HER-2 testing in breast cancer using immunohistochemical analysis and fluorescence in situ hybridization: A single-institution experience of 2,279 cases and comparison of dual-color and single-color scoring Journal Article
| Authors: | Lal, P.; Salazar, P. A.; Hudis, C. A.; Ladanyi, M.; Chen, B. |
| Article Title: | HER-2 testing in breast cancer using immunohistochemical analysis and fluorescence in situ hybridization: A single-institution experience of 2,279 cases and comparison of dual-color and single-color scoring |
| Abstract: | We analyzed concordance between immunohistochemical analysis and fluorescence in situ hybridization (FISH) in HER-2 status and studied the effect of dual-color (D-FISH) vs single-color FISH (S-FISH) scoring on the assignment of tumors to amplified or nonamplified categories. The assays were performed on formalin-fixed, paraffin-embedded sections of 2,279 invasive breast carcinomas. Immunohistochemical results were interpreted as negative (0, 1+) or positive (2+, 3+). For FISH analyses, a ratio for HER-2/chromosome 17 of 2.0 or more (D-FISH) or an absolute HER-2 copy number per nucleus of more than 4.0 (S-FISH) were interpreted as positive gene amplification. We found 547 (24.0%) cases positive immunohistochemically, 326 (14.3%) by D-FISH, and 351 (15.4%) by S-FISH. Overall concordance in HER-2 status with immunohistochemical analysis was 87% for D-FISH and 86% for S-FISH. Excellent concordance was found among groups scored immunohistochemically as 0, 1+, and 3+ (with D-FISH, 97%; with S-FISH, 96%). The most discordant category was the group scored 2+ immunohistochemically, in which only a quarter of the 2+ tumors were FISH(+). D-FISH and S-FISH scoring results were discordant in 89 tumors (4%), of which 8 (9%) had 3+ immunohistochemical staining and none showed high-level HER-2 amplification. Among all FISH(+) tumors, 10% were negative by immunohistochemical analysis, and notably almost half (47%) showed borderline to low HER-2 amplification (D-FISH score, 2.0-3.9); the clinical significance of these findings warrants further investigation. |
| Keywords: | immunohistochemistry; human tissue; major clinical study; cancer diagnosis; adenocarcinoma; reproducibility of results; in situ hybridization, fluorescence; breast cancer; gene amplification; breast neoplasms; oncogene; fluorescence in situ hybridization; dna, neoplasm; receptor, erbb-2; gene dosage; fish; erbb2; genes, erbb-2; chromosome 17; oncogene neu; her-2/neu; reagent kits, diagnostic; humans; human; female; priority journal; article |
| Journal Title: | American Journal of Clinical Pathology |
| Volume: | 121 |
| Issue: | 5 |
| ISSN: | 0002-9173 |
| Publisher: | Oxford University Press |
| Date Published: | 2004-05-01 |
| Start Page: | 631 |
| End Page: | 636 |
| Language: | English |
| DOI: | 10.1309/ve78-62v2-646b-r6ex |
| PROVIDER: | scopus |
| PUBMED: | 15151202 |
| DOI/URL: | |
| Notes: | Am. J. Clin. Pathol. -- Cited By (since 1996):95 -- Export Date: 16 June 2014 -- CODEN: AJCPA -- Source: Scopus |
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