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Application of a risk-management framework for integration of stromal tumor-infiltrating lymphocytes in clinical trials
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, na...
| Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
Nature Publishing Group UK
2020
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| Materias: | |
| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7217941/ https://www.ncbi.nlm.nih.gov/pubmed/32436923 http://dx.doi.org/10.1038/s41523-020-0155-1 |
| _version_ | 1783532692739981312 |
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| author | Hudeček, Jan Voorwerk, Leonie van Seijen, Maartje Nederlof, Iris de Maaker, Michiel van den Berg, Jose van de Vijver, Koen K. Sikorska, Karolina Adams, Sylvia Demaria, Sandra Viale, Giuseppe Nielsen, Torsten O. Badve, Sunil S. Michiels, Stefan Symmans, William Fraser Sotiriou, Christos Rimm, David L. Hewitt, Stephen M. Denkert, Carsten Loibl, Sibylle Loi, Sherene Bartlett, John M. S. Pruneri, Giancarlo Dillon, Deborah A. Cheang, Maggie C. U. Tutt, Andrew Hall, Jacqueline A. Kos, Zuzana Salgado, Roberto Kok, Marleen Horlings, Hugo M. |
| author_facet | Hudeček, Jan Voorwerk, Leonie van Seijen, Maartje Nederlof, Iris de Maaker, Michiel van den Berg, Jose van de Vijver, Koen K. Sikorska, Karolina Adams, Sylvia Demaria, Sandra Viale, Giuseppe Nielsen, Torsten O. Badve, Sunil S. Michiels, Stefan Symmans, William Fraser Sotiriou, Christos Rimm, David L. Hewitt, Stephen M. Denkert, Carsten Loibl, Sibylle Loi, Sherene Bartlett, John M. S. Pruneri, Giancarlo Dillon, Deborah A. Cheang, Maggie C. U. Tutt, Andrew Hall, Jacqueline A. Kos, Zuzana Salgado, Roberto Kok, Marleen Horlings, Hugo M. |
| author_sort | Hudeček, Jan |
| collection | PubMed |
| description | 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. |
| format | Online Article Text |
| id | pubmed-7217941 |
| institution | National Center for Biotechnology Information |
| language | English |
| publishDate | 2020 |
| publisher | Nature Publishing Group UK |
| record_format | MEDLINE/PubMed |
| spelling | pubmed-72179412020-05-14 Application of a risk-management framework for integration of stromal tumor-infiltrating lymphocytes in clinical trials Hudeček, Jan Voorwerk, Leonie van Seijen, Maartje Nederlof, Iris de Maaker, Michiel van den Berg, Jose van de Vijver, Koen K. Sikorska, Karolina Adams, Sylvia Demaria, Sandra Viale, Giuseppe Nielsen, Torsten O. Badve, Sunil S. Michiels, Stefan Symmans, William Fraser Sotiriou, Christos Rimm, David L. Hewitt, Stephen M. Denkert, Carsten Loibl, Sibylle Loi, Sherene Bartlett, John M. S. Pruneri, Giancarlo Dillon, Deborah A. Cheang, Maggie C. U. Tutt, Andrew Hall, Jacqueline A. Kos, Zuzana Salgado, Roberto Kok, Marleen Horlings, Hugo M. NPJ Breast Cancer Review Article 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. Nature Publishing Group UK 2020-05-12 /pmc/articles/PMC7217941/ /pubmed/32436923 http://dx.doi.org/10.1038/s41523-020-0155-1 Text en © The Author(s) 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/. |
| spellingShingle | Review Article Hudeček, Jan Voorwerk, Leonie van Seijen, Maartje Nederlof, Iris de Maaker, Michiel van den Berg, Jose van de Vijver, Koen K. Sikorska, Karolina Adams, Sylvia Demaria, Sandra Viale, Giuseppe Nielsen, Torsten O. Badve, Sunil S. Michiels, Stefan Symmans, William Fraser Sotiriou, Christos Rimm, David L. Hewitt, Stephen M. Denkert, Carsten Loibl, Sibylle Loi, Sherene Bartlett, John M. S. Pruneri, Giancarlo Dillon, Deborah A. Cheang, Maggie C. U. Tutt, Andrew Hall, Jacqueline A. Kos, Zuzana Salgado, Roberto Kok, Marleen Horlings, Hugo M. Application of a risk-management framework for integration of stromal tumor-infiltrating lymphocytes in clinical trials |
| title | Application of a risk-management framework for integration of stromal tumor-infiltrating lymphocytes in clinical trials |
| title_full | Application of a risk-management framework for integration of stromal tumor-infiltrating lymphocytes in clinical trials |
| title_fullStr | Application of a risk-management framework for integration of stromal tumor-infiltrating lymphocytes in clinical trials |
| title_full_unstemmed | Application of a risk-management framework for integration of stromal tumor-infiltrating lymphocytes in clinical trials |
| title_short | Application of a risk-management framework for integration of stromal tumor-infiltrating lymphocytes in clinical trials |
| title_sort | application of a risk-management framework for integration of stromal tumor-infiltrating lymphocytes in clinical trials |
| topic | Review Article |
| url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7217941/ https://www.ncbi.nlm.nih.gov/pubmed/32436923 http://dx.doi.org/10.1038/s41523-020-0155-1 |
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