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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)

Authors
 Shin-Wha Lee  ;  Yong-Man Kim  ;  Young Tae Kim  ;  Soon Beom Kang 
Citation
 JOURNAL OF GYNECOLOGIC ONCOLOGY, Vol.28(3) : 26, 2017 
Journal Title
 JOURNAL OF GYNECOLOGIC ONCOLOGY 
ISSN
 2005-0380 
Issue Date
2017
MeSH
Adult ; Aged ; Antineoplastic Agents, Phytogenic/administration & dosage* ; Antineoplastic Agents, Phytogenic/adverse effects ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use* ; Carboplatin/administration & dosage* ; Dose-Response Relationship, Drug ; Drug Administration Schedule ; Female ; Humans ; Micelles ; Middle Aged ; Neoplasms, Glandular and Epithelial/drug therapy* ; Ovarian Neoplasms/drug therapy* ; Paclitaxel/administration & dosage* ; Paclitaxel/adverse effects ; Polyethylene Glycols/adverse effects ; Republic of Korea
Keywords
Carboplatin ; Clinical Trial, Phase I ; Genexol-PM ; Maximum Tolerated Dose ; Ovarian Neoplasms ; Toxicity Tests
Abstract
OBJECTIVE: 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.
Files in This Item:
T201702005.pdf Download
DOI
10.3802/jgo.2017.28.e26
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Obstetrics and Gynecology (산부인과학교실) > 1. Journal Papers
Yonsei Authors
Kim, Young Tae(김영태) ORCID logo https://orcid.org/0000-0002-7347-1052
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/154226
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