Application of a risk-management framework for integration of stromal tumor-infiltrating lymphocytes in clinical trials
Publication year
2020Author(s)
Source
NPJ breast cancer, 6, (2020), article 15ISSN
Publication type
Article / Letter to editor

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Organization
Pathology
Medical Imaging
Journal title
NPJ breast cancer
Volume
vol. 6
Subject
Radboudumc 14: Tumours of the digestive tract RIHS: Radboud Institute for Health Sciences; Radboudumc 17: Women's cancers RIHS: Radboud Institute for Health SciencesAbstract
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.
This item appears in the following Collection(s)
- Academic publications [227904]
- Electronic publications [107411]
- Faculty of Medical Sciences [86236]
- Open Access publications [76524]
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