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 Loibl; Sherene 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; 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

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, International Immuno-Oncology Biomarker Working Group

^*Corresponding author for this work

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

15 Citations (Scopus)

51 Downloads (Pure)

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
Pages (from-to)	1-8
Number of pages	8
Journal	npj Breast Cancer
Volume	6
Issue number	1
DOIs	https://doi.org/10.1038/s41523-020-0155-1
Publication status	Published - 12 May 2020

Bibliographical note

Copyright the Author(s) 2020. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.

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Hudeček, J., Voorwerk, L., van Seijen, M., Nederlof, I., de Maaker, M., van den Berg, J., van de Vijver, K. K., Sikorska, K., Adams, S., Demaria, S., Viale, G., Nielsen, T. O., Badve, S. S., Michiels, S., Symmans, W. F., Sotiriou, C., Rimm, D. L., Hewitt, S. M., Denkert, C., ... International Immuno-Oncology Biomarker Working Group (2020). Application of a risk-management framework for integration of stromal tumor-infiltrating lymphocytes in clinical trials. npj Breast Cancer, 6(1), 1-8. Article 15. https://doi.org/10.1038/s41523-020-0155-1

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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 = "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. 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Aubrey} and Edi Brogi and Edith Perez and ElGabry, {Ehab A.} and Stovgaard, {Elisabeth Specht} and Blackley, {Elizabeth F.} and Elvire Roblin and Emily Reisenbichler and Enrique Bellolio and Eva Balslev and Ewa Chmielik and Fabien Gaire and Fabrice Andre and Fang-I. Lu and Farid Azmoudeh-Ardalan and Federico Rojo and Tina Gruosso and Francesco Ciompi and Franklin Peale and Hirsch, {Fred R.} and Frederick Klauschen and Fr{\'e}d{\'e}rique Penault-Llorca and {Acosta Haab}, Gabriela and Gelareh Farshid and {van den Eynden}, Gert and Giuseppe Curigliano and Giuseppe Floris and Glenn Broeckx and Paula Gonzalez-Ericsson and Harmut Koeppen and Haynes, {Harry R.} and Heather McArthur and Heikki Joensuu and Helena Olofsson and Lien, {Huang Chun} and I.-Chun Chen and Ian Cree and Isabel Frahm and Iva Brcic and Jack Chan and James Ziai and Jane Brock and Jelle Wesseling and Jennifer Giltnane and Kerner, {Jennifer K.} and Jeppe Thagaard and Braybrooke, {Jeremy P.} and {van der Laak}, {Jeroen A. W. 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note = "Copyright the Author(s) 2020. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.",

year = "2020",

month = may,

day = "12",

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

language = "English",

volume = "6",

pages = "1--8",

journal = "npj Breast Cancer",

issn = "2374-4677",

publisher = "Springer, Springer Nature",

number = "1",

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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 2020, 'Application of a risk-management framework for integration of stromal tumor-infiltrating lymphocytes in clinical trials', npj Breast Cancer, vol. 6, no. 1, 15, pp. 1-8. https://doi.org/10.1038/s41523-020-0155-1

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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 - International Immuno-Oncology Biomarker Working Group

AU - Hyytiäinen, Aini

AU - Hida, Akira I.

AU - Thompson, Alastair

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AU - Kooreman, Loes F. S.

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AU - Preusser, Matthias

AU - Khojasteh, Mehrnoush

AU - Sanders, Melinda E.

AU - Regan, Meredith M.

AU - Barnes, Michael

AU - Christie, Michael

AU - Misialek, Michael

AU - Ignatiadis, Michail

AU - van Bockstal, Mieke

AU - Castillo, Miluska

AU - Amgad, Mohamed

AU - Harbeck, Nadia

AU - Tung, Nadine

AU - Laudus, Nele

AU - Sirtaine, Nicolas

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AU - Radosevic-Robin, Nina

AU - Gluz, Oleg

AU - Grimm, Oliver

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AU - Kim, Rim S.

AU - Pierce, Robert H.

AU - Hills, Robert

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AU - Souza, Sandra C.

AU - O’Toole, Sandra

AU - Swain, Sandra

AU - Dudgeon, Sarah

AU - Willis, Scooter

AU - Ely, Scott

AU - Kim, Seong Rim

AU - Bedri, Shahinaz

AU - Irshad, Sheeba

AU - Liu, Shi Wei

AU - Goel, Shom

AU - Hendry, Shona

AU - Bianchi, Simonetta

AU - Bragança, Sofia

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AU - Naber, Stephen

AU - Schnitt, Stuart J.

AU - Sua, Luz F.

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AU - Fineberg, Susan

AU - Soler, Teresa

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AU - D’Alfonso, Timothy

AU - John, Tom

AU - Sugie, Tomohagu

AU - Kurkure, Uday

AU - Bossuyt, Veerle

AU - Manem, Venkata

AU - Cámara, Vincente Peg

AU - Tong, Weida

AU - Chen, Weijie

AU - Yang, Wentao

AU - Tran, William T.

AU - Wang, Yihong

AU - Yuan, Yinyin

AU - Allory, Yves

AU - Husian, Zaheed

AU - Bago-Horvath, Zsuzsanna

N1 - Copyright the Author(s) 2020. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.

PY - 2020/5/12

Y1 - 2020/5/12

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 - http://www.scopus.com/inward/record.url?scp=85083420171&partnerID=8YFLogxK

U2 - 10.1038/s41523-020-0155-1

DO - 10.1038/s41523-020-0155-1

M3 - Review article

C2 - 32436923

AN - SCOPUS:85083420171

SN - 2374-4677

VL - 6

SP - 1

EP - 8

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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