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Fulvestrant Effective Alternative to Anastrozole in Metastatic Breast Cancer: Presented at SABCS

By Charlene Laino

SAN ANTONIO, TX -- December 18, 2003 -- Fulvestrant is an effective alternative to anastrozole for the treatment of postmenopausal women with advanced breast cancer who have progressed following tamoxifen therapy, according to a prospective combined survival analysis of two multicentre trials.

"These data show that women with advanced breast cancer have options when other hormonal therapies fail," said John E. Pippen, MD, Baylor-Sammons Cancer Center, Dallas, Texas, United States. "Fulvestrant is at least as effective as anastrozole with respect to overall survival in the treatment of postmenopausal women with advanced breast cancer."

Dr. Pippen presented the findings here on December 5^th at the 26^th Annual San Antonio Breast Cancer Symposium.

Fulvestrant, a novel estrogen-receptor (ER) antagonist that downregulates the ER, is administered as a once-monthly intramuscular injection.

The multicenter, randomized, controlled phase III trials enrolled a total of 851 postmenopausal women with advanced breast cancer who had progressed on prior endocrine treatment. The women were randomised to fulvestrant as a 250 mg monthly intramuscular injection, or 1 mg of oral anastrozole daily, until their disease progressed or they discontinued therapy. The women were followed until they died.

At an extended median follow-up of 27.2 months, almost 75% (319) of the patients in the fulvestrant group and 76% (322) in the anastrozole group had died of any cause. A Cox proportional hazards regression model showed that fulvestrant was not significantly different from anastrozole in terms of duration of survival. The median time to death was 27.4 months and 27.7 months in the fulvestrant and anastrozole groups, respectively (HR 0.98; 95% CI 0.84, 1.15; P =.81).

Dr. Pippen noted that no new safety issues arose in the 12 months since the initial analysis showed that the drugs were equivalent in terms of time to progression and overall response rates.


[Study Title: Fulvestrant (Faslodex) Versus Anastrozole (Arimidex) For the Treatment of Advanced Breast Cancer: a Prospective Combined Survival Analysis of Two Multicenter Trials. Abstract 426]

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