- U.S. Data Highlights Oral Xeloda versus Standard Infusional Chemotherapy
in Gastroesophageal and Colorectal Cancers -
NUTLEY, N.J., Jan. 24 /PRNewswire/ -- Roche announced today that a total of 33 abstracts involving its oral chemotherapy Xeloda(R) have been accepted for presentation at the 2008 Gastrointestinal Cancers Symposium in Orlando, Fla., from Jan. 25 to 27.
Five poster presentations based on U.S. data offer additional knowledge
about Xeloda. Two of these U.S. abstracts compare the safety profile and
usage patterns of therapy with oral Xeloda to that of intravenous
fluorouracil (5-FU) therapy in gastroesophageal cancer. A second pair of
U.S. abstracts evaluates the usage patterns and cost of Xeloda-based
regimens against those of 5-FU-based regimens in colon and rectal cancer.
The fifth U.S. abstract highlights preclinical efficacy and tolerability
results of a novel Xeloda regimen (7/7, or 7 days on, 7 days off) using
higher daily doses for the treatment of colorectal cancer.
-- Jan. 25, noon to 1 p.m., [Poster No. 72], A claims database analysis of
capecitabine treatment patterns in patients with gastroesophageal
cancer (GEC) (Presenter: Wasif Saif)
-- Jan. 25, noon to 1 p.m., [Poster No. 71], Capecitabine in patients with
gastroesophageal cancer (GEC): A claims database analysis of adverse
events (AEs) (Presenter: Wasif Saif)
-- Jan. 26, 5:30 to 6:30 p.m., [Poster No. 364], A claims database cost-
comparison analysis of capecitabine in the treatment of patients with
colon or rectal cancer (CRC) (Presenter: Edward Chu)
-- Jan. 27, 7 to 8 a.m., [Poster No. 465], Capecitabine use in patients
with colon and rectal cancer (CRC): A claims database analysis of
treatment (Presenter: Edward Chu)
-- Jan. 27, 7 to 8 a.m., [Poster No. A29], In vivo activity of traditional
vs. novel regimens of capecitabine (C) alone and in combination in a
colorectal cancer xenograft model (Presenter: Kenneth Kolinsky)
Collectively, the findings of these studies highlight the efficacy and safety of oral Xeloda as a potential alternative to 5-FU in gastroesophageal and colorectal cancers and support further clinical testing to examine the efficacy and safety benefits of the 7/7 Xeloda dosing regimen. Global data presentations, including a meta-analysis that compares the overall survival benefit between Xeloda and 5-FU in adjuvant and metastatic settings, provide similar insights.
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.
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 2007 Roche was named Top Company of the Year by Med Ad News, one of the Top 20 Employers (Science) and ranked the No. 1 Company to Sell For (Selling Power). In previous years, Roche has been named as a Top Company for Older Workers (AARP) and one of the Best Companies to Work For in America (Fortune). For additional information about the U.S. pharmaceuticals business, visit our websites: http://www.rocheusa.com or http://www.roche.us.
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