Assessment of HER-2/neu overexpression and/or gene amplification in breast carcinomas: should in situ hybridization be the method of choice?

摘要: Aims: Since the release of Herceptin®, pathology laboratories have been requested to test breast carcinomas for HER-2/neu overexpression and/or gene amplification. Standardized IHC and FISH are mandatory in order get reliable results, but there problems even with standardized procedures. We decided evaluate two methods determine which, or possibly if both, should be primary investigation method(s). Methods Results: The material consisted 215 invasive complete clinical follow-up 15 years. protein expression was determined all specimens, whereas assessing signal number done 165 cases. double-checked three different antibodies 35 tumours, including cases discrepancies between FISH. Among these, were a third. found 13% amplification 18%. Discordance 11 (8%). Five tumours IHC+/FISH− six IHC−/FISH+. positive as well only had same prognosis respecting survival. Tumours >2 ≤4 HER-2 signals per nucleus survival >4 nucleus. In contrast, without similar that IHC−/FISH− tumours. Conclusions: From our data, it seems more important assess than overexpression. Failure detect FISH-amplified (IHC-negative) would an adverse effect on these patients. On other hand, appear belong better prognostic group, failure them probably not negative women. Even though is complex expensive procedure, considered method choice assessment status cancer