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BMC Cancer
Published in: BMC Cancer 1/2019

Open Access 01-12-2019 | Breast Cancer | Research article

Influence of patient and tumor characteristics on therapy persistence with letrozole in postmenopausal women with advanced breast cancer: results of the prospective observational EvAluate-TM study

Authors: Markus Wallwiener, Naiba Nabieva, Manuel Feisst, Tanja Fehm, Johann de Waal, Mahdi Rezai, Bernd Baier, Gerold Baake, Hans-Christian Kolberg, Martin Guggenberger, Mathias Warm, Nadia Harbeck, Rachel Wuerstlein, Jörg-Uwe Deuker, Peter Dall, Barbara Richter, Grischa Wachsmann, Cosima Brucker, Jan Willem Siebers, Milos Popovic, Thomas Kuhn, Christopher Wolf, Hans-Walter Vollert, Georg-Peter Breitbach, Wolfgang Janni, Robert Landthaler, Andreas Kohls, Daniela Rezek, Thomas Noesselt, Gunnar Fischer, Stephan Henschen, Thomas Praetz, Volker Heyl, Thorsten Kühn, Thomas Krauss, Christoph Thomssen, Andre Hohn, Hans Tesch, Christoph Mundhenke, Alexander Hein, Claudia Rauh, Christian M. Bayer, Katja Schmidt, Erik Belleville, Sara Y. Brucker, Peyman Hadji, Matthias W. Beckmann, Diethelm Wallwiener, Sherko Kümmel, Andreas Hartkopf, Peter A. Fasching

Published in: BMC Cancer | Issue 1/2019

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Abstract

Background

Treatment of postmenopausal, hormone receptor-positive metastatic breast cancer (MBC) patients varies despite clear therapy guidelines, favoring endocrine treatment (ET). Aim of this study was to analyze persistence of palliative aromatase inhibitor (AI) monotherapy in MBC patients.

Methods

EvAluate-TM is a prospective, multicenter, noninterventional study to evaluate treatment with letrozole in postmenopausal women with hormone receptor–positive breast cancer. To assess therapy persistence, defined as the time from therapy start to the end of the therapy (TTEOT), two pre-specified study visits took place after 6 and 12 months. Competing risk survival analyses were performed to identify patient and tumor characteristics that predict TTEOT.

Results

Out of 200 patients, 66 patients terminated treatment prematurely, 26 (13%) of them due to causes other than disease progression. Persistence rate for reasons other than progression at 12 months was 77.7%. Persistence was lower in patients who reported any adverse event (AE) in the first 30 days of ET (89.5% with no AE and 56% with AE). Furthermore, patients had a lower persistence if they reported compliance problems in the past before letrozole treatment.

Conclusions

Despite suffering from a life-threatening disease, AEs of an AI will result in a relevant number of treatment terminations that are not related to progression. Some subgroups of patients have very low persistence rates. Especially with regard to novel endocrine combination therapies, these data imply that some groups of patients will need special attention to guide them through the therapy process.

Trial registration

Clinical Trials Number: CFEM345DDE19
Appendix
Available only for authorised users
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Metadata
Title
Influence of patient and tumor characteristics on therapy persistence with letrozole in postmenopausal women with advanced breast cancer: results of the prospective observational EvAluate-TM study
Authors
Markus Wallwiener
Naiba Nabieva
Manuel Feisst
Tanja Fehm
Johann de Waal
Mahdi Rezai
Bernd Baier
Gerold Baake
Hans-Christian Kolberg
Martin Guggenberger
Mathias Warm
Nadia Harbeck
Rachel Wuerstlein
Jörg-Uwe Deuker
Peter Dall
Barbara Richter
Grischa Wachsmann
Cosima Brucker
Jan Willem Siebers
Milos Popovic
Thomas Kuhn
Christopher Wolf
Hans-Walter Vollert
Georg-Peter Breitbach
Wolfgang Janni
Robert Landthaler
Andreas Kohls
Daniela Rezek
Thomas Noesselt
Gunnar Fischer
Stephan Henschen
Thomas Praetz
Volker Heyl
Thorsten Kühn
Thomas Krauss
Christoph Thomssen
Andre Hohn
Hans Tesch
Christoph Mundhenke
Alexander Hein
Claudia Rauh
Christian M. Bayer
Katja Schmidt
Erik Belleville
Sara Y. Brucker
Peyman Hadji
Matthias W. Beckmann
Diethelm Wallwiener
Sherko Kümmel
Andreas Hartkopf
Peter A. Fasching
Publication date
01-12-2019
Publisher
BioMed Central
Published in
BMC Cancer / Issue 1/2019
Electronic ISSN: 1471-2407
DOI
https://doi.org/10.1186/s12885-019-5806-y

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