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New Overall Survival Study Results Confirm Oral Xeloda(R) plus Oxaliplatin (XELOX) is Comparable to FOLFOX-4 for the First-Line Treatment of Advanced Colorectal Cancer
Date:1/13/2009

-Growing Body of Data Supports XELOX as Effective Alternative to Standard of Care-

NUTLEY, N.J., Jan. 13 /PRNewswire-FirstCall/ -- Overall survival results from a 14-month follow-up of the international, Phase III NO16966 study confirm that oral Xeloda(R) plus oxaliplatin (XELOX) is comparable to a current standard treatment, FOLFOX-4 (infused 5-FU/leucovorin plus oxaliplatin) in the first-line treatment of advanced (metastatic) colorectal cancer.

In the study, patients receiving XELOX lived for a median of 19.0 months, while patients receiving FOLFOX-4 lived for a median of 18.5 months. The consistency of these results were also further demonstrated in a subset population from the original two-arm part of the study (XELOX v. FOLFOX). These data will be presented later this week at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI) in San Francisco, Calif.

"These compelling data validate previous studies showing that XELOX is comparable to FOLFOX-4 for the treatment of advanced colorectal cancer, while providing the added flexibility of the proven oral component Xeloda," said Edward Chu, M.D., chief of medical oncology, Yale Cancer Center. "Together, these studies confirm the value and importance of combination therapy with oral Xeloda for the thousands of patients with this insidious disease."

Colorectal cancer is the third most common cancer in the United States. The American Cancer Society estimated that in 2008 more than 148,000 people in the U.S. would be diagnosed and about 50,000 people would die from the disease. (1)

Previous data reported from the NO16966 study showed that XELOX is comparable to FOLFOX-4 in terms of progression-free survival, and the addition of Avastin to chemotherapy (FOLFOX-4 and XELOX) significantly improved progression-free survival by investigator assessment compared to chemotherapy alone. Fu
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SOURCE Roche
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