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The Drug Livial Increases Breast Cancer Recurrence

Posted by Chrissie Cole
Wednesday, February 18, 2009 12:09 AM EST
Category: Major Medical
Tags: FDA and Prescription Drugs, Breast Cancer, Menopause, Livial, Schering-Plough, Tibolone


IMAGE SOURCE: © Wikimedia Commons / structural diagram of Tibolone / author: Fvasconcellos

A large study of the drug Livial was halted six months early after researchers found, the synthetic alternative to hormone replacement therapy, significantly raises the risk that breast cancer will return.

Livial, generic name tibolone, is marketed mainly in Europe and licensed in 90 countries to help ease symptoms associated with menopause. The drug is also approved for osteoporosis treatment in 55 countries.

Tibolone is a selective tissue estrogenic activity regulator (STEAR), which acts like estrogen to strengthen bones and prevent hot flashes associated with menopause, while avoiding estrogen’s known cancer-promoting effects in the breast.

But, unlike estrogen and progesterone, it has been believed that tibolone would reduce the risk of some cancers.

The findings show women with known, past, or suspected breast cancer should not be given Livial, Peter Kenemans of the VU University Medical Centre in Amsterdam said.

“The trial findings will provide better basis for gynecologists, oncologists, general practioners and other doctors that counsel patients with breast cancer that are symptomatic with night sweats and hot flushes that interfere with sleep thereby mpairing quality of life,” researchers wrote.

For the study, researchers assessed whether 2.5 milligrams of Livial once daily increased breast cancer recurrence in more than 3,000 women who had previously undergone breast cancer removal. Half the patients received the drug and the others got a placebo.

237 women (15.2 percent) of the 1,556 women taking tibolone experienced a cancer recurrence compared to the 165 (10.7 percent) of the 1,542 women taking the placebo.

Based on the findings researchers determined that women taking tibolone had a 40 percent greater risk of recurrent cancers. They also found that 70 percent of the recurrences among the group of women taking the drug were distant metastases, which are usually fatal.

Researchers theorize the most likely explanation is that the hormone interferes with the protective effect of different cancer drugs and may stimulate dormant tumours.

“There is insufficient data to establish the safety of Livial and the drug should not be given to these women,” researchers concluded.

Another recently published study found the drug Zometa, used to prevent bone loss and prevent fractures in cancer patients, may also be effective in reducing the risk of early breast cancer reoccurrence or death in premenopausal women. #

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