PMID- 11070154 OWN - NLM STAT- MEDLINE DCOM- 20010118 LR - 20220317 IS - 1084-8592 (Print) IS - 1084-8592 (Linking) VI - 5 IP - 3 DP - 2000 Sep TI - HER-2/neu assessment in breast cancer by immunohistochemistry and fluorescence in situ hybridization: comparison of results and correlation with survival. PG - 199-207 AB - BACKGROUND: HER-2/neu immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) results guide breast cancer therapy; however, few studies compared the results and no published studies have correlated them with patient outcome. METHODS AND RESULTS: We compared results, cost, and turnaround time in 117 archival, invasive breast carcinomas and compared 50-month survival in 65 of these cases using commercial HER-2/neu IHC and FISH assays. Twenty-one of 112 FISH (19%) and 33 of 117 IHC cases (28%) were positive. Concordance was high overall (88%; 98 of 112 cases) and in IHC 3+ cases (88%; 14 of 16 cases) but low in IHC 2+ cases (35%; six of 17 cases). Survival correlated with IHC results in 3+ cases (P =.02) and FISH cases with signal ratio greater than 4.0 (P =.03), but not in IHC 2+ cases (P=.7). Cost and turnaround time were greater for FISH. CONCLUSION: IHC is appropriate for initial HER-2/neu assessment; however, patients with tumors scored less than 3+, particularly those interpreted as 2+, would benefit from FISH to more accurately assess HER-2/neu status and avoid inaccurate prognostication and inappropriate treatment. FAU - Kakar, S AU - Kakar S AD - Department of Pathology, University of Illinois at Chicago, Chicago, IL 60612, USA. FAU - Puangsuvan, N AU - Puangsuvan N FAU - Stevens, J M AU - Stevens JM FAU - Serenas, R AU - Serenas R FAU - Mangan, G AU - Mangan G FAU - Sahai, S AU - Sahai S FAU - Mihalov, M L AU - Mihalov ML LA - eng PT - Comparative Study PT - Evaluation Study PT - Journal Article PL - United States TA - Mol Diagn JT - Molecular diagnosis : a journal devoted to the understanding of human disease through the clinical application of molecular biology JID - 9614965 RN - 0 (DNA, Neoplasm) RN - 0 (Reagent Kits, Diagnostic) RN - EC 2.7.10.1 (Receptor, ErbB-2) SB - IM CIN - Mol Diagn. 2000 Sep;5(3):191-2. PMID: 11186126 MH - Breast Neoplasms/*diagnosis/genetics/metabolism/mortality MH - Carcinoma/*diagnosis/genetics/metabolism/mortality MH - Cell Nucleus/ultrastructure MH - DNA, Neoplasm/*analysis MH - Female MH - Gene Amplification MH - Humans MH - Immunohistochemistry/economics/*standards MH - In Situ Hybridization, Fluorescence/economics/*standards MH - Prognosis MH - Reagent Kits, Diagnostic MH - Receptor, ErbB-2/*genetics/immunology/*metabolism MH - *Survival Rate EDAT- 2000/11/09 11:00 MHDA- 2001/02/28 10:01 CRDT- 2000/11/09 11:00 PHST- 2000/11/09 11:00 [pubmed] PHST- 2001/02/28 10:01 [medline] PHST- 2000/11/09 11:00 [entrez] AID - S1084-8592(00)70774-0 [pii] AID - 10.1054/modi.2000.16690 [doi] PST - ppublish SO - Mol Diagn. 2000 Sep;5(3):199-207. doi: 10.1054/modi.2000.16690.