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Annals of Oncology Advance Access published online on June 24, 2005
Annals of Oncology, doi:10.1093/annonc/mdi302
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© 2005 European Society for Medical Oncology
Received January 13, 2005
Revised April 5, 2005
Accepted April 13, 2005

Review

Should women be advised to take prophylactic endocrine treatment outside of a clinical trial setting?

H. Gogas 1*, C. Markopoulos 2, and R. Blamey 3

1 First Department of Internal Medicine, Athens Medical School, National and Kapodistrian University of Athens, Athens, Greece
2 Breast Unit, 2nd Pr. Department of Surgery, Athens Medical School, National and Kapodistrian University of Athens, Athens, Greece
3 The Breast Institute, Nottingham City Hospital, Hucknall Rd, Nottingham, UK

* To whom correspondence should be addressed.
H. Gogas, E-mail: hgogas{at}hol.gr


  Abstract

Epidemiological, experimental and clinical data strongly support the possibility that breast cancer can be prevented by using anti-estrogenic interventions in healthy women. Four trials involving over 25 000 women have so far been reported using tamoxifen 20 mg/day or placebo in healthy women to chemoprevent breast cancer, and several trials utilizing raloxifene or aromatase inhibitors are underway. Interim analyses of the Royal Marsden tamoxifen trial and the Italian national trial showed no effect on the early incidence of breast cancer. The NSABP-P1 showed a 49% reduction in early incidence of breast cancer. This was associated with a reduction in osteoporotic fractures but increases in the risks of endometrial cancer, cataract and thromboembolism. The IBIS trial showed a 32% reduction with a two-fold increase in endometrial cancer and in thromboembolic events. Mortality rates of breast cancer in women receiving tamoxifen prophylactically should be monitored and further follow-up of these trials is needed to determine whether tamoxifen provides an overall health benefit or increase specific or overall survival of breast cancer. High-risk women should not be advised to take anti-estrogens outside of a clinical trial setting.

Keywords: breast cancer; prophylactic endocrine treatment; chemoprevention.
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