SAN ANTONIO, Dec. 11 /PRNewswire-FirstCall/ -- Important new data from two Phase II studies evaluating FASLODEX(R) (fulvestrant) Injection as treatment for postmenopausal women with advanced breast cancer, who have experienced disease progression on aromatase inhibitor therapy, were presented at the San Antonio Breast Cancer Symposium (SABCS).
The first of the two studies, conducted by Dr. L. Perey from the Swiss Group for Clinical Cancer Research (SAKK) in Bern, Switzerland, evaluated treatment with FASLODEX in 67 postmenopausal women with advanced breast cancer who had previously responded to aromatase inhibitor treatment but had experienced disease progression. In this study, 19 patients (28%) experienced a partial response or disease stabilization for six months or more. The most common adverse reactions observed were hot flashes (18%), fatigue (9%), injection site pain (8%), and injection site reactions (6%).
The second study, a Phase II trial conducted under the North Central Cancer Treatment Group (NCCTG) by Dr. J. Ingle from the Mayo Clinic in Minnesota, assessed treatment with FASLODEX in 77 postmenopausal women with advanced breast cancer, who had disease progression following treatment with an aromatase inhibitor (AI) and, at most, one additional prior hormonal agent. In this study, 25 of the 77 patients (32.5%) achieved a partial response or stable disease for six months or more. Of the 21 patients who had received only an AI as prior hormonal therapy, 11 (52.3%) experienced partial response or stable disease. The most common adverse reactions observed were fatigue (25%), hot flashes (17%), nausea (13%), injection site reactions (13%), anorexia (11%), arthralgia (8%), peripheral nerve sensitivity (8%) and alopecia (8%).
The U.S. 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.
A new clinical trial that will assess the efficacy and tolerability of FASLODEX in postmenopausal women with hormone receptor-positive metastatic breast cancer following aromatase inhibitor therapy is currently enrolling patients. The trial, called EFECT (Evaluation of FASLODEX vs. Exemestane Clinical Trial), will enroll 660 women from 100 to 150 centers in the United States and throughout the world.
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 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, regardless of the investigator's assessment of causality, were gastrointestinal symptoms (nausea, vomiting, constipation, diarrhea, abdominal pain), headache, back pain, hot flashes, 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 injections 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, and allows healthcare professionals the opportunity to monitor patient compliance.
AstraZeneca maintains its long-standing commitment at the forefront of the fight against breast cancer in the United States. Scientists at AstraZeneca have researched and developed a wide range of products that have made significant contributions to risk reduction and treatment of breast cancer around the world. Millions of women have been treated with breast cancer products from AstraZeneca. The long heritage at AstraZeneca of commitment, innovation, and the ability to develop new concepts in medicine has made it one of the premier pharmaceutical companies in the world.
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 $18.8 billion and leading positions in sales of gastrointestinal, oncology, cardiovascular, neuroscience and respiratory products. In the United States, AstraZeneca is an $8.7 billion healthcare business with more than 11,000 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 on FASLODEX please visit http://www.astrazeneca-us.com/ or http://www.faslodex.com/.
FASLODEX is a registered trademark of the AstraZeneca group of companies.
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 2003.