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Title: No Differences in Time to Response for Fulvestrant and Anastrozole in Advanced Breast Cancer Patients: Presented at SABCS

"No Differences in Time to Response for Fulvestrant and Anastrozole in Advanced Breast Cancer Patients: Presented at SABCS"

By Ed Susman SAN ANTONIO, TX -- December 13, 2005 -- Doctors said that treatment with daily oral anastrozole or a once-monthly injection with fulvestrant showed no difference in time to response among women with advanced breast cancer who had experienced recurrence or progression of disease. "These data suggest that patients without rapidly progressive disease should be kept on endocrine treatment for at least 3 months to allow a response to be achieved prior to considering changing treatments," said John Pippen, Jr., MD, attending physician, Baylor University Medical Center, Dallas, Texas. Dr. Pippen noted that because fulvestrant is administered as a sustained-release, monthly intramuscular injection that takes up to 6 months to achieve optimal therapeutic blood levels, there has been "speculation amongst some physicians that the pharmacokinetic differences between fulvestrant and other treatments such as the aromatase inhibitors may result in a delayed time to response." However, in his poster presentation here on December 10[^th at the 28^th Annual San Antonio Breast Cancer Symposium, Dr. Pippen noted that when compared with anastrozole the time-to-response graphs overlap, indicating no differences between anastrozole and fulvestrant.

Additional charts indicated similar relationships between fulvestrant and tamoxifen, Dr. Pippen said.

He compared data from two clinical trials that were analyzed to determine median time to response with each treatment -- the period from randomization to the observation of an objective complete or partial response.

The trials compared responses among women receiving fulvestrant 250 mg in a once-monthly injection or a 1 mg once-daily tablet of anastrozole. Another study looked at treatment with 250 mg of fulvestrant and 20-mg daily tablets of tamoxifen, as well as the relationship between doses of tamoxifen and anastrozole. Time to response occurred between 2.5 and 3 months for all the treatments.

"The once-a-month injection treatment may have some advantages of the daily pill," Dr. Pippen said. "The 1one injection a month may insure adherence. It may also allow a woman to proceed with activities of daily living without that daily reminder, as she takes the tablet, that she has breast cancer."

[Presentation title: Similar Time to Response Between Fulvestrant and Anastrozole: Comparison From Two Phase III Trials. Abstract 5092]

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