PMID- 29679775
OWN - NLM
STAT- MEDLINE
DCOM- 20190128
LR  - 20220409
IS  - 1879-0852 (Electronic)
IS  - 0959-8049 (Linking)
VI  - 96
DP  - 2018 Jun
TI  - 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.
PG  - 82-90
LID - S0959-8049(18)30750-0 [pii]
LID - 10.1016/j.ejca.2018.03.020 [doi]
AB  - 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.
CI  - Copyright (c) 2018 Elsevier Ltd. All rights reserved.
FAU - Nabieva, N
AU  - Nabieva N
AD  - Department of Obstetrics and Gynecology, Erlangen University Hospital, 
      Comprehensive Cancer Center Erlangen-European Metropolitan Area Nuremberg, 
      Friedrich-Alexander University Erlangen-Nuremberg, Erlangen, Germany.
FAU - Fehm, T
AU  - Fehm T
AD  - Department of Gynecology, Heinrich Heine University of Dusseldorf, Dusseldorf, 
      Germany; Department of Gynecology, University of Tubingen, Tubingen, Germany.
FAU - Haberle, L
AU  - Haberle L
AD  - Department of Obstetrics and Gynecology, Erlangen University Hospital, 
      Comprehensive Cancer Center Erlangen-European Metropolitan Area Nuremberg, 
      Friedrich-Alexander University Erlangen-Nuremberg, Erlangen, Germany; 
      Biostatistics Unit, Department of Gynecology, Erlangen University Hospital, 
      Erlangen, Germany.
FAU - de Waal, J
AU  - de Waal J
AD  - Department of Gynecology, Dachau Clinic, Dachau, Germany.
FAU - Rezai, M
AU  - Rezai M
AD  - Luisen-Hospital Dusseldorf, Dusseldorf, Germany.
FAU - Baier, B
AU  - Baier B
AD  - Department of Gynecology, Dachau Clinic, Dachau, Germany.
FAU - Baake, G
AU  - Baake G
AD  - Oncological Medical Practice Pinneberg, Pinneberg, Germany.
FAU - Kolberg, H-C
AU  - Kolberg HC
AD  - Marien-Hospital Bottrop, Bottrop, Germany.
FAU - Guggenberger, M
AU  - Guggenberger M
AD  - Tuttlingen Clinic, Tuttlingen, Germany.
FAU - Warm, M
AU  - Warm M
AD  - Breast Center, Department of Gynecology, Cologne University Hospital, Cologne, 
      Germany; Breast Center, Clinics of Cologne GmbH, Holweide, Cologne, Germany.
FAU - Harbeck, N
AU  - Harbeck N
AD  - Breast Center, Department of Gynecology, Cologne University Hospital, Cologne, 
      Germany; University Hospital Munich (LMU), Dept. of Gynecology and Obstetrics, 
      Breast Center and CCC Munich, Munich, Germany.
FAU - Wuerstlein, R
AU  - Wuerstlein R
AD  - Breast Center, Department of Gynecology, Cologne University Hospital, Cologne, 
      Germany; University Hospital Munich (LMU), Dept. of Gynecology and Obstetrics, 
      Breast Center and CCC Munich, Munich, Germany.
FAU - Deuker, J-U
AU  - Deuker JU
AD  - Vinzenz-Hospital Hannover GmbH, Hannover, Germany.
FAU - Dall, P
AU  - Dall P
AD  - Department of Gynecology, Luneburg Clinic, Luneburg, Germany.
FAU - Richter, B
AU  - Richter B
AD  - Elbland Clinics, Meissen-Radebeul, Germany.
FAU - Wachsmann, G
AU  - Wachsmann G
AD  - County Hospital of Boblingen, Boblingen, Germany.
FAU - Brucker, C
AU  - Brucker C
AD  - Department of Gynecology, University Hospital, Paracelsus Private Medical 
      University of Nuremberg, Nuremberg, Germany.
FAU - Siebers, J W
AU  - Siebers JW
AD  - Department of Gynecology, St. Josef's Hospital, Offenburg, Germany.
FAU - Popovic, M
AU  - Popovic M
AD  - Department of Gynecology, Bayreuth Clinic GmbH, CCC ER-EMN, Bayreuth, Germany.
FAU - Kuhn, T
AU  - Kuhn T
AD  - Karl-Olga-Hospital Stuttgart, Diakonie Klinikum Stuttgart, Stuttgart, Germany.
FAU - Wolf, C
AU  - Wolf C
AD  - Medical Center Ulm, Ulm, Germany.
FAU - Vollert, H-W
AU  - Vollert HW
AD  - Friedrichshafen Clinic, Friedrichshafen, Germany.
FAU - Breitbach, G-P
AU  - Breitbach GP
AD  - Department of Gynecology, Neunkirchen Clinic, Neunkirchen, Germany.
FAU - Janni, W
AU  - Janni W
AD  - Department of Gynecology, Ulm University Hospital, Ulm, Germany.
FAU - Landthaler, R
AU  - Landthaler R
AD  - Gynecological Medical Practice of the County Hospital of Krumbach, Krumbach, 
      Germany.
FAU - Kohls, A
AU  - Kohls A
AD  - Evangelic County Hospital Ludwigsfelde-Teltow, Ludwigsfelde-Teltow, Germany.
FAU - Rezek, D
AU  - Rezek D
AD  - Marien-Hospital Wesel, Wesel, Germany.
FAU - Noesselt, T
AU  - Noesselt T
AD  - Department of Gynecology of the County Hospital of Hameln, Hameln, Germany.
