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...(rofiles with no unexpected toxicities. T...),Health

Date:1/13/2009

rofiles, with no unexpected toxicities. There was a lower incidence of grade 3/4 adverse events (AEs) and hematologic AEs in the pooled XELOX group compared to the FOLFOX-4 group. Grade 3/4 gastrointestinal disorders and hand-foot syndrome were more common with XELOX compared to FOLFOX-4.

Results regarding overall survival in addition to progression-free survival were previously presented at ASCO GI in 2007. These 14-month follow-up data result from the overall survival analysis and include all patients involved in the trial (pooled XELOX-containing arms vs. pooled FOLFOX-4-containing arms).

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.
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