Repository logo
 

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

Published version
Peer-reviewed

Change log

Authors

Voorwerk, Leonie 
van Seijen, Maartje 
Nederlof, Iris 
de Maaker, Michiel 

Abstract

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, 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.

Description

Funder: Breast Cancer Research Foundation (BCRF); doi: https://doi.org/10.13039/100001006

Keywords

Review Article, /631/67/1347, /692/53, /631/67/1857, /692/4028/67/580, review-article

Journal Title

npj Breast Cancer

Conference Name

Journal ISSN

2374-4677

Volume Title

6

Publisher

Nature Publishing Group UK