New data published in the December issue of the European Journal of Urology indicates improvement in overall survival (OS) and prostate specific antigen progression free survival (PSA PFS) for degarelix (FIRMAGON®), a gonadotropin releasing hormone (GnRH) antagonist, compared to commonly prescribed luteinising hormone-releasing hormone (LHRH) agonists.
New data published in the December issue of the European Journal of Urology indicates improvement in overall survival (OS) and prostate specific antigen progression free survival (PSA PFS) for degarelix (FIRMAGON®), a gonadotropin releasing hormone (GnRH) antagonist, compared to commonly prescribed luteinising hormone-releasing hormone (LHRH) agonists.
In addition, the data showed a reduction in the incidence of joint, musculoskeletal and urinary tract adverse events for those men with prostate cancer treated with degarelix rather than LHRH agonists. However, the overall rate of any adverse event (including hot flush and injection-site reactions) was higher in the degarelix group than the LHRH agonist group.
Results showed a 29% improvement in PSA PFS* (p=0.017) and 53% improvement in overall survival (p=0.023) for men with prostate cancer who were treated with degarelix instead of an LHRH agonist.
Lead study author Professor Laurence Klotz, MD, Sunnybrook Health Sciences Centre, University of Toronto, Canada, said, “These pooled data showed degarelix improved overall survival rates compared to LHRH agonists. This is encouraging for physicians making treatment decisions for their prostate cancer patients.”
These findings are based on a pooled analysis of 1925 men with prostate cancer from 5 prospective Phase III or IIIb randomised trials. (1) Men requiring androgen deprivation therapy for the treatment of prostate cancer received degarelix (n=1266) or an existing LHRH agonist (goserelin, n=458; leuprolide, n=201). The full analysis set used for efficacy analysis consisted of 1920 patients. Of those, 1263 received degarelix, 456 goserelin and 201 leuprolide. Those patients being treated with degarelix received a 240mg dose in all trials and most patients received a maintenance dose of 80mg. The majority of patients (1458) received treatment for 1 year, while the remaining patients were treated for 3 months.
In terms of disease-related adverse events, for those patients taking degarelix, there were significantly fewer musculoskeletal events (p=0.007) and a significantly lower incidence of any urinary tract infections (p=0.023) compared to the LHRH agonist-treated patients. In addition, in the degarelix group there were fewer patients that experienced a fracture (p=0.064) (although this was not statistically significant) and there were significantly less frequent joint-related signs and symptoms (p=0.041) compared to the LHRH agonist treatment arm.
The overall rate of any adverse event was significantly higher in the degarelix group (74%) compared to the LHRH agonist group (68%), (p=0.002). Specifically, hot flush and injection-site reactions, including pain, erythema, swelling and nodules, were more frequent in the degarelix group.
FIRMAGON® (degarelix) was approved for the treatment of advanced hormone-dependent prostate cancer in both the EU and US in 2009. It is available in approximately 40 countries around the world, including a growing number in Asia, Latin America and the Middle East.
Reference:
- Klotz,L. et al. Disease Control Outcomes from Analysis of Pooled Individual Patient Data from Five Comparative Randomised Clinical Trials of Degarelix Versus Luteinising Hormone-releasing Hormone Agonists, European Urology. 66(6), p. 1101-1108.
