一项比较2007年与2013年美国临床肿瘤学会和美国病理学家学会HER2评分方法在黏液性上皮性卵巢癌中检测性能特征的定性研究。
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.
作者信息
Chen Chi-Kuan, Lee Ming-Yung, Lin Wea-Lung, Wang Yu-Ting, Han Chih-Ping, Yu Cheng-Ping, Chao Wan-Ru
机构信息
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).
出版信息
Medicine (Baltimore). 2014 Dec;93(27):e171. doi: 10.1097/MD.0000000000000171.
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.
曲妥珠单抗和其他新开发的抗HER2（人表皮生长因子受体2）疗法在乳腺癌、胃癌或胃食管交界癌患者中取得了显著成功，这促使我们研究HER2状态及其在黏液性上皮性卵巢癌（EOC）中的潜在治疗意义。然而，目前黏液性EOC中HER2评分标准尚无标准化。在本研究中，我们旨在比较2007年和2013年美国临床肿瘤学会及美国病理学家学会评分方法的检测性能特征。分别采用2007年和2013年标准，通过免疫组织化学（IHC）和荧光原位杂交（FISH）检测分析了49例亚洲女性黏液性EOC组织芯片样本。2007年标准下IHC与FISH的总体一致性为97.92%（kappa = 0.921），2013年标准下为100%（kappa = 1.000）。分别根据2007年和2013年标准，Her2 FISH扩增病例的百分比通过相应的HER2 IHC序数呈显著上升趋势（P < 0.001，P < 0.001）。排除可疑病例后，2007年或2013年标准下的特异性（100%）和阳性预测值（100%）均未改变。2013年标准下HER2 IHC的敏感性（100%）、阴性预测值（NPV）（100%）和准确性（100%）高于2007年标准下的（敏感性87.5%、NPV 97.6%和准确性97.9%）。在49例病例中，2013年标准下HER2 IHC可疑结果的数量（n = 4）比2007年标准下的（n = 1）高4倍（8.16%对2.04%）。总之，如果首先通过IHC检测，2013年标准比2007年标准导致更多HER2 IHC可疑病例进行Her2 FISH检测。这降低了HER2状态的假阴性率，提高了黏液性EOC中HER2阳性的检出率。
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