ASCOA biweekly dosing regimen of capecitabine (Xeloda) was well tolerated in a dose-escalation study of metastatic breast cancer patients, allowing safe delivery of higher daily doses than routinely used in practice, Maria Theodoulou, MD, Memorial Sloan-Kettering Cancer Center, reported at the ASCO 2007 meeting (abstract 1045). Capecitabine is typically delivered on a 14-days-on/7-days-off schedule at 1,250 mg/m2 twice daily (total of 2,500 mg/m2/d). In the current study, the agent was given on a 7-days-on/7-days-off schedule with a maximum tolerated dose of 2,000 mg/m2 twice daily (total of 4,000 mg/m2/d).
The design of the single-center, open-label, phase I/II study was based on Norton-Simon mathematical modeling that predicted the optimal dosing schedule for capecitabine. There were no grade 4-5 toxicities, and grade 3 toxicities were transient and manageable. "This new dosing regimen for capecitabine will serve as a platform for combination treatment with targeted therapies," said lead author Clifford Hudis, MD, chief of the Breast Cancer Medicine Service.