Press Release: Xeloda Combination Meets Primary Endpoint in Phase III Study
Xeloda Combination Meets Primary Endpoint in International Phase III Advanced Colorectal Cancer Study - XELOX (Xeloda plus oxaliplatin) Delays Disease Progression in Patients with Recurring Cancer - NUTLEY, N.J., Dec. 11 -- Roche announced today that a large, international Phase III study (NO16967) of 627 previously treated patients with advanced colorectal cancer met its primary endpoint of progression-free survival. Study results showed that the chemotherapy combination XELOX (oral Xeloda plus oxaliplatin) is as effective in delaying disease progression as the chemotherapy combination FOLFOX-4 (infused 5-FU/leucovorin plus oxaliplatin). "Our data complement the findings of the NO16966 study, suggesting that XELOX is a very reasonable treatment option for patients with recurrent colorectal cancer," said Mace Rothenberg, MD, lead investigator and Professor of Medicine at Vanderbilt University Medical Center and Ingram Professor of Cancer Research at Vanderbilt-Ingram Cancer Center. "By demonstrating that Xeloda in combination with oxaliplatin was as effective as FOLFOX-4, these two studies provide the strongest evidence yet that Xeloda may be used in place of IV 5-FU in the treatment of patients with advanced colorectal cancer." Colorectal cancer is the third most common cancer in the United States. The American Cancer Society estimates that in 2006, more than 148,000 people in the U.S. will be diagnosed and about 55,000 people will die from the disease. "Roche is committed to advancing treatment for patients with colorectal cancer," said Lars E. Birgerson, Vice President, Medical Affairs, Roche. "Based on the data from the NO16966 and NO16967 studies, we are pleased to report that our filings with worldwide regulatory authorities will continue as planned." Results from the NO16967 study will be submitted for presentation at future major medical meetings. About the Study The NO16967 trial is a large, international phase III trial that randomized 627 patients who had previously received chemotherapy and whose disease had returned or continued to progress. The trial compared XELOX (oral Xeloda plus oxaliplatin) vs. FOLFOX-4 (intravenous bolus and infusional 5-fluorouracil/leucovorin plus oxaliplatin) as first line colorectal cancer treatment. The primary objective was to determine whether the XELOX regimen was as effective as FOLFOX-4 in terms of progression-free survival (a measure of time to disease progression or death). The secondary outcomes included overall survival, overall response rates and safety profile. There were no unexpected safety findings in the study. About XELOX XELOX is an abbreviation for a type of combination chemotherapy used to treat colorectal cancer; it contains Xeloda (capecitabine) plus oxaliplatin. About XELODA (capecitabine) 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 phosphorylase, or TP, Xeloda is transformed into 5-FU, a cytotoxic (cell-killing) drug. Because many cancers have higher levels of TP than does normal tissue, more 5-FU is delivered to the tumor than to other tissue. A clinically important drug interaction between Xeloda and warfarin has been demonstrated; altered coagulation parameters and/or bleeding and death have been reported. Clinically significant increases in prothrombin time (PT) and INR have been observed within days to months after starting Xeloda, and infrequently within one month of stopping Xeloda. For patients receiving both drugs concomitantly, frequent monitoring of INR or PT is recommended. Age greater than 60 and a diagnosis of cancer independently predispose patients to an increased risk of coagulopathy. Xeloda is contraindicated in patients who have a known hypersensitivity to 5-fluorouracil, and in patients with known dihydropyrimidine dehydrogenase (DPD) deficiency. Xeloda is contraindicated in patients with severe renal impairment. For patients with moderate renal impairment, dose reduction is required. The most common adverse events (greater than or equal to 20%) of Xeloda monotherapy were diarrhea, nausea, stomatitis and hand-foot syndrome. As with any cancer therapy, there is a risk of side effects, and these are usually manageable and reversible with dose modification or interruption. About Roche Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S. pharmaceuticals headquarters of the Roche Group, one of the world's leading research-oriented healthcare groups with core businesses in pharmaceuticals and diagnostics. For more than 100 years, the Roche Group has been committed to developing innovative products and services that address prevention, diagnosis and treatment of diseases, thus enhancing people's health and quality of life. An employer of choice, in 2005, Roche was named one of Fortune magazine's Best Companies to Work For in America, one of the Top 20 Employers (Science magazine), ranked as the No. 3 Best Company to Work For in NJ (NJ Biz magazine), the No. 1 Company to Sell For (Selling Power), and one of AARP's Top Companies for Older Workers. For additional information about the U.S. pharmaceuticals business, visit our websites: http://www.rocheusa.com or http://www.roche.us.