N Nabieva1, T Fehm2, L Häberle3, J de Waal4, M Rezai5, B Baier4, G Baake6, H-C Kolberg7, M Guggenberger8, M Warm9, N Harbeck10, R Wuerstlein10, J-U Deuker11, P Dall12, B Richter13, G Wachsmann14, C Brucker15, J W Siebers16, M Popovic17, T Kuhn18, C Wolf19, H-W Vollert20, G-P Breitbach21, W Janni22, R Landthaler23, A Kohls24, D Rezek25, T Noesselt26, G Fischer27, S Henschen28, T Praetz29, V Heyl30, T Kühn31, T Krauss32, C Thomssen33, A Hohn34, H Tesch35, C Mundhenke36, A Hein1, C C Hack1, K Schmidt37, E Belleville38, S Y Brucker39, S Kümmel40, M W Beckmann1, D Wallwiener39, P Hadji41, P A Fasching42. 1. Department of Obstetrics and Gynecology, Erlangen University Hospital, Comprehensive Cancer Center Erlangen-European Metropolitan Area Nuremberg, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen, Germany. 2. Department of Gynecology, Heinrich Heine University of Düsseldorf, Düsseldorf, Germany; Department of Gynecology, University of Tübingen, Tübingen, Germany. 3. 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. 4. Department of Gynecology, Dachau Clinic, Dachau, Germany. 5. Luisen-Hospital Düsseldorf, Düsseldorf, Germany. 6. Oncological Medical Practice Pinneberg, Pinneberg, Germany. 7. Marien-Hospital Bottrop, Bottrop, Germany. 8. Tuttlingen Clinic, Tuttlingen, Germany. 9. Breast Center, Department of Gynecology, Cologne University Hospital, Cologne, Germany; Breast Center, Clinics of Cologne GmbH, Holweide, Cologne, Germany. 10. 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. 11. Vinzenz-Hospital Hannover GmbH, Hannover, Germany. 12. Department of Gynecology, Lüneburg Clinic, Lüneburg, Germany. 13. Elbland Clinics, Meissen-Radebeul, Germany. 14. County Hospital of Böblingen, Böblingen, Germany. 15. Department of Gynecology, University Hospital, Paracelsus Private Medical University of Nuremberg, Nuremberg, Germany. 16. Department of Gynecology, St. Josef's Hospital, Offenburg, Germany. 17. Department of Gynecology, Bayreuth Clinic GmbH, CCC ER-EMN, Bayreuth, Germany. 18. Karl-Olga-Hospital Stuttgart, Diakonie Klinikum Stuttgart, Stuttgart, Germany. 19. Medical Center Ulm, Ulm, Germany. 20. Friedrichshafen Clinic, Friedrichshafen, Germany. 21. Department of Gynecology, Neunkirchen Clinic, Neunkirchen, Germany. 22. Department of Gynecology, Ulm University Hospital, Ulm, Germany. 23. Gynecological Medical Practice of the County Hospital of Krumbach, Krumbach, Germany. 24. Evangelic County Hospital Ludwigsfelde-Teltow, Ludwigsfelde-Teltow, Germany. 25. Marien-Hospital Wesel, Wesel, Germany. 26. Department of Gynecology of the County Hospital of Hameln, Hameln, Germany. 27. Mittweida Hospital gGmbH, Mittweida, Germany. 28. Johanniter Hospital Genthin Stendal gGmbH, Hansestadt Stendal, Germany. 29. Caritas-Hospital Bad Mergentheim, Bad Mergentheim, Germany. 30. Asklepios Paulinen Clinic Wiesbaden, Wiesbaden, Germany. 31. Department of Gynecology, Esslingen Clinics a.N., Esslingen, Germany. 32. Department of Gynecology Passau, Passau, Germany. 33. Department of Gynecology, Martin Luther University of Halle-Wittenberg, Halle (Saale), Germany. 34. County Hospital Kiel GmbH, Kiel, Germany. 35. Oncology Bethanien Frankfurt, Frankfurt, Germany. 36. Department of Gynecology, University Hospital of Schleswig-Holstein, Campus Kiel, Kiel, Germany. 37. Novartis Pharma GmbH Nuremberg, Nuremberg, Germany. 38. Clin-Sol GmbH Würzburg, Würzburg, Germany. 39. Department of Gynecology, University of Tübingen, Tübingen, Germany. 40. Breast Unit, Essen Mitte Clinics, Evang. Huyssens-Stiftung/Knappschaft GmbH, Essen, Germany. 41. Department of Bone Oncology, Nordwest Hospital, Frankfurt, Germany. 42. 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.
Abstract
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.
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 EBCpatients 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 EBCpatients. 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.
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Authors: Manfred Welslau; Andreas D Hartkopf; Volkmar Müller; Achim Wöckel; Michael P Lux; Wolfgang Janni; Johannes Ettl; Diana Lüftner; Erik Belleville; Florian Schütz; Peter A Fasching; Hans-Christian Kolberg; Naiba Nabieva; Friedrich Overkamp; Florin-Andrei Taran; Sara Y Brucker; Markus Wallwiener; Hans Tesch; Andreas Schneeweiss; Tanja N Fehm Journal: Geburtshilfe Frauenheilkd Date: 2019-10-22 Impact factor: 2.915
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Authors: Daniel L Hertz; Karen Lisa Smith; Yuhua Zong; Christina L Gersch; Andrea M Pesch; Jennifer Lehman; Amanda L Blackford; N Lynn Henry; Kelley M Kidwell; James M Rae; Vered Stearns Journal: Front Genet Date: 2021-06-15 Impact factor: 4.599