Effectiveness and Distribution of Testosterone Levels within First Year of Androgen Deprivation Therapy in a Real-World Setting: Results from the Non-Interventional German Cohort LEAN Study
Schmitz-Dräger BJ, Mühlich S, Lange C, Benderska-Söder N, Bismarck E, Starlinger R, Ottillinger B, Hakenberg OW (2021)
Publication Type: Journal article
Publication year: 2021
Journal
DOI: 10.1159/000513073
Abstract
Background: Observational studies generate information on real-world therapy and complement data from prospective randomized trials. LEAN is an open-label, non-interventional, multi-centre, German cohort study on leuprorelin in routine clinical practice. Objectives: To extend knowledge on the use, effectiveness, and tolerability of HEXAL/Sandoz leuprorelin (in this article, the term Leuprone® HEXAL® covers Leuprorelin Sandoz® as well) solid implant in patients with prostate cancer (PCa) in a real-world setting. Methods: 959 PCa patients scheduled for androgen deprivation therapy (ADT) received leuprorelin acetate implant. Metabolism, serum prostate-specific antigen (PSA), and testosterone data, if available, were collected at baseline and follow-up visits for ≥12 months. Results: Of 694 patients in the modified full analysis set, 26.4% received GnRH analogues ≤6 months before enrolment. Fifty-one percent of patients were treated for locally advanced or metastatic PCa. In 19.6% of patients, ADT was used in neoadjuvant or adjuvant settings and in 28.5% with rising PSA after definite therapy. Testosterone levels <0.5 ng/mL were achieved in >90% of patients. Safety profile was in line with the summary of product characteristics. Therapy was well tolerated, with patient-triggered therapy discontinuation in 3.6%. Conclusions: This interim analysis confirmed previous efficacy findings for leuprorelin implant in a real-world setting. This contemporary cohort showed a shift in the use of ADT to non-metastatic PCa stages.
Additional Organisation(s)
Involved external institutions
Ottillinger Life Sciences
Germany (DE)
Universität Rostock
Germany (DE)
Sandoz International GmbH
Germany (DE)
Germany (DE)
Universität Rostock
Germany (DE)
Sandoz International GmbH
Germany (DE)
How to cite
APA:
Schmitz-Dräger, B.J., Mühlich, S., Lange, C., Benderska-Söder, N., Bismarck, E., Starlinger, R.,... Hakenberg, O.W. (2021). Effectiveness and Distribution of Testosterone Levels within First Year of Androgen Deprivation Therapy in a Real-World Setting: Results from the Non-Interventional German Cohort LEAN Study. Urologia Internationalis. https://doi.org/10.1159/000513073
MLA:
Schmitz-Dräger, Bernd J., et al. "Effectiveness and Distribution of Testosterone Levels within First Year of Androgen Deprivation Therapy in a Real-World Setting: Results from the Non-Interventional German Cohort LEAN Study." Urologia Internationalis (2021).
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