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Fulvestrant (Faslodex) Demonstrates Non-inferiority to Anastrozole in Advanced Hormone-Sensitive Breast Cancer: Presented at IBCC

By Alison Palkhivala

BANFF, AB -- August 5, 2003 -- Fulvestrant (Faslodex), a novel estrogen receptor antagonist, appears to be at least as effective as anastrozole for the treatment of postmenopausal women with advanced, hormone-sensitive breast cancer. The drug is also known by its trade name.

Stephen E. Jones, MD, Baylor-Charles A. Sammons Cancer Center, Dallas, Texas, led a trial on behalf of the Faslodex Study Investigators, which randomized 400 postmenopausal women with locally advanced or metastatic breast cancer to treatment with fulvestrant or anastrozole. Results were presented in a poster at the Second Annual Future of Breast Cancer: An International Breast Cancer Congress, held here July 31^st to August 3^rd.

All participants had disease that had progressed following prior anti-estrogen therapy, had estrogen or progesterone receptor positive tumors or a previous response to hormonal therapy, and had a life expectancy of more than 3 months.

The 206 women randomized to fulvestrant took 250 mg of the agent intramuscularly once per month. The 194 patients randomized to anastrozole took 1 mg of the agent orally once per day. More than 90% of patients in both groups had previously been treated with tamoxifen.

After a median follow-up of 28.3 months, 73.8% of patients in the fulvestrant group and 76.8% in the anastrozole group had died. Median time to death was 27.8 months in the fulvestrant group and 30 months in the anastrozole group. There was no significant difference between either group with respect to time to death. The upper confidence interval (CI) for the risk of death was 1.24. The fact that CI was less than 1.25 suggests the non-inferiority of fulvestrant compared with anastrozole with respect to risk of death.

Based on these results, the authors concluded that fulvestrant is at least as effective as anastrozole with respect to overall survival in this patient group.

"Because of its unique mechanism of action and lack of cross-resistance with tamoxifen, fulvestrant offers a new treatment option for women with endocrine-responsive advanced breast cancer who have progressed following prior anti-estrogen therapy," the researchers concluded.


[Study title: Fulvestrant Versus Anastrozole After Progression on Prior Endocrine Treatment: Survival Analysis in Patients with Advanced Breast Cancer in the North American Trial 0021. Poster 13]

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