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‘Real-life’ experience of fulvestrant from an Austrian centre involved in a Compassionate Use Programme
Standard management for patients with advanced, hormone-sensitive breast cancer is the sequential use of non-cross-resistant endocrine therapies. There is a need for new agents that which can be added into the endocrine treatment sequence thus delaying recourse to less well-tolerated cytotoxic treatments and prolonging patients’ quality of life. Fulvestrant (‘Faslodex’) is a new oestrogen receptor (ER) antagonist with no agonist effects and a novel mode of action; it binds, blocks and degrades the ER. We recently described our experience of using fulvestrant in a Compassionate Use Programme including 126 postmenopausal patients with metastatic breast cancer who had received prior endocrine therapy. Patients received fulvestrant as first- to fourth-line endocrine treatment for advanced disease with the most commonly used prior therapies being tamoxifen, anastrozole, letrozole and exemestane. At a median follow-up of 13 months (range: 1–38+ months), fulvestrant treatment resulted in an objective response (OR) rate of 9.5% and a clinical benefit (CB; OR + stable disease ³6 months) rate of 43.6%. CB was similar in patients receiving fulvestrant as first- to fourth-line treatment, although the proportion experiencing ORs appeared to decrease when it was used later in the sequence. Fulvestrant was effective in patients progressing on a variety of different endocrine treatments and notably also provided CB in 9/18 patients with human epidermal growth factor receptor 2 (HER2)-positive disease. Treatment was very well tolerated, with no grade III/IV adverse events observed. To date, this is the largest report of the use of fulvestrant in a single centre, outside of a clinical trial. Our ‘real-life’ experience supports what has previously been observed in phase III trials, showing that fulvestrant is an effective and well-tolerated treatment for postmenopausal women with advanced breast cancer progressing on prior endocrine therapies. The novel mode of action of fulvestrant limits the potential for cross-resistance with other commonly used endocrine agents such as tamoxifen and aromatase inhibitors; ongoing phase III trials will further define the optimum position of fulvestrant in the treatment sequence. Bibliographical reference:
Guenther G. Steger Division of Oncology, Department of Internal Medicine I, Medical University of Vienna, Vienna, Austria
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