期刊
APPLIED IMMUNOHISTOCHEMISTRY & MOLECULAR MORPHOLOGY
卷 29, 期 9, 页码 635-642出版社
LIPPINCOTT WILLIAMS & WILKINS
DOI: 10.1097/PAI.0000000000000946
关键词
breast carcinoma; quality assurance; quality control; reproducibility of results; HER2 fluorescent in situ hybridization; laboratory testing; ErbB-2
资金
- The authors thank the participating laboratories: Stanford University Medical Center, University of Rochester Medical Center, Cleveland Clinic, Vitro Molecular, University of Washington Medical Center, and Allina Health Laboratories.
- Allina Health Laboratories
This study presents specific observations and interpretation strategies that laboratories can use when faced with challenging HER2 cases. It also discusses communication strategies that a laboratory may employ to discuss unusual HER2 results with the clinical team.
Objective: College of American Pathologists and the American Society of Clinical Oncology guidelines provide straightforward criteria for HER2 interpretation in breast carcinomas; however, a subset of cases present unusual diagnostic dilemmas.Materials and Methods: Ten challenging HER2 fluorescence in situ hybridization (FISH) cases were selected for analysis. The study included a variety of problematic cases such as those with discordant immunohistochemistry (IHC) and FISH results, cases with high intratumoral variability in HER2 copy number, a case with a highly amplified clone in 5% to 10% of the tumor sample, and a case with tumor cells containing tightly clumped HER2 signals. Six high volume HER2 FISH laboratories performed and interpreted HER2 FISH (adding HER2 IHC if necessary). Interpretation strategies were discussed.Results: There was 100% concordance between laboratories in 4/10 cases. Tumors with increased intratumoral variability (tumors with high variability in HER2 copy number per cell but which otherwise do not fulfill College of American Pathologists and the American Society of Clinical Oncology criteria for heterogeneity) exhibited 100% concordance in 3/4 cases, but 1 case had only 50% agreement. Low positive HER2 cases (group 1 cases with <6 average HER2 copies/cell) had 1 laboratory disagreeing with the majority in 4/4 cases, and this was the only category with discordance between IHC and FISH methodologies. All laboratories identified the case with heterogeneity and interpreted it as positive. Five of the 6 laboratories interpreted the case with tightly clustered HER2 signals as positive.Conclusions: This study offers specific observations and interpretation strategies that laboratories can use when confronted with difficult HER 2 cases. It then highlights communication strategies a laboratory may use to discuss these unusual HER2 results with the clinical team.
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