Nabieva, N., Fehm, T., Haeberle, L., de Waal, J., Rezai, M., Baier, B., Baake, G., Kolberg, H. -C., Guggenberger, M., Warm, M., Harbeck, N., Wuerstlein, R., Deuker, J. -U., Dall, P., Richter, B., Wachsmann, G., Brucker, C., Siebers, J. W., Popovic, M., Kuhn, T., Wolf, C., Vollert, H. -W., Breitbach, G. -P., Janni, W., Landthaler, R., Kohls, A., Rezek, D., Noesselt, T., Fischer, G., Henschen, S., Praetz, T., Heyl, V., Kuehn, T., Krauss, T., Thomssen, C., Hohn, A., Tesch, H., Mundhenke, C., Hein, A., Hack, C. C., Schmidt, K., Belleville, E., Brucker, S. Y., Kuemmel, S., Beckmann, M. W., Wallwiener, D., Hadji, P. and Fasching, P. A. (2018). 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. Eur. J. Cancer, 96. S. 82 - 91. OXFORD: ELSEVIER SCI LTD. ISSN 1879-0852

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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. (C) 2018 Elsevier Ltd. All rights reserved.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Nabieva, N.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fehm, T.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Haeberle, L.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
de Waal, J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rezai, M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Baier, B.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Baake, G.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kolberg, H. -C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Guggenberger, M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Warm, M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Harbeck, N.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wuerstlein, R.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Deuker, J. -U.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Dall, P.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Richter, B.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wachsmann, G.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Brucker, C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Siebers, J. W.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Popovic, M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kuhn, T.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wolf, C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Vollert, H. -W.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Breitbach, G. -P.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Janni, W.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Landthaler, R.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kohls, A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rezek, D.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Noesselt, T.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fischer, G.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Henschen, S.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Praetz, T.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Heyl, V.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kuehn, T.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Krauss, T.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Thomssen, C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hohn, A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Tesch, H.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mundhenke, C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hein, A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hack, C. C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schmidt, K.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Belleville, E.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Brucker, S. Y.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kuemmel, S.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Beckmann, M. W.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wallwiener, D.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hadji, P.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fasching, P. A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-185515
DOI: 10.1016/j.ejca.2018.03.020
Journal or Publication Title: Eur. J. Cancer
Volume: 96
Page Range: S. 82 - 91
Date: 2018
Publisher: ELSEVIER SCI LTD
Place of Publication: OXFORD
ISSN: 1879-0852
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
ADJUVANT ANASTROZOLE THERAPY; AROMATASE INHIBITOR THERAPY; ENDOCRINE THERAPY; HORMONAL-THERAPY; RANDOMIZED-TRIAL; FREE SURVIVAL; WOMEN; TAMOXIFEN; SYMPTOMS; ADHERENCEMultiple languages
OncologyMultiple languages
Refereed: Yes
URI: http://kups.ub.uni-koeln.de/id/eprint/18551

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