Phase II study evaluating the efficacy and safety of sagopilone (ZK-EPO) in patients with metastatic breast cancer that has progressed following chemotherapy.

Abstract

Sagopilone is a novel, fully synthetic epothilone that has shown promising preclinical activity in a range of tumor models, including platinum-resistant ovarian cancer and metastatic breast cancer (MBC). This open-label, multicenter, Phase II study investigated the efficacy, safety, and tolerability of sagopilone administered to patients with MBC. Women with MBC whose previous chemotherapy regimen included a taxane and an anthracycline received sagopilone 16 or 22 mg/m(2) as a 3-h intravenous infusion every 21 days. Efficacy (using modified Response Evaluation Criteria in Solid Tumors), safety, and tolerability were assessed in this population. A total of 65 patients received sagopilone at either 16 mg/m(2) (N = 39) or 22 mg/m(2) (N = 26). Patients received a median of two cycles of sagopilone. Among the 65 patients who were evaluable for efficacy, there were three confirmed tumor responses over both treatment arms; however, the primary target of the study was not reached. The main treatment-related adverse events were sensory neuropathy (81.5%) and fatigue (44.6%). There were no deaths related to the study drug. Sagopilone was moderately tolerated in both treatment arms and showed limited activity in heavily pre-treated patients with MBC.

• Authors: Phuong K Morrow, Stephen Divers, Louise Provencher, Shiuh-Wen Luoh, Teresa M Petrella, Marius Giurescu, Thomas Schmelter, Yao Wang, Gabriel N Hortobagyi, Linda T Vahdat
• Journal: Breast cancer research and treatment (Breast Cancer Res Treat) Vol. 123 Issue 3 Pg. 837-42 (Oct 2010) ISSN: 1573-7217 [Electronic] Netherlands
• PMID: 20697802 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Antineoplastic Agents
• Benzothiazoles
• Epothilones
• sagopilone

Topics

• Adult
• Aged
• Antineoplastic Agents (administration & dosage, adverse effects, therapeutic use)
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Benzothiazoles (administration & dosage, adverse effects, therapeutic use)
• Breast Neoplasms (drug therapy, secondary)
• Canada
• Disease Progression
• Disease-Free Survival
• Drug Administration Schedule
• Epothilones (administration & dosage, adverse effects, therapeutic use)
• Fatigue (chemically induced)
• Female
• Germany
• Humans
• Infusions, Parenteral
• Kaplan-Meier Estimate
• Middle Aged
• Nervous System Diseases (chemically induced)
• Prospective Studies
• Time Factors
• Treatment Failure
• United States