1 462

Cited 470 times in

Multicenter phase II trial of Genexol-PM, a Cremophor-free, polymeric micelle formulation of paclitaxel, in patients with metastatic breast cancer

Authors
 Keun Seok Lee  ;  Hyun Cheol Chung  ;  Seock Ah Im  ;  Yeon Hee Park  ;  Chul Soo Kim  ;  Sung-Bae Kim  ;  Sun Young Rha  ;  Min Young Lee  ;  Jungsil Ro 
Citation
 BREAST CANCER RESEARCH AND TREATMENT, Vol.108(2) : 241-250, 2008 
Journal Title
BREAST CANCER RESEARCH AND TREATMENT
ISSN
 0167-6806 
Issue Date
2008
MeSH
Adult ; Aged ; Antineoplastic Agents, Phytogenic/administration & dosage ; Antineoplastic Agents, Phytogenic/adverse effects ; Antineoplastic Agents, Phytogenic/chemistry ; Antineoplastic Agents, Phytogenic/therapeutic use* ; Breast Neoplasms/drug therapy* ; Breast Neoplasms/mortality ; Breast Neoplasms/pathology ; Chemistry, Pharmaceutical ; Drug Administration Schedule ; Drug Carriers* ; Drug Compounding ; Female ; Humans ; Infusions, Intravenous ; Kaplan-Meier Estimate ; Korea ; Micelles* ; Middle Aged ; Neoplasm Metastasis ; Paclitaxel/administration & dosage ; Paclitaxel/adverse effects ; Paclitaxel/chemistry ; Paclitaxel/therapeutic use* ; Polyethylene Glycols/chemistry ; Polymers/chemistry* ; Time Factors ; Treatment Outcome
Keywords
Breast cancer ; Clinical trial ; Genexol-PM ; Phase II
Abstract
Genexol-PM is a novel Cremophor EL-free polymeric micelle formulation of paclitaxel. This single arm, multicenter phase II study was designed to evaluate the efficacy and safety of Genexol-PM in patients with histologically confirmed metastatic breast cancer (MBC). Forty-one women received Genexol-PM by intravenous infusion at 300 mg/m2 over 3 h every 3 weeks without premedication until disease progression or intolerability. A total of 331 chemotherapy cycles were administered, with a median of 8 cycles per patient (range, 1-16). Overall response rate was 58.5% (95% CI: 43.5-72.3) with 5 complete responses and 19 partial responses. Thirty-seven patients who received Genexol-PM as a first-line therapy for their metastatic disease showed a response rate of 59.5% (95% CI: 43.5-73.7), and two responses were reported in four patients treated in the second-line setting for their metastatic disease. The median time to progression (TTP) for all patients was 9.0 months (range, 1.0-17.0+ months). Grade 3 non-hematologic toxicities included sensory peripheral neuropathy (51.2%), and myalgia (2.4%). Eight patients (19.5%) experienced hypersensitivity reactions, with grade 3 in two patients. Hematologic toxicities were grade 3 and 4 neutropenia (51.2 and 17.1%, respectively), and grade 1 and 2 thrombocytopenia (22.0%). Notably, no febrile neutropenia was observed. Genexol-PM appears a promising new paclitaxel in view of significant efficacies. Further trials with different dosing schedules, durations of delivery, or in combination with other drugs are warranted.
Full Text
http://link.springer.com/article/10.1007/s10549-007-9591-y
DOI
10.1007/s10549-007-9591-y
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Rha, Sun Young(라선영) ORCID logo https://orcid.org/0000-0002-2512-4531
Chung, Hyun Cheol(정현철) ORCID logo https://orcid.org/0000-0002-0920-9471
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/106255
사서에게 알리기
  feedback

qrcode

Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.

Browse

Links