title: Fulvestrant (Faslodex) in advanced breast cancer: clinical experience from a Belgian cooperative study.
abstract: Fulvestrant (Faslodex) is a new estrogen receptor (ER) antagonist with no agonist effects that is licensed for the treatment of postmenopausal women with hormone-sensitive advanced breast cancer (ABC) who have progressed/recurred on prior antiestrogen therapy. The Faslodex Compassionate Use Program (CUP) provides expanded access to fulvestrant in countries where it is not yet available for patients who are not eligible to enter clinical trials. This analysis pools data from 402 patients who received fulvestrant as part of the CUP in Belgium, predominantly as 3rd- to 5th-line endocrine therapy for ABC. Two patients experienced partial responses and 118 experienced stable disease lasting>or=6 months, resulting in an overall clinical benefit rate of 29.9%. Fulvestrant was active in patients with multiple sites of metastases, visceral metastases, human epidermal growth factor receptor 2-positive disease and after heavy endocrine pre-treatment. Fulvestrant was well tolerated, with only six patients (1.5%) discontinuing treatment following adverse events. These data support the findings of previous CUP analyses and Phase II and III trials, suggesting that fulvestrant is a valuable addition to the treatment sequence for postmenopausal women with ABC who have progressed/recurred on prior endocrine therapy.
authors.affiliation: Multidisciplinary Breast Centre & Gynaecological Oncology, UZ KULeuven, Leuven, Belgium. patrick.neven@uz.kuleuven.ac.be
authors.forename: Patrick
authors.initials: P
authors.lastname: Neven
authors.forename: Robert
authors.initials: R
authors.lastname: Paridaens
authors.forename: Gino
authors.initials: G
authors.lastname: Pelgrims
authors.forename: Marc
authors.initials: M
authors.lastname: Martens
authors.forename: Alain
authors.initials: A
authors.lastname: Bols
authors.forename: Jean Charles
authors.initials: JC
authors.lastname: Goeminne
authors.forename: Anita
authors.initials: A
authors.lastname: Vindevoghel
authors.forename: Jan
authors.initials: J
authors.lastname: Demol
authors.forename: Barbara
authors.initials: B
authors.lastname: Stragier
authors.forename: Jacques
authors.initials: J
authors.lastname: De Greve
authors.forename: Christel
authors.initials: C
authors.lastname: Fontaine
authors.forename: Danielle
authors.initials: D
authors.lastname: Van Den Weyngaert
authors.forename: Dominique
authors.initials: D
authors.lastname: Becquart
authors.forename: Marleen
authors.initials: M
authors.lastname: Borms
authors.forename: Veronique
authors.initials: V
authors.lastname: Cocquyt
authors.forename: Rudy
authors.initials: R
authors.lastname: Van Den Broecke
authors.forename: Jean
authors.initials: J
authors.lastname: Selleslags
authors.forename: Ahmad
authors.initials: A
authors.lastname: Awada
authors.forename: Luc
authors.initials: L
authors.lastname: Dirix
authors.forename: Peter
authors.initials: P
authors.lastname: Van Dam
authors.forename: Marie Agnes
authors.initials: MA
authors.lastname: Azerad
authors.forename: Guy
authors.initials: G
authors.lastname: Vandenhoven
authors.forename: Marie Rose
authors.initials: MR
authors.lastname: Christiaens
authors.forename: Ignace
authors.initials: I
authors.lastname: Vergote
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use*; D001530:Belgium; D001943:Breast Neoplasms / Q000188:drug therapy*; D004703:Endocrine System; D004958:Estradiol / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004967:Estrogens / Q000378:metabolism; D005260:Female; D000077267:Fulvestrant; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D016896:Treatment Outcome
chemical_list: D018931:Antineoplastic Agents, Hormonal; D004967:Estrogens; D000077267:Fulvestrant; D004958:Estradiol