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Positive Xeloda(R) Five-Year Overall Survival Study Data in the Adjuvant Treatment of Colon Cancer Presented at Leading European Cancer Meeting
Date:9/25/2007

e to 5-FU/LV," said Lars Birgerson, Vice President, Medical Affairs, Roche. "Roche is committed to providing colon cancer patients with the safest and most effective treatment options that allow patients to continue their active lifestyles."

Colorectal cancer is the third most common cancer in the United States. The American Cancer Society estimates that in 2007 more than 153,500 people in the U.S. will be diagnosed and about 52,000 people will die from the disease, accounting for almost 10 percent of all cancer deaths. When colorectal cancer is detected at an early, localized stage, the five-year survival is 90 percent; however, only 39 percent of colorectal cancers are diagnosed at this stage, mostly due to low rates of screening.

About the X-ACT Trial

The international, Phase III X-ACT trial enrolled 1,987 patients (1,004 patients were randomly assigned to Xeloda; 983 patients were assigned to intravenous 5-FU/LV) who were treated for a period of 24 weeks between 1998 and 2001 at 164 centers worldwide. The primary study objective was to show equivalence in disease-free survival between Xeloda and intravenous 5-FU/LV. Secondary objectives included: relapse-free survival, overall survival and safety.

Xeloda three-year disease-free survival and relapse-free survival rates demonstrated non-inferiority to 5-FU/LV (intent-to-treat analysis, P < 0.0001; P=0.0407, respectively). Xeloda was associated with fewer adverse events than 5-FU/LV (P < 0.001).

With a median follow-up of 7 years, updated study results presented at ECCO show five-year overall survival rates for Xeloda at 71.4 percent compared to 68.4 percent in the 5-FU/LV arm.

About Xeloda

Xeloda is the only FDA-approved oral chemotherapy for both metastatic breast cancer and adjuvant and metastatic colorectal cancer. Inactive in pill form, Xeloda is enzymatically activated within the body; when it comes into contact with a naturally occurring protein called thymidine phos
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SOURCE Roche
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