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乳腺癌中基于RNA的诊断性基因表达分析的分析前变量及性能

Preanalytical variables and performance of diagnostic RNA-based gene expression analysis in breast cancer.

作者信息

Poremba Christopher, Uhlendorff Jennifer, Pfitzner Berit M, Hennig Guido, Bohmann Kerstin, Bojar Hans, Krenn Veit, Brase Jan C, Haufe Franziska, Averdick Manuela, Dietel Manfred, Kronenwett Ralf, Denkert Carsten

机构信息

Institute of Pathology Munich-North, Ernst-Platz-Straße 2, 80992, Munich, Germany,

出版信息

Virchows Arch. 2014 Oct;465(4):409-17. doi: 10.1007/s00428-014-1652-0. Epub 2014 Sep 14.

DOI:10.1007/s00428-014-1652-0
PMID:25218890
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4180906/
Abstract

Prognostic multigene expression assays have become widely available to provide additional information to standard clinical parameters and to support clinicians in treatment decisions. In this study, we analyzed the impact of variations in tissue handling on the diagnostic EndoPredict test results. EndoPredict is a quantitative reverse transcription PCR assay conducted on RNA from formalin-fixed, paraffin-embedded (FFPE) tissue that predicts the likelihood of distant recurrence in patients with ER-positive/HER2-negative breast cancer. In this study, we performed a total of 138 EndoPredict assays to study the effects of preanalytical variables such as time to fixation, fixation time, tumor cell content, and section storage time on the EndoPredict test results. A time to fixation of up to 12 h and fixation of up to 5 days did not affect the results of the gene expression test. Paired samples of FFPE sections with tumor cell content ranging from 15 to 95 % and tumor-enriched samples showed a correlation coefficient of 0.97. Test results of tissue sections that have been stored for 12 months at +4 or +20 °C showed a correlation of 0.99 when compared to results of nonstored sections. In conclusion, preanalytical tissue handling is not a critical factor for diagnostic gene expression analysis with the EndoPredict assay. The test can therefore be easily integrated into the standard workflow of molecular pathology.

摘要

预后多基因表达检测已广泛应用，旨在为标准临床参数提供更多信息，并辅助临床医生做出治疗决策。在本研究中，我们分析了组织处理差异对诊断性EndoPredict检测结果的影响。EndoPredict是一种基于福尔马林固定、石蜡包埋（FFPE）组织RNA进行的定量逆转录PCR检测，用于预测雌激素受体阳性/人表皮生长因子受体2阴性乳腺癌患者远处复发的可能性。在本研究中，我们共进行了138次EndoPredict检测，以研究诸如固定时间、固定时长、肿瘤细胞含量和切片保存时间等分析前变量对EndoPredict检测结果的影响。固定时间长达12小时以及固定时长长达5天均未影响基因表达检测结果。肿瘤细胞含量在15%至95%之间的FFPE切片配对样本以及富含肿瘤的样本显示相关系数为0.97。在4℃或20℃下保存12个月的组织切片检测结果与未保存切片的结果相比，相关性为0.99。总之，分析前组织处理并非EndoPredict检测诊断性基因表达分析的关键因素。因此，该检测可轻松融入分子病理学的标准工作流程。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ebef/4180906/2868a3a38b18/428_2014_1652_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ebef/4180906/5d4b5886c4ca/428_2014_1652_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ebef/4180906/485c0e1c1caf/428_2014_1652_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ebef/4180906/16e4626774ba/428_2014_1652_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ebef/4180906/7bcafe86bde4/428_2014_1652_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ebef/4180906/2868a3a38b18/428_2014_1652_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ebef/4180906/5d4b5886c4ca/428_2014_1652_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ebef/4180906/485c0e1c1caf/428_2014_1652_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ebef/4180906/16e4626774ba/428_2014_1652_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ebef/4180906/7bcafe86bde4/428_2014_1652_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ebef/4180906/2868a3a38b18/428_2014_1652_Fig5_HTML.jpg

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