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Senior Citizen Health & Medicine
Older Women with Early Breast Cancer have Better
Survival with Aromasin
Company says 17% less deaths when
switched from tamoxifen
June 3, 2006 - New data from the Intergroup
Exemestane Study (IES) showed for the first time today that hormone
sensitive postmenopausal early breast cancer patients who switched to
Aromasin after 2 to 3 years of tamoxifen were 17% more likely to be
alive and were 25% less likely to have their cancer return than patients
who continued on tamoxifen for a full 5 years of therapy. The news was
issued by the company.
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"Exemestane (founding Aromasin) is the only
anti-hormonal therapy that has been shown to demonstrate improved
overall survival over tamoxifen alone," said Lead Investigator Professor
Charles Coombes, director of cancer medicine, Imperial College, London.
These significant survival benefits were seen in
patients who are considered hormone sensitive, which represents 97% of
the study population. Although not statistically significant in the
intent to treat population, 15% of patients taking Aromasin were more
likely to be alive versus those that continued on tamoxifen.
These new findings were based on nearly 5 years of
follow-up after randomization in the IES trial.
IES was a large randomized double blind
multinational trial of postmenopausal women with early breast cancer
which was designed to compare the clinical benefits of switching 2352
patients to Aromasin after 2 to 3 years of tamoxifen versus continuing
2372 patients on tamoxifen for a full 5 years of therapy. The 5 year
follow-up time includes a period of observation lasting over 2 years
after completion of all treatment.
Earlier results of the IES trial, which led to FDA
and European regulatory approvals of Aromasin for treatment of early
breast cancer, found that postmenopausal hormone receptor positive
patients, which represented 85% of all patients in the trial, who
switched to Aromasin reduced their risk of breast cancer recurring by
35% versus patients who stayed on tamoxifen for 5 years. At the earlier
time point, a difference in overall survival had not been seen.
Breast cancer is one of the most common cancers
occurring in women with more than one million women diagnosed each year
worldwide.
"The Aromasin overall survival data announced today
means that women are moving closer to the goal of longer survival." said
Lead US Investigator, Stephen Jones, M.D., medical director, and
co-chair, breast cancer research committee of the US Oncology Research
Network and director of breast cancer research at the Texas Oncology
Baylor-Sammons Cancer Center in Dallas.
With the new 5 year follow-up data, no clinically
meaningful changes in the safety profile were noted. According to
Professor Coombes, "We have also now been able to study the long-term
effects of exemestane after completion of therapy, and our results
provide women and their physicians with important long-term information
on the use of exemestane."
At 34.5 months of follow-up, the most common side
effects were mild-to-moderate and include hot flushes (21.2% for
Aromasin vs. 19.9% for tamoxifen), fatigue (16.1% vs. 14.7%), arthralgia
(14.6% vs. 8.6%), headache (13.1% vs. 10.8%), insomnia (12.4% vs. 8.9%),
and increased sweating (11.8% vs. 10.4%).
Aromasin should not be used in women who are
premenopausal, are nursing or pregnant, have a known hypersensitivity to
the drug, or are taking estrogen-containing agents. Dose modification is
recommended for patients who are receiving certain medications,
including strong CYP 3A4 inducers. In patients with early breast cancer,
elevations in bilirubin, alkaline phosphatase, and creatinine were more
common in those receiving AROMASIN than either tamoxifen or placebo.
Aromasin was approved in the United States in 2005
for treatment of postmenopausal women with estrogen-receptor positive
early breast cancer following two-to-three years of tamoxifen, for a
combined total of five consecutive years of therapy. It also is approved
for use in Canada, Europe, Japan and South America. Currently, Aromasin
is available in more than 80 countries and approved in the early breast
cancer setting in more than 40 countries.
>> For more information including full prescribing
information, please visit
www.AROMASIN.com or 1-888-AROMASIN.
>> To read FDA data on Aromasin –
click here.
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