In:
Urologia Internationalis, S. Karger AG, Vol. 105, No. 5-6 ( 2021), p. 436-445
Abstract:
〈 b 〉 〈 i 〉 Background: 〈 /i 〉 〈 /b 〉 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. 〈 b 〉 〈 i 〉 Objectives: 〈 /i 〉 〈 /b 〉 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. 〈 b 〉 〈 i 〉 Methods: 〈 /i 〉 〈 /b 〉 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. 〈 b 〉 〈 i 〉 Results: 〈 /i 〉 〈 /b 〉 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 & #x3c;0.5 ng/mL were achieved in & #x3e;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%. 〈 b 〉 〈 i 〉 Conclusions: 〈 /i 〉 〈 /b 〉 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.
Type of Medium:
Online Resource
ISSN:
0042-1138
,
1423-0399
Language:
English
Publisher:
S. Karger AG
Publication Date:
2021
detail.hit.zdb_id:
1464417-4
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