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Supplement: Section 7
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, 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. Certainly it did not look detrimental.
I think that
the package insert dose of 2,500 mg/m2 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
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