Section 1
Breast Cancer in the elderly

CLINICAL TRIALS IN ELDERLY BREAST CANCER PATIENTS

Many of our earlier clinical trials had age cutoffs — for example at age 70. Now 70-year-old women play tennis. We did a study 2 in the CALGB that addressed the issue of protocol accrual in elderly patients in which we matched older and younger women who were eligible for a breast cancer clinical trial at the same institution, who had the same physician. We found that women 65 and older were offered a trial 35 percent of the time, but women who were less than 65 were offered a trial 51 percent of the time. What was interesting was that of the patients who were offered trial participation, about half in each group agreed. So, if you offered an older woman a trial, she went on with the same frequency.

Discussions about protocol design must consider issues such as co-morbidity and co-existing illness, which are certainly age-related. And how should that be factored in? A wonderful example of looking at co-existing illness was the superb analysis of Mitch Gail 3 and his colleagues looking at the potential benefits of tamoxifen prevention factored in with United States data concerning stroke, myocardial infarction and endometrial cancer. These are data we really don’t have available at all in breast cancer adjuvant chemotherapy in older women. Perhaps diseases that we believe shorten lives and lower quality of life are not that bad, and women may be willing to enter adjuvant chemotherapy trials to extend their lives, even though their general medical health may not be that good.

—Hyman Muss, MD

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