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

Tombal, Bertrand;Miller, Kurt;Boccon-Gibod, Laurent;Schroeder, Fritz;Persson, Bo-Eric;et.al.
(2010) European Urology — Vol. 57, n° 5, p. 836-842 (2010)

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  • Tombal, Bertrandorcid-logoUCLouvain
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  • Miller, Kurt
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  • Boccon-Gibod, Laurent
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  • Schroeder, Fritz
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  • Persson, Bo-Eric
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Abstract
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. (C) 2009 European Association of Urology. Published by Elsevier B. V. All rights reserved.
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Tombal, B., Miller, K., Boccon-Gibod, L., Schroeder, F., Shore, N., Crawford, E. D., Moul, J., Jensen, J.-K., Olesen, T. K., & 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. European Urology, 57(5), 836-842. https://doi.org/10.1016/j.eururo.2009.11.029 (Original work published 2010)