PMID- 25501060
OWN - NLM
STAT- MEDLINE
DCOM- 20150223
LR  - 20210109
IS  - 1536-5964 (Electronic)
IS  - 0025-7974 (Print)
IS  - 0025-7974 (Linking)
VI  - 93
IP  - 27
DP  - 2014 Dec
TI  - A qualitative study comparing the assay performance characteristics between the 
      2007 and the 2013 American Society for Clinical Oncology and College of American 
      Pathologists HER2 scoring methods in mucinous epithelial ovarian cancer.
PG  - e171
LID - 10.1097/MD.0000000000000171 [doi]
LID - e171
AB  - The remarkable success of trastuzumab and other newly developed anti-HER2 (human 
      epidermal growth factor receptor 2) therapies in breast, gastric, or 
      gastroesophageal junction cancer patients has supported us to investigate the 
      HER2 status and its possible therapeutic implication in mucinous epithelial 
      ovarian cancer (EOC). However, there is currently no standardization of HER2 
      scoring criteria in mucinous EOC. In this study, we aimed to compare both the 
      assay performance characteristics of the 2007 and the 2013 American Society for 
      Clinical Oncology and College of American Pathologists scoring methods. 
      Forty-nine tissue microarray samples of mucinous EOC from Asian women were 
      analyzed by immunohistochemistry (IHC) and fluorescence in situ hybridization 
      (FISH) tests using the 2007 and the 2013 criteria, respectively. The overall 
      concordance between IHC and FISH by the 2007 criteria was 97.92 % (kappa = 
      0.921), and that by the 2013 criteria was 100% (kappa = 1.000). The percentage of 
      Her2 FISH-amplified cases showed an increasing trend significantly through their 
      corresponding HER2 IHC ordinals by the 2007 and the 2013 criteria, respectively 
      (P < 0.001, P < 0.001). After excluding equivocal cases, the specificity (100%) 
      and positive predictive value (100%) were unchanged under either the 2007 or the 
      2013 criteria. The sensitivity (100%), negative predictive value (NPV) (100%), 
      and accuracy (100%) of HER2 IHC were higher under the 2013 criteria than those 
      (sensitivity 87.5%, NPV 97.6%, and accuracy 97.9%) under the 2007 criteria. Of 
      the total 49 cases, the number (n = 4) of HER2 IHC equivocal results under the 
      2013 criteria was 4-fold higher than that (n = 1) under the 2007 criteria (8.16% 
      vs 2.04%). Conclusively, if first tested by IHC, the 2013 criteria caused more 
      equivocal HER2 IHC cases to be referred to Her2 FISH testing than the 2007 
      criteria. That decreased the false-negative rate of HER2 status and increased the 
      detection rates of HER2 positivity in mucinous EOC.
FAU - Chen, Chi-Kuan
AU  - Chen CK
AD  - From the Graduate Institute of Life Sciences, National Defense Medical Center 
      (C-KC); Department of Pathology, Laboratory Medicine (C-KC); Department of 
      Medicine, Mackay Medical College, Taipei (C-KC); Department of Statistics and 
      Informatics Science, Providence University (M-YL); Department of Pathology (W-LL, 
      Y-TW, C-PH, W-RC); Department of Obstetrics and Gynecology, School of Medicine, 
      Chung-Shan Medical University and Chung-Shan Medical University Hospital, 
      Taichung (C-PH); Graduate Institute of Life Sciences (C-PY); Department of 
      Pathology, Tri-Service General Hospital, National Defense Medical Center, Taipei 
      (C-PY); and Institute of Medicine, Chung-Shan Medical University, Taichung, 
      Taiwan (W-RC).
FAU - Lee, Ming-Yung
AU  - Lee MY
FAU - Lin, Wea-Lung
AU  - Lin WL
FAU - Wang, Yu-Ting
AU  - Wang YT
FAU - Han, Chih-Ping
AU  - Han CP
FAU - Yu, Cheng-Ping
AU  - Yu CP
FAU - Chao, Wan-Ru
AU  - Chao WR
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Medicine (Baltimore)
JT  - Medicine
JID - 2985248R
SB  - IM
MH  - Adenocarcinoma, Mucinous/genetics/*pathology
MH  - Algorithms
MH  - Female
MH  - *Genes, erbB-2
MH  - Humans
MH  - Immunohistochemistry
MH  - In Situ Hybridization, Fluorescence
MH  - Ovarian Neoplasms/genetics/*pathology
MH  - Process Assessment, Health Care
MH  - Quality Improvement
PMC - PMC4602799
COIS- The author declares that there were no competing interests.
EDAT- 2014/12/17 06:00
MHDA- 2015/02/24 06:00
PMCR- 2014/12/12
CRDT- 2014/12/16 06:00
PHST- 2014/12/16 06:00 [entrez]
PHST- 2014/12/17 06:00 [pubmed]
PHST- 2015/02/24 06:00 [medline]
PHST- 2014/12/12 00:00 [pmc-release]
AID - 00005792-201412020-00014 [pii]
AID - 10.1097/MD.0000000000000171 [doi]
PST - ppublish
SO  - Medicine (Baltimore). 2014 Dec;93(27):e171. doi: 10.1097/MD.0000000000000171.