Breast Cancer Update

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Section 1
Breast Cancer in the elderly

INTERGROUP TRIAL OF ADJUVANT CHEMOTHERAPY IN OLDER WOMEN

We are currently close to launching a trial for women age 65 and older who have either node-positive or high-risk, node-negative breast cancer. Patients will be randomized to either capecitabine or standard therapy with either CMF or CA. This will be an equivalence trial to see if oral capecitabine for six courses is equivalent to either CMF or CA. Quality of life and the influence of co-morbidity on outcome will also be studied, as will the functional status of the patients. We’re very excited about this, because we believe that if capecitabine is equivalent to more intensive regimens, it might be very attractive for many patients as an adjuvant regimen. I believe that a lot of physicians will be willing to put patients on this trial. The patients are there, and I feel confident we will meet accrual.

If you look at Phase II trials in metastatic breast cancer as second-and third-line therapies, there is now a reasonable database for capecitabine demonstrating response rates of about 20 to 30 percent, 4-7 which really is comparable to taxanes, vinorelbine and other very active agents. So, if you look at capecitabine as a single agent, it fits in. Taxanes have been extensively compared to regimens like CAF and CMF and have proven to be as good, if not superior, and so if you take a Boolean approach, capecitabine should be reasonable to consider for an equivalence trial to CA or CMF.

There is also a very small comparison of capecitabine versus CMF in metastatic disease where the response rate was higher, although not significantly for capecitabine. 8 Certainly it did not look detrimental.

I think that the package insert dose of 2,500 mg/m 2 per day of capecitabine is too high, and in our adjuvant trial, we’re going to start at 2,000 mg, and we’re even going to watch that very closely. I suspect that we’re not going to lose much by lowering the dose, because lowering the dose will still leave you with very high-quality serum levels that should be effective.

The major toxicity we expect with capecitabine is hand-foot syndrome, diarrhea and occasionally stomatitis,which will be monitored very closely. I’m hoping that it won ’t be that bad an experience at all,and logistically, it should be much more user-friendly for patients.

—Hyman Muss, MD