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.
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.
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.
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%.
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.
Urologia internationalis. 2021 Feb 25 [Epub ahead of print]
Bernd J Schmitz-Dräger, Stephan Mühlich, Carsten Lange, Natalya Benderska-Söder, Ekkehardt Bismarck, Roland Starlinger, Bertram Ottillinger, Oliver W Hakenberg
Urologie 24, Nuremberg, Germany, ., Urological Practice, Bamberg, Germany., Schwerpunktpraxis Urologie, Bernburg, Germany., Urologie 24, Nuremberg, Germany., Global Medical Affairs, Sandoz International GmbH, Holzkirchen, Germany., Ottillinger Life Sciences, Brunnthal, Germany., Department of Urology, Rostock University, Rostock, Germany.
PubMed http://www.ncbi.nlm.nih.gov/pubmed/33631760