Cancer Res Treat.  2018 Jan;50(1):195-203. 10.4143/crt.2016.376.

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)

• Lee SW
• Kim YM
• Cho CH
• Kim YT
• Kim SM
• Hur SY
• Kim JH
• Kim BG
• Kim SC
• Ryu HS
• Kang SB

• KMID: 2403489
• DOI: http://doi.org/10.4143/crt.2016.376

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/m2 or Genexol 175 mg/m2 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/m2 Genexol-PM or 174.24±3.81 mg/m2 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.

Keyword

Genexol-PM; Genexol; Carboplatin; Phase II trial; Ovarian neoplasms

MeSH Terms

Appointments and Schedules
Carboplatin
Follow-Up Studies
Gynecology
Humans
Incidence
Neutropenia
Obstetrics
Ovarian Neoplasms*
Paclitaxel*
Peripheral Nervous System Diseases
Polymers*
Carboplatin
Paclitaxel
Polymers

Figure

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  Fig. 1. Analyzed patient populations. ITT, intention-to-treat; PP, per-protocol.

• 

  Fig. 2. Time to progression (A) and overall survival (OS) (B) in intention-to-treat analysis.

Reference

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