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BMJ 2005;331:1202 (19 November), doi:10.1136/bmj.331.7526.1202
| The first 150 words of the full text of this article appear below. |
EDITORThe results of recent trials are likely to continue to fuel the demand for trastuzumab in the adjuvant setting of early breast cancer,1 as well as a possible neoadjuvant treatment in the near future. However, Dent and Clemons did not discuss the difficulty in obtaining accurate and reproducible assessment of HER2/neu gene overexpression. Immunohistochemical testing measures HER2/neu protein expression whereas in situ hybridisation measures gene amplification.
Patients with equivocal immunohistochemical results require in situ hybridisation to determine definitive status because interobserver variability using immunohistochemical testing is appreciable.
At least 20% of patients with positive immunohistochemical results will be truly negative for HER2/neu gene amplification; these patients would not benefit from trastuzumab.2
These difficulties in assessing HER2/neu status have been encountered in studies testing trastuzumab, and in situ hybridisation testing has been used as the gold standard.3 As the clinical utility of trastuzumab widens guidelines on HER2/neu testing must
Malcolm R Kell, consultant surgeon
malcolm.kell@breastcheck.ie
Mater Misericordiae University Hospital, University College Dublin, Republic of Ireland
Colm P Power
Mater Misericordiae University Hospital, University College Dublin, Republic of Ireland