Fulvestrant (Faslodex) in advanced breast cancer: clinical experience from a Belgian cooperative study.
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.
Neven
Patrick
P
Multidisciplinary Breast Centre & Gynaecological Oncology, UZ KULeuven, Leuven, Belgium. patrick.neven@uz.kuleuven.ac.be
Paridaens
Robert
R
Pelgrims
Gino
G
Martens
Marc
M
Bols
Alain
A
Goeminne
Jean Charles
JC
Vindevoghel
Anita
A
Demol
Jan
J
Stragier
Barbara
B
De Greve
Jacques
J
Fontaine
Christel
C
Van Den Weyngaert
Danielle
D
Becquart
Dominique
D
Borms
Marleen
M
Cocquyt
Veronique
V
Van Den Broecke
Rudy
R
Selleslags
Jean
J
Awada
Ahmad
A
Dirix
Luc
L
Van Dam
Peter
P
Azerad
Marie Agnes
MA
Vandenhoven
Guy
G
Christiaens
Marie Rose
MR
Vergote
Ignace
I
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
D018931:Antineoplastic Agents, Hormonal; D004967:Estrogens; D000077267:Fulvestrant; D004958:Estradiol