Document Detail

Additional analysis of the secondary end point of biochemical recurrence rate in a phase 3 trial (CS21) comparing degarelix 80 mg versus leuprolide in prostate cancer patients segmented by baseline characteristics.
MedLine Citation:
PMID:  19962227     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: Recent data suggest prostate-specific antigen (PSA) progression may predict overall survival in prostate cancer patients.
OBJECTIVE: To compare the activity of degarelix and leuprolide regarding PSA recurrence-free survival.
DESIGN, SETTING, AND PARTICIPANTS: Phase 3, 1-yr, multicentre, randomised, open-label trial comparing the efficacy and safety of degarelix at 240 mg for 1 mo, and then 80 mg monthly (240/80 mg); degarelix at 240 mg for 1 mo, and then 160 mg monthly; and leuprolide at 7.5 mg/mo. Overall, 610 patients with histologically confirmed prostate cancer (all stages), for whom androgen deprivation therapy was indicated, were included. The primary end point of this trial has been reported previously; the protocolled and exploratory subgroup analyses reported in this paper focus on degarelix at 240/80 mg (dose approved by the US Food and Drug Administration and the European Medicine Evaluation Association for the treatment of patients with hormone-naive advanced prostate cancer).
MEASUREMENTS: PSA progression-free survival (two consecutive increases in PSA of 50% compared with nadir and ≥ 5 ng/ml on two consecutive measurements at least 2 wk apart or death) and change in PSA were reviewed. Effects of baseline disease stage (localised, locally advanced, and metastatic) and PSA level (<10, 10-20, >20-50, and >50 ng/ml) were analysed.
RESULTS AND LIMITATIONS: Patients receiving degarelix showed a significantly lower risk of PSA progression or death compared with leuprolide (p=0.05). PSA recurrences occurred mainly in patients with advanced disease and exclusively in those with baseline PSA >20 ng/ml. Patients with PSA >20 ng/ml had a significantly longer time to PSA recurrence with degarelix (p=0.04). The relatively low number of patients in each subgroup is a limitation of this study.
CONCLUSIONS: These results generate the hypothesis that degarelix at 240/80 mg offers improved PSA control compared with leuprolide. PSA recurrences occurred almost exclusively in patients with metastatic prostate cancer or high baseline PSA during this 1-yr study. Further studies are warranted to confirm these findings.
Bertrand Tombal; Kurt Miller; Laurent Boccon-Gibod; Fritz Schröder; Neal Shore; E David Crawford; Judd Moul; Jens-Kristian Jensen; Tine Kold Olesen; Bo-Eric Persson
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Publication Detail:
Type:  Clinical Trial, Phase III; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2009-11-20
Journal Detail:
Title:  European urology     Volume:  57     ISSN:  1873-7560     ISO Abbreviation:  Eur. Urol.     Publication Date:  2010 May 
Date Detail:
Created Date:  2010-10-11     Completed Date:  2011-01-31     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  7512719     Medline TA:  Eur Urol     Country:  Switzerland    
Other Details:
Languages:  eng     Pagination:  836-42     Citation Subset:  IM    
Copyright Information:
Copyright © 2009 European Association of Urology. Published by Elsevier B.V. All rights reserved.
Cliniques Universitaires Saint Luc/Université Catholique de Louvain, Brussels, Belgium.
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MeSH Terms
Antineoplastic Agents, Hormonal / administration & dosage*
Disease-Free Survival
Gonadotropin-Releasing Hormone / antagonists & inhibitors*
Leuprolide / administration & dosage*
Neoplasm Recurrence, Local / blood,  epidemiology
Oligopeptides / administration & dosage*
Prostate-Specific Antigen / blood
Prostatic Neoplasms / blood,  drug therapy*,  epidemiology
Reg. No./Substance:
0/Antineoplastic Agents, Hormonal; 0/Oligopeptides; 0/acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide; 33515-09-2/Gonadotropin-Releasing Hormone; 53714-56-0/Leuprolide; EC Antigen

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