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

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.

• 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
• Journal: Breast cancer research and treatment (Breast Cancer Res Treat) Vol. 108 Issue 2 Pg. 241-50 (Mar 2008) ISSN: 0167-6806 [Print] Netherlands
• PMID: 17476588 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Antineoplastic Agents, Phytogenic
• Drug Carriers
• Micelles
• Polymers
• cremophor
• Polyethylene Glycols
• Paclitaxel

Topics

• Adult
• Aged
• Antineoplastic Agents, Phytogenic (administration & dosage, adverse effects, chemistry, therapeutic use)
• Breast Neoplasms (drug therapy, mortality, 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, adverse effects, chemistry, therapeutic use)
• Polyethylene Glycols (chemistry)
• Polymers (chemistry)
• Time Factors
• Treatment Outcome