NUTLEY, N.J., Dec. 9 /PRNewswire/ -- Roche announced today that a total of 20 U.S. and global abstracts involving its oral chemotherapy Xeloda(R) (capecitabine) have been accepted for presentation at the 2008 San Antonio Breast Cancer Symposium (SABCS) in San Antonio December 12-14, including a late-breaking study in early breast cancer to be presented on Sunday, December 14, by the Finnish Breast Cancer Group.
Two U.S. abstracts to be presented at the meeting compare the impact of chemotherapy-related costs on direct medical expenditures among patients with metastatic breast cancer who were treated with oral Xeloda monotherapy compared with vinorelbine monotherapy in one study or gemcitabine monotherapy in the other. The data showed that metastatic breast cancer patients treated with Xeloda monotherapy had statistically significant lower total health care costs than patients treated with vinorelbine monotherapy or gemcitabine monotherapy.
The third U.S. abstract demonstrated the accuracy of using p53 gene mutations to predict short-term clinical and pathological responses in women with operable early stage breast cancer in the Phase II XeNA (Xeloda in NeoAdjuvant) trial. The fourth U.S. abstract compares the characteristics of and survival among North Carolina metastatic breast cancer patients treated with Xeloda or taxane monotherapy.
-- Dec. 14, 7:00 to 9:00 a.m., [Poster No. 6107], Capecitabine is associated with lower chemotherapy-related expenditures than those associated with vinorelbine in women with metastatic breast cancer (Lead Author: Michael Lee)
-- Dec. 14, 7:00 to 9:00 a.m., [Poster No. 6108], Capecitabine is associated with lower chemotherapy-related expenditures than those associated with gemcitabine in women with metastatic breast cancer (Lead Author: Michael Lee)
-- Dec. 14, 7:00 to 9:00 a.m., [Poster No. 6047], p53 mutational status, but not immunohistochemical staining (IHC), is associated with a clinical response of the primary tumor in women receiving neoadjuvant docetaxel-capecitabine chemotherapy for locally advanced breast cancer (Lead Author: Jeffrey Ross)
-- Dec. 14, 7:00 to 9:00 a.m., [Poster No. 6091], Survival outcome is similar for first-line chemotherapy with capecitabine or taxane for metastatic breast cancer (Lead Author: Gretchen Kimmick)
The majority of the 15 ex-U.S. abstracts being presented highlight Xeloda as a cornerstone of combination treatment. The remaining Xeloda abstract is a non-Roche sponsored study.
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 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. For additional information about the U.S. pharmaceuticals business, visit our website http://www.rocheusa.com. Product and treatment information for U.S. healthcare professionals is available at www.RocheExchange.com.
CONTACT: Ginny Valenze of Roche, +1-973-562-2783, cell, +1-973-943-9219,
Virginia.Valenze@roche.com
Web site: http://www.rocheusa.com/
