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Influence of side-effects on early therapy persistence with letrozole in post-menopausal patients with early breast cancer: Results of the prospective EvAluate-TM study

Authors :
Tanja Fehm
Carolin C. Hack
R. Landthaler
J.-U. Deuker
Rachel Wuerstlein
Daniela Rezek
C Brucker
G. Fischer
Peter Dall
Peter A. Fasching
H.-W. Vollert
T. Praetz
M. Popovic
Mahdi Rezai
T Noesselt
Sara Y. Brucker
M. Guggenberger
V. Heyl
J. de Waal
G. Wachsmann
Barbara Richter
P. Hadji
S. Henschen
J.W. Siebers
M Warm
Thorsten Kühn
C. Thomssen
Hans-Christian Kolberg
A. Hohn
Thomas Krauss
C. Wolf
M. W. Beckmann
Lothar Häberle
Erik Belleville
Alexander Hein
Katja Schmidt
Diethelm Wallwiener
G. Baake
A. Kohls
Sherko Kümmel
B. Baier
Christoph Mundhenke
Wolfgang Janni
Hans Tesch
Naiba Nabieva
G. P. Breitbach
Nadia Harbeck
Source :
European Journal of Cancer. 96:82-90
Publication Year :
2018
Publisher :
Elsevier BV, 2018.

Abstract

Background Endocrine treatment (ET) with an aromatase inhibitor (AI) is the treatment of choice in post-menopausal patients with hormone receptor–positive early breast cancer (EBC). However, adverse events (AEs) often lead to treatment discontinuation. This analysis aimed to identify side-effects that lead to patients failing to persist with letrozole treatment. Patients and methods Post-menopausal hormone receptor–positive EBC patients starting ET with letrozole were enroled in EvAluate-TM, a non-interventional study. Information regarding treatment compliance and persistence was gathered in months 6 and 12. Persistence was defined as the time from 30 d after the start to the end of treatment. The influence on persistence of musculoskeletal syndrome, menopausal disorder, sleep disorder and other AEs within the first 30 d was analysed using Cox regression analyses. Results Among 3887 patients analysed, the persistence rate after 12 months was >85%. In all, 568 patients (14.6%) discontinued the treatment, 358 of whom (63.0%) did so only because of side-effects. The main AEs influencing persistence were musculoskeletal symptoms (hazard ratio [HR] 2.55; 95% confidence interval [CI], 1.90–3.42), sleep disorders (HR 1.95; 95% CI, 1.41–2.70) and other AEs (HR 2.03; 95% CI, 1.51–2.73). Menopausal disorder was not associated with non-persistence (HR 1.17; 95% CI, 0.74–1.84). Conclusions These results suggest that side-effects of AIs such as musculoskeletal syndrome and sleep disorder lead to ET discontinuation within the first treatment year in significant numbers of EBC patients. Compliance programmes adapted for subgroups that are at risk for early non-persistence might help to ensure the recommended therapy duration. Clinical Trials Number CFEM345DDE19.

Details

ISSN :
09598049
Volume :
96
Database :
OpenAIRE
Journal :
European Journal of Cancer
Accession number :
edsair.doi.dedup.....9f70e23098641460fee6f2f0795ec534
Full Text :
https://doi.org/10.1016/j.ejca.2018.03.020