HER-2/neu testing in breast carcinoma: a combined immunohistochemical and fluorescence in situ hybridization approach.

摘要: We evaluated 750 consecutive invasive breast carcinomas for HER-2/neu utilizing a combination of immunohistochemical (IHC) and fluorescence in situ hybridization (FISH) methodologies. IHC reactions 3+ were considered positive 0 1+ negative. 2+ inconclusive reflexed to FISH analysis. In addition, 10% sampling validation analysis was performed on the negative tests. One hundred thirty-eight cases (18.4%) by and/or FISH. twenty-three (89%) 14 amplified There concordance with 77 78 (98.7%) or that tested (95% confidence interval [CI] = 93.1 100%). A single IHC-negative case showed amplification Thirty-nine (5.2%); (36%) amplified, 24 (62%) not one interpretable. positivity observed 34% grade 3 ductal carcinomas, 11.4% 2 3.2% 1 lobular carcinomas. Occasional discordant expression within carcinoma elements also identified. reliably characterized approximately 95% studied CI 93.0 96.2%) effective as primary method evaluating status. this study, heterogeneous group best regarded indeterminate inconclusive; series, only 36% Our findings suggest testing reflexly all can optimize testing.