Fulvestrant (FaslodexTM) in advanced breast cancer: clinical experience from a Belgian cooperative study

Fulvestrant (FaslodexTM) 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
FaslodexTM 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 ‡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.