PMID- 11208826 OWN - NLM STAT- MEDLINE DCOM- 20010329 LR - 20220409 IS - 0732-183X (Print) IS - 0732-183X (Linking) VI - 19 IP - 2 DP - 2001 Jan 15 TI - Her-2/neu analysis in archival tissue samples of human breast cancer: comparison of immunohistochemistry and fluorescence in situ hybridization. PG - 354-63 AB - PURPOSE: The objective of our study was to compare the methods used in the literature to analyze HER-2/neu status on archival breast cancer tissue. Therefore, a series of antibodies was evaluated to assess their immunohistochemical (IHC) sensitivity in correlation to gene amplification determined by fluorescence in situ hybridization (FISH). MATERIALS AND METHODS: HER-2/neu overexpression was studied on paraffin sections of 85 invasive breast cancers using a panel of five monoclonal (9G6, 3B5, CB11, TAB250, GSF-HER2) and two polyclonal antibodies (A8010, A0485) in addition to the HercepTest (DAKO, Glostrup, Denmark). HER-2/neu gene amplification was determined by FISH using a dual-color probe (PathVysion; Vysis, Stuttgart-Fasanenhof, Germany). RESULTS: HER-2/neu overexpression was demonstrated in 26% (9G6, TAB250, GSF-HER2), 27% (3B5, CB11), 33% (A8010) and 42% (A0485, HercepTest) of the tumors. FISH on paraffin sections identified gene amplification in 28% of the tumors. Strongly positive IHC results (3+) were always associated with gene amplification. Among the 16 tumors presented with weakly positive IHC results (2+) using the HercepTest, 12 (75%) lacked gene amplification. CONCLUSION: The comparison of IHC and FISH demonstrated an excellent correlation of high-level HER-2/neu overexpression (3+) with gene amplification; ie, FISH does not provide further information in these tumors. However, weakly positive IHC results (2+) obtained with the HercepTest share only a minor association with gene amplification. FAU - Lebeau, A AU - Lebeau A AD - Pathologisches Institut and Klinik fur Frauenheilkunde und Geburtshilfe Klinikum-GroBhadern, Ludwig-Maximilians-Universitat, Munchen, Germany. a.lebeau@lrz.uni-muenchen.de FAU - Deimling, D AU - Deimling D FAU - Kaltz, C AU - Kaltz C FAU - Sendelhofert, A AU - Sendelhofert A FAU - Iff, A AU - Iff A FAU - Luthardt, B AU - Luthardt B FAU - Untch, M AU - Untch M FAU - Lohrs, U AU - Lohrs U LA - eng PT - Comparative Study PT - Journal Article PL - United States TA - J Clin Oncol JT - Journal of clinical oncology : official journal of the American Society of Clinical Oncology JID - 8309333 RN - 0 (Antibodies, Monoclonal) RN - EC 2.7.10.1 (Receptor, ErbB-2) SB - IM MH - Antibodies, Monoclonal MH - Breast Neoplasms/genetics/*metabolism/pathology MH - Gene Amplification MH - Genes, erbB-2 MH - Humans MH - *Immunohistochemistry MH - *In Situ Hybridization, Fluorescence MH - Nucleic Acid Amplification Techniques MH - Receptor, ErbB-2/immunology/*metabolism EDAT- 2001/02/24 11:00 MHDA- 2001/04/03 10:01 CRDT- 2001/02/24 11:00 PHST- 2001/02/24 11:00 [pubmed] PHST- 2001/04/03 10:01 [medline] PHST- 2001/02/24 11:00 [entrez] AID - 10.1200/JCO.2001.19.2.354 [doi] PST - ppublish SO - J Clin Oncol. 2001 Jan 15;19(2):354-63. doi: 10.1200/JCO.2001.19.2.354.