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Application of a risk-management framework for integration of stromal tumor-infiltrating lymphocytes in clinical trials

Hudeček, Jan (author)
Netherlands Cancer Institute
Voorwerk, Leonie (author)
Netherlands Cancer Institute
van Seijen, Maartje (author)
Netherlands Cancer Institute
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Nederlof, Iris (author)
Netherlands Cancer Institute
de Maaker, Michiel (author)
Netherlands Cancer Institute
van den Berg, Jose (author)
Netherlands Cancer Institute
van de Vijver, Koen K (author)
Ghent University Hospital
Sikorska, Karolina (author)
Netherlands Cancer Institute
Adams, Sylvia (author)
New York University
Demaria, Sandra (author)
Weill Cornell Medicine
Viale, Giuseppe (author)
University of Milan
Nielsen, Torsten O (author)
University of British Columbia
Badve, Sunil S (author)
Michiels, Stefan (author)
Symmans, William Fraser (author)
University of Texas MD Anderson Cancer Center
Sotiriou, Christos (author)
Université Libre de Bruxelles (ULB)
Rimm, David L (author)
Yale University
Hewitt, Stephen M (author)
National Cancer Institute, NCI
Denkert, Carsten (author)
Philipp University of Marburg
Loibl, Sibylle (author)
Loi, Sherene (author)
University of Melbourne
Bartlett, John M S (author)
Western General Hospital
Pruneri, Giancarlo (author)
University of Milan
Dillon, Deborah A (author)
Cheang, Maggie C U (author)
Tutt, Andrew (author)
Hall, Jacqueline A (author)
Kos, Zuzana (author)
University of Ottawa
Salgado, Roberto (author)
Kok, Marleen (author)
Netherlands Cancer Institute
Horlings, Hugo M (author)
Netherlands Cancer Institute
Ehinger, Anna (creator_code:cre_t)
Lund 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
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 (creator_code:org_t)
 
2020-05-12
2020
English.
In: npj Breast Cancer. - : Springer Science and Business Media LLC. - 2374-4677. ; 6:1
Related links:
http://dx.doi.org/10... (free)
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https://www.nature.c...
https://lup.lub.lu.s...
https://doi.org/10.1...
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  • Research review (peer-reviewed)
Abstract Subject headings
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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

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Cancer and Oncology (hsv//eng)

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