eprintid: 26657
rev_number: 13
eprint_status: archive
userid: 1589
dir: disk0/00/02/66/57
datestamp: 2019-06-27 09:15:28
lastmod: 2024-04-06 06:55:49
status_changed: 2019-06-27 09:15:28
type: article
metadata_visibility: show
creators_name: Wallwiener, Markus
creators_name: Nabieva, Naiba
creators_name: Feisst, Manuel
creators_name: Fehm, Tanja
creators_name: de Waal, Johann
creators_name: Rezai, Mahdi
creators_name: Baier, Bernd
creators_name: Baake, Gerold
creators_name: Kolberg, Hans-Christian
creators_name: Guggenberger, Martin
creators_name: Warm, Mathias
creators_name: Harbeck, Nadia
creators_name: Wuerstlein, Rachel
creators_name: Deuker, Jörg-Uwe
creators_name: Dall, Peter
creators_name: Richter, Barbara
creators_name: Wachsmann, Grischa
creators_name: Brucker, Cosima
creators_name: Siebers, Jan Willem
creators_name: Popovic, Milos
creators_name: Kuhn, Thomas
creators_name: Wolf, Christopher
creators_name: Vollert, Hans-Walter
creators_name: Breitbach, Georg-Peter
creators_name: Janni, Wolfgang
creators_name: Landthaler, Robert
creators_name: Kohls, Andreas
creators_name: Rezek, Daniela
creators_name: Noesselt, Thomas
creators_name: Fischer, Gunnar
creators_name: Henschen, Stephan
creators_name: Praetz, Thomas
creators_name: Heyl, Volker
creators_name: Kühn, Thorsten
creators_name: Krauss, Thomas
creators_name: Thomssen, Christoph
creators_name: Hohn, Andre
creators_name: Tesch, Hans
creators_name: Mundhenke, Christoph
creators_name: Hein, Alexander
creators_name: Rauh, Claudia
creators_name: Bayer, Christian M.
creators_name: Schmidt, Katja
creators_name: Belleville, Erik
creators_name: Brucker, Sara Y.
creators_name: Hadji, Peyman
creators_name: Beckmann, Matthias W.
creators_name: Wallwiener, Diethelm
creators_name: Kümmel, Sherko
creators_name: Hartkopf, Andreas
creators_name: Fasching, Peter A.
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
subjects: 610
divisions: 910400
divisions: 911800
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
date: 2019
publisher: BioMed Central ; Springer
id_scheme: DOI
ppn_swb: 1670556484
own_urn: urn:nbn:de:bsz:16-heidok-266570
language: eng
bibsort: WALLWIENERINFLUENCEO2019
full_text_status: public
publication: BMC cancer
volume: 16
number: 611
place_of_pub: London ; Berlin ; Heidelberg
pagerange: 1-9
issn: 1471-2407
citation:   Wallwiener, Markus ; Nabieva, Naiba ; Feisst, Manuel ; Fehm, Tanja ; de Waal, Johann ; Rezai, Mahdi ; Baier, Bernd ; Baake, Gerold ; Kolberg, Hans-Christian ; Guggenberger, Martin ; Warm, Mathias ; Harbeck, Nadia ; Wuerstlein, Rachel ; Deuker, Jörg-Uwe ; Dall, Peter ; Richter, Barbara ; Wachsmann, Grischa ; Brucker, Cosima ; Siebers, Jan Willem ; Popovic, Milos ; Kuhn, Thomas ; Wolf, Christopher ; Vollert, Hans-Walter ; Breitbach, Georg-Peter ; Janni, Wolfgang ; Landthaler, Robert ; Kohls, Andreas ; Rezek, Daniela ; Noesselt, Thomas ; Fischer, Gunnar ; Henschen, Stephan ; Praetz, Thomas ; Heyl, Volker ; Kühn, Thorsten ; Krauss, Thomas ; Thomssen, Christoph ; Hohn, Andre ; Tesch, Hans ; Mundhenke, Christoph ; Hein, Alexander ; Rauh, Claudia ; Bayer, Christian M. ; Schmidt, Katja ; Belleville, Erik ; Brucker, Sara Y. ; Hadji, Peyman ; Beckmann, Matthias W. ; Wallwiener, Diethelm ; Kümmel, Sherko ; Hartkopf, Andreas ; Fasching, Peter A.  (2019) 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.  BMC cancer, 16 (611).  pp. 1-9.  ISSN 1471-2407     
document_url: https://archiv.ub.uni-heidelberg.de/volltextserver/26657/1/12885_2019_Article_5806.pdf