PMID- 17638622 OWN - NLM STAT- MEDLINE DCOM- 20071018 LR - 20171116 IS - 1875-6263 (Electronic) IS - 1028-4559 (Linking) VI - 46 IP - 2 DP - 2007 Jun TI - Comparison of immunohistochemical and fluorescence in situ hybridization assessment for HER-2/neu status in Taiwanese breast cancer patients. PG - 146-51 AB - OBJECTIVE: Accurate diagnostic assessment of human epidermal growth factor receptor-2 (HER-2) is essential and a prerequisite for appropriate application of the humanized anti-HER-2 monoclonal antibody trastuzumab (Herceptin) to the treatment of patients with breast cancer. Immunohistochemistry (IHC) is the most widely applicable diagnostic modality in studying HER-2 status. Fluorescence in situ hybridization (FISH) is also recognized as a modality in cases with an equivocal IHC status (score, 2+). Some authors claimed that FISH alone is sufficient. The aim of this study was to correlate the test results of IHC and FISH for HER-2 gene amplification in breast cancer patients. FISH for topoisomerase IIalpha (TOP2A) was also studied to see if deletion or amplification of TOP2A has any supplementary role to HER-2, FISH and IHC. MATERIALS AND METHODS: Assessment of HER-2 gene amplification and TOP2A gene amplification/deletion was made by FISH analysis using the LSI TOP2A/HER-2/CEP 17 multicolor probe or the LSI HER-2/CEP dual color probe (Vysis, Downers Grove, IL, USA) in formalin-fixed and paraffin-embedded tissue sections of 54 breast cancer patients who were grouped into stages 1+, 2+ or 3+ based on IHC (HercepTest; DakoCytomation, Carpinteria, CA, USA) observations. RESULTS: None of IHC 1+ breast tumors was HER-2 FISH positive, but three of 18 (17%) IHC 3+ tumors were HER-2 FISH negative. Overall, 53% of the IHC 2+ and 83% of the IHC 3+ cases were HER-2 FISH positive. Only one case with IHC 3+ tumor that was HER-2 FISH positive was found to have TOP2A amplification (>2.0) and no IHC 2+ cases were found to have TOP2A amplification. There were no cases with TOP2A deletion (<0.8) in our whole series. There were also no cases of HER-2 FISH negative tumors, but IHC scored as 2+ or 3+ (0 of 10), to be found with TOP2A amplification. The discordance rates by IHC were high (46.7% in IHC 2+, 16.7% in IHC 3+, 30.3% overall in IHC 2+ or 3+). On the contrary, the discordance rates were zero if by FISH. CONCLUSION: The current algorithm to use HER-2 FISH as a supplementary role to IHC HercepTest 2+ may need some modifications according to the local setting. TOP2A FISH adds little value to HER-2 FISH and IHC staining in our study. FAU - Kuo, Shou-Jen AU - Kuo SJ AD - Department of Medical Research, Changhua Christian Hospital, Changhua, Taiwan. FAU - Wang, Boris Bao-Tyan AU - Wang BB FAU - Chang, Cheng-Shyong AU - Chang CS FAU - Chen, Tze-Ho AU - Chen TH FAU - Yeh, Kun-Tu AU - Yeh KT FAU - Lee, Dong-Jay AU - Lee DJ FAU - Yin, Pao-Lun AU - Yin PL FAU - Chen, Ming AU - Chen M LA - eng PT - Comparative Study PT - Journal Article PL - China (Republic : 1949- ) TA - Taiwan J Obstet Gynecol JT - Taiwanese journal of obstetrics & gynecology JID - 101213819 RN - 0 (Antigens, Neoplasm) RN - 0 (DNA-Binding Proteins) RN - 0 (Poly-ADP-Ribose Binding Proteins) RN - EC 2.7.10.1 (ERBB2 protein, human) RN - EC 2.7.10.1 (Receptor, ErbB-2) RN - EC 5.99.1.3 (DNA Topoisomerases, Type II) RN - EC 5.99.1.3 (TOP2A protein, human) SB - IM MH - Antigens, Neoplasm/genetics/metabolism MH - Breast Neoplasms/*genetics/metabolism/pathology MH - Carcinoma, Ductal, Breast/genetics/metabolism/pathology MH - Carcinoma, Lobular/genetics/metabolism/pathology MH - DNA Topoisomerases, Type II/genetics/metabolism MH - DNA-Binding Proteins/genetics/metabolism MH - Female MH - Gene Amplification MH - Gene Deletion MH - Gene Expression Regulation, Neoplastic MH - Humans MH - *Immunohistochemistry MH - *In Situ Hybridization, Fluorescence MH - Poly-ADP-Ribose Binding Proteins MH - Receptor, ErbB-2/*genetics/metabolism MH - Taiwan EDAT- 2007/07/20 09:00 MHDA- 2007/10/19 09:00 CRDT- 2007/07/20 09:00 PHST- 2007/07/20 09:00 [pubmed] PHST- 2007/10/19 09:00 [medline] PHST- 2007/07/20 09:00 [entrez] AID - S1028-4559(07)60008-4 [pii] AID - 10.1016/S1028-4559(07)60008-4 [doi] PST - ppublish SO - Taiwan J Obstet Gynecol. 2007 Jun;46(2):146-51. doi: 10.1016/S1028-4559(07)60008-4.