For How Long Will I Take Hormonal Therapy?

— -- Question: For how long will I have to take hormonal therapy?

Answer: The issue of duration of therapy is based on the clinical stage of disease. So if a woman has early-stage breast cancer -- in other words, having completed either a mastectomy or a lumpectomy, plus radiation therapy, but no evidence of disease elsewhere in her body -- and she is a candidate for tamoxifen, then we tell that women that the optimal duration is five years. We've known through the process of clinical trials that durations of tamoxifen less than five years does not provide as much benefit in terms of risk reduction -- either in terms of recurrence or dying of the disease -- as does five years.

The bigger issue that we continue to evaluate is whether longer durations of tamoxifen therapy beyond five years provides additional benefit. In the clinical trials that have addressed that issue have been not completely clear at this point, so were awaiting the completion of much larger trials involving tens of thousands of patients that ask the question, "Is ten tears better than five years?" The state-of-the-art and the standard of care today is five years of therapy.

If a patient has metastatic disease -- so in other words, disease that has spread to distant parts of the body -- then we typically continue endocrine or hormonal therapy -- be that tamoxifen, an aromatase inhibitor -- for as long as the therapy appears to be controlling the disease. So that is a very different situation than somebody with early-stage breast cancer. So as long as the disease appears to be stable or shrinking, we continue that therapy; at the first sign that the disease is getting worse or progressing, that's the reason to change therapy at that point.

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