ROWAN T CHLEBOWSKI, MD, PhD: The FACT study is interesting. On the basis of strong preclinical data, a Phase III study was undertaken comparing anastrozole in combination with a loading dose of fulvestrant — 500 milligrams on day one, then 250 milligrams on days 14 and 28 followed by 250 milligrams monthly — to anastrozole alone. The patient population was postmenopausal women with relapsed metastatic breast cancer who had received one prior hormone therapy. Interestingly, with hundreds of patients, the study turned out to be basically negative. No evidence was seen of a difference in time to disease progression or overall survival between the study arms. It’s back again to the Aman Buzdar principle with hormone therapy, in which one plus one equals one.
It was a disappointing result. Depending on how one interprets the CONFIRM trial results in terms of high-dose fulvestrant (see presentation 1 of this 5MJC issue), it may be that an inferior dose of fulvestrant was used in the FACT study. The authors conclude that you should not use this regimen, which is easy to agree with.
Dr Chlebowski is Professor of Medicine at the David Geffen School of Medicine at UCLA and Chief of the Division of Medical Oncology and Hematology at Harbor-UCLA Medical Center in Torrance, California.
