title: Effects of fulvestrant 250mg in premenopausal women with oestrogen receptor-positive primary breast cancer.
abstract: 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.
authors.affiliation: Unit of Surgery, Nottingham City Hospital, Hucknall Road, Nottingham NG5 1PB, UK. john.robertson@nottingham.ac.uk
authors.forename: J F R
authors.initials: JF
authors.lastname: Robertson
authors.forename: V
authors.initials: V
authors.lastname: Semiglazov
authors.forename: G
authors.initials: G
authors.lastname: Nemsadze
authors.forename: G
authors.initials: G
authors.lastname: Dzagnidze
authors.forename: M
authors.initials: M
authors.lastname: Janjalia
authors.forename: R I
authors.initials: RI
authors.lastname: Nicholson
authors.forename: J M W
authors.initials: JM
authors.lastname: Gee
authors.forename: J
authors.initials: J
authors.lastname: Armstrong
mesh_terms: D000328:Adult; D018931:Antineoplastic Agents, Hormonal / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood; D014408:Biomarkers, Tumor / Q000378:metabolism; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000378:metabolism; D004958:Estradiol / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000097:blood; D005260:Female; D005498:Follicular Phase; D000077267:Fulvestrant; D006801:Humans; D019394:Ki-67 Antigen / Q000378:metabolism; D008183:Luteal Phase; D008875:Middle Aged; D011960:Receptors, Estrogen / Q000378:metabolism*; D011980:Receptors, Progesterone / Q000378:metabolism
chemical_list: D018931:Antineoplastic Agents, Hormonal; D014408:Biomarkers, Tumor; D019394:Ki-67 Antigen; D011960:Receptors, Estrogen; D011980:Receptors, Progesterone; D000077267:Fulvestrant; D004958:Estradiol