An interim analysis of the XCALIBr
(Xeloda in Combination with Avastin as First-Line Treatment for
HER2-Negative Metastatic Breast Cancer) trial suggested that first-line
therapy with oral Xeloda(R) (capecitabine) in combination with Avastin(R)
(bevacizumab) may offer clinical benefit in metastatic breast cancer
patients who have no prior history of treatment. These data were presented
at the 29th Annual San Antonio Breast Cancer Symposium (SABCS) in San
Antonio, Texas.



At the time of study analysis, 72% of enrolled patients experienced a
clinical benefit (a measure of response rate and stable disease) with
Xeloda plus Avastin. The combination regimen was well tolerated by
patients, with the majority of adverse events being mild or moderate.



"We are very encouraged by these data which suggest that oral Xeloda in
combination with Avastin may provide clinical benefit for women with
advanced breast cancer," said clinical trial investigator William J.
Gradishar, MD, Associate Professor of Medicine in the Division of
Hematology and Medical Oncology at Northwestern University Medical School.
"Although the medical community has made great strides in the treatment of
early-stage breast cancer, there is still an urgent need for novel
treatment strategies to improve outcomes in advanced disease, which
currently has a five-year survival rate of only 20 percent."



Breast cancer is the most common cancer among women, other than skin
cancer. It is the second leading cause of cancer death in women, after lung
cancer. According to the American Cancer Society, about 212,920 women in
the United States will be found to have invasive breast cancer in 2006 and
about 40,970 women will die from the disease this year. Currently, there
are an estimated 2 million women living in the United States who have been
treated for breast cancer.



"These promising interim Phase II results in advanced breast cancer
patients underscore the potential of combinations using cornerstone anti-
cancer therapies such as Xeloda," said Lars Birgerson, MD, PhD, Vice
President, Medical Affairs, Roche. "Roche is committed to supporting
ongoing clinical trial programs that explore the potential of Xeloda in
combination with targeted and anti-angiogenic therapies."



Mature data from the XCALIBr trial will be presented at a future major
medical meeting.



About the Study



The primary objective of the multi-center, single arm, Phase II trial
was to evaluate progression-free survival in chemotherapy-naive metastatic
breast cancer patients receiving first-line Xeloda/Avastin combination
therapy. The first phase of the study was designed to evaluate efficacy and
tolerability. Study participants were limited to female outpatients
diagnosed with HER2- negative metastatic breast cancer or locally recurrent
breast cancer who are age 18 and older and are not pregnant.
















In the study, patients received first-line therapy with Xeloda 1000
mg/m2 twice a day for 14 days with seven days off in combination with
Avastin 15mg/kg IV in three-week cycles until first progression or
intolerance to treatment. Once progression was documented, patients were
treated with second-line therapy of Avastin 10mg/kg IV every two weeks in
combination with either weekly paclitaxel 80 mg/m2 or vinorelbine 25 mg/m2
on four-week cycles. Clinical investigators chose whether the patient
received paclitaxel or vinorelbine.



In an interim study analysis of 103 patients from a total of 109
patients enrolled, 44 patients (42.7%) remained progression free on
first-line therapy with Xeloda plus Avastin and 21 patients (20%) had
progressed to second-line therapy after a median duration of 4.2 months of
treatment. Forty-three patients were off protocol for reasons not related
to adverse reactions.



Treatment with Xeloda plus Avastin produced a 72% clinical benefit, a
measure of response rate and stable disease. Specifically, the combination
regimen resulted in a 5% complete response and a 29% partial response for
an overall response rate of 34% (95% CI: 24.9-44); 38% of patients had
stable (non-progressed) disease following combination treatment.



The analysis demonstrated that treatment with Xeloda plus Avastin was
well tolerated in most patients. The most common grade 3 adverse events
were hand- foot syndrome (13%), a skin condition that is commonly seen with
fluoropyrimidine agents, and pain (10%). The only grade 4 toxicity reported
was pulmonary embolism (2%). In those patients who have died (18%), the
cause of death was breast cancer or other causes unrelated to study
medication.



About Xeloda



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, the Roche Group 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 2005, Roche was named
one of Fortune magazine's Best Companies to Work For in America, one of the
Top 20 Employers (Science magazine), ranked as the No. 3 Best Company to
Work For in NJ (NJ Biz magazine), the No. 1 Company to Sell For (Selling
Power), and one of AARP's Top Companies for Older Workers. For additional
information about the U.S. pharmaceuticals business, visit our websites:
rocheusa or roche.us.


Roche

rocheusa


View drug information on Avastin; Warfarin Sodium tablets; Xeloda.

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