Wallwiener, Markus, Nabieva, Naiba, Feisst, Manuel, Fehm, Tanja, de Waal, Johann, Rezai, Mahdi, Baier, Bernd, Baake, Gerold, Kolberg, Hans-Christian, Guggenberger, Martin, Warm, Mathias, Harbeck, Nadia, Wuerstlein, Rachel, Deuker, Joerg-Uwe, Dall, Peter, Richter, Barbara, Wachsmann, Grischa, Brucker, Cosima, Siebers, Jan Willem, Popovic, Milos, Kuhn, Thomas, Wolf, Christopher, Vollert, Hans-Walter, Breitbach, Georg-Peter, Janni, Wolfgang, Landthaler, Robert, Kohls, Andreas, Rezek, Daniela, Noesselt, Thomas, Fischer, Gunnar, Henschen, Stephan, Praetz, Thomas, Heyl, Volker, Kuehn, Thorsten, Krauss, Thomas, Thomssen, Christoph, Hohn, Andre, Tesch, Hans, Mundhenke, Christoph, Hein, Alexander ORCID: 0000-0003-2601-3398, Rauh, Claudia, Bayer, Christian M., Schmidt, Katja, Belleville, Erik, Brucker, Sara Y., Hadji, Peyman, Beckmann, Matthias W., Wallwiener, Diethelm, Kuemmel, Sherko, Hartkopf, Andreas and Fasching, Peter A. (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. BMC Cancer, 19. LONDON: BMC. ISSN 1471-2407

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Abstract

BackgroundTreatment 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.MethodsEvAluate-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 12months. Competing risk survival analyses were performed to identify patient and tumor characteristics that predict TTEOT.ResultsOut 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 12months was 77.7%. Persistence was lower in patients who reported any adverse event (AE) in the first 30days 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.ConclusionsDespite 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 registrationClinical Trials Number: CFEM345DDE19

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Wallwiener, MarkusUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Nabieva, NaibaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Feisst, ManuelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fehm, TanjaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
de Waal, JohannUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rezai, MahdiUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Baier, BerndUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Baake, GeroldUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kolberg, Hans-ChristianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Guggenberger, MartinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Warm, MathiasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Harbeck, NadiaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wuerstlein, RachelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Deuker, Joerg-UweUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Dall, PeterUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Richter, BarbaraUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wachsmann, GrischaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Brucker, CosimaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Siebers, Jan WillemUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Popovic, MilosUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kuhn, ThomasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wolf, ChristopherUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Vollert, Hans-WalterUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Breitbach, Georg-PeterUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Janni, WolfgangUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Landthaler, RobertUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kohls, AndreasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rezek, DanielaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Noesselt, ThomasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fischer, GunnarUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Henschen, StephanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Praetz, ThomasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Heyl, VolkerUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kuehn, ThorstenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Krauss, ThomasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Thomssen, ChristophUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hohn, AndreUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Tesch, HansUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mundhenke, ChristophUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hein, AlexanderUNSPECIFIEDorcid.org/0000-0003-2601-3398UNSPECIFIED
Rauh, ClaudiaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bayer, Christian M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schmidt, KatjaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Belleville, ErikUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Brucker, Sara Y.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hadji, PeymanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Beckmann, Matthias W.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wallwiener, DiethelmUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kuemmel, SherkoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hartkopf, AndreasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fasching, Peter A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-137535
DOI: 10.1186/s12885-019-5806-y
Journal or Publication Title: BMC Cancer
Volume: 19
Date: 2019
Publisher: BMC
Place of Publication: LONDON
ISSN: 1471-2407
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
ADJUVANT HORMONAL-THERAPY; ENDOCRINE THERAPY; CLINICAL-PRACTICE; ADHERENCE; DISCONTINUATION; GUIDELINES; TAMOXIFEN; TRIALMultiple languages
OncologyMultiple languages
Refereed: Yes
URI: http://kups.ub.uni-koeln.de/id/eprint/13753

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