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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 and Demaria, Sandra , et al. (2020) In npj Breast Cancer 6(1).
Abstract

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,... (More)

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.

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contributor
LU orcid
author collaboration
organization
publishing date
type
Contribution to journal
publication status
published
subject
in
npj Breast Cancer
volume
6
issue
1
article number
15
publisher
Nature Publishing Group
external identifiers
  • pmid:32436923
  • scopus:85083420171
  • pmid:32436923
ISSN
2374-4677
DOI
10.1038/s41523-020-0155-1
language
English
LU publication?
yes
additional info
© The Author(s) 2020.
id
532ceeeb-b614-450a-b496-bab82d76be46
date added to LUP
2020-06-13 03:32:42
date last changed
2025-01-10 13:10:53
@article{532ceeeb-b614-450a-b496-bab82d76be46,
  abstract     = {{<p>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.</p>}},
  author       = {{Hudeček, Jan and Voorwerk, Leonie and van Seijen, Maartje and Nederlof, Iris and de Maaker, Michiel and van den Berg, Jose and van de Vijver, Koen K and Sikorska, Karolina and Adams, Sylvia and Demaria, Sandra and Viale, Giuseppe and Nielsen, Torsten O and Badve, Sunil S and Michiels, Stefan and Symmans, William Fraser and Sotiriou, Christos and Rimm, David L and Hewitt, Stephen M and Denkert, Carsten and Loibl, Sibylle and Loi, Sherene and Bartlett, John M S and Pruneri, Giancarlo and Dillon, Deborah A and Cheang, Maggie C U and Tutt, Andrew and Hall, Jacqueline A and Kos, Zuzana and Salgado, Roberto and Kok, Marleen and Horlings, Hugo M}},
  issn         = {{2374-4677}},
  language     = {{eng}},
  month        = {{12}},
  number       = {{1}},
  publisher    = {{Nature Publishing Group}},
  series       = {{npj Breast Cancer}},
  title        = {{Application of a risk-management framework for integration of stromal tumor-infiltrating lymphocytes in clinical trials}},
  url          = {{http://dx.doi.org/10.1038/s41523-020-0155-1}},
  doi          = {{10.1038/s41523-020-0155-1}},
  volume       = {{6}},
  year         = {{2020}},
}