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The Austrian Fulvestrant Registry: Results From A Prospective Observation Of Fulvestrant In Postmenopausal Patients With Metastatic Breast Cancer

R. Bartsch, B. Mlineritsch, M. Gnant, T. Niernberger, U. Pluschnig, R. Greil, C. Wenzel, P. Sevelda, J. Thaler, M. Rudas, M. Pober, C. Zielinski, G. G. Steger, on behalf of the Austrian Fulvestrant Registry
Published 2008 · Medicine

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Background Endocrine therapy is the preferred treatment in oestrogen- and/or progesterone-receptor (ER/PgR) positive breast cancer. Fulvestrant is a pure ER-antagonist. We present results from the Austrian Fulvestrant Registry. Methods Three-hundred and fifty patients were included. Time to progression (TTP) was defined as primary endpoint. A multivariate analysis was performed to identify factors significantly associated with TTP. Results Fulvestrant was administered as first-line therapy in 26%, second-line in 49%, and third-line or beyond in 25%. TTP was median 7 months. We observed a response in 15% of patients and 41% had SD ≥ 6 months. First-line treatment and non-visceral metastases were associated with longer TTP. One case of pulmonary embolism was reported. Grade 3 toxicities consisted of joint pain (1.4%), nausea (1.4%) and hot flashes (0.3%). Conclusions Fulvestrant was effective and well tolerated. TTP was superior to other trials, due to the large proportion of first-line patients. Activity is apparently independent of Her2-status.
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