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Novel Xeloda(R) Dosing Schedule May Offer Well-Tolerated Alternative for Treatment of Advanced Breast Cancer
Date:4/18/2008

r parts of the body, has an especially poor prognosis, with a five-year survival rate of 27 percent. Currently, there are two and a half million breast cancer survivors in the United States. According to the ACS, breast cancer death rates are going down; the decline may be the result of early detection and treatment.

About the Study

Prior to study initiation, the Norton-Simon mathematical model (Norton et al, AACR 2005) -- which explores how the growth characteristics of a cancer affect response to chemotherapy -- was applied to determine that the maximum impact of Xeloda treatment in breast cancer patients occurs after seven days. Based on this finding, the single-center, open-label phase I/II trial was designed to determine the maximum tolerated dose (MTD) of Xeloda administered orally for seven days, followed by a seven-day rest (7-on/7-off), in patients with advanced-stage breast cancer. MTD was defined as the highest dose for which the incidence of dose-limiting toxicity (DLT) is less than 33 percent. DLT was defined as grade 3/4 hematologic toxicity lasting greater than two weeks despite growth factor support, or any grade 3/4 nonhematologic toxicity.

The Phase I study dose escalation scheme was a standard "3+3" design, using flat dosing that begins at 1,500 mg twice daily and increases by 500 mg/dose level until the MTD is reached. All patients in a cohort were observed for 28 days before enrollment to the next level is permitted to monitor for delayed toxicity.

The study showed that the dose dense regimen was well-tolerated in patients with advanced breast cancer, allowing safe delivery of higher daily doses than routinely used in practice. Of the 21 patients recruited for the trial, 18 were treated with Xeloda and reached a maximum tolerated dose of 2,000 mg twice daily. There were no grade 4/5 toxicities and grade 3 toxicities (which included one dose-limiting incident of hand-foot syndrome at 2,000 mg twice daily and two at 2,0
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SOURCE Roche
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