Cited 4 times in
Efficacy and safety of degarelix in Korean patients with prostate cancer requiring androgen deprivation therapy: Open-label multicenter phase III study
DC Field | Value | Language |
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dc.contributor.author | 정병하 | - |
dc.date.accessioned | 2018-03-26T16:53:33Z | - |
dc.date.available | 2018-03-26T16:53:33Z | - |
dc.date.issued | 2015 | - |
dc.identifier.issn | 2287-8882 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/156925 | - |
dc.description.abstract | PURPOSE: To assess the noninferiority, efficacy, and safety of degarelix in achieving and maintaining testosterone at castrate levels (≤0.5 ng/mL) in Korean patients (CS42) versus non-Asian patients with prostate cancer (PCa). METHODS: A Phase III, open-label, multicenter, single-arm trial was conducted in Korean patients with PCa. Degarelix was administered at a starting dose of 240 mg followed by monthly (28-day intervals) maintenance doses of 80 mg (240/80 mg dose regimen) for 7 months. The results were compared with non-Asian patients receiving degarelix 240/80 mg in the CS21 study. RESULTS: The estimated difference in the cumulative probabilities of testosterone ≤0.5 ng/mL from Day 28 to Day 196 between the trials was -2.3% (96.7% in CS42 vs. 99.0% in CS21). The lower limit of the 95% confidence interval was -5.5%, i.e., above the predefined noninferiority limit of -10% and thus noninferiority was established. Decreases in serum testosterone, prostate-specific antigen, and luteinizing hormone over time were similar in CS42 and CS21. There were no clinically significant differences in incidence of treatment-emergent adverse events (72% in CS42 vs. 70% in CS21) and changes in clinical chemistry and hematology parameters between the two trials. The most common adverse event was injection-site reaction. CONCLUSIONS: Overall, degarelix was effective and well tolerated in Korean patients. Testosterone suppression was noninferior to that in non-Asian patients and safety findings were as would be expected for elderly men with PCa undergoing androgen deprivation therapy. | - |
dc.description.statementOfResponsibility | open | - |
dc.language | English | - |
dc.publisher | Asian Pacific Prostate Society | - |
dc.relation.isPartOf | PROSTATE INTERNATIONAL | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.rights | https://creativecommons.org/licenses/by-nc-nd/2.0/kr/ | - |
dc.title | Efficacy and safety of degarelix in Korean patients with prostate cancer requiring androgen deprivation therapy: Open-label multicenter phase III study | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine | - |
dc.contributor.department | Dept. of Urology | - |
dc.contributor.googleauthor | Dalsan You | - |
dc.contributor.googleauthor | Byung Ha Chung | - |
dc.contributor.googleauthor | Sang Eun Lee | - |
dc.contributor.googleauthor | Choung-Soo Kim | - |
dc.identifier.doi | 10.1016/j.prnil.2015.02.005 | - |
dc.contributor.localId | A03607 | - |
dc.relation.journalcode | J02559 | - |
dc.identifier.eissn | 2287-903X | - |
dc.identifier.pmid | 26157762 | - |
dc.subject.keyword | Androgen deprivation therapy | - |
dc.subject.keyword | Degarelix | - |
dc.subject.keyword | Korean | - |
dc.subject.keyword | Prostate cancer | - |
dc.subject.keyword | Testosterone | - |
dc.contributor.alternativeName | Chung, Byung Ha | - |
dc.contributor.affiliatedAuthor | Chung, Byung Ha | - |
dc.citation.volume | 3 | - |
dc.citation.number | 1 | - |
dc.citation.startPage | 22 | - |
dc.citation.endPage | 26 | - |
dc.identifier.bibliographicCitation | PROSTATE INTERNATIONAL, Vol.3(1) : 22-26, 2015 | - |
dc.identifier.rimsid | 41234 | - |
dc.type.rims | ART | - |
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