The results of two clinical trials evaluating fulvestrant (Faslodex) for the
treatment of advanced breast cancer in postmenopausal women with disease
progression following antiestrogen therapy were published in a recent issue of
the Journal of Clinical Oncology (20:3386-3395;3396-3403, 2002). The findings
demonstrate the effectiveness and tolerability of fulvestrant compared with
anastrozole (Arimidex) in these patients.
Publication of these articles follow the recent approval of fulvestrant by
the US Food and Drug Administration for the treatment of hormone-receptor-positive
metastatic breast cancer in postmenopausal women with disease progression
following antiestrogen therapy. Approval was based on data from the studies
(trials 20 and 21) discussed in the articles.
Viable Treatment Option
"Faslodex provides a new choice for patients progressing following
tamoxifen therapy," said lead author C. Kent Osborne, md, Baylor College of
Medicine, Houston. "These published data, comparing Faslodex to an
aromatase inhibitor, allows physicians to become better informed about Faslodex
as a viable treatment option for postmenopausal women with advanced breast
Trial 21 was a randomized, double-blind, double-dummy, phase III study
conducted in North America. Trial 20 was an open label, randomized, multicenter,
phase III study conducted in Europe, Australia, and South Africa. The trials
were designed to compare fulvestrant, 250 mg per month administered as an
intramuscular injection, with oral anastrozole, 1 mg daily. A total of 851
postmenopausal women with disease progression following antiestrogen therapy
(usually tamoxifen) were enrolled in the trial.