BMC Cancer (Jun 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
- Markus Wallwiener,
- Naiba Nabieva,
- Manuel Feisst,
- Tanja Fehm,
- Johann de Waal,
- Mahdi Rezai,
- Bernd Baier,
- Gerold Baake,
- Hans-Christian Kolberg,
- Martin Guggenberger,
- Mathias Warm,
- Nadia Harbeck,
- Rachel Wuerstlein,
- Jörg-Uwe Deuker,
- Peter Dall,
- Barbara Richter,
- Grischa Wachsmann,
- Cosima Brucker,
- Jan Willem Siebers,
- Milos Popovic,
- Thomas Kuhn,
- Christopher Wolf,
- Hans-Walter Vollert,
- Georg-Peter Breitbach,
- Wolfgang Janni,
- Robert Landthaler,
- Andreas Kohls,
- Daniela Rezek,
- Thomas Noesselt,
- Gunnar Fischer,
- Stephan Henschen,
- Thomas Praetz,
- Volker Heyl,
- Thorsten Kühn,
- Thomas Krauss,
- Christoph Thomssen,
- Andre Hohn,
- Hans Tesch,
- Christoph Mundhenke,
- Alexander Hein,
- Claudia Rauh,
- Christian M. Bayer,
- Katja Schmidt,
- Erik Belleville,
- Sara Y. Brucker,
- Peyman Hadji,
- Matthias W. Beckmann,
- Diethelm Wallwiener,
- Sherko Kümmel,
- Andreas Hartkopf,
- Peter A. Fasching
Affiliations
- Markus Wallwiener
- Department of Gynecology, University of Tübingen
- Naiba Nabieva
- Department of Gynecology, University Hospital Erlangen, Friedrich-Alexander University Erlangen-Nuremberg, Comprehensive Cancer Center Erlangen-EMN
- Manuel Feisst
- Institute of Medical Biometry and Informatics, University of Heidelberg
- Tanja Fehm
- Department of Gynecology, Heinrich Heine University of Dusseldorf
- Johann de Waal
- Department of Gynecology, Dachau Clinic
- Mahdi Rezai
- Luisen-Hospital Dusseldorf
- Bernd Baier
- Department of Gynecology, Dachau Clinic
- Gerold Baake
- Oncological Medical Practice Pinneberg
- Hans-Christian Kolberg
- Marien-Hospital Bottrop
- Martin Guggenberger
- Tuttlingen Clinic
- Mathias Warm
- Breast center, Department of Gynecology, University Hospital Cologne
- Nadia Harbeck
- Breast center, Department of Gynecology, University Hospital Cologne
- Rachel Wuerstlein
- Breast center, Department of Gynecology, University Hospital Cologne
- Jörg-Uwe Deuker
- Vinzenz-Hospital Hanover GmbH
- Peter Dall
- Department of Gynecology, Lüneburg Clinic
- Barbara Richter
- Elbland Clinics
- Grischa Wachsmann
- County hospital Böblingen
- Cosima Brucker
- Department of Gynecology and Obstetrics, Paracelsus Medical University
- Jan Willem Siebers
- Department of Gynecology of the St. Josef’s Clinic Offenburg
- Milos Popovic
- Department of Gynecology, Bayreuth clinic GmbH, CCC ER-EMN
- Thomas Kuhn
- Brustzentrum am Diakonie Klinikum Stuttgart
- Christopher Wolf
- Medical Center ULM
- Hans-Walter Vollert
- Medical Campus Bodensee, Klinikum Friedrichshafen
- Georg-Peter Breitbach
- Department of Gynecology, Neunkirchen Clinic
- Wolfgang Janni
- Department of Gynecology, University Hospital Ulm
- Robert Landthaler
- Gynecological Medical Practice of the County Hospital Krumbach
- Andreas Kohls
- Evangelic County Hospital Ludwigsfelde-Teltow
- Daniela Rezek
- Marien-Hospital Wesel
- Thomas Noesselt
- Department of Gynecology of the Sana hospital Hameln
- Gunnar Fischer
- Mittweida Hospital gGmbH
- Stephan Henschen
- Johanniter Hospital Genthin Stendal gGmbH
- Thomas Praetz
- Caritas-Hospital Bad Mergentheim
- Volker Heyl
- Asklepios Paulinen Clinic Wiesbaden
- Thorsten Kühn
- Department of Gynecology, Esslingen Clinics a.N
- Thomas Krauss
- Department of Gynecology Passau
- Christoph Thomssen
- Department of Gynecology, Martin-Luther-University Halle-Wittenberg
- Andre Hohn
- Städtisches Krankenhaus Kiel GmbH
- Hans Tesch
- Oncology Bethanien Frankfurt
- Christoph Mundhenke
- Department of Gynecology, University Hospital Schleswig-Holstein Campus Kiel
- Alexander Hein
- Department of Gynecology, University Hospital Erlangen, Friedrich-Alexander University Erlangen-Nuremberg, Comprehensive Cancer Center Erlangen-EMN
- Claudia Rauh
- Department of Gynecology, University Hospital Erlangen, Friedrich-Alexander University Erlangen-Nuremberg, Comprehensive Cancer Center Erlangen-EMN
- Christian M. Bayer
- Department of Gynecology, University Hospital Erlangen, Friedrich-Alexander University Erlangen-Nuremberg, Comprehensive Cancer Center Erlangen-EMN
- Katja Schmidt
- Novartis Pharma GmbH Nuremberg
- Erik Belleville
- Clin-Sol GmbH Würzburg
- Sara Y. Brucker
- Department of Gynecology, University of Tübingen
- Peyman Hadji
- Department of Gynecology, Nordwest Hospital
- Matthias W. Beckmann
- Department of Gynecology, University Hospital Erlangen, Friedrich-Alexander University Erlangen-Nuremberg, Comprehensive Cancer Center Erlangen-EMN
- Diethelm Wallwiener
- Department of Gynecology, University of Tübingen
- Sherko Kümmel
- Breast center, Essen Mitte Clinics, Evang. Huyssens-Stiftung/Knappschaft GmbH
- Andreas Hartkopf
- Department of Gynecology, University of Tübingen
- Peter A. Fasching
- Department of Gynecology, University Hospital Erlangen, Friedrich-Alexander University Erlangen-Nuremberg, Comprehensive Cancer Center Erlangen-EMN
- DOI
- https://doi.org/10.1186/s12885-019-5806-y
- Journal volume & issue
-
Vol. 19,
no. 1
pp. 1 – 9
Abstract
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
Keywords
- Advanced/metastatic breast cancer
- Palliative/metastatic treatment
- Compliance
- Persistence
- Endocrine treatment/therapy
- Aromatase inhibitor