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NUTLEY, N.J. (Map) -
A U.S. abstract to be published in The 2008 ASCO Proceedings I, compares
the preclinical efficacy of an investigational, seven-days-on/seven-days-off
(7-on/7-off) Xeloda regimen versus the current standard Xeloda dosing of
fourteen-days-on/seven-days-off (14-on/7-off) in colorectal cancer. Findings
from this study appeared to indicate improved tumor growth inhibition with the
7-on/7-off Xeloda regimen; results support clinical testing of this regimen in
colorectal cancer patients. [See 2008 ASCO Proceedings I - An alternative
preclinical regimen of capecitabine ( C ) enhances single agent & combination
activity in a colorectal cancer xenograft model. (Lead Author:
Among ex-U.S. Xeloda abstracts being presented, 16 breast cancer and 15 colorectal cancer abstracts highlight Xeloda as the cornerstone of combination treatment. The remaining Xeloda abstracts are also ex-U.S. or sponsored by non-Roche entities.
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
All trademarks used or mentioned in this release are protected by law. Contacts: Ginny Valenze Roche Office: 973-562-2783 Cell: 973-943-9219 Virginia.Valenze@roche.com Daphne Hoytt Manning Selvage & Lee Office: 212-468-3558 Cell: 917-406-2779 Daphne.Hoytt@mslpr.com
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