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

  • 1Center for Breast Cancer, National Cancer Center, Goyang, Korea.
  • 2Department of Oncology, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
  • 3Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
  • 4Division of Hematology-Oncology, Pusan National University Hospital, Busan, Korea.
  • 5Medical Oncology Center, Seoul National University Hospital, Seoul, Korea.
  • 6Division of Hematology-Oncology, Gachon University Gil Medical Center, Incheon, Korea.
  • 7Division of Hematology-Oncology, Kosin University Gospel Hospital, Busan, Korea.
  • 8Division of HematologyOncology, Keimyung University Dongsan Medical Center, Daegu, Korea.
  • 9Department of Hematology-Oncology, Korea University Guro Hospital, Seoul, Korea.
  • 10Division of HematologyOncology, Daegu Catholic University Medical Center, Daegu, Korea.
  • 11Division of Hematology-Oncology, Daegu Fatima Hospital, Daegu, Korea.
  • 12Konkuk University Medical Center, Konkuk University School of Medicine, Seoul, Korea.
  • 13Division of Hematology-Oncology, Inha University Hospital, Incheon, Korea.
  • 14Division of Hematology-Oncology, National Health Insurance Service Ilsan Hospital, Goyang, Korea.
  • 15Division of Hematology-Oncology, Kyung Hee University Medical Center, Seoul, Korea.
  • 16Samyang Biopharmaceuticals Corporation, Seoul, Korea.


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).
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).
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.
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.


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