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| |  ASCO: Study Reports on Endometrial Changes Comparing Tamoxifen With Arimidex (Anastrazole) in Postmenopausal Women Treated for Early Breast Cancer New Data From ATAC Study Presented at ASCO Annual Meeting Report Endometrial Safety Profile of Arimidex Compared to Tamoxifen in Postmenopausal Early Breast Cancer Treatment ORLANDO, FL -- May 21, 2002 -- The results of the endometrial sub-protocol study conducted to assess the incidence of endometrial abnormalities in a subgroup of patients from the ATAC (Arimidex and Tamoxifen, Alone or in Combination) study were presented today at the annual meeting of the American Society of Clinical Oncology (ASCO). The results in postmenopausal women with early breast cancer, based on serial endometrial evaluations, were consistent with the main trial findings which had shown a significantly lower incidence of endometrial cancer, vaginal bleeding and vaginal discharge in the Arimidex groups compared to tamoxifen alone or in combination with Arimidex. Arimidex is the only aromatase inhibitor (AI) with reported clinical trial data for the treatment of early breast cancer. "The ATAC study is a well-designed double-blind randomized trial involving a vast number of women worldwide. This has given us a unique opportunity to rigorously investigate the effects of these treatments in a large sample size," said Gerard T. Kennealey, M.D., Vice President of Clinical Research, Oncology, for AstraZeneca. "This subprotocol is very important because it will help us to evaluate the findings in the main study and add to our understanding of the relative risks of uterine cancer in tamoxifen and Arimidex treated patients." Overall results from the ATAC trial, involving over 9,300 post-menopausal women, were first presented last December at the San Antonio Breast Cancer Symposium and reported for the first time the effect of Arimidex as an adjuvant treatment in postmenopausal women with early breast cancer. After a median of 33.3 months follow-up and a median duration of treatment of 30.7 months, 317 of 3,125 women in the Arimidex group had a relapse of their breast cancer or died, compared with 379 of 3,116 women in the tamoxifen group (p=0.0129). This represents a 17% reduction in the risk of disease recurrence with Arimidex treatment compared to tamoxifen. The reduction in the risk of recurrence was 22% in women with confirmed hormone-sensitive tumors with Arimidex treatment compared to tamoxifen (p=0.0054). The incidence of contralateral breast cancer, a secondary endpoint in the trial, was 14 of 3,125 women with Arimidex and 33 of 3,116 women with tamoxifen, a 58% reduction in incidence. Study results showed that the Arimidex/tamoxifen combination was no more effective than tamoxifen alone. These data will be featured in a special ASCO session on Monday dedicated to significant new data that has been previously presented at other scientific meetings. The new data comes from a sub-protocol study undertaken in 279 ATAC trial patients (Arimidex n=99, tamoxifen n=92 combination treatment n=88), who underwent annual hysteroscopy and trans-vaginal ultrasound investigations during the trial to explore the effects of treatment on the endometrium in more depth. So far, 179 patients have been evaluated at baseline, 12 and 24 months. Among these patients, fewer endometrial abnormalities were seen in the Arimidex group than in either the tamoxifen group or combination therapy patients (9%, 17% and 27% respectively), but this did not reach statistical significance. Atypical hyperplasia, a potential precursor of endometrial cancer, was only observed in the tamoxifen treatment group (1.9%). Arimidex is currently FDA approved for first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor- unknown locally advanced or metastatic breast cancer and also for treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Arimidex can cause fetal harm when administered to a pregnant woman. Before starting treatment, pregnancy must be excluded (see warnings in full prescribing information). Common side effects seen in clinical trials included hot flashes, nausea, asthenia, pain, back and bone pain and increased cough. Joint pain and stiffness has also been reported. AstraZeneca (NYSE: AZN) is a major international healthcare business engaged in the research, development, manufacture and marketing of ethical (prescription) pharmaceuticals and the supply of healthcare services. It is one of the top five pharmaceutical companies in the world with healthcare sales of over $16.4 billion and leading positions in sales of gastrointestinal, oncology, anesthesia (including pain management), cardiovascular, central nervous system (CNS) and respiratory products. In the United States, AstraZeneca is an $8.7 billion healthcare business with more than 10,000 employees. For more information about AstraZeneca and full prescribing information on Arimidex and Nolvadex 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 2000. SOURCE: AstraZeneca
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