Efficacy and Safety of Degarelix in Taiwanese Patients with Prostate Cancer Requiring Androgen Deprivation Therapy: An Open-label, Multicenter Phase III Study

  • Tony Wu Division of Urology, Kaohsiung Veterans General Hospital, Kaohsiung City, Taiwan
  • Kun-Hung Shen Urology Department, Chi Mei Medical Center, Tainan City
  • Chao-Yuan Huang Department of Urology, National Taiwan University Hospital, Taipei City
  • Yen-Hwa Chang Division of Urology, Taipei Veterans General Hospital, Taipei City
  • Po-Hui Chiang Department of Urology, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung City
  • Yen-Chuan Ou Department of Urology, Taichung Veterans General Hospital, Taichung City
  • Hsi-Chin Wu Tainan Municipal An-Nan Hospital-China Medical University, Tainan City
  • Chih-Shou Chen Urology Out-patient Department, Chiayi Chang Gung Memorial Hospital, Chiayi County
  • See-Tong Pang Division of Urology, Gung Memorial Hospital, Taipei
  • Ming-Kuen Lai Department of Urology, Camillians Saint Mary’s Hospital Luodon

Abstract

Background: Pivotal phase III data have shown the efficacy and safety of degarelix (240 mg starting dose/80 mg maintenance dose [240/80 mg]) in North American and European patients with prostate cancer (PCa). This open-label, multicenter, single-arm trial has evaluated the efficacy and safety of degarelix in Taiwanese patients with PCa.Methods: Eligible patients received degarelix 240/80 mg monthly for 6 months. The primary objective was the efficacy of degarelix in achieving and maintaining serum testosterone below castrate levels (≤0.5 ng/mL). Secondary objectives included changes in serum testosterone and PSA, and safety.Results: One hundred and ten patients were allocated to treatment. Over six months, degarelix maintained serum testosterone at castrate levels; from Days 28-168, the cumulative probability of sustained castrate level testosterone was 97.2% (95% CI: 91.6-99.1%), meeting the primary objective. Degarelix rapidly suppressed serum testosterone levels, with castrate levels achieved by Days 3 in 93.5% of patients. PSA decreased rapidly from baseline, with a median reduction of 92.4% by Day 28. Degarelix was well tolerated, with the most frequent adverse events (AEs) being mild to moderate injection site reactions (ISRs), occurring mostly with the initial dose of degarelix. There were no immediate-onset systemic hypersensitivity reactions observed.Conclusions: In Taiwanese patients with PCa, a monthly degarelix 240/80 mg/mL dose regimen rapidly decreased testosterone and PSA levels, and maintained testosterone at castrate levels (≤ 0.5 ng/ mL) over 6 months. The safety profile of degarelix was consistent with that expected for elderly men with PCa undergoing androgen deprivation therapy (ADT).
Published
Dec 31, 2016
How to Cite
WU, Tony et al. Efficacy and Safety of Degarelix in Taiwanese Patients with Prostate Cancer Requiring Androgen Deprivation Therapy: An Open-label, Multicenter Phase III Study. Journal of Cancer Biology and Therapeutics, [S.l.], v. 2, n. 1, dec. 2016. ISSN 2379-5972. Available at: <http://www.gratisoa.org/journals/index.php/GJCT/article/view/73>. Date accessed: 27 may 2017. doi: http://dx.doi.org/10.18314/gjct.v1i2.73.
Section
Research Articles