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An Open-Label, Randomized, Parallel, Phase II Trial to Evaluate the Efficacy and Safety of a Cremophor-Free Polymeric Micelle Formulation of Paclitaxel as First-Line Treatment for Ovarian Cancer: A Korean Gynecologic Oncology Group Study (KGOG-3021)

 Shin-Wha Lee  ;  Yong-Man Kim  ;  Chi Heum Cho  ;  Young Tae Kim  ;  Seok Mo Kim  ;  Soo Young Hur  ;  Jae-Hoon Kim  ;  Byoung-Gie Kim  ;  Seung-Cheol Kim  ;  Hee-Sug Ryu  ;  Soon Beom Kang 
 CANCER RESEARCH AND TREATMENT, Vol.50(1) : 195-203, 2018 
Journal Title
Issue Date
Carboplatin ; Genexol ; Genexol-PM ; Ovarian neoplasms ; Phase II trial
PURPOSE: Genexol-PM is a biodegradable cremophor EL-free polymeric micelle formulation of paclitaxel. Here,we compared efficacy and safety of Genexol-PM plus carboplatin versus Genexol plus carboplatin for ovarian cancer treatment. MATERIALS AND METHODS: In this multicenter, randomized, phase II study, patients with International Federation of Gynecology and Obstetrics IC-IV epithelial ovarian cancer were randomly assigned (1:1) to receive Genexol-PM 260 mg/m(2) or Genexol 175 mg/m(2) with 5 area under the curve carboplatin every 3weeks (6 cycles). The primary endpointwas the carbohydrate antigen 125 and Response Evaluation Criteria In Solid Tumor composite overall response rate (ORR). RESULTS: Of 131 enrolled patients, 98 were included in intention-to-treat analysis. Mean dosages were 260.00+/-0.00 mg/m(2) Genexol-PM or 174.24+/-3.81 mg/m(2) Genexol. Median followup was 18.0 months (range, 6.1 to 33.8 months). ORR was 88.0% (95% confidence interval [CI], 80.4 to 95.6) with Genexol-PM, and 77.1% (95% CI, 67.1 to 87.1) with Genexol (noninferiority threshold, 16.3%). Median time to progression was 14.8 months (95% CI, 11.3 to 20.2) with Genexol-PM and 15.4 months (95% CI, 13.2 to 29.6) with Genexol (p=0.550). Overall, six patients died. Neutropenia was the most common toxicity (incidences of 86.0% vs. 77.1%, p=0.120). Peripheral neuropathy incidences were 84.0% versus 64.6% (p= 0.148). Peripheral neuropathy of >/= grade 3 occurred in one patient receiving Genexol. All toxicities were manageable. CONCLUSION: Genexol-PM plus carboplatin as first-line treatment in patients with epithelial ovarian cancer demonstrated non-inferior efficacy and well-tolerated toxicities compared with the standard paclitaxel regimen. Further studies are warranted to optimize the dose and schedule, and to investigate long-term outcomes.
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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
Kim, Jae Hoon(김재훈) ORCID logo https://orcid.org/0000-0001-6599-7065
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