New Overall Survival Study Results Confirm Oral Xeloda(R) plus Oxaliplatin (XELOX) is Comparable to FOLFOX-4 for the First-Line Treatment of Advanced Colorec...(rthermore results from a separate intern...),Health

"We're excited to see the continued promise of Xeloda as a cornerstone of combination cancer treatments," said Lars Birgerson, M.D., Ph.D., Vice President, Global Head, Medical Affairs, Roche. "With these overall survival data in advanced colorectal cancer, we have strong evidence that XELOX may offer an important new option for a difficult-to-treat patient population."

The ASCO GI meeting also will feature five additional Roche U.S. Xeloda abstracts, including a second XELOX abstract. All other Xeloda abstracts are ex-U.S. or non-Roche sponsored studies.

About the Study

Study NO16966 is a large, randomized, international, Phase III trial of 2,034 advanced colorectal cancer patients that initially compared first-line XELOX (Xeloda + oxaliplatin) versus

FOLFOX-4 (intravenous bolus and infusional 5-fluorouracil + oxaliplatin). After release of Avastin data in colorectal cancer in 2003, the protocol was amended to investigate, using a two by factorial design, XELOX + placebo versus XELOX + Avastin (7.5 mg/kg q3w) versus FOLFOX-4 + placebo versus FOLFOX-4 + Avastin (5.0 mg/kg q2w). The two-arm study recruited 634 patients; after transition to the two by factorial design, an additional 1,400 patients were recruited.

The primary protocol objectives were to answer: 1) whether the XELOX regimen was comparable to FOLFOX-4 in terms of clinical efficacy and 2) whether the addition of Avastin to chemotherapy improved results compared to chemotherapy alone. The secondary endpoints included overall survival, overall response rates, time to, and duration of, response and safety profile.

Both study arms had acceptable and similar safety p
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