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Alright, read this and if anybody understands the science behind it I have a few questions at the end of the abstract.
Faslodex® (fulvestrant, ICI 182, 780), which is completing phase III trials now, is a “pure” anti-estrogen for ER-positive patients for whom tamoxifen has not been effective. It is a new class of drug, a so-called down-regulator that targets and degrades the estrogen receptor. It carries no risk of endometrial cancer, and no other major side effects have yet been observed. About one-fourth of women on Faslodex experienced hot flashes, and half suffered some minor gastrointestinal disturbances, comparable to those experienced with Arimidex. Only 2.5 percent of patients withdrew from the studies.
Two major randomized studies, with a total of 851 patients, were presented at the Symposium, both comparing Faslodex to Arimidex® (anastrazole), the most commonly used aromatase inhibitor, in tamoxifen-resistant, ER-positive, postmenopausal patients with advanced breast cancer.
In the North American trials, Faslodex offered a longer duration of response than Arimidex as second-line hormonal therapy, an additional nine months before the disease progresses. In the European trials, Faslodex was as effective as Arimidex in time to progression, the primary endpoint, and in several other endpoints. Current trials are looking at the optimal sequence of hormonal therapy to determine which drug should be given first, second, and third.
“Faslodex has great promise,” said Ken Osborne, lead investigator for the North American trial. “These data suggest that Faslodex is as effective as a proven advanced breast cancer therapy and provides a durable response. That extra time can be extremely meaningful to women with advanced breast cancer and their families.”
AstraZeneca, the manufacturer, will be applying for a new drug license in the first quarter of 2001, so the drug may be available soon. This is potentially good news for ER-positive women whose tumors respond to hormonal treatment, because it represents a new hormonal option, different from any other available today—and another major tool for metastatic breast cancer. Every indication is that this drug is at least equal—or superior—to the best third-generation hormonal therapies such as Aromasin or Femara. [6, 7]
Questions
1) Can a down-regulator that targets and degrades the estrogen receptor have a permanent E lowering effect?
2) Combined with Armidex could this be: Amazing/overkill/a waste of $$?
Faslodex® (fulvestrant, ICI 182, 780), which is completing phase III trials now, is a “pure” anti-estrogen for ER-positive patients for whom tamoxifen has not been effective. It is a new class of drug, a so-called down-regulator that targets and degrades the estrogen receptor. It carries no risk of endometrial cancer, and no other major side effects have yet been observed. About one-fourth of women on Faslodex experienced hot flashes, and half suffered some minor gastrointestinal disturbances, comparable to those experienced with Arimidex. Only 2.5 percent of patients withdrew from the studies.
Two major randomized studies, with a total of 851 patients, were presented at the Symposium, both comparing Faslodex to Arimidex® (anastrazole), the most commonly used aromatase inhibitor, in tamoxifen-resistant, ER-positive, postmenopausal patients with advanced breast cancer.
In the North American trials, Faslodex offered a longer duration of response than Arimidex as second-line hormonal therapy, an additional nine months before the disease progresses. In the European trials, Faslodex was as effective as Arimidex in time to progression, the primary endpoint, and in several other endpoints. Current trials are looking at the optimal sequence of hormonal therapy to determine which drug should be given first, second, and third.
“Faslodex has great promise,” said Ken Osborne, lead investigator for the North American trial. “These data suggest that Faslodex is as effective as a proven advanced breast cancer therapy and provides a durable response. That extra time can be extremely meaningful to women with advanced breast cancer and their families.”
AstraZeneca, the manufacturer, will be applying for a new drug license in the first quarter of 2001, so the drug may be available soon. This is potentially good news for ER-positive women whose tumors respond to hormonal treatment, because it represents a new hormonal option, different from any other available today—and another major tool for metastatic breast cancer. Every indication is that this drug is at least equal—or superior—to the best third-generation hormonal therapies such as Aromasin or Femara. [6, 7]
Questions
1) Can a down-regulator that targets and degrades the estrogen receptor have a permanent E lowering effect?
2) Combined with Armidex could this be: Amazing/overkill/a waste of $$?
