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Application of a ri...
Application of a risk-management framework for integration of stromal tumor-infiltrating lymphocytes in clinical trials
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- Hudeček, Jan (author)
- Netherlands Cancer Institute
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- Voorwerk, Leonie (author)
- Netherlands Cancer Institute
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- van Seijen, Maartje (author)
- Netherlands Cancer Institute
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- Nederlof, Iris (author)
- Netherlands Cancer Institute
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- de Maaker, Michiel (author)
- Netherlands Cancer Institute
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- van den Berg, Jose (author)
- Netherlands Cancer Institute
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- van de Vijver, Koen K (author)
- Ghent University Hospital
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- Sikorska, Karolina (author)
- Netherlands Cancer Institute
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- Adams, Sylvia (author)
- New York University
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- Demaria, Sandra (author)
- Weill Cornell Medicine
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- Viale, Giuseppe (author)
- University of Milan
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- Nielsen, Torsten O (author)
- University of British Columbia
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Badve, Sunil S (author)
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Michiels, Stefan (author)
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- Symmans, William Fraser (author)
- University of Texas MD Anderson Cancer Center
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- Sotiriou, Christos (author)
- Université Libre de Bruxelles (ULB)
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- Rimm, David L (author)
- Yale University
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- Hewitt, Stephen M (author)
- National Cancer Institute, NCI
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- Denkert, Carsten (author)
- Philipp University of Marburg
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Loibl, Sibylle (author)
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- Loi, Sherene (author)
- University of Melbourne
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- Bartlett, John M S (author)
- Western General Hospital
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- Pruneri, Giancarlo (author)
- University of Milan
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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, Zuzana (author)
- University of Ottawa
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Salgado, Roberto (author)
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- Kok, Marleen (author)
- Netherlands Cancer Institute
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- Horlings, Hugo M (author)
- Netherlands Cancer Institute
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- 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)
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- 2020-05-12
- 2020
- English.
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In: npj Breast Cancer. - : Springer Science and Business Media LLC. - 2374-4677. ; 6:1
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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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- By the author/editor
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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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show more...
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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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- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Cancer and Oncol ...
- Articles in the publication
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npj Breast Cance ...
- By the university
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Lund University