Department of Pathology and Laboratory Medicine, Emory University, Atlanta, Georgia.
Winship Cancer Institute, Emory University, Atlanta, Georgia.
Breast J. 2018 Nov;24(6):889-893. doi: 10.1111/tbj.13110. Epub 2018 Sep 19.
INTRODUCTION: Oncotype DX (ODX) testing uses reverse transcription polymerase chain reaction (RT-PCR) to predict distant recurrence rate of estrogen receptor positive (ER+)/HER2-negative (HER2-)/lymph node-negative (LN-) breast cancers. ODX also reports the status of breast cancer biomarkers, ER, progesterone receptor (PR), and HER2. This study examined the discrepancy rate of breast cancer biomarker status as reported by ODX vs routinely used immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) methods. METHODS: A total of 610 breast cancer cases (609 ER+ and 1 ER-negative (ER-) by IHC) with ODX reports were reviewed. ER, PR, and HER2 status from ODX reports were compared with results from IHC and FISH studies. RESULTS: There was an overall high concordance rate between IHC and ODX for ER expression (603/610 concordant, 98.9%) and moderate concordance for PR expression (549/610 concordant, 90%). Of the seven ER-discrepant cases, six were positive by IHC but negative by ODX. Of the 61 PR-discrepant cases, 41 were positive by IHC but negative by ODX. Of the 610 cases, 568 had HER2 results reported by ODX. Five cases were HER2+ by IHC/FISH (0.88%). One of these five cases was reported as HER2+, two as HER2-, and two as HER2-equivocal by ODX. None of the cases that were HER2- or equivocal by IHC/FISH was reported as HER2+ by ODX. CONCLUSIONS: There is good concordance between IHC and ODX for ER and PR expression, but IHC is more sensitive. The significant discordance in HER2+ cases may discourage reporting HER2 status by ODX testing.
简介：Oncotype DX（ODX）检测使用逆转录聚合酶链反应（RT-PCR）来预测雌激素受体阳性（ER+）/人表皮生长因子受体 2 阴性（HER2-）/淋巴结阴性（LN-）乳腺癌的远处复发率。ODX 还报告了乳腺癌生物标志物 ER、孕激素受体（PR）和 HER2 的状态。本研究检查了 ODX 报告的乳腺癌生物标志物状态与常规使用免疫组织化学（IHC）和荧光原位杂交（FISH）方法报告的状态之间的差异率。
方法：共回顾了 610 例 ODX 报告的乳腺癌病例（609 例 ER+，1 例 IHC 检测 ER-）。比较了 ODX 报告中 ER、PR 和 HER2 状态与 IHC 和 FISH 研究的结果。
结果：ER 表达的 IHC 和 ODX 之间总体具有高一致性率（603/610 例一致，98.9%），PR 表达的一致性率为中度（549/610 例一致，90%）。在 7 例 ER 不一致的病例中，6 例 IHC 阳性但 ODX 阴性。在 61 例 PR 不一致的病例中，41 例 IHC 阳性但 ODX 阴性。在 610 例病例中，568 例有 ODX 报告的 HER2 结果。5 例 IHC/FISH 为 HER2+（0.88%）。这 5 例中的 1 例被 ODX 报告为 HER2+，2 例为 HER2-，2 例为 HER2 不确定。IHC/FISH 为 HER2-或不确定的病例均未被 ODX 报告为 HER2+。
结论：IHC 和 ODX 检测在 ER 和 PR 表达方面具有良好的一致性，但 IHC 更敏感。在 HER2+病例中存在显著差异，可能会阻止 ODX 检测报告 HER2 状态。
Appl Immunohistochem Mol Morphol. 2013-5
Breast Cancer Res Treat. 2021-5
Breast Cancer Res Treat. 2021-5
Zotero 插件