PMID- 26566289 OWN - NLM STAT- MEDLINE DCOM- 20160624 LR - 20190221 IS - 1932-6203 (Electronic) IS - 1932-6203 (Linking) VI - 10 IP - 11 DP - 2015 TI - Assessment of HER2 Status Using Immunohistochemistry (IHC) and Fluorescence In Situ Hybridization (FISH) Techniques in Mucinous Epithelial Ovarian Cancer: A Comprehensive Comparison between ToGA Biopsy Method and ToGA Surgical Specimen Method. PG - e0142135 LID - 10.1371/journal.pone.0142135 [doi] LID - e0142135 AB - We aimed to compare the assay performance characteristics of HER2 status in mucinous epithelial ovarian cancer (EOC) by ToGA (Trastuzumab for Gastric Cancer) biopsy versus ToGA surgical specimen methods. Forty-nine tissue microarray (TMA) samples of mucinous EOC from Asian women were analyzed by immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) tests using ToGA trial HER2 scoring methods. The overall concordance between IHC and FISH by the ToGA surgical specimen method is 97.56% and by the ToGA biopsy specimen method is 97.14%. The agreements of HER2 IHC results under both biopsy and surgical specimen methods were nearly perfect (weighted kappa = 0.845). Additionally, the percentage of Her2 FISH amplification showed increasing trend with increasing HER2 IHC ordinals (negative, equivocal, positive) by both TOGA biopsy (P<0.001) and surgical specimen method (P<0.001). After excluding equivocal cases, the sensitivity (100%), PPV (88.89%) and NPV (100%) of HER2 IHC were unchanged under either surgical specimen method or biopsy method. However, the specificity (96.97%) and accuracy (97.56%) of HER2 IHC was slightly higher under the surgical specimen method than those (specificity 96.30%, accuracy 97.14%) under the biopsy method. Of the total 49 cases, the number (n = 14) of HER2 IHC equivocal results under the ToGA biopsy method was 1.75-fold higher than those (n = 8) under the ToGA surgical specimen method (28.57% vs. 16.32%). Therefore, compared to ToGA surgery specimen method, the ToGA biopsy method caused more equivocal IHC cases to be referred to FISH testing and did not increase the detection rates of Her2 FISH amplification. FAU - Chao, Wan-Ru AU - Chao WR AD - Department of Pathology, Chung-Shan Medical University and Chung Shan Medical University Hospital, Taichung, Taiwan. FAU - Lee, Ming-Yung AU - Lee MY AD - Department of Statistics and Informatics Science, Providence University, Taichung, Taiwan. FAU - Ruan, Alexandra AU - Ruan A AD - Keck School of Medicine of the University of Southern California, Los Angeles, California, United States of America. FAU - Sheng, Huang Pin AU - Sheng HP AD - Department of Obstetrics and Gynecology, School of Medicine, Chung-Shan Medical University and Chung-Shan Medical University Hospital, Taichung, Taiwan. FAU - Hsu, Jeng-Dong AU - Hsu JD AD - Department of Pathology, Chung-Shan Medical University and Chung Shan Medical University Hospital, Taichung, Taiwan. FAU - Han, Chih-Ping AU - Han CP AD - Department of Pathology, Chung-Shan Medical University and Chung Shan Medical University Hospital, Taichung, Taiwan. AD - Department of Obstetrics and Gynecology, School of Medicine, Chung-Shan Medical University and Chung-Shan Medical University Hospital, Taichung, Taiwan. FAU - Koo, Chiew-Loon AU - Koo CL AD - Department of Pathology, Tungs' Taichung MetroHarbor Hospital, Taichung, Taiwan. LA - eng PT - Comparative Study PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20151113 PL - United States TA - PLoS One JT - PloS one JID - 101285081 RN - EC 2.7.10.1 (ERBB2 protein, human) RN - EC 2.7.10.1 (Receptor, ErbB-2) SB - IM MH - Biopsy/methods MH - Carcinoma, Ovarian Epithelial MH - Female MH - Gene Amplification MH - Gene Dosage MH - Gene Expression Regulation, Neoplastic MH - Humans MH - Immunohistochemistry/methods MH - In Situ Hybridization, Fluorescence/methods MH - Neoplasms, Glandular and Epithelial/*genetics/*pathology MH - Ovarian Neoplasms/*genetics/*pathology MH - Ovary/metabolism/*pathology MH - Receptor, ErbB-2/analysis/*genetics MH - *Specimen Handling/methods PMC - PMC4643932 COIS- Competing Interests: The authors have declared that no competing interests exist. EDAT- 2015/11/14 06:00 MHDA- 2016/06/25 06:00 PMCR- 2015/11/13 CRDT- 2015/11/14 06:00 PHST- 2015/08/14 00:00 [received] PHST- 2015/10/16 00:00 [accepted] PHST- 2015/11/14 06:00 [entrez] PHST- 2015/11/14 06:00 [pubmed] PHST- 2016/06/25 06:00 [medline] PHST- 2015/11/13 00:00 [pmc-release] AID - PONE-D-15-35701 [pii] AID - 10.1371/journal.pone.0142135 [doi] PST - epublish SO - PLoS One. 2015 Nov 13;10(11):e0142135. doi: 10.1371/journal.pone.0142135. eCollection 2015.