TY  - JOUR
TI  - 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
SP  - 1
JF  - BMC cancer
AV  - public
ID  - heidok26657
VL  - 16
EP  - 9
PB  - BioMed Central ; Springer
IS  - 611
Y1  - 2019///
SN  - 1471-2407
A1  - Wallwiener, Markus
A1  - Nabieva, Naiba
A1  - Feisst, Manuel
A1  - Fehm, Tanja
A1  - de Waal, Johann
A1  - Rezai, Mahdi
A1  - Baier, Bernd
A1  - Baake, Gerold
A1  - Kolberg, Hans-Christian
A1  - Guggenberger, Martin
A1  - Warm, Mathias
A1  - Harbeck, Nadia
A1  - Wuerstlein, Rachel
A1  - Deuker, Jörg-Uwe
A1  - Dall, Peter
A1  - Richter, Barbara
A1  - Wachsmann, Grischa
A1  - Brucker, Cosima
A1  - Siebers, Jan Willem
A1  - Popovic, Milos
A1  - Kuhn, Thomas
A1  - Wolf, Christopher
A1  - Vollert, Hans-Walter
A1  - Breitbach, Georg-Peter
A1  - Janni, Wolfgang
A1  - Landthaler, Robert
A1  - Kohls, Andreas
A1  - Rezek, Daniela
A1  - Noesselt, Thomas
A1  - Fischer, Gunnar
A1  - Henschen, Stephan
A1  - Praetz, Thomas
A1  - Heyl, Volker
A1  - Kühn, Thorsten
A1  - Krauss, Thomas
A1  - Thomssen, Christoph
A1  - Hohn, Andre
A1  - Tesch, Hans
A1  - Mundhenke, Christoph
A1  - Hein, Alexander
A1  - Rauh, Claudia
A1  - Bayer, Christian M.
A1  - Schmidt, Katja
A1  - Belleville, Erik
A1  - Brucker, Sara Y.
A1  - Hadji, Peyman
A1  - Beckmann, Matthias W.
A1  - Wallwiener, Diethelm
A1  - Kümmel, Sherko
A1  - Hartkopf, Andreas
A1  - Fasching, Peter A.
CY  - London ; Berlin ; Heidelberg
UR  - https://archiv.ub.uni-heidelberg.de/volltextserver/26657/
N2  - 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
ER  -