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Novel Xeloda® Dosing Schedule May Offer Well-Tolerated Alternative for Treatment of Advanced Breast Cancer


--Investigational Study Results Published in Journal of Clinical Oncology Pave Way for Phase II Efficacy Trial--

A novel biweekly dosing schedule of Xeloda® (capecitabine) enabled safe delivery of higher daily doses in the treatment of advanced breast cancer, according to an investigational study published in the April 10, 2008 issue of the Journal of Clinical Oncology. The data showed that a seven-days-on/seven-days-off (7-on/7-off) regimen, called “dose dense”, was generally well-tolerated up to 2,000 mg twice daily (4,000 mg/day), providing a potential alternative to the standard Xeloda dosing of 14 days on and seven days off (14-on/7-off).

“As we predicted using the Norton-Simon mathematical model – the basis for the dose dense approach to therapy that was pioneered at MSKCC – these results demonstrate that a biweekly regimen of capecitabine appears to be well-tolerated, at dosing levels that are higher than previously thought possible,” said Tiffany A. Traina, M.D., a medical oncologist in the Breast Cancer Medicine Service at Memorial Sloan-Kettering Cancer Center (MSKCC) in New York and lead author of the study. “We’re currently conducting later-phase trials to determine the efficacy of this 7-on/7-off dosing schedule.”

Efficacy of the 7-on/7-off schedule using Xeloda is being determined in a Phase II clinical trial program in patients with advanced breast cancer and is also being tested in combination with Avastin® (bevacizumab).

Breast cancer is the most common cancer among women, other than skin cancer. According to the American Cancer Society (ACS), about 182,460 women in the United States will be found to have invasive breast cancer in 2008. Breast cancer is the second leading cause of cancer death in women, after lung cancer – about 40,930 women will die from the disease this year. Metastatic breast cancer, or cancer that has spread from the breast to other 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.


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