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

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.

• Authors: Rupert Bartsch, 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
• Journal: Breast cancer research and treatment (Breast Cancer Res Treat) Vol. 115 Issue 2 Pg. 373-80 (May 2009) ISSN: 1573-7217 [Electronic] Netherlands
• PMID: 18661231 (Publication Type: Clinical Trial, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Antineoplastic Agents, Hormonal
• Receptors, Estrogen
• Receptors, Progesterone
• Fulvestrant
• Estradiol

Topics

• Adult
• Aged
• Aged, 80 and over
• Antineoplastic Agents, Hormonal (therapeutic use)
• Austria
• Breast Neoplasms (drug therapy, metabolism, pathology)
• Estradiol (analogs & derivatives, therapeutic use)
• Female
• Fulvestrant
• Genes, erbB-2
• Humans
• Kaplan-Meier Estimate
• Middle Aged
• Receptors, Estrogen (metabolism)
• Receptors, Progesterone (metabolism)
• Registries