Results from Phase III trials announced at 28th Annual San Antonio Breast Cancer Symposium
SAN ANTONIO, Texas, Dec. 10 /PRNewswire-FirstCall/ -- An analysis of two Phase III studies evaluating time to response (TTR) with FASLODEX(R) (fulvestrant) Injection compared to ARIMIDEX(R) (anastrozole) as treatment for postmenopausal women with advanced breast cancer were presented at the San Antonio Breast Cancer Symposium. Results indicated that there is a similar TTR between FASLODEX and ARIMIDEX despite the administration method (injection versus oral therapy) and pharmacokinetics.
Trials 0020 and 0021 compared the efficacy and tolerability of FASLODEX with ARIMIDEX in postmenopausal women with advanced breast cancer whose disease progressed following tamoxifen therapy. In these studies, patients received FASLODEX 250 mg given as an intramuscular injection once a month or ARIMIDEX 1 mg given orally once daily. An analysis of the combined data from these studies reflected an objective response rate of 19.2 percent in the FASLODEX group (n=428) versus 16.5 percent in the ARIMIDEX group (n=423). The time taken to achieve a response was similar with FASLODEX and ARIMIDEX. Median TTR was 3.10 (range 0.9 -- 33.1) months with FASLODEX versus 2.99 (range 0.7 -- 20.2) months with ARIMIDEX.
"These data indicate that some of the patients taking FASLODEX took up to 33 months to see an objective response, suggesting that a response may still occur even after many months of stable disease with FASLODEX treatment," said John Pippen, MD, Baylor-Sammons Cancer Center and US Oncology research, Dallas, Texas, and Principal Investigator of the study. "These results suggest that patients be kept on endocrine therapy for at least three months to allow a response to be achieved before they consider changing treatments."
The US Food and Drug Administration (FDA) approved FASLODEX in 2002 for the treatment of hormone receptor-positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy, such as tamoxifen. FASLODEX is the only approved hormonal therapy for advanced breast cancer administered as a once-monthly intramuscular injection.
FASLODEX is a prescription medication and is only for postmenopausal women. FASLODEX can cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be advised not to become pregnant while receiving FASLODEX.
Because FASLODEX(R) (fulvestrant) Injection is administered intramuscularly, it should not be used in patients with certain blood disorders or in patients receiving anticoagulants (sometimes called blood thinners, for example, warfarin).
In clinical trials, the most commonly reported adverse events seen with FASLODEX(R) (fulvestrant) Injection, regardless of the investigator's assessment of causality, were gastrointestinal symptoms (nausea, vomiting, constipation, diarrhea, abdominal pain), headache, back pain, hot flushes, and sore throat. Injection site reactions with mild, transient pain and inflammation were reported in 7% of patients (1% of treatments) given single 5 mL injection and 27% of patients (4.6% of treatments) given 2 x 2.5 mL injections of FASLODEX.
FASLODEX is administered as a once-monthly intramuscular injection, which allows health care professionals the opportunity to monitor patient compliance.
About ARIMIDEX(R) (anastrozole)
ARIMIDEX is approved for the initial treatment of postmenopausal women with hormone receptor-positive or hormone receptor-unknown locally advanced or metastatic breast cancer, and for the treatment of postmenopausal women with advanced breast cancer that has progressed following treatment with tamoxifen. Patients with hormone receptor-negative disease and patients who did not previously respond to tamoxifen therapy rarely responded to ARIMIDEX.
Important Safety Information About ARIMIDEX
ARIMIDEX should only be used in postmenopausal women. ARIMIDEX can cause fetal harm when administered to a pregnant woman. Before starting treatment, pregnancy must be excluded (see WARNINGS in full Prescribing Information). In advanced breast cancer clinical trials, the most common side effects seen with ARIMIDEX versus tamoxifen include hot flashes, nausea, decreased energy and weakness, pain, back pain, bone pain, and increased cough. Joint pain/stiffness has been reported in association with the use of ARIMIDEX.
ARIMIDEX should not be taken with tamoxifen or estrogen-containing therapies.
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of over $21.4 billion and leading positions in sales of gastrointestinal, cardiovascular, respiratory, oncology and neuroscience products. In the United States, AstraZeneca is a $9.6 billion healthcare business with more than 12,000 employees. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.
For more information about AstraZeneca and full Prescribing Information, please visit: http://www.astrazeneca-us.com/
This press release contains forward-looking statements with respect to AstraZeneca's business. By their nature, forward-looking statements and forecasts involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. There are a number of factors that could cause actual results and developments to differ materially. For a discussion of those risks and uncertainties, please see the company's Annual Report/Form 20-F for 2004.
FASLODEX and ARIMIDEX are registered trademarks of the AstraZeneca group of companies.
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