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An open-label, multicenter, phase I trial of a cremophor-free, polymeric micelle formulation of paclitaxel combined with carboplatin as a first-line treatment for advanced ovarian cancer: a Korean Gynecologic Oncology Group study (KGOG-3016)

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dc.contributor.author김영태-
dc.date.accessioned2017-11-02T08:13:46Z-
dc.date.available2017-11-02T08:13:46Z-
dc.date.issued2017-
dc.identifier.issn2005-0380-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/154226-
dc.description.abstractOBJECTIVE: This phase I study aimed to determine the maximum tolerated dose (MTD) of Genexol-PM, when combined with carboplatin, as a first-line treatment in patients with advanced ovarian cancer. METHODS: This open-label, multicenter, phase I, dose-escalation study included 18 patients (median age: 59.0 years, range: 40-75 years) diagnosed with advanced epithelial ovarian cancer. All patients had measurable residual disease after debulking surgery. Patients were assigned to groups (n=6 each group) that received different doses of Genexol-PM (220, 260, and 300 mg/m², once every 3 weeks) and 5 area under the curve (AUC) carboplatin. Safety and efficacy were analyzed for each dose group. RESULTS: In this intention-to-treat population, 3 out of 18 patients dropped out of the study: 1 due to dose-limiting toxicity (DLT), 1 due to hypersensitivity, and 1 was lost during follow-up. DLTs were not reported at 220 mg/m² or 260 mg/m², but at 300 mg/m², 1 patient experienced DLT (grade 3 general pain). The MTD of Genexol-PM was not determined, but a dose of 300 mg/m² or less could be recommended for the phase II study. Most patients (73.9%) with adverse events recovered without sequelae, and no death occurred that was related to the disease or treatment. The best overall response rate was 94.1%. CONCLUSION: Genexol-PM combined with carboplatin was well tolerated as a first-line treatment, and good responses were observed in patients with advanced ovarian cancer. Based on these results, we recommended a dose of 300 mg/m² or less for a phase II study.-
dc.description.statementOfResponsibilityopen-
dc.formatapplication/pdf-
dc.languageEnglish-
dc.publisherAsian Society of Gynecologic Oncology : Taehan Puin Chongyang Hakhoe-
dc.relation.isPartOfJOURNAL OF GYNECOLOGIC ONCOLOGY-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.rights.urihttps://creativecommons.org/licenses/by-nc-nd/2.0/kr/-
dc.subject.MESHAdult-
dc.subject.MESHAged-
dc.subject.MESHAntineoplastic Agents, Phytogenic/administration & dosage*-
dc.subject.MESHAntineoplastic Agents, Phytogenic/adverse effects-
dc.subject.MESHAntineoplastic Combined Chemotherapy Protocols/therapeutic use*-
dc.subject.MESHCarboplatin/administration & dosage*-
dc.subject.MESHDose-Response Relationship, Drug-
dc.subject.MESHDrug Administration Schedule-
dc.subject.MESHFemale-
dc.subject.MESHHumans-
dc.subject.MESHMicelles-
dc.subject.MESHMiddle Aged-
dc.subject.MESHNeoplasms, Glandular and Epithelial/drug therapy*-
dc.subject.MESHOvarian Neoplasms/drug therapy*-
dc.subject.MESHPaclitaxel/administration & dosage*-
dc.subject.MESHPaclitaxel/adverse effects-
dc.subject.MESHPolyethylene Glycols/adverse effects-
dc.subject.MESHRepublic of Korea-
dc.titleAn open-label, multicenter, phase I trial of a cremophor-free, polymeric micelle formulation of paclitaxel combined with carboplatin as a first-line treatment for advanced ovarian cancer: a Korean Gynecologic Oncology Group study (KGOG-3016)-
dc.typeArticle-
dc.publisher.locationKorea (South)-
dc.contributor.collegeCollege of Medicine-
dc.contributor.departmentDept. of Obstetrics & Gynecology-
dc.contributor.googleauthorShin-Wha Lee-
dc.contributor.googleauthorYong-Man Kim-
dc.contributor.googleauthorYoung Tae Kim-
dc.contributor.googleauthorSoon Beom Kang-
dc.identifier.doi10.3802/jgo.2017.28.e26-
dc.contributor.localIdA00729-
dc.relation.journalcodeJ01428-
dc.identifier.eissn2005-0399-
dc.relation.journalsince2011~-
dc.identifier.pmid28028994-
dc.relation.journalbefore~2010 Korean Journal of Gynecologic Oncology (부인종양)-
dc.subject.keywordCarboplatin-
dc.subject.keywordClinical Trial, Phase I-
dc.subject.keywordGenexol-PM-
dc.subject.keywordMaximum Tolerated Dose-
dc.subject.keywordOvarian Neoplasms-
dc.subject.keywordToxicity Tests-
dc.contributor.alternativeNameKim, Young Tae-
dc.contributor.affiliatedAuthorKim, Young Tae-
dc.citation.titleJournal of Gynecologic Oncology-
dc.citation.volume28-
dc.citation.number3-
dc.citation.startPage26-
dc.identifier.bibliographicCitationJOURNAL OF GYNECOLOGIC ONCOLOGY, Vol.28(3) : 26, 2017-
dc.date.modified2017-11-01-
dc.identifier.rimsid42195-
dc.type.rimsART-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Obstetrics and Gynecology (산부인과학교실) > 1. Journal Papers

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