PMID- 10874886 OWN - NLM STAT- MEDLINE DCOM- 20000713 LR - 20141120 IS - 0002-9173 (Print) IS - 0002-9173 (Linking) VI - 113 IP - 6 DP - 2000 Jun TI - HER-2/neu gene amplification compared with HER-2/neu protein overexpression and interobserver reproducibility in invasive breast carcinoma. PG - 852-9 AB - We compared the detection of HER-2/neu gene amplification by fluorescence in situ hybridization (FISH) with detection of HER-2/neu protein overexpression by immunohistochemistry using 2 antibodies on 100 archival invasive breast carcinomas. Protein overexpression for each marker was scored independently by 4 pathologists using standardized criteria, and consensus was compared with results obtained from gene amplification. The concordance rate between FISH and immunohistochemistry was 76% for e2-4001 and 91% for the HercepTest. Of the 37 cases positive by e2-4001, 21 demonstrated no gene amplification; 7 of 24 cases positive by the HercepTest demonstrated no gene amplification. However, 1 of 61 cases negative by e2-4001 showed gene amplification; none of the cases negative by the HercepTest showed amplification. The predictive values of gene amplification based on 0-1+, 2+, and 3+ immunohistochemical staining were best for cases scored as 3+ (75% for e2-4001 and 89% for the HercepTest). Complete agreement among observers for immunohistochemical scoring of e2-4001 and the HercepTest was achieved in 75 and 85 cases, respectively. The pairwise kappa agreement values were substantial for e2-4001 and substantial to almost perfect for the HercepTest. Immunohistochemical staining may be considered a useful screening test. While negative staining almost always correlated with a lack of gene amplification, positive membranous staining, especially 2+, did not predict gene amplification. The low interobserver reproducibility in separating 2+ from 3+ cases necessitates further confirmation by FISH before treatment decisions are made. FAU - Hoang, M P AU - Hoang MP AD - Department of Pathology, University of Texas M.D. Anderson Cancer Center, Houston 77030, USA. FAU - Sahin, A A AU - Sahin AA FAU - Ordonez, N G AU - Ordonez NG FAU - Sneige, N AU - Sneige N LA - eng PT - Comparative Study PT - Journal Article PL - England TA - Am J Clin Pathol JT - American journal of clinical pathology JID - 0370470 RN - EC 2.7.10.1 (Receptor, ErbB-2) SB - IM MH - Adenocarcinoma/*genetics/metabolism/pathology MH - Adult MH - Aged MH - Breast Neoplasms/*genetics/metabolism/pathology MH - Evaluation Studies as Topic MH - Female MH - *Gene Amplification MH - Genes, erbB-2/*genetics MH - Humans MH - Immunoenzyme Techniques MH - In Situ Hybridization, Fluorescence MH - Middle Aged MH - Observer Variation MH - Predictive Value of Tests MH - Receptor, ErbB-2/*biosynthesis MH - Reproducibility of Results EDAT- 2000/06/30 11:00 MHDA- 2000/07/15 11:00 CRDT- 2000/06/30 11:00 PHST- 2000/06/30 11:00 [pubmed] PHST- 2000/07/15 11:00 [medline] PHST- 2000/06/30 11:00 [entrez] AID - 10.1309/VACP-VLQA-G9DX-VUDF [doi] PST - ppublish SO - Am J Clin Pathol. 2000 Jun;113(6):852-9. doi: 10.1309/VACP-VLQA-G9DX-VUDF.