Dissemin is shutting down on January 1st, 2025

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Nature Research, npj Breast Cancer, 1(6), 2020

DOI: 10.1038/s41523-020-0155-1

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

Journal article published in 2020 by M. van Seijen, Jan Hudeček, Maartje van Seijen, Leonie Voorwerk, Koen K. van de Vijver, Torsten O. Nielsen, Iris Nederlof, Stefan Michiels, William Fraser Symmans, Christos Sotiriou, Michiel de Maaker, David L. Rimm, Stephen M. Hewitt, Sibylle Loibl, Jose van den Berg and other authors.
This paper is made freely available by the publisher.
This paper is made freely available by the publisher.

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Abstract

AbstractStromal 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.