PMID- 24164555 OWN - NLM STAT- MEDLINE DCOM- 20140402 LR - 20141120 IS - 1543-2165 (Electronic) IS - 0003-9985 (Linking) VI - 138 IP - 2 DP - 2014 Feb TI - A retrospective population-based comparison of HER2 immunohistochemistry and fluorescence in situ hybridization in breast carcinomas: impact of 2007 American Society of Clinical Oncology/College of American Pathologists criteria. PG - 213-9 LID - 10.5858/arpa.2012-0617-OA [doi] AB - CONTEXT: In 2007 the American Society of Clinical Oncology/College of American Pathologists made new recommendations for HER2 testing and redefined HER2 positivity. OBJECTIVE: To analyze results from simultaneous HER2 testing with immunohistochemistry and fluorescence in situ hybridization (FISH) in 2590 invasive breast carcinomas between 2002 and 2010, using 2 scoring systems. DESIGN: Cases from between 2002 and 2006 were scored by using original US Food and Drug Administration criteria (N = 1138) and those from between 2007 and 2010 were evaluated according to American Society of Clinical Oncology/College of American Pathologists criteria (N = 1452). Concordance between testing methods and clinicopathologic associations were determined. RESULTS: Overall concordance between immunohistochemistry/FISH in the 9-year period was 96.2% (kappa = 0.82), and positive concordance was lower. After 2007, the proportion of HER2/neu-positive and HER2/neu-negative cases was not significantly changed when using immunohistochemistry (10.5% versus 8.9%, P = .22 and 69.4% versus 63%, P = .13, respectively), but the number of equivocal cases was higher (19.9% versus 28%, P < .001). While the proportion of negative cases by FISH remained unchanged after 2007 (86.5% versus 88.2%, P = .76), the number of positive cases was lower (13.4% versus 9.2%, P < .001). In addition, 38 cases (2.6%) were FISH equivocal, 16 of which were also equivocal by immunohistochemistry. Overall, immunohistochemistry/FISH concordance was 95.9% between 2002 and 2006 (kappa = 0.82) and 96.4% after 2007 (kappa = 0.82). However, an approximately 13% lower positive assay concordance was noted in the last period. CONCLUSIONS: Application of American Society of Clinical Oncology/College of American Pathologists recommendations is associated with comparable overall immunohistochemistry/FISH concordance, reduced positive concordance, and increased equivocal results. FAU - Schalper, Kurt A AU - Schalper KA AD - From the Department of Pathology, Yale School of Medicine, New Haven, Connecticut (Drs Schalper, Kumar, Hui, Rimm, and Gershkovich) and Servicio de Anatomia Patologica, Clinica Alemana de Santiago, Chile (Dr Schalper). FAU - Kumar, Sudha AU - Kumar S FAU - Hui, Pei AU - Hui P FAU - Rimm, David L AU - Rimm DL FAU - Gershkovich, Peter AU - Gershkovich P LA - eng PT - Comparative Study PT - Journal Article DEP - 20131028 PL - United States TA - Arch Pathol Lab Med JT - Archives of pathology & laboratory medicine JID - 7607091 RN - 0 (Neoplasm Proteins) RN - EC 2.7.10.1 (ERBB2 protein, human) RN - EC 2.7.10.1 (Receptor, ErbB-2) SB - IM MH - Adult MH - Aged MH - Aged, 80 and over MH - Breast Neoplasms/*metabolism/pathology MH - Carcinoma/*metabolism/pathology MH - Cohort Studies MH - Connecticut MH - Female MH - Hospitals, University MH - Humans MH - Immunohistochemistry MH - In Situ Hybridization, Fluorescence MH - Mammary Glands, Human/*metabolism/pathology MH - Middle Aged MH - Neoplasm Grading MH - Neoplasm Invasiveness MH - Neoplasm Proteins/*metabolism MH - *Practice Guidelines as Topic MH - Receptor, ErbB-2/*metabolism MH - Retrospective Studies MH - Societies, Medical MH - United States MH - United States Food and Drug Administration EDAT- 2013/10/30 06:00 MHDA- 2014/04/03 06:00 CRDT- 2013/10/30 06:00 PHST- 2013/10/30 06:00 [entrez] PHST- 2013/10/30 06:00 [pubmed] PHST- 2014/04/03 06:00 [medline] AID - 10.5858/arpa.2012-0617-OA [doi] PST - ppublish SO - Arch Pathol Lab Med. 2014 Feb;138(2):213-9. doi: 10.5858/arpa.2012-0617-OA. Epub 2013 Oct 28.