Synthetic steroid increases risk of recurrence in breast cancer survivors

February 17, 2009

Tibolone--a synthetic steroid used to treat menopausal symptoms and to prevent osteoporosis--significantly increases the risk of recurrence for breast cancer patients, according to findings published Online First and in the February issue of The Lancet Oncology.

Tibolone should not, therefore, be prescribed to any woman with known, past, or suspected breast cancer.

Women with breast cancer undergoing treatments such as chemotherapy often find themselves subject to an early menopause. They face debilitating symptoms such as hot flushes, night sweats, and bone loss. Such episodes can be mitigated by hormonal therapies, but concerns that these drugs might cause a recurrence of the cancer have led to hormonal therapies being ruled out for patients with breast cancer.

Tibolone is licensed for use in 90 countries for alleviating the symptoms of the menopause; 55 countries have approved its use in treating osteoporosis. Many patients with breast cancer presently use the drug to counteract the effects of the menopause.

Professor Peter Kenemans (VU University Medical Centre, Amsterdam, Netherlands) and colleagues assessed whether a dose of 2•5 mg per day of tibolone increases the risk of breast-cancer recurrence in women experiencing hot flushes and associated complaints who have been surgically treated for breast cancer. 3098 women were assessed--1556 in the tibolone group, and 1542 in the placebo. Mean age at entry was 52.7 years, mean time since surgery was 2.7 years.

237 (15.2%) of the women receiving tibolone had a recurrence of their cancer, compared with 165 (10.7%) of the women receiving placebo -- which was a 40% increased risk for the tibolone recipients. The increased risk was so pronounced that the trial was stopped 6 months early. Moreover, 70% of these recurrences were distant metastases, which are invariably fatal.

There are limitations to the study, breast-cancer risk factors were not assessed, nor were the primary tumours subject to detailed analysis. The profile of future groups of breast-cancer patients might differ from that of the survey: tamoxifen might not be as widespread, for example, or patients might not be undergoing adjuvant systemic therapy.

"There are insufficient data to establish the safety of tibolone in women who have had breast cancer and do not require or have finished adjuvant therapy", Prof Kenemans concludes. According to the authors, as things stand, no subgroup of breast-cancer patients for which the use of tibolone is safe can be identified and its use should be discontinued for all such patients.

Tibolone is contraindicated for use in women with a history of breast cancer, this study has shown that this contraindication should be maintained.
-end-
Prof Peter Kenemans, Department of Obstetrics and Gynaecology, VU University Medical Centre, PO Box 7057, 1007 MB Amsterdam, Netherlands T) Telephone: +31 20 4444 813 E): kenemans@vumc.nl

For full Article see: http://press.thelancet.com/TLOtibolone.pdf

Notes to editors:

Professor Kenemans and colleagues conducted the study on behalf of the LIBERATE (Livial Intervention following Breast cancer: Efficacy, Recurrence, And Tolerability Endpoints) Study Group.

LIBERATE was a multinational, multicentre, randomised, double-blind, parallel group, placebo-controlled trial, designed to assess the safety and efficacy of tibolone in women with vasomotor symptoms and a history of breast cancer.

The number of distant recurrences was significantly increased in the intervention group compared with placebo (37.8% increase).

Lancet

Related Breast Cancer Articles from Brightsurf:

Oncotarget: IGF2 expression in breast cancer tumors and in breast cancer cells
The Oncotarget authors propose that methylation of DVDMR represents a novel epigenetic biomarker that determines the levels of IGF2 protein expression in breast cancer.

Breast cancer: AI predicts which pre-malignant breast lesions will progress to advanced cancer
New research at Case Western Reserve University in Cleveland, Ohio, could help better determine which patients diagnosed with the pre-malignant breast cancer commonly as stage 0 are likely to progress to invasive breast cancer and therefore might benefit from additional therapy over and above surgery alone.

Partial breast irradiation effective treatment option for low-risk breast cancer
Partial breast irradiation produces similar long-term survival rates and risk for recurrence compared with whole breast irradiation for many women with low-risk, early stage breast cancer, according to new clinical data from a national clinical trial involving researchers from The Ohio State University Comprehensive Cancer Center - Arthur G.

Breast screening linked to 60 per cent lower risk of breast cancer death in first 10 years
Women who take part in breast screening have a significantly greater benefit from treatments than those who are not screened, according to a study of more than 50,000 women.

More clues revealed in link between normal breast changes and invasive breast cancer
A research team, led by investigators from Georgetown Lombardi Comprehensive Cancer Center, details how a natural and dramatic process -- changes in mammary glands to accommodate breastfeeding -- uses a molecular process believed to contribute to survival of pre-malignant breast cells.

Breast tissue tumor suppressor PTEN: A potential Achilles heel for breast cancer cells
A highly collaborative team of researchers at the Medical University of South Carolina and Ohio State University report in Nature Communications that they have identified a novel pathway for connective tissue PTEN in breast cancer cell response to radiotherapy.

Computers equal radiologists in assessing breast density and associated breast cancer risk
Automated breast-density evaluation was just as accurate in predicting women's risk of breast cancer, found and not found by mammography, as subjective evaluation done by radiologists, in a study led by researchers at UC San Francisco and Mayo Clinic.

Blood test can effectively rule out breast cancer, regardless of breast density
A new study published in PLOS ONE demonstrates that Videssa® Breast, a multi-protein biomarker blood test for breast cancer, is unaffected by breast density and can reliably rule out breast cancer in women with both dense and non-dense breast tissue.

Study shows influence of surgeons on likelihood of removal of healthy breast after breast cancer dia
Attending surgeons can have a strong influence on whether a patient undergoes contralateral prophylactic mastectomy after a diagnosis of breast cancer, according to a study published by JAMA Surgery.

Young breast cancer patients undergoing breast conserving surgery see improved prognosis
A new analysis indicates that breast cancer prognoses have improved over time in young women treated with breast conserving surgery.

Read More: Breast Cancer News and Breast Cancer Current Events
Brightsurf.com is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to Amazon.com.