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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

Authors
 In Hae Park  ;  Joo Hyuk Sohn  ;  Sung Bae Kim  ;  Keun Seok Lee  ;  Joo Seop Chung  ;  Soo Hyeon Lee  ;  Tae You Kim  ;  Kyung Hae Jung  ;  Eun Kyung Cho  ;  Yang Soo Kim  ;  Hong Suk Song  ;  Jae Hong Seo  ;  Hun Mo Ryoo  ;  Sun Ah Lee  ;  So Young Yoon  ;  Chul Soo Kim  ;  Yong Tai Kim  ;  Si Young Kim  ;  Mi Ryung Jin  ;  Jungsil Ro 
Citation
 Cancer Research and Treatment, Vol.49(3) : 569-577, 2017 
Journal Title
 Cancer Research and Treatment 
ISSN
 1598-2998 
Issue Date
2017
MeSH
Adult ; Aged ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use* ; Biomarkers, Tumor ; Breast Neoplasms/drug therapy* ; Breast Neoplasms/metabolism ; Breast Neoplasms/mortality ; Breast Neoplasms/pathology ; Female ; Glycerol/administration & dosage ; Glycerol/adverse effects ; Glycerol/analogs & derivatives* ; Humans ; Micelles* ; Middle Aged ; Neoplasm Metastasis ; Neoplasm Staging ; Paclitaxel/administration & dosage* ; Paclitaxel/adverse effects ; Polymers* ; Proportional Hazards Models ; Receptor, ErbB-2 ; Recurrence ; Retreatment ; Risk Factors ; Treatment Outcome
Keywords
Cremophor EL-free ; Genexol-PM ; Metastatic breast cancer ; Polymeric micelle paclitaxel
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) (pnon-inferiority=0.021, psuperiority=0.016). The two groups did not differ significantly in overall survival (28.8 months for Genexol-PM vs. 23.8 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.
URI
http://ir.ymlib.yonsei.ac.kr/handle/22282913/160898
DOI
10.4143/crt.2016.289
Appears in Collections:
1. Journal Papers (연구논문) > 1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실)
Yonsei Authors
손주혁(Sohn, Joo Hyuk) ; 이수현(Lee, Soo Hyeon)
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