Healthcare Industry News: HER2
News Release - December 14, 2006
Data Presented Today Show ARIMIDEX(R) Combined With Herceptin(R) Extended Progression-Free Survival in Patients With Advanced HER-2-Positive and Hormone Receptor-Positive Breast CancerPhase III TAnDEM Study Results Presented at the San Antonio Breast Cancer Symposium
SAN ANTONIO, Dec. 14 (HSMN NewsFeed) -- Data was presented today showing that postmenopausal women who received ARIMIDEX (anastrozole) and Herceptin (trastuzumab) in combination had a significant improvement in progression-free survival when treated for advanced breast cancer that was both human epidermal growth factor receptor-2 (HER-2)-positive and hormone receptor-positive. Data from the TAnDEM randomized clinical trial evaluating "co-positive" patients was presented today for the first time in North America at the 2006 San Antonio Breast Cancer Symposium (SABCS).
Study participants who received ARIMIDEX and Herceptin in combination demonstrated an extended median progression-free survival of 4.8 months, representing an extension of 2.4 months over patients receiving ARIMIDEX alone. The overall median survival for patients receiving ARIMIDEX with Herceptin was 28.5 months.
"The combination of ARIMIDEX plus Herceptin suggests a significant improvement in progression-free survival for this unique patient population, whose disease can be particularly aggressive," said Dr. Joseph Purvis, AstraZeneca, Executive Director, Clinical Research, Oncology.
About TAnDEM Results
The multi-center trial began enrollment in 2001 and evaluated 208 postmenopausal women in 22 countries. In women receiving ARIMIDEX plus Herceptin, time to tumor progression (TTP) was doubled (4.8 versus 2.4 months) and median overall survival (OS) prolonged by 4.6 months compared to women receiving ARIMIDEX alone (28.5 versus 23.9 months). Patients in the combination arm had an overall response rate that was higher than those receiving ARIMIDEX alone (20.3 % versus 6.8%).
ARIMIDEX was scheduled at a dose of 1 mg daily until disease progression. Herceptin was administered in 2 mg/kg weekly (after an initial loading dose of 4 mg/kg) until disease progression. While patients who participated in this study continue to be followed for any side effects, overall safety data in both arms of the TAnDEM trial were consistent with the known safety profile of each of the drugs in the advanced breast cancer setting.
About Advanced Breast Cancer
Breast cancer is considered advanced when it has spread from its original site to distant areas of the body. There are two different ways advanced breast cancer can be classified: locally advanced or metastatic. Locally advanced breast cancer indicates that the cancer is large (greater than two inches) or may have spread to other nearby tissue such as skin, underlying muscle, or chest wall, or there is extensive lymph node involvement. Metastatic breast cancer indicates that the cancer has spread from the breast and lymph nodes to other parts of the body such as bone, lung, liver, or brain.
Approximately two-thirds of breast cancer patients are hormone receptor- positive(1) and of these, nearly 25 percent have the HER-2 genetic mutation.(2) This HER-2 mutation marks the presence of a protein that promotes the growth of cancerous cells, typically resulting in a more aggressive tumor.
Important Information about ARIMIDEX® (anastrozole) Tablets
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
Prescription ARIMIDEX is only for postmenopausal women. ARIMIDEX should not be taken if you are pregnant because it may harm your unborn child. 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.
Please see full Prescribing Information.
AstraZeneca is a major international healthcare business engaged in the research, development, manufacturing and marketing of prescription pharmaceutical companies with healthcare sales of $23.95 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. In the United States, AstraZeneca is a $10.77 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, please visit: http://www.astrazeneca-us.com.
ARIMIDEX is a registered trademark of the AstraZeneca group of companies. Herceptin is marketed by Genentech, Inc. in the United States.
1 K. C. Chu and W. F. Anderson. Rates for breast cancer characteristics by estrogen and progesterone receptor status in the major racial/ethnic groups. Breast Cancer Research and Treatment 74: 199-211, 2002.
2 F. Penault-Llorca, A. Vincent-Salomon, M. C. Mathieu, et al. On Behalf Of The Esther Study Group. Incidence and implications of HER2 and hormonal receptor overexpression in newly diagnosed metastatic breast cancer (MBC). American Society of Clinical Oncology (ASCO) Meeting Meeting Abstracts, 23: 764, 2005.
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