Data released today show a continued benefit of ARIMIDEX when compared to tamoxifen
in treating postmenopausal women with hormone receptor-positive (HR+) early
breast cancer. Results of the ATAC (ARIMIDEX, Tamoxifen, Alone or in
Combination) trial, reported today at the 2007 San Antonio Breast Cancer
Symposium, represent a median follow-up of more than eight years and show
an absolute reduction in the risk of recurrence and distant recurrence with
ARIMIDEX. The ATAC trial is one of the world’s longest and largest breast
cancer studies and is supported by AstraZeneca.
With approximately 2.5 million breast cancer survivors in the United
States today, the ATAC 100-month analysis marks a major milestone in
understanding the treatment of HR+ early breast cancer(1). The data show
that the effects of ARIMIDEX in decreasing the risk of recurrence compared
with tamoxifen continue even after patients have completed therapy.
At a median follow-up of 100 months, more than three years after the
completion of treatment, ARIMIDEX significantly reduces the risk of
recurrence in comparison with tamoxifen in postmenopausal patients with HR+
breast cancer. A significant benefit of ARIMIDEX on distant recurrence is
now evident (HR+population p=0.027), and ARIMIDEX is also shown to reduce
the risk of distant metastases. Although there was no difference in overall
survival, the impact of ARIMIDEX at reducing distant metastases is
important, as distant recurrence-free survival is an important predictor
for survival related to breast cancer(2).
“The long-term data from the ATAC trial continue to impact the way
physicians worldwide treat postmenopausal women with hormone
receptor-positive early breast cancer,” said Aman U. Buzdar, MD, who
represents North America on the ATAC Steering Committee and is the
principle investigator for the trial in the United States. “ARIMIDEX has
been shown to be significantly superior to tamoxifen in terms of
disease-free survival, time to recurrence, time to distant metastases and
contralateral breast cancer.”
The ATAC trial is one of the largest studies evaluating five years of
primary adjuvant therapy with an aromatase inhibitor (AI).
The availability of 100 months of follow-up data is also providing
long- term information on the safety profile of five years of treatment
with ARIMIDEX. During the treatment period, ARIMIDEX was associated with an
increased incidence of joint symptoms and fractures (10 percent versus 7
percent). However, the 100-month analysis showed that fracture rates
decreased after completion of treatment and were similar in both treatment
arms.
About ARIMIDEX
Prescription ARIMIDEX is only for postmenopausal women. ARIMIDEX should
not be taken if you are pregnant because it may harm your unborn child.
In the early breast cancer clinical trial, the most common side effects
seen with ARIMIDEX include hot flashes, joint symptoms, weakness, mood
changes, pain, sore throat, nausea and vomiting, depression, high blood
pressure, osteoporosis, swelling of arms/legs, and headache. Fractures
(including fractures of the spine, hip, and wrist) occurred more frequently
with ARIMIDEX than with tamoxifen (10 percent versus 7 percent).
ARIMIDEX should not be taken with tamoxifen or estrogen-containing
therapies.
For more information, please see ARIMIDEX full Prescribing Information
available at http://www.Arimidex.com.
About AstraZeneca
AstraZeneca (NYSE: AZN) is a major international health care business
engaged in the research, development, manufacture and marketing of
prescription pharmaceuticals and the supply of health care services. It is
one of the world’s leading pharmaceutical companies with health care sales
of $26.47 billion and leading positions in sales of gastrointestinal,
cardiovascular, neuroscience, respiratory, oncology and infection products.
AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as
well as the FTSE4Good Index.
In the United States, AstraZeneca is a $12.44 billion health care
business with more than 12,000 employees. For nearly three decades,
AstraZeneca has offered drug assistance programs side by side with its
medicines, and over the past five years, has provided over three billion in
savings to more than one million patients throughout the U.S. and Puerto
Rico. AstraZeneca has been named one of the “100 Best Companies for Working
Mothers” by Working Mother magazine and is the only large pharmaceutical
company named to FORTUNE magazine’s 2007 list of “100 Best Companies to
Work For.” In 2006, for the fifth consecutive year, Science magazine named
AstraZeneca a “Top Employer” on its ranking of the world’s most respected
biopharmaceutical employers.
For more information about AstraZeneca, please visit: http://www.astrazeneca-
us.com
ARIMIDEX is a registered trademark of the AstraZeneca group of
companies.
(1) American Cancer Society. What Are the Key Statistics for Breast
Cancer?
http://www.cancer.org/docroot/CRI/content/CRI_2_4_1X_What_are_the_key_s
tatisti
cs_for_breast_cancer_5.asp (Due to the length of the URL, please copy
and paste URL into browser to view.) Accessed 10/31/2007.
(2) Del Mastro et al. Reducing the risk of distant metastases in breast
cancer patients: role of aromatase inhibitors.
Cancer Treatment Rev 2007 In Press.
SOURCE AstraZeneca