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

International Immuno-Oncology Biomarker Working Group

doi:10.1038/s41523-020-0155-1

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

International Immuno-Oncology Biomarker Working Group

Biomedical Informatics

Netherlands Cancer Institute
Ghent University
New York University
Cornell University
IRCCS Istituto Europeo di Oncologia - Milano
University of Milan
University of British Columbia
Indiana University Bloomington
Université Paris-Saclay
University of Texas MD Anderson Cancer Center
Université libre de Bruxelles
Yale University
National Institutes of Health
Charité – Universitätsmedizin Berlin
University of Marburg
German Breast Group
University of Melbourne
Ontario Institute for Cancer Research
IGMM
NHS Lothian
IRCCS Fondazione Istituto Nazionale per lo studio e la cura dei tumori - Milano
Harvard University
The Institute of Cancer Research
Vivactiv Ltd
University of Ottawa
Department of Oral and Maxillofacial Diseases
Matsuyama Shimin Hospital
Baylor College of Medicine
Roche Diagnostics
PhenoPath Laboratories
Genentech, Inc
University of Turin
Case Western Reserve University
VA Medical Center
Johns Hopkins University
PathAI, Inc
University of Iowa
IVO
Guy's and St Thomas' NHS Foundation Trust
King's College London
Lund University
Dana-Farber Cancer Institute

Research output: Contribution to journal › Review article › peer-review

17 Scopus citations

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 language	English
Article number	15
Journal	npj Breast Cancer
Volume	6
Issue number	1
DOIs	https://doi.org/10.1038/s41523-020-0155-1
State	Published - Dec 1 2020

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@article{79f469241a1f4b52975518ad2443a3a9,

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

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.",

author = "\{International Immuno-Oncology Biomarker Working Group\} and Jan Hude{\v c}ek and Leonie Voorwerk and \{van Seijen\}, Maartje and Iris Nederlof and \{de Maaker\}, Michiel and \{van den Berg\}, Jose and \{van de Vijver\}, \{Koen K.\} and Karolina Sikorska and Sylvia Adams and Sandra Demaria and Giuseppe Viale and Nielsen, \{Torsten O.\} and Badve, \{Sunil S.\} and Stefan Michiels and Symmans, \{William Fraser\} and Christos Sotiriou and Rimm, \{David L.\} and Hewitt, \{Stephen M.\} and Carsten Denkert and Sibylle Loibl and Sherene Loi and Bartlett, \{John M.S.\} and Giancarlo Pruneri and Dillon, \{Deborah A.\} and Cheang, \{Maggie C.U.\} and Andrew Tutt and Hall, \{Jacqueline A.\} and Zuzana Kos and Roberto Salgado and Marleen Kok and Horlings, \{Hugo M.\} and Aini Hyyti{\"a}inen and Hida, \{Akira I.\} and Alastair Thompson and Alex Lefevre and Lazar, \{Alexander J.\} and Allen Gown and Amy Lo and Anna Sapino and Anant Madabhushi and Andre Moreira and Andrea Richardson and Andrea Vingiani and Beck, \{Andrew H.\} and Bellizzi, \{Andrew M.\} and Angel Guerrero and Anita Grigoriadis and Anna Ehinger and Ana Garrido-Castro and Joel Saltz",

note = "Publisher Copyright: {\textcopyright} 2020, The Author(s).",

year = "2020",

month = dec,

day = "1",

doi = "10.1038/s41523-020-0155-1",

language = "English",

volume = "6",

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T1 - Application of a risk-management framework for integration of stromal tumor-infiltrating lymphocytes in clinical trials

AU - International Immuno-Oncology Biomarker Working Group

AU - Hudeček, Jan

AU - Voorwerk, Leonie

AU - van Seijen, Maartje

AU - Nederlof, Iris

AU - de Maaker, Michiel

AU - van den Berg, Jose

AU - van de Vijver, Koen K.

AU - Sikorska, Karolina

AU - Adams, Sylvia

AU - Demaria, Sandra

AU - Viale, Giuseppe

AU - Nielsen, Torsten O.

AU - Badve, Sunil S.

AU - Michiels, Stefan

AU - Symmans, William Fraser

AU - Sotiriou, Christos

AU - Rimm, David L.

AU - Hewitt, Stephen M.

AU - Denkert, Carsten

AU - Loibl, Sibylle

AU - Loi, Sherene

AU - Bartlett, John M.S.

AU - Pruneri, Giancarlo

AU - Dillon, Deborah A.

AU - Cheang, Maggie C.U.

AU - Tutt, Andrew

AU - Hall, Jacqueline A.

AU - Kos, Zuzana

AU - Salgado, Roberto

AU - Kok, Marleen

AU - Horlings, Hugo M.

AU - Hyytiäinen, Aini

AU - Hida, Akira I.

AU - Thompson, Alastair

AU - Lefevre, Alex

AU - Lazar, Alexander J.

AU - Gown, Allen

AU - Lo, Amy

AU - Sapino, Anna

AU - Madabhushi, Anant

AU - Moreira, Andre

AU - Richardson, Andrea

AU - Vingiani, Andrea

AU - Beck, Andrew H.

AU - Bellizzi, Andrew M.

AU - Guerrero, Angel

AU - Grigoriadis, Anita

AU - Ehinger, Anna

AU - Garrido-Castro, Ana

AU - Saltz, Joel

PY - 2020/12/1

Y1 - 2020/12/1

N2 - 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.

AB - 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.

UR - https://www.scopus.com/pages/publications/85083420171

U2 - 10.1038/s41523-020-0155-1

DO - 10.1038/s41523-020-0155-1

M3 - Review article

AN - SCOPUS:85083420171

SN - 2374-4677

VL - 6

JO - npj Breast Cancer

JF - npj Breast Cancer

IS - 1

M1 - 15

ER -

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

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