FAU - Fischer, G
AU  - Fischer G
AD  - Mittweida Hospital gGmbH, Mittweida, Germany.
FAU - Henschen, S
AU  - Henschen S
AD  - Johanniter Hospital Genthin Stendal gGmbH, Hansestadt Stendal, Germany.
FAU - Praetz, T
AU  - Praetz T
AD  - Caritas-Hospital Bad Mergentheim, Bad Mergentheim, Germany.
FAU - Heyl, V
AU  - Heyl V
AD  - Asklepios Paulinen Clinic Wiesbaden, Wiesbaden, Germany.
FAU - Kuhn, T
AU  - Kuhn T
AD  - Department of Gynecology, Esslingen Clinics a.N., Esslingen, Germany.
FAU - Krauss, T
AU  - Krauss T
AD  - Department of Gynecology Passau, Passau, Germany.
FAU - Thomssen, C
AU  - Thomssen C
AD  - Department of Gynecology, Martin Luther University of Halle-Wittenberg, Halle 
      (Saale), Germany.
FAU - Hohn, A
AU  - Hohn A
AD  - County Hospital Kiel GmbH, Kiel, Germany.
FAU - Tesch, H
AU  - Tesch H
AD  - Oncology Bethanien Frankfurt, Frankfurt, Germany.
FAU - Mundhenke, C
AU  - Mundhenke C
AD  - Department of Gynecology, University Hospital of Schleswig-Holstein, Campus Kiel, 
      Kiel, Germany.
FAU - Hein, A
AU  - Hein A
AD  - Department of Obstetrics and Gynecology, Erlangen University Hospital, 
      Comprehensive Cancer Center Erlangen-European Metropolitan Area Nuremberg, 
      Friedrich-Alexander University Erlangen-Nuremberg, Erlangen, Germany.
FAU - Hack, C C
AU  - Hack CC
AD  - Department of Obstetrics and Gynecology, Erlangen University Hospital, 
      Comprehensive Cancer Center Erlangen-European Metropolitan Area Nuremberg, 
      Friedrich-Alexander University Erlangen-Nuremberg, Erlangen, Germany.
FAU - Schmidt, K
AU  - Schmidt K
AD  - Novartis Pharma GmbH Nuremberg, Nuremberg, Germany.
FAU - Belleville, E
AU  - Belleville E
AD  - Clin-Sol GmbH Wurzburg, Wurzburg, Germany.
FAU - Brucker, S Y
AU  - Brucker SY
AD  - Department of Gynecology, University of Tubingen, Tubingen, Germany.
FAU - Kummel, S
AU  - Kummel S
AD  - Breast Unit, Essen Mitte Clinics, Evang. Huyssens-Stiftung/Knappschaft GmbH, 
      Essen, Germany.
FAU - Beckmann, M W
AU  - Beckmann MW
AD  - Department of Obstetrics and Gynecology, Erlangen University Hospital, 
      Comprehensive Cancer Center Erlangen-European Metropolitan Area Nuremberg, 
      Friedrich-Alexander University Erlangen-Nuremberg, Erlangen, Germany.
FAU - Wallwiener, D
AU  - Wallwiener D
AD  - Department of Gynecology, University of Tubingen, Tubingen, Germany.
FAU - Hadji, P
AU  - Hadji P
AD  - Department of Bone Oncology, Nordwest Hospital, Frankfurt, Germany.
FAU - Fasching, P A
AU  - Fasching PA
AD  - Department of Obstetrics and Gynecology, Erlangen University Hospital, 
      Comprehensive Cancer Center Erlangen-European Metropolitan Area Nuremberg, 
      Friedrich-Alexander University Erlangen-Nuremberg, Erlangen, Germany. Electronic 
      address: peter.fasching@uk-erlangen.de.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20180418
PL  - England
TA  - Eur J Cancer
JT  - European journal of cancer (Oxford, England : 1990)
JID - 9005373
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Aromatase Inhibitors)
RN  - 7LKK855W8I (Letrozole)
SB  - IM
MH  - Aged
MH  - Antineoplastic Agents/*adverse effects
MH  - Aromatase Inhibitors/*adverse effects
MH  - Breast Neoplasms/*drug therapy/pathology
MH  - Female
MH  - Germany
MH  - Humans
MH  - Letrozole/*adverse effects
MH  - *Medication Adherence
MH  - Middle Aged
MH  - *Postmenopause
MH  - Prospective Studies
MH  - Risk Factors
MH  - Time Factors
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Adherence
OT  - Adverse events
OT  - Aromatase inhibitor
OT  - Breast cancer
OT  - Compliance
OT  - Endocrine treatment/therapy
OT  - Letrozole
OT  - Persistence
OT  - Side-effects
EDAT- 2018/04/22 06:00
MHDA- 2019/01/29 06:00
CRDT- 2018/04/22 06:00
PHST- 2017/12/07 00:00 [received]
PHST- 2018/03/15 00:00 [revised]
PHST- 2018/03/19 00:00 [accepted]
PHST- 2018/04/22 06:00 [pubmed]
PHST- 2019/01/29 06:00 [medline]
PHST- 2018/04/22 06:00 [entrez]
AID - S0959-8049(18)30750-0 [pii]
AID - 10.1016/j.ejca.2018.03.020 [doi]
PST - ppublish
SO  - Eur J Cancer. 2018 Jun;96:82-90. doi: 10.1016/j.ejca.2018.03.020. Epub 2018 Apr 
      18.