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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.

Publication ,  Journal Article
Tombal, B; Miller, K; Boccon-Gibod, L; Schröder, F; Shore, N; Crawford, ED; Moul, J; Jensen, J-K; Kold Olesen, T; Persson, B-E
Published in: Eur Urol
May 2010

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.

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Published In

Eur Urol

DOI

EISSN

1873-7560

Publication Date

May 2010

Volume

57

Issue

5

Start / End Page

836 / 842

Location

Switzerland

Related Subject Headings

  • Urology & Nephrology
  • Prostatic Neoplasms
  • Prostate-Specific Antigen
  • Oligopeptides
  • Neoplasm Recurrence, Local
  • Male
  • Leuprolide
  • Humans
  • Gonadotropin-Releasing Hormone
  • Disease-Free Survival
 

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Tombal, B., Miller, K., Boccon-Gibod, L., Schröder, F., Shore, N., Crawford, E. D., … Persson, B.-E. (2010). 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. Eur Urol, 57(5), 836–842. https://doi.org/10.1016/j.eururo.2009.11.029
Tombal, Bertrand, Kurt Miller, Laurent Boccon-Gibod, Fritz Schröder, Neal Shore, E David Crawford, Judd Moul, Jens-Kristian Jensen, Tine Kold Olesen, and Bo-Eric Persson. “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.Eur Urol 57, no. 5 (May 2010): 836–42. https://doi.org/10.1016/j.eururo.2009.11.029.
Tombal B, Miller K, Boccon-Gibod L, Schröder F, Shore N, Crawford ED, Moul J, Jensen J-K, Kold Olesen T, Persson B-E. 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. Eur Urol. 2010 May;57(5):836–842.
Journal cover image

Published In

Eur Urol

DOI

EISSN

1873-7560

Publication Date

May 2010

Volume

57

Issue

5

Start / End Page

836 / 842

Location

Switzerland

Related Subject Headings

  • Urology & Nephrology
  • Prostatic Neoplasms
  • Prostate-Specific Antigen
  • Oligopeptides
  • Neoplasm Recurrence, Local
  • Male
  • Leuprolide
  • Humans
  • Gonadotropin-Releasing Hormone
  • Disease-Free Survival