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Old 11-25-2008, 09:03 PM   #2
Nguyen
Senior Member
 
Join Date: Nov 2005
Posts: 516
From "track 15" of this interview:

http://www.breastcancerupdate.com/medonc/2008/4/ellis.asp

Track 15
DR LOVE: Can you describe your study of estrogen at high and low doses for metastatic breast cancer?
DR ELLIS: We’ve recently completed a multicenter study with 66 patients, evaluating 30 versus six milligrams of generic estradiol for patients who experienced disease progression while receiving an aromatase inhibitor. In this study, if the patient benefits from estrogen therapy, she is switched back to the aromatase inhibitor she was receiving before the progression.
The study is designed to determine whether oscillating between an aromatase inhibitor and estrogen therapy will produce a prolonged clinical benefit, and some tumors do appear to respond in that way. We will be presenting the data at the annual San Antonio Breast Cancer Symposium in December of this year.
Essentially, we’re seeing 10 to 15 percent actual responses — some quite dramatic — and approximately a 30 percent clinical benefit rate. Interestingly, the responses can be predicted by a PET flare.
We obtained a baseline PET image, and then 24 hours after treatment we examined the difference in glucose uptake. We found that the patients with a dramatic glucose uptake were the ones who went on to respond, so a biomarker for response does exist.
The 6-mg dose was as effective as and safer than the higher dose. We were careful to exclude patients with uncontrolled hypercalcemia and a history of thrombotic events or myocardial infarction.
In the trial, we saw no venous thrombotic events and found that the therapy was well tolerated. However, the flare reactions that you read about in textbooks are real.
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