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

Authors :
Hudecek, 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.
Loibl, S.
Loi, S.
Bartlett, J. M. S.
Pruneri, G.
Dillon, D. A.
Cheang, M. C. U.
Tutt, A.
Hall, J. A.
Kos, Z.
Salgado, R.
Kok, M.
Horlings, H. M.
Hyytiainen, A.
Hida, A. I.
Thompson, A.
Lefevre, A.
Lazar, A. J.
Gown, A.
Lo, A.
Sapino, A.
Madabhushi, A.
Moreira, A.
Richardson, A.
Vingiani, A.
Beck, A. H.
Bellizzi, A. M.
Guerrero, A.
Grigoriadis, A.
Ehinger, A.
Garrido-Castro, A.
Vincent-Salomon, A.
Laenkholm, A. -V.
Sharma, A.
Cimino-Mathews, A.
Srinivasan, A.
Acs, B.
Singh, B.
Calhoun, B.
Haibe-Kans, B.
Solomon, B.
Thapa, B.
Nelson, B. H.
Gallas, B. D.
Castaneda, C.
Ballesteros-Merino, C.
Criscitiello, C.
Boeckx, C.
Colpaert, C.
Quinn, C.
Chennubhotla, C. S.
Swanton, C.
Solinas, C.
Hiley, C.
Drubay, D.
Bethmann, D.
Moore, D. A.
Larsimont, D.
Sabanathan, D.
Peeters, D.
Zardavas, D.
Hoflmayer, D.
Johnson, D. B.
Thompson, E. A.
Brogi, E.
Perez, E.
Elgabry, E. A.
Stovgaard, E. S.
Blackley, E. F.
Roblin, E.
Reisenbichler, E.
Bellolio, E.
Balslev, E.
Chmielik, E.
Gaire, F.
Andre, F.
F. -I., Lu
Azmoudeh-Ardalan, F.
Rojo, F.
Gruosso, T.
Ciompi, F.
Peale, F.
Hirsch, F. R.
Klauschen, F.
Penault-Llorca, F.
Acosta Haab, G.
Farshid, G.
van den Eynden, G.
Curigliano, G.
Floris, G.
Broeckx, G.
Gonzalez-Ericsson
Koeppen, H.
Haynes, H. R.
Mcarthur, H.
Joensuu, H.
Olofsson, H.
Lien, H. -C.
Chen, I. -C.
Cree, I.
Frahm, I.
Brcic, I.
Chan, J.
Ziai, J.
Brock, J.
Wesseling, J.
Giltnane, J.
Kerner, J. K.
Thagaard, J.
Braybrooke, J. P.
van der Laak, J. A. W. M.
Lemonnier, J.
Zha, J.
Ribeiro, J.
Lennerz, J. K.
Carter, J. M.
Saltz, J.
Hartman, J.
Hainfellner, J.
Quesne, J. L.
Juco, J. W.
Reis-Filho, J.
Sanchez, J.
Sparano, J.
Cucherousset, J.
Araya, J. C.
Adam, J.
Balko, J. M.
Saeger, K.
Siziopikou, K.
Willard-Gallo, K.
Weber, K.
Pogue-Geile, K. L.
Steele, K. E.
Emancipator, K.
Abduljabbar, K.
El Bairi, K.
Blenman, K. R. M.
Allison, K. H.
Korski, K.
Pusztai, L.
Comerma, L.
Buisseret, L.
Cooper, L. A. D.
Shi, L.
Kooreman, L. F. S.
Molinero, L.
Estrada, M. V.
Lacroix-Triki, M.
Al Bakir, M.
Sebastian, M. M.
van de Vijver, M.
Balancin, M. L.
Dieci, M. V.
Mathieu, M. -C.
Rebelatto, M. C.
Piccart, M.
Hanna, M. G.
Goetz, M. P.
Preusser, M.
Khojasteh, M.
Sanders, M. E.
Regan, M. M.
Barnes, M.
Christie, M.
Misialek, M.
Ignatiadis, M.
van Bockstal, M.
Castillo, M.
Amgad, M.
Harbeck, N.
Tung, N.
Laudus, N.
Sirtaine, N.
Burchardi, N.
Ternes, N.
Radosevic-Robin, N.
Gluz, O.
Grimm, O.
Nuciforo, P.
Jank, P.
Gonzalez-Ericsson, P.
Kirtani, P.
Jelinic, P.
Watson, P. H.
Savas, P.
Francis, P. A.
Russell, P. A.
Singh, R.
Kim, R. S.
Pierce, R. H.
Hills, R.
Leon-Ferre, R.
de Wind, R.
Shui, R.
De Clercq, S.
Leung, S.
Tabbarah, S.
Souza, S. C.
O'Toole, S.
Swain, S.
Dudgeon, S.
Willis, S.
Ely, S.
Kim, S. -R.
Bedri, S.
Irshad, S.
Liu, S. -W.
Goel, S.
Hendry, S.
Bianchi, S.
Braganca, S.
Paik, S.
Wienert, S.
Fox, S. B.
Luen, S. J.
Naber, S.
Schnitt, S. J.
Sua, L. F.
Lakhani, S. R.
Fineberg, S.
Soler, T.
Gevaert, T.
D'Alfonso, T.
John, T.
Sugie, T.
Kurkure, U.
Bossuyt, V.
Manem, V.
Camara, V. P.
Tong, W.
Chen, W.
Yang, W.
Tran, W. T.
Wang, Y.
Yuan, Y.
Allory, Y.
Husain, Z.
Bago-Horvath, Z.
Division of Pathology and Laboratory Medicine
Università degli Studi di Milano [Milano] (UNIMI)-European Institute of Oncology [Milan] (ESMO)
Service de biostatistique et d'épidémiologie (SBE)
Direction de la recherche clinique [Gustave Roussy]
Institut Gustave Roussy (IGR)-Institut Gustave Roussy (IGR)
Institut Gustave Roussy (IGR)
Institut Jules Bordet [Bruxelles]
Faculté de Médecine [Bruxelles] (ULB)
Université libre de Bruxelles (ULB)-Université libre de Bruxelles (ULB)
Charité, Institute of Pathology, Translational Tumorpathology Unit
German Breast Group
Breast Cancer Translational Research Laboratory
Université libre de Bruxelles (ULB)-Université libre de Bruxelles (ULB)-Faculté de Médecine [Bruxelles] (ULB)
University of the Sunshine Coast (USC)
European Institute of Oncology [Milan] (ESMO)
Breakthrough Breast Cancer Centre
London Institute of Cancer
Department of Pathology
The Netherlands Cancer Institute
Division of Experimental Therapy
The Netherlands Cancer Institute NKI/AvL
Imagerie Moléculaire et Stratégies Théranostiques (IMoST)
Université Clermont Auvergne [2017-2020] (UCA [2017-2020])-Institut National de la Santé et de la Recherche Médicale (INSERM)
Centre Jean Perrin [Clermont-Ferrand] (UNICANCER/CJP)
UNICANCER
Hudeček, Jan [0000-0003-1071-5686]
van de Vijver, Koen K [0000-0002-2026-9790]
Demaria, Sandra [0000-0003-4426-0499]
Badve, Sunil S [0000-0001-8861-9980]
Symmans, William Fraser [0000-0002-1526-184X]
Rimm, David L [0000-0001-5820-4397]
Loi, Sherene [0000-0001-6137-9171]
Hall, Jacqueline A [0000-0003-0708-1360]
Horlings, Hugo M [0000-0003-4782-8828]
Apollo - University of Cambridge Repository
van de Vijver, Koen K. [0000-0002-2026-9790]
Badve, Sunil S. [0000-0001-8861-9980]
Rimm, David L. [0000-0001-5820-4397]
Hall, Jacqueline A. [0000-0003-0708-1360]
Horlings, Hugo M. [0000-0003-4782-8828]
Università degli Studi di Milano = University of Milan (UNIMI)-European Institute of Oncology [Milan] (ESMO)
Centre de recherche en épidémiologie et santé des populations (CESP)
Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay
Oncostat (U1018 (Équipe 2))
Institut Gustave Roussy (IGR)-Centre de recherche en épidémiologie et santé des populations (CESP)
Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay-Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay
German Breast Group (GBG)
Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020])
Source :
NPJ breast cancer, 6, npj Breast Cancer, npj Breast Cancer, Nature, 2020, 6 (1), pp.15. ⟨10.1038/s41523-020-0155-1⟩, NPJ Breast Cancer, npj Breast Cancer, Vol 6, Iss 1, Pp 1-8 (2020), 2020, ' Application of a risk-management framework for integration of stromal Tumor Infiltrating Lymphocytes in clinical trials ', NPJ Breast Cancer . https://doi.org/10.1038/s41523-020-0155-1, NPJ BREAST CANCER, npj Breast Cancer, 2020, 6 (1), pp.15. ⟨10.1038/s41523-020-0155-1⟩
Publication Year :
2020

