PMID- 22431535 OWN - NLM STAT- MEDLINE DCOM- 20120504 LR - 20211021 IS - 1943-7722 (Electronic) IS - 0002-9173 (Print) IS - 0002-9173 (Linking) VI - 137 IP - 4 DP - 2012 Apr TI - HER2 amplification in gastroesophageal adenocarcinoma: correlation of two antibodies using gastric cancer scoring criteria, H score, and digital image analysis with fluorescence in situ hybridization. PG - 583-94 LID - 10.1309/AJCPXQVS6YGHPDCY [doi] AB - We assessed 103 resected gastroesophageal adenocarcinomas for HER2 amplification by fluorescence in situ hybridization (FISH) and 2 commercial immunohistochemical assays. Of 103, 30 (29%) were FISH-amplified. Both immunohistochemical assays had greater than 95% concordance with FISH. However, as a screening test for FISH amplification, the Ventana Medical Systems (Tucson, AZ) 4B5 antibody demonstrated superior sensitivity (87%) compared with the DAKO (Carpinteria, CA) A0485 (70%). Of the cases, 28 were immunohistochemically 3+ or immunohistochemically 2+/FISH-amplified with the 4B5 assay compared with only 22 cases with the A0485 assay, representing a large potential difference in patient eligibility for anti-HER2 therapy. Cases with low-level FISH amplification (HER2/CEP17, 2.2-4.0) express lower levels of HER2 protein compared with cases with high-level amplification (HER2/CEP17, >/=4.0), raising the possibility of a differential response to anti-HER2 therapy. The H score and digital image analysis may have a limited role in improving HER2 test performance. FAU - Radu, Oana M AU - Radu OM AD - Department of Pathology, University of Pittsburgh School of Medicine, PA 15213, USA. FAU - Foxwell, Tyler AU - Foxwell T FAU - Cieply, Kathleen AU - Cieply K FAU - Navina, Sarah AU - Navina S FAU - Dacic, Sanja AU - Dacic S FAU - Nason, Katie S AU - Nason KS FAU - Davison, Jon M AU - Davison JM LA - eng GR - K07 CA151613/CA/NCI NIH HHS/United States PT - Journal Article PL - England TA - Am J Clin Pathol JT - American journal of clinical pathology JID - 0370470 RN - EC 2.7.10.1 (ERBB2 protein, human) RN - EC 2.7.10.1 (Receptor, ErbB-2) SB - IM MH - Adenocarcinoma/genetics/*metabolism/pathology MH - Aged MH - Aged, 80 and over MH - Esophageal Neoplasms/genetics/*metabolism/pathology MH - Female MH - Humans MH - In Situ Hybridization, Fluorescence/*methods MH - Male MH - Middle Aged MH - Receptor, ErbB-2/genetics/*metabolism MH - Stomach Neoplasms/genetics/*metabolism/pathology PMC - PMC4086745 MID - NIHMS597551 EDAT- 2012/03/21 06:00 MHDA- 2012/05/05 06:00 PMCR- 2014/07/08 CRDT- 2012/03/21 06:00 PHST- 2012/03/21 06:00 [entrez] PHST- 2012/03/21 06:00 [pubmed] PHST- 2012/05/05 06:00 [medline] PHST- 2014/07/08 00:00 [pmc-release] AID - 137/4/583 [pii] AID - 10.1309/AJCPXQVS6YGHPDCY [doi] PST - ppublish SO - Am J Clin Pathol. 2012 Apr;137(4):583-94. doi: 10.1309/AJCPXQVS6YGHPDCY.