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

DOI
https://doi.org/10.1186/s12885-019-5806-y
Journal volume & issue
Vol. 19, no. 1
pp. 1 – 9

Abstract

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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

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