Tumor tissue from patients with advanced breast cancer was analyzed for HER
-2/neu and p53 expression. The tissue samples from primary tumor and from a
xillary lymph nodes or distant metastases from 118 breast cancer patients w
ere obtained. Sections from formalin-fixed, paraffin-embedded materials wer
e immunostained for HER-2/neu and p53 oncoprotein expression. Staining resu
lts were correlated with survival times and disease-free survival times, fl
ow cytometric synthesis phase fractions, and DNA ploidy. No correlation cou
ld be found between HER-2/neu and p53 or any other tested factor, but grade
I primary cancers that were positive for HER-2/neu showed a tendency for b
etter outcome. The HER-2/neu staining of the metastases was independent of
the staining of the primary tumor. HER-2/neu can be used as a prognostic ma
rker for advanced breast cancer, when the primary tumor is well differentia
ted.