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Fulvestrant Shows Clinical Activity in Metastatic Breast Cancer Patients Who Fail Other Hormonal Therapies: Presented at ECCO

By Cameron Johnston

COPENHAGEN, DENMARK -- September 23, 2003 -- The selective oestrogen-receptor down regulator fulvestrant (Faslodex) has clinical activity in women with metastatic breast cancer who have failed previous regimens of anti-oestrogen therapy.

In a report presented here September 23^rd at ECCO 12: The European Cancer Conference, investigators from the University of Vienna, Austria, led by Guenther Steger, MD, department of internal medicine, described a relatively small study, involving 67 patients who were followed for periods ranging from 4 to 23 months.

Three of the women received fulvestrant as first-line therapy, but one-third received it as second-line therapy, and 45% received it as third-line therapy. Fifteen patients received it as a fourth-line therapy. Other hormonal therapies they had used, and failed, include tamoxifen, anastrozole, and exemestane.

The women received fulvestrant 250 mg once per month by intramuscular injections. They were evaluated every 3 months until there was disease progression.

Over the course of follow-up, 6 women showed a partial response to fulvestrant. Four of those 6 were estrogen-receptor (ER) and progestin-receptor positive. None was HER2-positive. Two women who showed a partial response were receiving fulvestrant as second-line therapy and 3 received it as third-line therapy, indicating that it can be effective even in the most heavily pretreated cases.

Also, 34 women showed stable disease lasting more than 6 months, while 27 patients had progressive disease. This indicates an objective response rate of 8.9% and a clinical benefit rate (partial response and stable disease) of 59.7%, the investigators said.

Although fulvestrant was used in women who had failed other hormonal therapies, Dr. Steger said there was no evidence of cross-resistance between this drug and the other hormonal therapies.

"From this perspective, these data suggest that patients with both ER-positive and progestin-receptor positive status may gain some benefit from fulvestrant treatment," Dr. Steger said.

The use of fulvestrant earlier in the endocrine treatment sequence may achieve even better responses than those observed in this study, he said, and an additional treatment step in endocrine therapy could allow a longer period of time in which well-tolerated hormonal therapies may be used before less well-tolerated agents are used, he added.


[Study title: Fulvestrant (Faslodex) Demonstrates Clinical Benefit in Heavily Pretreated Patients with Metastatic Breast Cancer. Poster 442]

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