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Influence of patient and tumor characteristics on early therapy persistence with letrozole in postmenopausal women with early breast cancer: results of the prospective Evaluate-TM study with 3941 patients

2017; Elsevier BV; Volume: 29; Issue: 1 Linguagem: Inglês

10.1093/annonc/mdx630

1569-8041

Naiba Nabieva, S. Kellner, Tanja Fehm, Lothar Häberle, J. De Waal, Mahdi Rezai, B. Baier, Gerold Baake, Hans‐Christian Kolberg, Martin Guggenberger, M Warm, Nadia Harbeck, Rachel Wuerstlein, Jörg-Uwe Deuker, Peter Dall, Barbara Richter, Grischa Wachsmann, Cosima Brucker, J. W. Siebers, N. Fersis, Thomas Kühn, Christopher Wolf, Hans‐Walter Vollert, G. P. Breitbach, Wolfgang Janni, R. Landthaler, A. Kohls, Daniela Rezek, Thomas Noesselt, G. Fischer, Stephan Henschen, Thomas Praetz, Volker Heyl, Thomas Kühn, Thomas F. Krauss, Christoph Thomssen, Andre Hohn, Hans Tesch, Christoph Mundhenke, Alexander Hein, Claudia Rauh, Christian Bayer, A. Jacob, Katja Schmidt, Erik Belleville, Sara Y. Brucker, Sherko Kümmel, MW Beckmann, D. Wallwiener, Peyman Hadji, Peter A. Fasching,

BRCA gene mutations in cancer

BackgroundPatients' compliance and persistence with endocrine treatment has a significant effect on the prognosis in early breast cancer (EBC). The purpose of this analysis was to identify possible reasons for non-persistence, defined as premature cessation of therapy, on the basis of patient and tumor characteristics in individuals receiving adjuvant treatment with letrozole.Patients and methodsThe EvAluate-TM study is a prospective, multicenter, noninterventional study in which treatment with the aromatase inhibitor letrozole was evaluated in postmenopausal women with hormone receptor-positive EBC in the early therapy phase. Treatment persistence was evaluated at two pre-specified study visits after 6 and 12 months. As a measure of early therapy persistence the time from the start to the end of treatment (TTEOT) was analyzed. Cox regression analyses were carried out to identify patient characteristics and tumor characteristics predicting TTEOT.ResultsOut of the total population of 3941 patients with EBC, 540 (13.7%) events involving treatment cessation unrelated to disease progression were observed. This was due to drug-related toxicity in the majority of cases (73.5%). Persistence rates were 92.2%, 86.9%, and 86.3% after 6, 12, and 15 months, respectively. The main factors influencing premature treatment discontinuation were older age [hazard ratio (HR) 1.02/year], comorbidities (HR 1.06 per comorbidity), low body mass index, and lower tumor grade (HR 0.85 per grade unit).ConclusionThese results support the view that older, multimorbid patients with low tumor grade and low body mass index are at the greatest risk for treatment discontinuation and might benefit from compliance and support programs.