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. 2021 Dec;15(4):204-208.
doi: 10.1097/CU9.0000000000000029. Epub 2021 Jun 25.

Patients and physician satisfaction of Degarelix in androgen deprivation therapy for advanced hormone-dependent prostate cancer in the Netherlands

Hossain Roshani  1 , Erik P M Roos  2 , Henk W Elzevier  3 , Cees van de Beek  4 , Peter van Winkel  5 , Rob C M Pelger  3
Affiliations

Patients and physician satisfaction of Degarelix in androgen deprivation therapy for advanced hormone-dependent prostate cancer in the Netherlands

Hossain Roshani et al. Curr Urol. 2021 Dec.

Abstract

Background: To explore the effectiveness and safety of the gonadotropin-releasing hormone antagonist, Degarelix, for the treatment of advanced hormone-dependent prostate cancer (PCa) in a real-world setting.

Methods: In this noninterventional study, patients with advanced hormone-dependent PCa were included. Primary endpoints were progression-free survival (PFS) failure defined as either prostate-specific antigen failure, additional therapy related to PCa, or death. Secondary endpoints included patient and physician satisfaction scores, urinary symptoms, and adverse events (AEs).

Results: Of 274 patients with PCa, 271 received at least 1 dose of Degarelix. At a median follow-up of 12.2 (interquartile range 6.2-22.0) months, 148 patients (60.2%) had PFS failure. Thirty-five patients (13%) withdrew from the study due to AEs, 23 patients (8.4%) died, and 36 patients (13%) completed 3 years' follow-up. Urinary symptoms significantly decreased over time. In the safety population, 87.8% of patients reported AEs, with injection-site reactions commonly reported. The majority of physicians and patients considered the therapy satisfactory and well tolerated.

Conclusions: In this observational study, Degarelix treatment was well accepted by men with advanced hormone-dependent PCa. Compared with phase III studies, a higher proportion of patients had PFS failure, possibly due to the inclusion of men with more advanced disease in the current study, and more men reported AEs.

Keywords: Androgen antagonists; Clinical trials; Degarelix; Prostate-specific antigen; Prostatic neoplasms.

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Conflict of interest statement

H Roshani: no conflict of interest. EPM Roos, HW Elzevier, C van de Beek, and RCM Pelger: received study fees from Ferring. P van Winkel: full-time employee of Ferring B.V., The Netherlands.

Figures

Figure 1
Figure 1
Survival curve of time in years until PSA failure or additional therapy for the treatment of PCa or death (efficacy population). PCa = prostate cancer; PSA = prostate-specific antigen.
See this image and copyright information in PMC

References

    1. Ferlay J, Steliarova-Foucher E, Lortet-Tieulent J, et al. Cancer incidence and mortality patterns in Europe: Estimates for 40 countries in 2012. Eur J Cancer 2013;49(6):1374–1403. - PubMed
    1. Klotz L, Boccon-Gibod L, Shore ND, et al. The efficacy and safety of degarelix: A 12-month, comparative, randomized, open-label, parallel-group phase III study in patients with prostate cancer. BJU Int 2008;102(11):1531–1538. - PubMed
    1. Tombal B, Miller K, Boccon-Gibod L, et al. 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;57(5):836–842. - PubMed
    1. Schröder FH, Tombal B, Miller K, et al. Changes in alkaline phosphatase levels in patients with prostate cancer receiving degarelix or leuprolide: Results from a 12-month, comparative, phase III study. BJU Int 2010;106(2):182–187. - PubMed
    1. Albertsen PC, Klotz L, Tombal B, Grady J, Olesen TK, Nilsson J. Cardiovascular morbidity associated with gonadotropin releasing hormone agonists and an antagonist. Eur Urol 2014;65(3):565–573. - PubMed