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PJ Online homeThe Pharmaceutical Journal
Vol 274 No 7333 p74
22 January 2005

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Fulvestrant adds benefit for women with advanced breast cancer following treatment with aromatase inhibitor

Fulvestrant (Faslodex) — an oestrogen receptor antagonist — provides clinical benefit in postmenopausal women with advanced breast cancer that has progressed, despite aromatase inhibitor therapy, results from three clinical trials show.

A European study, involving 67 postmenopausal women with advanced breast cancer that had progressed after previous treatment with tamoxifen followed by an aromatase inhibitor, showed that 28 per cent had a partial response or stable disease for 24 weeks or longer when treated with fulvestrant (250mg as a single 5ml intramuscular injection on day 1, repeated every 28 days).

Reporting the study, Lucien Perey, University Hospital, Lausanne, Switzerland, said: “These findings are important because they suggest that patients with advanced breast cancer who progress on aromatase inhibitor therapy have an additional effective hormonal treatment option.”

Dr Perey suggested that fulvestrant could be used to further delay the need for chemotherapy. Results showed that the drug was well tolerated, with only one patient leaving the study due to an adverse event. The most common side effect with fulvestrant was hot flushes, affecting 17.9 per cent of patients.

A second study in 77 postmenopausal women with advanced breast cancer that had progressed following treatment with an aromatase inhibitor and, at most, one additional hormonal agent, showed clinical benefit in almost one-third (29 per cent) of those included. A third, small study using fulvestrant as first-line therapy in 30 postmenopausal women with previously untreated breast cancer showed sustained down-regulation of their oestrogen receptors, with 79 per cent showing clinical benefit at six months.

Data from the trials were reported at the San Antonio Breast Cancer Symposium held in Texas last month.

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