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Twenty New Abstracts on Oral Xeloda(R) (capecitabine) Featured at the 31st San Antonio Breast Cancer Symposium

Tuesday, December 9, 2008 General News
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NUTLEY, N.J., Dec. 9 Roche announced today that a total of20 U.S. and global abstracts involving its oral chemotherapy Xeloda(R)(capecitabine) have been accepted for presentation at the 2008 San AntonioBreast Cancer Symposium (SABCS) in San Antonio December 12-14, including alate-breaking study in early breast cancer to be presented on Sunday, December14, by the Finnish Breast Cancer Group.
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Two U.S. abstracts to be presented at the meeting compare the impact ofchemotherapy-related costs on direct medical expenditures among patients withmetastatic breast cancer who were treated with oral Xeloda monotherapycompared with vinorelbine monotherapy in one study or gemcitabine monotherapyin the other. The data showed that metastatic breast cancer patients treatedwith Xeloda monotherapy had statistically significant lower total health carecosts than patients treated with vinorelbine monotherapy or gemcitabinemonotherapy.
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The third U.S. abstract demonstrated the accuracy of using p53 genemutations to predict short-term clinical and pathological responses in womenwith operable early stage breast cancer in the Phase II XeNA (Xeloda inNeoAdjuvant) trial. The fourth U.S. abstract compares the characteristics ofand survival among North Carolina metastatic breast cancer patients treatedwith Xeloda or taxane monotherapy.

-- Dec. 14, 7:00 to 9:00 a.m., [Poster No. 6107], Capecitabine isassociated with lower chemotherapy-related expenditures than those associatedwith vinorelbine in women with metastatic breast cancer (Lead Author: MichaelLee)

-- Dec. 14, 7:00 to 9:00 a.m., [Poster No. 6108], Capecitabine isassociated with lower chemotherapy-related expenditures than those associatedwith gemcitabine in women with metastatic breast cancer (Lead Author: MichaelLee)

-- Dec. 14, 7:00 to 9:00 a.m., [Poster No. 6047], p53 mutational status,but not immunohistochemical staining (IHC), is associated with a clinicalresponse of the primary tumor in women receiving neoadjuvantdocetaxel-capecitabine chemotherapy for locally advanced breast cancer (LeadAuthor: Jeffrey Ross)

-- Dec. 14, 7:00 to 9:00 a.m., [Poster No. 6091], Survival outcome issimilar for first-line chemotherapy with capecitabine or taxane for metastaticbreast cancer (Lead Author: Gretchen Kimmick)

The majority of the 15 ex-U.S. abstracts being presented highlight Xelodaas a cornerstone of combination treatment. The remaining Xeloda abstract is anon-Roche sponsored study.

About XELODA (capecitabine)

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.

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 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 been committedto developing innovative products and services that address prevention,diagnosis and treatment of diseases, thus enhancing people's health andquality of life. For additional information about the U.S. pharmaceuticalsbusiness, visit our website http://www.rocheusa.com. Product and treatmentinformation for U.S. healthcare professionals is available atwww.RocheExchange.com.All trademarks used or mentioned in this release are protected by law. Contacts: Ginny Valenze Roche Office: 973-562-2783 Cell: 973-943-9219 [email protected]

SOURCE Roche
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