Healthcare Industry News: p53
News Release - September 7, 2007
Xeloda XeNA Study Analyses of Xeloda, Docetaxel and Herceptin Combination Therapy for Metastatic Breast Cancer Featured at Major New Breast Cancer SymposiumSAN FRANCISCO, Sept. 7 (HSMN NewsFeed) -- Roche announced today that three clinical data abstracts about its oral chemotherapy treatment Xeloda have been accepted for presentation at the 2007 Breast Cancer Symposium in San Francisco, Sept. 7 and 8.
Two of the abstracts include data from the XeNA (Xeloda in NeoAdjuvant) trial, a study of Xeloda and docetaxel with or without Herceptin in patients with invasive breast cancer. The third presentation highlights findings that validate efficacy and cost benefits of Xeloda in breast cancer patients.
-- 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 © plus docetaxel (D) with or without trastuzumab (T) for newly diagnosed breast cancer (BC)." (Presenter: Nancy Patten)
-- Poster No. A41, [General Poster Session D, Sept. 8, 11:45 a.m. - 12:45 p.m.], "Capecitabine is associated with fewer adverse events than other standard therapies in patients with breast cancer: a claims database analysis." (Presenter: Hope Rugo, M.D.)
These studies affirm Roche's commitment to exploring the expanded use of Xeloda in combination with new therapies. Additionally, the data explore the potential of oral Xeloda to offer effective treatment with a lower incidence of adverse events compared with traditional intravenous chemotherapy.
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.
Conventional, approved Xeloda dosing on a 14-on/7-off schedule is 1250 mg/m(2) twice daily (total of 2500 mg/m(2)/day).
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.
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 in the U.S., Roche 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 2006, Roche was named one of the Top 20 Employers (Science magazine), ranked the No. 1 Company to Sell 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 Work For in America. For additional information about the U.S. pharmaceuticals business, visit our Web sites: http://www.rocheusa.com or www.roche.us.
Source: Roche Group
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