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Last updated on April 18, 2014 at 10:08 EDT

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

December 9, 2008

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 AntonioDecember 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.

    All trademarks used or mentioned in this release are protected by law.

     Contacts: Ginny Valenze
               Roche
               Office: 973-562-2783
               Cell: 973-943-9219
               Virginia.Valenze@roche.com

SOURCE Roche


Source: newswire