title: Fulvestrant ('Faslodex') in pre-treated patients with advanced breast cancer: a single-centre experience.
abstract: Fulvestrant ('Faslodex') is a new oestrogen receptor (ER) antagonist with no agonist effects. This report describes the experience of a single centre including 126 postmenopausal women with advanced breast cancer (ABC) in a fulvestrant Compassionate Use Programme. All patients had previously received endocrine treatment for early or ABC. Patients received fulvestrant as first- (n=7), second- (n=51), third- (n=50) or fourth-line endocrine therapy (n=18) for ABC (median duration of treatment: 4 months [range 3-27(+) months], follow-up: 13 months [range 1-38(+) months]). Twelve patients had partial responses (PR) and 43 patients experienced stable disease (SD) > or = 6 months (objective response rate: 9.5%; clinical benefit [CB] rate: 43.6%). Ten of 12 patients with a PR had HER2-negative tumours, and 9/12 had ER-positive and progesterone receptor (PgR)-positive disease (two patients had unknown HER2 status and one had unknown ER and PgR status). Nine of the 18 patients with HER2-positive tumours experienced CB with fulvestrant. Although CB rates were similar when fulvestrant was given as first- to fourth-line endocrine treatment, the proportion of those experiencing CB who had a PR appeared to decrease when fulvestrant was used later in the sequence. Fulvestrant was well tolerated; six patients experienced adverse events (all grade I/II). These data demonstrate that fulvestrant is an effective and well-tolerated therapy for patients with ABC progressing on prior therapies.
authors.affiliation: Division of Oncology, Department of Internal Medicine I, Medical University of Vienna, 18-20 Währinger Gürtel, A-1090 Vienna, Austria. guenther.steger@meduniwien.ac.at
authors.forename: G G
authors.initials: GG
authors.lastname: Steger
authors.forename: R
authors.initials: R
authors.lastname: Bartsch
authors.forename: C
authors.initials: C
authors.lastname: Wenzel
authors.forename: U
authors.initials: U
authors.lastname: Pluschnig
authors.forename: D
authors.initials: D
authors.lastname: Hussian
authors.forename: U
authors.initials: U
authors.lastname: Sevelda
authors.forename: G J
authors.initials: GJ
authors.lastname: Locker
authors.forename: M F
authors.initials: MF
authors.lastname: Gnant
authors.forename: R
authors.initials: R
authors.lastname: Jakesz
authors.forename: C C
authors.initials: CC
authors.lastname: Zielinski
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018931:Antineoplastic Agents, Hormonal / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy*; D018450:Disease Progression; D004958:Estradiol / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D000077267:Fulvestrant; D018734:Genes, erbB-2; D006801:Humans; D008875:Middle Aged; D017698:Postmenopause; D011960:Receptors, Estrogen / Q000378:metabolism; D016896:Treatment Outcome
chemical_list: D018931:Antineoplastic Agents, Hormonal; D011960:Receptors, Estrogen; D000077267:Fulvestrant; D004958:Estradiol