NEW PERSPECTIVE FOR CLIMATERIC SYMPTOMS TREATMENT IN WOMEN WITH INCREASED RISK OF BREAST CANCER. IS TSECs SAFE FOR THE ENDOMETRIUM OF HIGH RISK BREAST CANCER PACIENT?

Ana Paula Curi Spadella, Andreia Carneiro, Mauro Abi Haidar, Karen Borrelli, Joaquim Teodoro Araujo Neto, Rita de Cassia Maio Dardes

Institution: Universidade Federal de São Paulo-UNIFESP

“METHODS: A prospective, randomized, double-blind study was conduct at UNIFESP-EPM (Federal University of São Paulo) with 73 patients. The symptomatically postmenopausal high risk breast cancer (Gail Model > 1,66) patients were divided in three treatment groups during 12 months: raloxifene 60 mg/day, raloxifene 60 mg associated with conjugated estrogen 0.3mg/day, and conjugated estrogen 0.3mg/day. RESULTS: The literature shows that long term tamoxifen theray increases the risk of endometrial cancer (Vogel et al, 2010). However, in vitro and in vivo, raloxifene does not share the pro-estrogenic effects of tamoxifen on the endometrium (DeMichele et al, J Clin Oncol. 2008). Tamoxifen and raloxifene are SERMs approved as preventive drug for high risk women in developing invasive breast cancer. Unfortunately some postmenopausal patients present climacteric symptoms and need to be treated with estrogen. In the present study we have demonstrated endometrial safety with the association of raloxifene and low dose estrogen during one year treatment. This is a new concept of TSEC, SERM associated with estrogen, to achieve an ideal postmenopausal hormonal treatment. Our results demonstrated that the treatment group with associated raloxifene and conjugated estrogen did not significantly increase the risk of genital bleeding compared to isolated raloxifene group, neither promoted increased endometrial thickness (greater than 5 mm), compared to raloxifene. In addition, the combined treatment reduced menopausal symptoms, particularly hot flushes and sweating, with efficacy similar to conjugated estrogens.CONCLUSION: For the first time we have demonstrated that the use of raloxifene associated with low dose of estrogen during 12 months is safe for endometrium. In symptomatic (hot flushes) high-risk postmenopausal breast cancer patients, the use of Raloxifene associated with low dose estrogen was able to improve the symptoms.Keywords: raloxifene, estrogen and endometrium”