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Vol 272 No 7299 p599
15 May 2004

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New therapeutic option for advanced breast cancer

Post-menopausal women with advanced breast cancer that has recurred or progressed have another treatment option with the launch of a new drug this week.

Fulvestrant (Faslodex), launched by AstraZeneca, is an oestrogen-receptor antagonist licensed for the treatment of post-menopausal women with locally advanced or metastatic breast cancer that is oestrogen receptor-positive. It is given as a 250mg intramuscular injection into the buttocks once a month, to women whose breast cancer has progressed after previous treatment with an anti-oestrogen therapy.

Speaking at the launch of the drug this week, Anthony Howell, professor of medical oncology at the Christie Hospital in Manchester, said: “The beauty of Faslodex is that it is not only a new hormonal treatment, but it has a different mode of action and overcomes the problem of resistance to tamoxifen. It means we will have something else to offer women when tamoxifen stops working.” He pointed out that Faslodex is an oestrogen-receptor antagonist without the agonist effects that are seen with tamoxifen. These oestrogenic effects can give positive bone effects, but are associated with a number of side effects including thromboembolic events and endometrial cancer.

Data from phase III studies involving over 850 women showed that fulvestrant was at least as effective as the aromatase inhibitor, anastrozole (Arimidex), with respect to objective response rates, time to disease progression and overall survival (PJ, 1 June 2002, p751). It was shown to be well tolerated and to have a reduced incidence of joint disorders compared with aromatase inhibitors. Approximately 47 per cent of patients experienced adverse reactions to the drug, most commonly hot flushes, nausea and injection site reactions, but only 0.9 per cent of patients stopped therapy because of adverse reactions.

Faslodex was launched in the US in May 2002 and received its EU approval in March this year.


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