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Deprecated: Implicit conversion from float 314.4 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Ther+Adv+Urol 2015 ; 7 (3): 105-15 Nephropedia Template TP
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Efficacy of degarelix in prostate cancer patients following failure on luteinizing hormone-releasing hormone agonist treatment: results from an open-label, multicentre, uncontrolled, phase II trial (CS27) #MMPMID26161141
Miller K; Simson G; Goble S; Persson BE
Ther Adv Urol 2015[Jun]; 7 (3): 105-15 PMID26161141show ga
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.