| Title: |
Long-term Tolerability and Efficacy of Degarelix: 5-Year Results From a Phase III Extension Trial With a 1-Arm Crossover From Leuprolide to Degarelix |
| Authors: |
Crawford, ED; Shore, ND; Moul, JW; Tombal, B; Schröder, Fritz; Miller, K; Boccon-Gibod, L; Malmberg, A; Olesen, TK; Persson, BE; Klotz, L |
| Source: |
Crawford, ED, Shore, ND, Moul, JW, Tombal, B, Schröder, F, Miller, K, Boccon-Gibod, L, Malmberg, A, Olesen, TK, Persson, BE & Klotz, L 2014, 'Long-term Tolerability and Efficacy of Degarelix: 5-Year Results From a Phase III Extension Trial With a 1-Arm Crossover From Leuprolide to Degarelix', Urology, vol. 83, no. 5, pp. 1122-1128. https://doi.org/10.1016/j.urology.2014.01.013 |
| Publication Year: |
2014 |
| Subject Terms: |
/dk/atira/pure/keywords/researchprograms/AFL001000/EMCMM034901; name=EMC MM-03-49-01 |
| Description: |
OBJECTIVE To demonstrate the safety and efficacy of up to 5 years of degarelix treatment and the effects of crossing over from leuprolide to degarelix in the extension phase of a phase III pivotal 1-year trial. METHODS Patients receiving degarelix who completed the 1-year trial continued on 80 mg (n = 125) or 160 mg (n = 126) maintenance doses. Patients who received leuprolide were rerandomized to degarelix 240/80 mg (n = 69) or 240/160 mg (n = 65). Safety and tolerability were assessed (primary end point), as well as testosterone and prostate-specific antigen levels and prostate-specific antigen progression-free survival (secondary end points). RESULTS Adverse event frequency was similar between both the groups. Adverse events included initial injection site reactions, hot flushes, and increased weight. Testosterone and prostate-specific antigen values during the extension study were similar to those seen during the 1-year trial in patients who continued on degarelix or crossed over from leuprolide. The prostate-specific antigen progression-free survival hazard rate was decreased significantly after the crossover in the leuprolide to degarelix group (from 0.20 to 0.09; P = .002), whereas in patients who continued on degarelix, the rate did not change significantly. In patients with baseline prostate-specific antigen > 20 ng/mL, the same hazard rate change pattern was observed on crossover (from 0.38 to 0.19; P = .019). CONCLUSION Degarelix was well tolerated; no safety concerns were identified. The significant prostate-specific antigen progression-free survival benefit established for degarelix over leuprolide during year 1 remained consistent at 5 years. UROLOGY 83: 1122-1128, 2014. (C) 2014 Elsevier Inc. |
| Document Type: |
article in journal/newspaper |
| Language: |
unknown |
| ISSN: |
0090-4295; 1527-9995 |
| Relation: |
info:eu-repo/semantics/altIdentifier/pmid/24661333; info:eu-repo/semantics/altIdentifier/pissn/0090-4295; info:eu-repo/semantics/altIdentifier/eissn/1527-9995 |
| DOI: |
10.1016/j.urology.2014.01.013 |
| Availability: |
https://pure.eur.nl/en/publications/25bc645f-0fa3-4677-ad67-094581da0ce3; https://doi.org/10.1016/j.urology.2014.01.013; https://hdl.handle.net/1765/59706 |
| Rights: |
info:eu-repo/semantics/closedAccess |
| Accession Number: |
edsbas.59FE43B8 |
| Database: |
BASE |