OBJECTIVE: To evaluate the efficacy of second-line degarelix in patients with prostate cancer (PCa) after treatment failure with a luteinizing hormone-releasing hormone (LHRH) agonist. METHODS: This 1-year exploratory, multicentre, open-label phase II trial was performed in 2 patient cohorts (Cohort 1, n = 25; Cohort 2, n = 12) in Germany. Patients with castrate-resistant PCa after primary hormonal treatment received degarelix 240 mg, followed by 11 monthly maintenance doses of 80 mg. The primary endpoint was the proportion of patients with decreasing/stable prostate-specific antigen (PSA) (relative change ⩽+10% of baseline PSA) after 3 months. RESULTS: At Month 3, the response rate (intention-to-treat, last observation carried forward analysis) was 16.7% [95% confidence interval (CI): 4.74-37.38] in Cohort 1 and 33.3% (95% CI: 9.92-65.11) in Cohort 2. The probability of completing 12 months without PSA progression was 8.8% (95% CI: 1.51-24.3) in Cohort 1 and 8.3% (95% CI: 0.5-31.1) in Cohort 2. Degarelix was well tolerated; the most frequently reported adverse events were local injection-site reactions. CONCLUSIONS: In PCa patients who failed LHRH therapy, degarelix was well tolerated and achieved a limited PSA response. Phase III trials show that disease control benefits with degarelix versus agonists are more clearly demonstrated as first-line therapy.
OBJECTIVE: To evaluate the efficacy of second-line degarelix in patients with prostate cancer (PCa) after treatment failure with a luteinizing hormone-releasing hormone (LHRH) agonist. METHODS: This 1-year exploratory, multicentre, open-label phase II trial was performed in 2 patient cohorts (Cohort 1, n = 25; Cohort 2, n = 12) in Germany. Patients with castrate-resistant PCa after primary hormonal treatment received degarelix 240 mg, followed by 11 monthly maintenance doses of 80 mg. The primary endpoint was the proportion of patients with decreasing/stable prostate-specific antigen (PSA) (relative change ⩽+10% of baseline PSA) after 3 months. RESULTS: At Month 3, the response rate (intention-to-treat, last observation carried forward analysis) was 16.7% [95% confidence interval (CI): 4.74-37.38] in Cohort 1 and 33.3% (95% CI: 9.92-65.11) in Cohort 2. The probability of completing 12 months without PSA progression was 8.8% (95% CI: 1.51-24.3) in Cohort 1 and 8.3% (95% CI: 0.5-31.1) in Cohort 2. Degarelix was well tolerated; the most frequently reported adverse events were local injection-site reactions. CONCLUSIONS: In PCa patients who failed LHRH therapy, degarelix was well tolerated and achieved a limited PSA response. Phase III trials show that disease control benefits with degarelix versus agonists are more clearly demonstrated as first-line therapy.
Entities:
Keywords:
degarelix; luteinizing hormone-releasing hormone agonist; prostate cancer
Authors: A Jungwirth; G Galvan; J Pinski; G Halmos; K Szepeshazi; R Z Cai; K Groot; A V Schally Journal: Prostate Date: 1997-08-01 Impact factor: 4.104
Authors: A Jungwirth; J Pinski; G Galvan; G Halmos; K Szepeshazi; R Z Cai; K Groot; M Vadillo-Buenfil; A V Schally Journal: Eur J Cancer Date: 1997-06 Impact factor: 9.162
Authors: Howard I Scher; Karim Fizazi; Fred Saad; Mary-Ellen Taplin; Cora N Sternberg; Kurt Miller; Ronald de Wit; Peter Mulders; Kim N Chi; Neal D Shore; Andrew J Armstrong; Thomas W Flaig; Aude Fléchon; Paul Mainwaring; Mark Fleming; John D Hainsworth; Mohammad Hirmand; Bryan Selby; Lynn Seely; Johann S de Bono Journal: N Engl J Med Date: 2012-08-15 Impact factor: 91.245
Authors: Nima Sharifi; William L Dahut; Seth M Steinberg; William D Figg; Christopher Tarassoff; Philip Arlen; James L Gulley Journal: BJU Int Date: 2005-11 Impact factor: 5.588
Authors: Peter C Albertsen; Laurence Klotz; Bertrand Tombal; James Grady; Tine K Olesen; Jan Nilsson Journal: Eur Urol Date: 2013-11-01 Impact factor: 20.096