The Austrian fulvestrant registry: results from a prospective observation of fulvestrant in postmenopausal patients with metastatic breast cancer.
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.
Bartsch
Rupert
R
First Department of Medicine and Cancer Centre, Clinical Division of Oncology, Medical University of Vienna, Waehringer Guertel 18-20, Vienna 1090, Austria. rupert.bartsch@meduniwien.ac.at
Mlineritsch
Brigitte
B
Gnant
Michael
M
Niernberger
Thomas
T
Pluschnig
Ursula
U
Greil
Richard
R
Wenzel
Catharina
C
Sevelda
Paul
P
Thaler
Josef
J
Rudas
Margaretha
M
Pober
Michael
M
Zielinski
Christoph C
CC
Steger
Guenther G
GG
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use*; D001317:Austria; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000378:metabolism / Q000473:pathology; D004958:Estradiol / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D000077267:Fulvestrant; D018734:Genes, erbB-2; D006801:Humans; D053208:Kaplan-Meier Estimate; D008875:Middle Aged; D011960:Receptors, Estrogen / Q000378:metabolism; D011980:Receptors, Progesterone / Q000378:metabolism; D012042:Registries
D018931:Antineoplastic Agents, Hormonal; D011960:Receptors, Estrogen; D011980:Receptors, Progesterone; D000077267:Fulvestrant; D004958:Estradiol