Application of a risk-management framework for integration of stromal tumor-infiltrating lymphocytes in clinical trials.
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ICR Authors
Authors
Hudeček, J
Voorwerk, L
van Seijen, M
Nederlof, I
de Maaker, M
van den Berg, J
van de Vijver, KK
Sikorska, K
Adams, S
Demaria, S
Viale, G
Nielsen, TO
Badve, SS
Michiels, S
Symmans, WF
Sotiriou, C
Rimm, DL
Hewitt, SM
Denkert, C
Loibl, S
Loi, S
Bartlett, JMS
Pruneri, G
Dillon, DA
Cheang, MCU
Tutt, A
Hall, JA
Kos, Z
Salgado, R
Kok, M
Horlings, HM
International Immuno-Oncology Biomarker Working Group,
Voorwerk, L
van Seijen, M
Nederlof, I
de Maaker, M
van den Berg, J
van de Vijver, KK
Sikorska, K
Adams, S
Demaria, S
Viale, G
Nielsen, TO
Badve, SS
Michiels, S
Symmans, WF
Sotiriou, C
Rimm, DL
Hewitt, SM
Denkert, C
Loibl, S
Loi, S
Bartlett, JMS
Pruneri, G
Dillon, DA
Cheang, MCU
Tutt, A
Hall, JA
Kos, Z
Salgado, R
Kok, M
Horlings, HM
International Immuno-Oncology Biomarker Working Group,
Document Type
Journal Article
Date
2020-05-12
Date Accepted
2020-02-18
Date Available
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.
Citation
NPJ breast cancer, 2020, 6 pp. 15 - ?
Source Title
Publisher
NATURE RESEARCH
ISSN
2374-4677
eISSN
2374-4677
Collections
Research Team
Genomic Analysis – Clinical Trials