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Clinical Trial
. 2009 May;115(2):373-80.
doi: 10.1007/s10549-008-0132-0. Epub 2008 Jul 26.

The Austrian fulvestrant registry: results from a prospective observation of fulvestrant in postmenopausal patients with metastatic breast cancer

Rupert Bartsch  1 , Brigitte Mlineritsch, Michael Gnant, Thomas Niernberger, Ursula Pluschnig, Richard Greil, Catharina Wenzel, Paul Sevelda, Josef Thaler, Margaretha Rudas, Michael Pober, Christoph C Zielinski, Guenther G Steger; Austrian Fulvestrant Registry
Collaborators, Affiliations
Clinical Trial

The Austrian fulvestrant registry: results from a prospective observation of fulvestrant in postmenopausal patients with metastatic breast cancer

Rupert Bartsch et al. Breast Cancer Res Treat. 2009 May.

Abstract

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 > or = 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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