Fulvestrant for the treatment of advanced breast cancer in postmenopausal women: a Japanese study.
BACKGROUND
Fulvestrant ('Faslodex') is a new type of oestrogen receptor (ER) antagonist that down-regulates the ER and has no known agonist effects.


METHODS
In this open-label, Phase II trial, 30 postmenopausal Japanese women with hormone-sensitive advanced breast cancer, who had progressed on tamoxifen/toremifene following an initial response, received fulvestrant (250 mg; once-monthly intramuscular injection). Primary endpoints were objective tumour response rate (complete or partial response) and assessment of tolerability; secondary endpoints included clinical benefit (objective response, or stable disease > or = 24 weeks), duration of response and pharmacokinetic analysis.


RESULTS
The objective response rate was 23.3% and 60.0% of patients experienced clinical benefit. Adverse events were generally mild; the most common were pharyngitis (26.7%), headache (23.3%) and nausea (20.0%). Pharmacokinetic data were similar to a Western study of postmenopausal patients.


CONCLUSIONS
Fulvestrant 250 mg/month is effective and well-tolerated in Japanese patients who have relapsed after one prior endocrine treatment.
Watanabe
Toru
T
National Cancer Centre Hospital, 5-1-i, Tsukiji, Chuo-ku, Tokyo, Japan. watanabe-oncology@iuhw.ac.jp
Sano
Muneaki
M
Ohno
Shinji
S
Inaji
Hideo
H
Nishimura
Reiki
R
Shin
Eisei
E
Nomura
Yasuo
Y
Morris
Charles
C
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018931:Antineoplastic Agents, Hormonal / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy*; D004958:Estradiol / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D020847:Estrogen Receptor Modulators / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D000077267:Fulvestrant; D006801:Humans; D008875:Middle Aged; D017698:Postmenopause
D018931:Antineoplastic Agents, Hormonal; D020847:Estrogen Receptor Modulators; D000077267:Fulvestrant; D004958:Estradiol