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| |  Degarelix Controls Advanced Prostate Cancer Better Than Leuprolide: Presented at EMUC By Chris Berrie BARCELONA -- November 30, 2009 -- The new gonadotropin-releasing hormone (GnRH)-blocker degarelix offers better control of advanced prostate cancer than does the GnRH-receptor agonist leuprolide, according to an analysis presented here at the 2nd European Multidisciplinary Meeting on Urological Cancers (EMUC). “GnRH analogues are the standard treatment at this time for androgen-deprivation therapy [for prostate cancer],” noted coinvestigator Fritz H. Schröder, MD, Erasmus Medical Center, Rotterdam, the Netherlands, speaking here on November 29. “These treatments have been shown to be effective, but only suppress testosterone after a delay of about 3 weeks.” Testosterone suppression, he noted, occurs after an initial testosterone surge, which can result in clinical flare. The aim of this analysis was to further investigate the data from a recent randomised phase 3 study of patients with histologically confirmed advanced prostate cancer -- specifically to examine prostate-specific antigen (PSA) and serum alkaline phosphatase (S-ALP). The main trial compared 2 dose regimens of degarelix with leuprolide. The trial population (n = 610) was randomised to degarelix at a starting dose of 240 mg for 1 month followed by monthly maintenance doses of 80 mg (n = 207) or 160 mg (n = 202), or to leuprolide 7.5 mg/month (n = 201). In the current analysis, baseline characteristics across the degarelix 240/80 and leuprolide groups were similar for median age (72 vs 74 years) and testosterone level (4.11 vs 3.84 ng/mL), as well as for distribution of localised disease / locally advanced disease / metastatic disease (33%/31%/18% vs 31%/26%/23%). Baseline PSA levels of <10/10-20/20-50/>=50 ng/mL were also fairly similar (27%/25%/25%/23% vs 32%/22%/19%/27%). Testosterone suppression was achieved in both treatment groups, and the effects on PSA progression-free survival (PFS), PSA failure, and S-ALP levels were analysed according to disease stage and baseline PSA. For degarelix 240/80 versus leuprolide in patients with baseline PSA >20 ng/mL, PSA failure rates were significantly improved (P = .0436; log-rank), with PSA failure occurring in 7.7% of the degarelix patients (16/207) versus 12.9% of the leuprolide patients (26/201). Baseline levels of S-ALP were high in patients with metastatic disease (degarelix 240/80, 203 IU/L; leuprolide, 148 IU/L). An initial peak in S-ALP levels was seen in both treatment groups, which then reduced to below baseline around day 60 of treatment. With leuprolide, there was also a late rise in S-ALP from about day 220 that was not seen for degarelix 240/80 (day 364: 96 vs 179 IU/L). S-ALP levels by baseline PSA >50 ng/mL parallelled this selective late S-ALP rise with leuprolide treatment. The PSA PFS, therefore, was longer with degarelix treatment than with leuprolide in men with PSA >20 ng/mL during the first year of treatment, with degarelix appearing to offer better control of skeletal metastases. “This exploratory analysis has produced very suggestive, hypothesis-generating data ... and further studies are warranted to confirm these findings,” Dr. Schröder concluded. Funding for this study was provided by Ferring Pharmaceuticals Inc. EMUC was jointly organised by the United European Gastroenterology Federation (UEGF) and the World Gastroenterology Organisation (WGO), together with the World Organisation of Digestive Endoscopy (OMED) and the British Society of Gastroenterology (BSG). [Presentation title: Degarelix vs Leuprolide Treatment in Patients With Advanced Prostate Cancer: PSA Failures and Effects on S-ALP Levels During a Randomised, Phase 3 Trial (CS21). Oral Abstract O1]
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