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
Year: 2016
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
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 MethodsPatients were randomly assigned (1:1) to receive Genexol-PM 260 mg/m 2 or Genexol 175 mg/m 2 intravenously every 3 weeks.The primary outcome was the objective response rate (ORR). ResultsThe study enrolled 212 patients, of whom 105 were allocated to receive Genexol-PM.The mean received dose intensity of Genexol-PM was 246.8±21.3mg/m 2 (95.0%), and that of Genexol was 168.3±10.6 mg/m 2 (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) (pnon-inferiority=0.021, psuperiority=0.016).The two groups did not differ significantly in overall survival (28.8 months for Genexol-PM vs. 23.8months 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. ConclusionCompared with standard paclitaxel, Genexol-PM demonstrated non-inferior and even superior clinical efficacy with a manageable safety profile in patients with metastatic breast cancer.
Source: Cancer Research and Treatment
DOI: 10.4143/crt.2016.289
Institutions: National Cancer Center, Yonsei University, Severance Hospital, Yonsei University Health System, Asan Medical Center, University of Ulsan, Kyung Hee University Medical Center, Pusan National University Hospital, Daegu Fatima Hospital, Seoul National University Hospital, Gachon University Gil Medical Center, Kosin University Gospel Hospital, National Health Insurance Service Ilsan Hospital, Keimyung University Dongsan Medical Center, Keimyung University Dongsan Hospital, Korea University Guro Hospital, Daegu Catholic University Medical Center, Konkuk University Medical Center, Inha University, Inha University Hospital
Language: English
Subfield: Oncology
Field: Medicine
Domain: Health Sciences
Open Access status: diamond
OpenAlex ID: W2519399564