The HER-2/neu proto-oncogene is a useful prognostic and predictive biomarke
r in breast cancer. lit addition, use of a humanized monoclonal antibody ag
ainst HER-2/neu has recently been shown to have efficacy in the treatment o
f metastatic breast cancer in order to examine the potential of HER-2/neu a
s a biomarker and as a target for HER-2/neu monoclonal antibody treatment i
n melanoma, we examined the HER-2/neu status in 40 advanced stage melanomas
. Using fluorescence in situ hybridization for determining the gene amplifi
cation status and immunohistochemistry for detecting protein overexpression
, we found that only one out of 40 cases of melanoma had an altered HER-2/n
eu status. These results demonstrated that HER-2/neu amplification and over
expression are not common in advanced stage melanoma and thus HER-2/neu wou
ld have limited value as a biomarker or as a target for immunotherapy in me
lanoma.