All rights reserved.",
year = "2020",
month = dec,
doi = "10.1016/j.breast.2020.08.011",
language = "English",
volume = "54",
pages = "88--95",
journal = "BREAST",
issn = "0960-9776",
publisher = "Churchill Livingstone",

}

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 -