RESUMO
Fulvestrant (Faslodex) reduces markers of hormone sensitivity and proliferation in postmenopausal women. This Phase II double-blind, randomised, multicentre study compared the effects of a single 250mg intramuscular dose of fulvestrant and placebo 14-21 days prior to surgery of curative intent on the oestrogen receptor (ER), progesterone receptor and Ki67 levels in 66 premenopausal women with ER-positive primary breast cancer. There were no statistically significant differences between fulvestrant and placebo with respect to any of the three markers analysed. The most common adverse events in both groups were nausea, headache and pyrexia. Fulvestrant 250mg had no effects on markers of hormone-sensitivity and proliferation in premenopausal women with primary breast cancer when measured at 14-21 days after injection. These findings suggest that a higher fulvestrant dose may be required in this patient population. Further clinical trials are necessary to evaluate the efficacy of fulvestrant in premenopausal women.
Assuntos
Antineoplásicos Hormonais/administração & dosagem , Neoplasias da Mama/tratamento farmacológico , Estradiol/análogos & derivados , Receptores de Estrogênio/metabolismo , Adulto , Antineoplásicos Hormonais/efeitos adversos , Antineoplásicos Hormonais/sangue , Biomarcadores Tumorais/metabolismo , Neoplasias da Mama/metabolismo , Estradiol/administração & dosagem , Estradiol/efeitos adversos , Estradiol/sangue , Feminino , Fase Folicular , Fulvestranto , Humanos , Antígeno Ki-67/metabolismo , Fase Luteal , Pessoa de Meia-Idade , Receptores de Progesterona/metabolismoRESUMO
The lymphatic mapping and sentinel lymphadenectomy procedure is a highly accurate method of axillary staging in breast cancer. Because no other method accurately predicts axillary node status without complete axillary dissection, this technique has a potential to become the standard method of axillary staging for breast cancer in near future. The aim of the study was to evaluate efficiency of lymphatic mapping by intradermal injection of vital blue dye for sentinel node identification in T(1-2) N(0-1) M(0) stage breast cancer patients. The sentinel lymph node biopsy with total axillary dissection was performed in 36 patients. The efficiency of lymphatic mapping by intradermal injection of vital blue dye (identification rate) was 97,2%, specificity--100% and the false-negative rate was 2,8%.