High False- Negative Rate of HER2 Quantitative Reverse Transcription Polymerase Chain Reaction of the Oncotype DX Test: An Independent Quality Assurance Study
High False- Negative Rate of HER2 Quantitative Reverse Transcription Polymerase Chain Reaction of the Oncotype DX Test: An Independent Quality Assurance Study
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DOI：
10.1200/jco.2011.34.7963
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发表时间：
2011-11-10
影响因子：
45.3
通讯作者：
Bhargava, Rohit
中科院分区：
文献类型：
--
作者：
Dabbs, David J.;Klein, Molly E.;Bhargava, Rohit
目的：HER 2（ERBB 2）状态是乳腺癌重要的预后和预测指标。近年来，基因组健康（GHI），供应商的Oncotype DX测试，已单独报告HER 2通过逆转录聚合酶链反应（RT-PCR）的肿瘤学家。由于缺乏独立的评估，本质量保证研究进行了定义免疫组化（IHC）/荧光原位杂交（FISH）和GHI RT-PCR HER 2检测之间的一致率。（麦基妇女医院[宾夕法尼亚州匹兹堡]、克利夫兰诊所[俄亥俄州克利夫兰]和滨江卫理公会医院[哥伦布，OH]）以及GHI提供的HER 2 RT-PCR结果均纳入本研究中。所有IHC阳性和模棱两可的患者病例进行了进一步评估和分类FISH在各自的laborators.ResultsOf总843例患者的情况下，784（93%）被归类为阴性，36（4%）为阳性，和23（3%）为模棱两可的三个机构使用IHC/FISH。在784例阴性患者病例中，779例（99%）也被GHI RT-PCR检测归类为阴性。然而，所有23例可疑患者病例均被GHI报告为阴性。在36例阳性病例中，只有10例（28%; 95%CI，14%至45%）被报告为阳性，12例（33%）为可疑，14例（39%）为negative.ConclusionThere是一个不可接受的假阴性率与GHI HER 2检测在这个独立的研究HER 2状态。这可能会在靶向治疗的决策过程中造成混乱，如果只使用GHI HER 2信息，可能会导致乳腺癌患者的管理不善。J Clin Oncol 29：4279-4285. (C)2011年美国临床肿瘤学会
PurposeHER2 (ERBB2) status is an important prognostic and predictive marker in breast carcinoma. In recent years, Genomic Health (GHI), purveyors of the Oncotype DX test, has been separately reporting HER2 by reverse transcription polymerase chain reaction (RT-PCR) to oncologists. Because of the lack of independent evaluation, this quality assurance study was undertaken to define the concordance rate between immunohistochemistry (IHC)/fluorescent in situ hybridization (FISH) and GHI RT-PCR HER2 assay.MethodsAll patients at three participating laboratories (Magee-Womens Hospital [Pittsburgh, PA], Cleveland Clinic [Cleveland, OH], and Riverside Methodist Hospital [Columbus, OH]) with available HER2 RT-PCR results from GHI were included in this study. All IHC-positive and equivocal patient cases were further evaluated and classified by FISH at respective laboratories.ResultsOf the total 843 patient cases, 784 (93%) were classified as negative, 36 (4%) as positive, and 23 (3%) as equivocal at the three institutions using IHC/FISH. Of the 784 negative patient cases, 779 (99%) were also classified as negative by GHI RT-PCR assay. However, all 23 equivocal patient cases were reported as negative by GHI. Of the 36 positive cases, only 10 (28%; 95% CI, 14% to 45%) were reported as positive, 12 (33%) as equivocal, and 14 (39%) as negative.ConclusionThere was an unacceptable false-negative rate for HER2 status with GHI HER2 assay in this independent study. This could create confusion in the decision-making process for targeted treatment and potentially lead to mismanagement of patients with breast cancer if only GHI HER2 information is used. J Clin Oncol 29: 4279-4285. (C) 2011 by American Society of Clinical Oncology