Comparison of the RNA-based EndoPredict multigene test between core biopsies and corresponding surgical breast cancer sections
Berit Maria Müller, Jan C Brase, Franziska Haufe, Karsten E Weber, Jan Budzies, Christoph Petry, Judith Prinzler, Ralf Kronenwett, Manfred Dietel, Carsten Denkert, Berit Maria Müller, Jan C Brase, Franziska Haufe, Karsten E Weber, Jan Budzies, Christoph Petry, Judith Prinzler, Ralf Kronenwett, Manfred Dietel, Carsten Denkert
Abstract
Aim: This study compared the perfomance of the RNA-based EndoPredict multigene test on core biopsies and surgical breast cancer specimens and analysed the influence of biopsy-induced tissue injuries on the test result.
Methods: 80 formalin-fixed paraffin-embedded samples comprising paired biopsies and surgical specimens from 40 ER-positive, HER2-negative patients were evaluated. Total RNA was extracted and the EndoPredict score was determined.
Results: RNA yield was considerably lower in core biopsies, but sufficient to measure the assay in all samples. The EndoPredict score was highly correlated between paired samples (Pearson r=0.92), with an excellent concordance of classification into a low or high risk of metastasis (overall agreement 95%).
Conclusions: The measurements are comparable between core biopsies and surgical sections, which suggest that the EndoPredict assay can be performed on core biopsy tissue. Inflammatory changes induced by presurgical biopsies had no significant effect on the RNA-based risk assessment in surgical specimens.
Conflict of interest statement
Competing interests: KEW, CP, MD, RK and CD are shareholders in Sividon Diagnostics. The remaining authors report no competing interests.
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References
- Siegel R, Naishadham D, Jemal A. Cancer statistics, 2012. CA Cancer J Clin 2012;62:10–29
- Sotiriou C, Pusztai L. Gene-expression signatures in breast cancer. N Engl J Med 2009;360:790–800
- Wang Y, Klijn JGM, Zhang Y, et al. Gene-expression profiles to predict distant metastasis of lymph-node-negative primary breast cancer. Lancet 2005;365:671–79
- Filipits M, Rudas M, Jakesz R, et al. A new molecular predictor of distant recurrence in ER-positive, HER2-negative breast cancer adds independent information to conventional clinical risk factors. Clin Cancer Res 2011;17:6012–20
- Paik S, Shak S, Tang G, et al. A multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancer. N Engl J Med 2004;351:2817–26
- van de Vijver MJ, He YD, van 't Veer LJ, et al. A gene-expression signature as a predictor of survival in breast cancer. N Engl J Med 2002;347:1999–2009
- Haas S, Park T-W, Hahne J, et al. Influence of preoperative core biopsies on uPA/PAI-1 expression in breast cancer tissue. Virchows Arch 2008;452:277–83
- Dietel M, Ellis IO, Hofler H, et al. Comparison of automated silver enhanced in situ hybridisation (SISH) and fluorescence ISH (FISH) for the validation of HER2 gene status in breast carcinoma according to the guidelines of the American Society of Clinical Oncology and the College of American Pathologists. Virchows Arch 2007;451:19–25
- Bohmann K, Hennig G, Rogel U, et al. RNA extraction from archival formalin-fixed paraffin-embedded tissue: a comparison of manual, semiautomated, and fully automated purification methods. Clin Chem 2009;55:1719–27
- Hennig G, Gehrmann M, Stropp U, et al. Automated extraction of DNA and RNA from a single formalin-fixed paraffin-embedded tissue section for analysis of both single-nucleotide polymorphisms and mRNA expression. Clin Chem 2010;56:1845–53
- Muller BM, Kronenwett R, Hennig G, et al. Quantitative determination of estrogen receptor, progesterone receptor, and HER2 mRNA in formalin-fixed paraffin-embedded tissue – a new option for predictive biomarker assessment in breast cancer. Diagn Mol Pathol 2011;20:1–10
- Zanetti-Dallenbach R, Vuaroqueaux V, Wight E, et al. Comparison of gene expression profiles in core biopsies and corresponding surgical breast cancer samples. Breast Cancer Res 2006;8:R51.
Source: PubMed