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dc.contributor.authorHudeček, J
dc.contributor.authorVoorwerk, L
dc.contributor.authorvan Seijen, M
dc.contributor.authorNederlof, I
dc.contributor.authorde Maaker, M
dc.contributor.authorvan den Berg, J
dc.contributor.authorvan de Vijver, KK
dc.contributor.authorSikorska, K
dc.contributor.authorAdams, S
dc.contributor.authorDemaria, S
dc.contributor.authorViale, G
dc.contributor.authorNielsen, TO
dc.contributor.authorBadve, SS
dc.contributor.authorMichiels, S
dc.contributor.authorSymmans, WF
dc.contributor.authorSotiriou, C
dc.contributor.authorRimm, DL
dc.contributor.authorHewitt, SM
dc.contributor.authorDenkert, C
dc.contributor.authorLoibl, S
dc.contributor.authorLoi, S
dc.contributor.authorBartlett, JMS
dc.contributor.authorPruneri, G
dc.contributor.authorDillon, DA
dc.contributor.authorCheang, MCU
dc.contributor.authorTutt, A
dc.contributor.authorHall, JA
dc.contributor.authorKos, Z
dc.contributor.authorSalgado, R
dc.contributor.authorKok, M
dc.contributor.authorHorlings, HM
dc.contributor.authorInternational Immuno-Oncology Biomarker Working Group
dc.date.accessioned2020-06-08T14:36:33Z
dc.date.issued2020-01
dc.identifier.citationNPJ breast cancer, 2020, 6 pp. 15 - ?
dc.identifier.issn2374-4677
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/3700
dc.identifier.eissn2374-4677
dc.identifier.doi10.1038/s41523-020-0155-1
dc.description.abstractStromal tumor-infiltrating lymphocytes (sTILs) are a potential predictive biomarker for immunotherapy response in metastatic triple-negative breast cancer (TNBC). To incorporate sTILs into clinical trials and diagnostics, reliable assessment is essential. In this review, we propose a new concept, namely the implementation of a risk-management framework that enables the use of sTILs as a stratification factor in clinical trials. We present the design of a biomarker risk-mitigation workflow that can be applied to any biomarker incorporation in clinical trials. We demonstrate the implementation of this concept using sTILs as an integral biomarker in a single-center phase II immunotherapy trial for metastatic TNBC (TONIC trial, NCT02499367), using this workflow to mitigate risks of suboptimal inclusion of sTILs in this specific trial. In this review, we demonstrate that a web-based scoring platform can mitigate potential risk factors when including sTILs in clinical trials, and we argue that this framework can be applied for any future biomarker-driven clinical trial setting.
dc.formatElectronic-eCollection
dc.format.extent15 - ?
dc.languageeng
dc.language.isoeng
dc.rights.urihttps://creativecommons.org/licenses/by/4.0
dc.subjectInternational Immuno-Oncology Biomarker Working Group
dc.titleApplication of a risk-management framework for integration of stromal tumor-infiltrating lymphocytes in clinical trials.
dc.typeJournal Article
dcterms.dateAccepted2020-02-18
rioxxterms.versionofrecord10.1038/s41523-020-0155-1
rioxxterms.licenseref.urihttps://creativecommons.org/licenses/by/4.0
rioxxterms.licenseref.startdate2020-01
rioxxterms.typeJournal Article/Review
dc.relation.isPartOfNPJ breast cancer
pubs.notesNot known
pubs.organisational-group/ICR
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/ICR Divisions
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Genomic Analysis – Clinical Trials
pubs.organisational-group/ICR
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/ICR Divisions
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Genomic Analysis – Clinical Trials
pubs.publication-statusPublished
pubs.volume6
pubs.embargo.termsNot known
icr.researchteamGenomic Analysis – Clinical Trialsen_US
dc.contributor.icrauthorCheang, Chonen


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Except where otherwise noted, this item's license is described as https://creativecommons.org/licenses/by/4.0