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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)

Title
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)
Authors
Lee, Shin-WhaKim, Yong-ManCho, Chi HeumKim, Young TaeKim, Seok MoHur, Soo YoungKim, Jae-HoonKim, Byoung-GieKim, Seung-CheolRyu, Hee-SugKang, Soon Beom
Ewha Authors
김승철
SCOPUS Author ID
김승철scopus
Issue Date
2018
Journal Title
CANCER RESEARCH AND TREATMENT
ISSN
1598-2998JCR Link2005-9256JCR Link
Citation
vol. 50, no. 1, pp. 195 - 203
Keywords
Genexol-PMGenexolCarboplatinPhase II trialOvarian neoplasms
Publisher
KOREAN CANCER ASSOCIATION
Indexed
SCIE; SCOPUS; KCI WOS
Abstract
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/m2 with 5 area under the curve carboplatin every 3 weeks (6 cycles). The primary endpoint was 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 follow-up 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 (non-inferiority 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.
DOI
10.4143/crt.2016.376
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의과대학 > 의학과 > Journal papers
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