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

Jan Hudeček, Leonie Voorwerk, Maartje van Seijen, Iris Nederlof, Michiel de Maaker, Jose van den Berg, Koen K. van de Vijver, Karolina Sikorska, Sylvia Adams, Sandra Demaria, Giuseppe Viale, Torsten O. Nielsen, Sunil S. Badve, Stefan Michiels, William Fraser Symmans, Christos Sotiriou, David L. Rimm, Stephen M. Hewitt, Carsten Denkert, Sibylle LoiblSherene Loi, John M. S. Bartlett, Giancarlo Pruneri, Deborah A. Dillon, Maggie C. U. Cheang, Andrew Tutt, Jacqueline A. Hall, Zuzana Kos, Roberto Salgado, Marleen Kok, Hugo M. Horlings

Research output: Contribution to journalArticlepeer-review

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.
Original languageEnglish
Journalnpj Breast Cancer
Volume6
DOIs
Publication statusPublished - 2020

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