Evaluation of the pharmacokinetics of ixabepilone for the treatment of breast cancer.

INTRODUCTION: Chemotherapeutic agents, such as anthracyclines, taxanes and fluoropyrimidines, have significantly improved the outcome of breast cancer patients. However, mechanisms of resistance limit the effectiveness of these drugs. The microtubule-stabilizing agent ixabepilone has been approved for treatment of metastatic breast cancer (MBC) patients resistant or refractory to taxanes, anthracycline and capecitabine. AREAS COVERED: In this review, we summarized data on pharmacodynamics, pharmacokinetics, preclinical and clinical studies of ixabepilone in breast cancer. This article was compiled through searches on ixabepilone up to March 2015 in the PubMed and the clinicaltrials.gov databases; the FDA and European Medicine Agency (EMA) websites; and the ASCO and AACR proceedings. EXPERT OPINION: Ixabepilone is a well-tolerated and effective drug in MBC at the approved dose. The most important challenges that ongoing clinical trials are still addressing are: the optimal dosing schedule that might improve the risk/benefit ratio, the clinical efficacy of ixabepilone in early breast cancer, the efficacy in triple-negative breast cancer (TNBC) patients and the identification of biomarkers predictive of response.