Cancer Res Treat.  2017 Jul;49(3):569-577. 10.4143/crt.2016.289.

An Open-Label, Randomized, Parallel, Phase III Trial Evaluating the Efficacy and Safety of Polymeric Micelle-Formulated Paclitaxel Compared to Conventional Cremophor EL-Based Paclitaxel for Recurrent or Metastatic HER2-Negative Breast Cancer

• Park IH
• Sohn JH
• Kim SB
• Lee KS
• Chung JS
• Lee SH
• Kim TY
• Jung KH
• Cho EK
• Kim YS
• Song HS
• Seo JH
• Ryoo HM
• Lee SA
• Yoon SY
• Kim CS
• Kim YT
• Kim SY
• Jin MR
• Ro J

• KMID: 2388302
• DOI: http://doi.org/10.4143/crt.2016.289

Abstract

PURPOSE
Genexol-PM is a Cremophor EL-free formulation of low-molecular-weight, non-toxic, and biodegradable polymeric micelle-bound paclitaxel. We conducted a phase III study comparing the clinical efficacy and toxicity of Genexol-PM with conventional paclitaxel (Genexol).
MATERIALS AND METHODS
Patients were randomly assigned (1:1) to receive Genexol-PM 260 mg/m² or Genexol 175 mg/m² intravenously every 3 weeks. The primary outcome was the objective response rate (ORR).
RESULTS
The study enrolled 212 patients, of whom 105 were allocated to receive Genexol-PM. The mean received dose intensity of Genexol-PM was 246.8±21.3 mg/m² (95.0%), and that of Genexol was 168.3±10.6 mg/m² (96.2%). After a median follow-up of 24.5 months (range, 0.0 to 48.7 months), the ORR of Genexol-PM was 39.1% (95% confidence interval [CI], 31.2 to 46.9) and the ORR of Genexol was 24.3% (95% CI, 17.5 to 31.1) (p(non-inferiority)=0.021, p(superiority)=0.016). The two groups did not differ significantly in overall survival (28.8 months for Genexol-PM vs. 23.8 months for Genexol; p=0.52) or progression-free survival (8.0 months for Genexol-PM vs. 6.7 months for Genexol; p=0.26). In both groups, the most common toxicities were neutropenia, with 68.6% occurrence in the Genexol-PM group versus 40.2% in the Genexol group (p < 0.01). The incidences of peripheral neuropathy of greater than grade 2 did not differ significantly between study treatments.
CONCLUSION
Compared with standard paclitaxel, Genexol-PM demonstrated non-inferior and even superior clinical efficacy with a manageable safety profile in patients with metastatic breast cancer.

Keyword

Polymeric micelle paclitaxel; Cremophor EL-free; Genexol-PM; Metastatic breast cancer

MeSH Terms

Breast Neoplasms*
Breast*
Disease-Free Survival
Follow-Up Studies
Humans
Incidence
Neutropenia
Paclitaxel*
Peripheral Nervous System Diseases
Polymers*
Treatment Outcome
Paclitaxel
Polymers

Figure

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  Fig. 1. CONSORT diagram.

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  Fig. 2. Subgroup analysis of overall response rate.

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  Fig. 3. Survial analysis according to treatment. (A) Overall survival. (B) Progression-free survival.

Reference

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