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Two of the abstracts include data from the XeNA (Xeloda in NeoAdjuvant)trial, a study of Xeloda and docetaxel with or without Herceptin in patientswith invasive breast cancer. The third presentation highlights findings thatvalidate efficacy and cost benefits of Xeloda in breast cancer patients.
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These studies affirm Roche's commitment to exploring the expanded use ofXeloda in combination with new therapies.
About Xeloda
Xeloda is the only FDA-approved oral chemotherapy for both metastaticbreast cancer and adjuvant and metastatic colorectal cancer. Inactive in pillform, Xeloda is enzymatically activated within the body; when it comes intocontact with a naturally occurring protein called thymidine phosphorylase, orTP, Xeloda is transformed into 5-FU, a cytotoxic (cell-killing) drug. Becausemany cancers have higher levels of TP than does normal tissue, more 5-FU isdelivered to the tumor than to other tissue.
Conventional, approved Xeloda dosing on a 14-on/7-off schedule is 1250mg/m(2) twice daily (total of 2500 mg/m(2)/day).
A clinically important drug interaction between Xeloda and warfarin hasbeen demonstrated; altered coagulation parameters and/or bleeding and deathhave been reported. Clinically significant increases in prothrombin time (PT)and INR have been observed within days to months after starting Xeloda, andinfrequently within one month of stopping Xeloda. For patients receiving bothdrugs concomitantly, frequent monitoring of INR or PT is recommended. Agegreater than 60 and a diagnosis of cancer independently predispose patients toan increased risk of coagulopathy.
Xeloda is contraindicated in patients who have a known hypersensitivity to5-fluorouracil, and in patients with known dihydropyrimidine dehydrogenase(DPD) deficiency. Xeloda is contraindicated in patients with severe renalimpairment. For patients with moderate renal impairment, dose reduction isrequired.
The most common adverse events (greater than or equal to 20%) of Xelodamonotherapy were diarrhea, nausea, stomatitis and hand-foot syndrome. As withany cancer therapy, there is a risk of side effects, and these are usuallymanageable 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 leadingresearch-oriented healthcare groups with core businesses in pharmaceuticalsand diagnostics. For more than 100 years in the U.S., Roche has beencommitted to developing innovative products and services that addressprevention, diagnosis and treatment of diseases, thus enhancing people'shealth and quality of life. An employer of choice, in 2006, Roche was namedone of the Top 20 Employers (Science magazine), ranked the No. 1 Company toSell For (Selling Power), and one of AARP's Top Companies for Older Workers,and in 2005, Roche was named one of Fortune magazine's Best Companies to WorkFor in America. For additional information about the U.S. pharmaceuticalsbusiness, visit our Web sites: http://www.rocheusa.com or http://www.roche.us.-- Poster No. A54, [General Poster Session A, Sept. 7, 12:00 - 12:45 p.m.], "Frequency of circulating tumor cells (CTCs) in an open-label study of neoadjuvant capecitabine, docetaxel and trastuzumab (CDT) combination therapy in patients with HER2+ breast cancer (BC)." (Presenter: Stefan Gluck) -- Poster No. 100, [General Poster Session C, Sept. 8, 7:00 - 8:00 a.m.], "Distribution of p53 mutations by AmpliChip assay in patients receiving neoadjuvant capecitabine (C) plus docetaxel (D) with
