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Application of a ri...
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Hudeček, JanNetherlands Cancer Institute
(author)
Application of a risk-management framework for integration of stromal tumor-infiltrating lymphocytes in clinical trials
- Article/chapterEnglish2020
Publisher, publication year, extent ...
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2020-05-12
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Springer Science and Business Media LLC,2020
Numbers
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LIBRIS-ID:oai:lup.lub.lu.se:532ceeeb-b614-450a-b496-bab82d76be46
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https://lup.lub.lu.se/record/532ceeeb-b614-450a-b496-bab82d76be46URI
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https://doi.org/10.1038/s41523-020-0155-1DOI
Supplementary language notes
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Language:English
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Summary in:English
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Subject category:for swepub-publicationtype
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Subject category:ref swepub-contenttype
Notes
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Stromal 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.
Subject headings and genre
Added entries (persons, corporate bodies, meetings, titles ...)
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Voorwerk, LeonieNetherlands Cancer Institute
(author)
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van Seijen, MaartjeNetherlands Cancer Institute
(author)
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Nederlof, IrisNetherlands Cancer Institute
(author)
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de Maaker, MichielNetherlands Cancer Institute
(author)
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van den Berg, JoseNetherlands Cancer Institute
(author)
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van de Vijver, Koen KGhent University Hospital
(author)
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Sikorska, KarolinaNetherlands Cancer Institute
(author)
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Adams, SylviaNew York University
(author)
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Demaria, SandraWeill Cornell Medicine
(author)
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Viale, GiuseppeUniversity of Milan
(author)
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Nielsen, Torsten OUniversity of British Columbia
(author)
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Badve, Sunil S
(author)
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Michiels, Stefan
(author)
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Symmans, William FraserUniversity of Texas MD Anderson Cancer Center
(author)
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Sotiriou, ChristosUniversité Libre de Bruxelles (ULB)
(author)
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Rimm, David LYale University
(author)
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Hewitt, Stephen MNational Cancer Institute, NCI
(author)
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Denkert, CarstenPhilipp University of Marburg
(author)
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Loibl, Sibylle
(author)
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Loi, ShereneUniversity of Melbourne
(author)
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Bartlett, John M SWestern General Hospital
(author)
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Pruneri, GiancarloUniversity of Milan
(author)
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Dillon, Deborah A
(author)
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Cheang, Maggie C U
(author)
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Tutt, Andrew
(author)
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Hall, Jacqueline A
(author)
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Kos, ZuzanaUniversity of Ottawa
(author)
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Salgado, Roberto
(author)
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Kok, MarleenNetherlands Cancer Institute
(author)
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Horlings, Hugo MNetherlands Cancer Institute
(author)
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Ehinger, AnnaLund University,Lunds universitet,LUCC: Lunds universitets cancercentrum,Övriga starka forskningsmiljöer,Patologi, Lund,Sektion V,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,LUCC: Lund University Cancer Centre,Other Strong Research Environments,Pathology, Lund,Section V,Department of Clinical Sciences, Lund,Faculty of Medicine,Skåne University Hospital(Swepub:lu)pat-amm
(creator_code:cre_t)
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Netherlands Cancer InstituteGhent University Hospital
(creator_code:org_t)
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International Immuno-Oncology Biomarker Working Group
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In:npj Breast Cancer: Springer Science and Business Media LLC6:12374-4677
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Hudeček, Jan
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Voorwerk, Leonie
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van Seijen, Maar ...
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Nederlof, Iris
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de Maaker, Michi ...
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van den Berg, Jo ...
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van de Vijver, K ...
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Sikorska, Karoli ...
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Adams, Sylvia
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Demaria, Sandra
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Viale, Giuseppe
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Nielsen, Torsten ...
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Badve, Sunil S
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Michiels, Stefan
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Symmans, William ...
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Sotiriou, Christ ...
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Rimm, David L
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Hewitt, Stephen ...
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Denkert, Carsten
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Loibl, Sibylle
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Loi, Sherene
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Bartlett, John M ...
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Pruneri, Giancar ...
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Dillon, Deborah ...
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Cheang, Maggie C ...
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Tutt, Andrew
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Hall, Jacqueline ...
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Kos, Zuzana
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Salgado, Roberto
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Kok, Marleen
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Horlings, Hugo M
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Ehinger, Anna
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npj Breast Cance ...
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