An international reproducibility study validating quantitative determination of ERBB2, ESR1, PGR, and MKI67 mRNA in breast cancer using MammaTyper (R)

Show simple item record Varga, Zsuzsanna Lebeau, Annette Bu, Hong Hartmann, Arndt Penault-Llorca, Frederique Guerini-Rocco, Elena Schraml, Peter Symmans, Fraser Stoehr, Robert Teng, Xiaodong Turzynski, Andreas von Wasielewski, Reinhard Guertler, Claudia Laible, Mark Schlombs, Kornelia Joensuu, Heikki Keller, Thomas Sinn, Peter Sahin, Ugur Bartlett, John Viale, Giuseppe 2017-06-13T11:20:01Z 2017-06-13T11:20:01Z 2017-05-11
dc.identifier.citation Varga , Z , Lebeau , A , Bu , H , Hartmann , A , Penault-Llorca , F , Guerini-Rocco , E , Schraml , P , Symmans , F , Stoehr , R , Teng , X , Turzynski , A , von Wasielewski , R , Guertler , C , Laible , M , Schlombs , K , Joensuu , H , Keller , T , Sinn , P , Sahin , U , Bartlett , J & Viale , G 2017 , ' An international reproducibility study validating quantitative determination of ERBB2, ESR1, PGR, and MKI67 mRNA in breast cancer using MammaTyper (R) ' , Breast Cancer Research , vol. 19 , 55 .
dc.identifier.other PURE: 85519351
dc.identifier.other PURE UUID: c5f49bb6-d63a-4297-a623-d507d414b93d
dc.identifier.other WOS: 000401632700001
dc.identifier.other Scopus: 85019101718
dc.identifier.other ORCID: /0000-0003-0281-2507/work/33999292
dc.description.abstract Background: Accurate determination of the predictive markers human epidermal growth factor receptor 2 (HER2/ERBB2), estrogen receptor (ER/ESR1), progesterone receptor (PgR/PGR), and marker of proliferation Ki67 (MKI67) is indispensable for therapeutic decision making in early breast cancer. In this multicenter prospective study, we addressed the issue of inter- and intrasite reproducibility using the recently developed reverse transcription-quantitative real-time polymerase chain reaction-based MammaTyper (R) test. Methods: Ten international pathology institutions participated in this study and determined messenger RNA expression levels of ERBB2, ESR1, PGR, and MKI67 in both centrally and locally extracted RNA from formalin-fixed, paraffin-embedded breast cancer specimens with the MammaTyper (R) test. Samples were measured repeatedly on different days within the local laboratories, and reproducibility was assessed by means of variance component analysis, Fleiss' kappa statistics, and interclass correlation coefficients (ICCs). Results: Total variations in measurements of centrally and locally prepared RNA extracts were comparable; therefore, statistical analyses were performed on the complete dataset. Intersite reproducibility showed total SDs between 0.21 and 0.44 for the quantitative single-marker assessments, resulting in ICC values of 0.980-0.998, demonstrating excellent agreement of quantitative measurements. Also, the reproducibility of binary single-marker results (positive/negative), as well as the molecular subtype agreement, was almost perfect with kappa values ranging from 0.90 to 1.00. Conclusions: On the basis of these data, the MammaTyper (R) has the potential to substantially improve the current standards of breast cancer diagnostics by providing a highly precise and reproducible quantitative assessment of the established breast cancer biomarkers and molecular subtypes in a decentralized workup. en
dc.format.extent 13
dc.language.iso eng
dc.relation.ispartof Breast Cancer Research
dc.rights unspecified
dc.rights.uri info:eu-repo/semantics/openAccess
dc.subject MammaTyper
dc.subject Reproducibility
dc.subject RT-qPCR
dc.subject FFPE
dc.subject Breast cancer
dc.subject ERBB2
dc.subject ESR1
dc.subject PGR
dc.subject MKI67
dc.subject WORKING GROUP
dc.subject RT-QPCR
dc.subject KI67
dc.subject 3122 Cancers
dc.title An international reproducibility study validating quantitative determination of ERBB2, ESR1, PGR, and MKI67 mRNA in breast cancer using MammaTyper (R) en
dc.type Article
dc.contributor.organization Clinicum
dc.contributor.organization Heikki Joensuu / Principal Investigator
dc.contributor.organization Department of Oncology
dc.description.reviewstatus Peer reviewed
dc.relation.issn 1465-542X
dc.rights.accesslevel openAccess
dc.type.version publishedVersion

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