title: A meta-analysis and systematic review of randomized controlled trials with degarelix versus gonadotropin-releasing hormone agonists for advanced prostate cancer.
abstract: Our aim was to systematically evaluate the benefits of degarelix as antagonist versus agonists of gonadotropin-releasing hormones (GnRH) for the treatment of advanced prostate cancer (PC). This comparison was performed either in terms of biochemical or oncological or safety profiles. To this end we, carried out a systematic review and meta-analysis of the literature.We selected only studies directly and prospectively analyzing the two treatments in the same population (randomized phase III studies). We followed the Preferred Reporting Items for Systematic Reviews and meta-analyses process for reporting studies.After we eliminated studies according to the exclusion criteria, 9 publications were considered relevant to this review. These articles described 5 clinical trials that were eligible for inclusion. The follow-up duration in all trials did not exceed 364 days. This meta-analysis and review comprised a total of 1719 men, 1061 randomized to degarelix versus 658 to GnRH agonists treatment for advanced PC. Oncological results were evaluated only in 1 trial (CS21:408 cases) and they were not the primary endpoints of the study. Treatment emerging adverse events were reported in 61.4% and 58.8% of patients in the degarelix and GnRH agonists group, respectively (odds ratio, OR = 1.17; 95% confidence interval, 95% CI: 0.78-1.77, P > 0.1). Treatment related severe cardiovascular side effects were reported (trial CS21-30-35) in 1.6% and 3.6% of patients in the degarelix and GnRH agonists group, respectively (OR = 0.55, 95% CI: 0.26-1.14, P > 0.1).Our analysis evidences relevant limitations in particular for the comparative evaluation of the efficacy and the oncological results related to degarelix.
authors.affiliation: Department of Urological Sciences, University Sapienza, Rome Statistics Institute, Rome Department of Radiological Sciences, Oncology & Pathology, University Sapienza, Rome Department of Experimental Medicine, University Sapienza, Rome.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Sciarra
authors.forename: Andrea
authors.initials: A
authors.lastname: Fasulo
authors.forename: Antonio
authors.initials: A
authors.lastname: Ciardi
authors.forename: Elisa
authors.initials: E
authors.lastname: Petrangeli
authors.forename: Alessandro
authors.initials: A
authors.lastname: Gentilucci
authors.forename: Martina
authors.initials: M
authors.lastname: Maggi
authors.forename: Michele
authors.initials: M
authors.lastname: Innocenzi
authors.forename: Federico
authors.initials: F
authors.lastname: Pierella
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Gentile
authors.forename: Stefano
authors.initials: S
authors.lastname: Salciccia
authors.forename: Susanna
authors.initials: S
authors.lastname: Cattarino
mesh_terms: D007987:Gonadotropin-Releasing Hormone / Q000819:agonists*; D006801:Humans; D008297:Male; D009367:Neoplasm Staging; D009842:Oligopeptides / Q000627:therapeutic use*; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000473:pathology; D016032:Randomized Controlled Trials as Topic
chemical_list: D009842:Oligopeptides; C431566:acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide; D007987:Gonadotropin-Releasing Hormone