Most clinical trials using dose-intensive chemotherapy exclude patients wit
h brain metastases. This exclusion was based on anecdotal experience reflec
ting high treatment-related mortality. We analyzed the outcome of 11 patien
ts with metastatic breast cancer who had brain metastases, diagnosed either
before or during high-dose chemotherapy. In three patients, the death was
attributed to non-central nervous system (CNS) regimen-related toxicity. Fi
ve patients died as a results of non-CNS disease progression. One patient d
ied as a result of both CNS and non-CNS disease progression. Two patients a
re alive without disease progression with follow-up of 13.4 and 7.3 months,
respectively. Of the five patients who have survived 1 year, four have hor
mone receptor expression and continued on antihormone therapy after high-do
se therapy. These results are the first to show that breast cancer patients
having brain metastases who receive high-dose chemotherapy do not experien
ce more treatment-related complications or treatment failure as a result of
the metastatic CNS disease. To this end, exclusion of these patients from
high-dose therapy trials, especially those with expression of hormone recep
tors, needs to be reevaluated.