Open AccessEffectiveness 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
Author(s) -
Bernd J. SchmitzDräger,
Stephan Mühlich,
Carsten Lange,
Natalya Benderska-Söder,
E. Bismarck,
Roland Starlinger,
Bertram Ottillinger,
Oliver W. Hakenberg
Publication year - 2021
Publication title -
urologia internationalis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.771
H-Index - 53
eISSN - 1423-0399
pISSN - 0042-1138
DOI - 10.1159/000513073
Subject(s) - leuprorelin , medicine , prostate cancer , androgen deprivation therapy , discontinuation , tolerability , testosterone (patch) , flutamide , urology , oncology , adverse effect , luteinizing hormone , cancer , androgen receptor , hormone , gonadotropin releasing hormone
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.