716 ANALYSIS OF DISEASE CONTROL-RELATED OUTCOMES FROM SIX COMPARATIVE RANDOMISED CLINICAL TRIALS OF DEGARELIX VERSUS LUTEINISING HORMONE-RELEASING HORMONE AGONISTS

Abstract

You have accessJournal of UrologyProstate Cancer: Advanced (I)1 Apr 2013716 ANALYSIS OF DISEASE CONTROL-RELATED OUTCOMES FROM SIX COMPARATIVE RANDOMISED CLINICAL TRIALS OF DEGARELIX VERSUS LUTEINISING HORMONE-RELEASING HORMONE AGONISTS Neal Shore, Kurt Miller, Bertrand Tombal, E. David Crawford, Cathrina Karup, Egbert van der Meulen, and Bo-Eric Persson Neal ShoreNeal Shore Myrtle Beach, SC More articles by this author , Kurt MillerKurt Miller Berlin, Germany More articles by this author , Bertrand TombalBertrand Tombal Brussels, Belgium More articles by this author , E. David CrawfordE. David Crawford Aurora, CO More articles by this author , Cathrina KarupCathrina Karup Copenhagen, Denmark More articles by this author , Egbert van der MeulenEgbert van der Meulen Copenhagen, Denmark More articles by this author , and Bo-Eric PerssonBo-Eric Persson Saint-Prex, Switzerland More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2013.02.275AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES The gonadotrophin releasing hormone (GnRH) antagonist degarelix has a mechanism of action distinct from luteinizing hormone-releasing hormone (LHRH) agonists. Prior studies have suggested differences in disease control. Pooled data on adverse events and their specific impact on musculoskeletal and urinary symptoms from comparative trials have been analyzed. METHODS Data were pooled from 6 prospective, randomized trials (n=2328). The majority of patients, 1686, received 1 year of degarelix or LHRH agonist treatment; the remaining 642 patients had 3 to 7 months? treatment. Events were analysed using Kaplan Meier plots and a log-rank test for homogeneity on relevant groups of MedDRA terms. RESULTS Groups receiving degarelix (n=1491) or an LHRH agonist (goserelin, n=458; leuprolide, n=379) were balanced for baseline characteristics including age, testosterone, PSA and disease stage. Reports of muscle or bone pain were less frequent with degarelix treatment (9% vs. 12%, p=0.0822). Overall probability of fracture (<1% vs. 2%, p=0.0411) and rate of joint related AEs (4% vs. 6%, p=0.0116) were significantly lower in men receiving degarelix. A greater reduction in alkaline phosphatase (ALP) was recorded with degarelix throughout the year of treatment in men with metastatic disease (p=0.0373). There was a significantly lower overall probability of urinary tract AEs (p<0.0001) and a significantly longer time to first urinary infection (p=0.0010) in men treated with degarelix. Incidence of urinary infections was also reduced (5% vs. 8% with agonists). There was better disease control for men with baseline PSA >50 ng/mL treated with degarelix, as they demonstrated significantly better PSA PFS at 1 year vs. agonist treated patients (66.0% vs. 54.7%, p=0.0245). Overall survival for 1 year of treatment was significantly higher for degarelix patients (98.3% vs. 96.7%, p=0.0329). CONCLUSIONS This analysis of 2328 men demonstrates improved disease control for men treated with degarelix vs. men receiving an LHRH agonist as evidenced by lower ALP, significantly fewer fractures and a lower incidence of urinary tract symptoms. In patients with baseline PSA >50 ng/mL, PSA PFS was improved and across all patients higher overall survival was seen during the first year of treatment for men receiving degarelix vs. an LHRH agonist. © 2013 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 189Issue 4SApril 2013Page: e294 Advertisement Copyright & Permissions© 2013 by American Urological Association Education and Research, Inc.MetricsAuthor Information Neal Shore Myrtle Beach, SC More articles by this author Kurt Miller Berlin, Germany More articles by this author Bertrand Tombal Brussels, Belgium More articles by this author E. David Crawford Aurora, CO More articles by this author Cathrina Karup Copenhagen, Denmark More articles by this author Egbert van der Meulen Copenhagen, Denmark More articles by this author Bo-Eric Persson Saint-Prex, Switzerland More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...