PMID- 23108020 OWN - NLM STAT- MEDLINE DCOM- 20130212 LR - 20151119 IS - 1532-0979 (Electronic) IS - 0147-5185 (Linking) VI - 37 IP - 1 DP - 2013 Jan TI - Clinicopathologic characteristics of HER2 FISH-ambiguous breast cancer at a single institution. PG - 120-7 LID - 10.1097/PAS.0b013e31826ab19d [doi] AB - BACKGROUND: : The typical algorithm for human epidermal growth factor-2 (HER2) testing is immunohistochemistry (IHC), followed by reflex HER2 fluorescence in situ hybridization (FISH) for HER2 IHC-ambiguous (2+) cases. At our institution, HER2 FISH testing is initially performed as part of routine breast cancer testing, with HER2 FISH-ambiguous (HER2:CEP17 ratio, 1.8 to 2.2) cases reflexed to HER2 IHC. This provides a unique dataset for lesions that may not routinely undergo FISH testing. The clinicopathologic characteristics of HER2 FISH-ambiguous cases are described. DESIGN: : The electronic pathology database in our institution was searched for HER2 FISH-ambiguous cases from 2007 to December 2011. Review of clinical and pathologic characteristics was performed. RESULTS: : Sixty cases from 60 patients were reported as HER2 FISH ambiguous. Reflex HER2 IHC testing was performed on all 60 cases, of which 26 were HER2 IHC negative (0 to 1+), 18 were HER2 IHC ambiguous (2+), and 16 were HER2 IHC positive (3+). Of the 46 HER2 FISH-ambiguous patients with available clinical records, 13 (32%) pursued anti-HER2 treatment (10 IHC 3+, 1 IHC 2+, 2 IHC 0 to 1+). All were grade II or III ductal carcinomas, with 1 grade III metaplastic carcinoma. CONCLUSIONS: : Reflex HER2 IHC testing after initially ambiguous HER2 FISH testing provides definitive HER2 status in a majority of cases (70%). However, a substantial percentage (30%) of HER2 FISH-ambiguous cases is also HER2 IHC ambiguous, suggesting an intermediate HER2 biology. Most HER2 FISH-ambiguous patients who received trastuzumab were HER2 IHC 3+, grade III, and had associated high-grade ductal carcinoma in situ. Although not statistically significant and with only minimal follow-up, no recurrences have occurred in those patients treated with trastuzumab (P=0.5754). FAU - Clay, Michael R AU - Clay MR AD - Department of Pathology, Stanford Hospital and Clinics, Stanford, CA 94305, USA. mrclay@stanford.edu FAU - Iberri, David J AU - Iberri DJ FAU - Bangs, Charles D AU - Bangs CD FAU - Cherry, Athena AU - Cherry A FAU - Jensen, Kristin C AU - Jensen KC LA - eng PT - Journal Article PL - United States TA - Am J Surg Pathol JT - The American journal of surgical pathology JID - 7707904 RN - 0 (Antibodies, Monoclonal, Humanized) RN - 0 (Antineoplastic Agents) RN - 0 (Biomarkers, Tumor) RN - EC 2.7.10.1 (ERBB2 protein, human) RN - EC 2.7.10.1 (Receptor, ErbB-2) RN - P188ANX8CK (Trastuzumab) SB - IM MH - Adult MH - Aged MH - Aged, 80 and over MH - Antibodies, Monoclonal, Humanized/therapeutic use MH - Antineoplastic Agents/therapeutic use MH - Biomarkers, Tumor/genetics/metabolism MH - Breast Neoplasms/*diagnosis/drug therapy/*genetics MH - Carcinoma, Ductal, Breast/diagnosis/drug therapy/*genetics MH - Carcinoma, Intraductal, Noninfiltrating/diagnosis/drug therapy/*genetics MH - Combined Modality Therapy MH - Databases, Factual MH - Female MH - Humans MH - Immunohistochemistry/methods MH - In Situ Hybridization, Fluorescence MH - Mastectomy MH - Middle Aged MH - Neoplasm Recurrence, Local MH - Neoplasm Staging MH - Receptor, ErbB-2/*genetics/metabolism MH - Reproducibility of Results MH - Trastuzumab MH - Young Adult EDAT- 2012/10/31 06:00 MHDA- 2013/02/13 06:00 CRDT- 2012/10/31 06:00 PHST- 2012/10/31 06:00 [entrez] PHST- 2012/10/31 06:00 [pubmed] PHST- 2013/02/13 06:00 [medline] AID - 10.1097/PAS.0b013e31826ab19d [doi] PST - ppublish SO - Am J Surg Pathol. 2013 Jan;37(1):120-7. doi: 10.1097/PAS.0b013e31826ab19d.