Xeloda® Plus Avastin® Combination Delays Disease Progression in Women with Advanced Breast Cancer

-- Phase II XCALIBr Study Results Show Combination is Well-Tolerated--


Results of the XCALIBr (Xeloda in Combination with Avastin as First-Line Treatment for HER2-Negative Metastatic Breast Cancer) trial showed that oral Xeloda® (capecitabine) in combination with Avastin® (bevacizumab) effectively delayed time to disease progression (TTP) in metastatic breast cancer patients with no prior history of treatment. Metastatic breast cancer – or cancer that has spread from the breast to other parts of the body – has a poor prognosis, with a five-year survival rate of 20 percent.

In the Phase II study, the Xeloda/Avastin combination delayed breast cancer progression by a median of 5.7 months overall. Women with advanced ER+ (estrogen receptor positive) breast cancer demonstrated an especially significant delay in disease progression, with a median delay of 8.9 months; in fact, ten ER+ patients currently remain on treatment in the trial as their disease has not progressed to date. These data were presented today at the 43rd American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL.

“These encouraging results show that oral Xeloda in combination with Avastin appears to be an active first-line treatment option for metastatic ER+ breast cancer,” said clinical trial investigator, George Sledge, M.D., Professor of Medicine and Pathology, Indiana University Cancer Center. “There continues to be an urgent need for new strategies to improve clinical outcomes in advanced breast cancer patients. Any potential option that offers increased time to disease progression is an important development.”

Breast cancer is the most common cancer among women, other than skin cancer. It is the second leading cause of cancer death in women, after lung cancer. According to the American Cancer Society (ACS), about 178,480 women in the United States will be found to have invasive breast cancer in 2007 and about 40,460 women will die from the disease this year. Currently, there are slightly more than 2 million women living in the United States who have been treated for breast cancer. According to the ACS, breast cancer death rates are going down; the decline may be the result of early detection and treatment.

“These results highlight the promise of Xeloda as a foundational chemotherapy in combination with biotargeted agents designed to increase clinical benefit in women with advanced breast cancer,” said Lars Birgerson, MD, PhD, Vice President, Global Head Medical Affairs, Roche. “Roche is committed to supporting trials such as XCALIBr that explore the expanded use of Xeloda.”