Managing menopausal symptoms after breast cancer -Tibolone still contraindicated

The Lancet Oncology, Early Online Publication, 23 January 2009

Press release from The Australasian Menopause Society

Women near menopause should be reassured that tibolone (Livial), which is a form of hormone replacement therapy(HRT) used as an alternative to postmenopausal HRT,  remains a safe option for the treatment of postmenopausal symptoms and osteoporosis in otherwise healthy women.  However, the recently published results of a large well conducted international randomised placebo controlled trial of tibolone in women with a history of invasive breast cancer (The LIBERATE trial) showed an increased risk of recurrence of breast cancer in those treated with tibolone compared to placebo. This increase was not significantly greater than the expected recurrence rate during the three year trial (15%) but the recurrence rate (10.5%) of breast cancer in the placebo group was significantly less than in the group randomised to receive tibolone.  A likely reason for this finding is that tibolone reduced the efficacy of the breast cancer treatments that most women in the trial were still receiving.

Livial (tibolone) is a synthetic agent for the control of menopausal symptoms and osteoporosis which has hormonal-like properties and alleviates many menopausal symptoms. In women without breast cancer this treatment has not been associated with an increase in breast cancer in double blind randomised trials and tibolone does not increase breast density or breast tenderness. In view of tibolone's apparent lack of effect on the breast and its ability to reduce many menopausal symptoms it had the potential to be a therapeutic option for women with disabling menopausal symptoms after the diagnosis of breast cancer. Thus, an international study called LIBERATE was initiated to test its efficacy and safety in women with a history of breast cancer who maintained their ongoing adjuvant therapy with Tamoxifen, aromatase inhibitors or chemotherapy where relevant.

The LIBERATE study involved 3148 women who had already been treated for breast cancer and included women from Australia, Asia and Europe.   The results of this important trial are published this week in the Lancet.

http://www.thelancet.com/journals/lancet/article/PIIS1470-2045(08)70341-3/fulltext

Women who have had a breast cancer often lose quality of life from menopausal symptoms e.g. hot flushes & sleeplessness, either at natural menopause or because some breast cancer treatments can induce or exacerbate menopausal symptoms further reducing quality of life.

"Women who have had breast cancer often have severe menopausal symptoms" said Dr Alice MacLennan, President of the Australasian Menopause Society, "and they deserve special help. However, there is a limited number of evidence-based safe and effective options for them. These include some non-hormonal prescription therapies and in some special cases oestrogen therapy without added progestogens. These women may need care from those specialising in menopause therapy. It is not appropriate to ignore their problems or offer alternative/complementary therapies that have not been proven to be safe or effective in this group of women. They can be helped and trials like LIBERATE are helping define which options are best".

More independent advice about the management of the menopause can be found at the Australasian Menopause Society Website http://www.menopause.org.au/

Media Contacts:

Dr Alice MacLennan 0417 806 057 or This e-mail address is being protected from spambots. You need JavaScript enabled to view it

Dr Elizabeth Farrell  (03) 9419-4877 or This e-mail address is being protected from spambots. You need JavaScript enabled to view it

A/Prof Rod Baber  04141376 348 or This e-mail address is being protected from spambots. You need JavaScript enabled to view it