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.<br />info:eu-repo/semantics/published

Subjects

Subjects :
0301 basic medicine
Oncology
medicine.medical_specialty
[SDV]Life Sciences [q-bio]
medicine.medical_treatment
MEDLINE
[SDV.CAN]Life Sciences [q-bio]/Cancer
Review Article
lcsh:RC254-282
631/67/1857
Tumour biomarkers
Tumours of the digestive tract Radboud Institute for Health Sciences [Radboudumc 14]
03 medical and health sciences
0302 clinical medicine
Breast cancer
692/53
Internal medicine
Medicine and Health Sciences
medicine
Pharmacology (medical)
Radiology, Nuclear Medicine and imaging
692/4028/67/580
Stromal tumor
Biomarkers
Tumour immunology
business.industry
Risk management framework
review-article
Médecine pathologie humaine
631/67/1347
Immunotherapy
Sciences bio-médicales et agricoles
lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens
medicine.disease
Women's cancers Radboud Institute for Health Sciences [Radboudumc 17]
3. Good health
Review article
Clinical trial
Cancérologie
030104 developmental biology
030220 oncology & carcinogenesis
Biomarker (medicine)
business

Details

Language :
English
ISSN :
23744677
Database :
OpenAIRE
Journal :
NPJ breast cancer, 6, npj Breast Cancer, npj Breast Cancer, Nature, 2020, 6 (1), pp.15. ⟨10.1038/s41523-020-0155-1⟩, NPJ Breast Cancer, npj Breast Cancer, Vol 6, Iss 1, Pp 1-8 (2020), 2020, ' Application of a risk-management framework for integration of stromal Tumor Infiltrating Lymphocytes in clinical trials ', NPJ Breast Cancer . https://doi.org/10.1038/s41523-020-0155-1, NPJ BREAST CANCER, npj Breast Cancer, 2020, 6 (1), pp.15. ⟨10.1038/s41523-020-0155-1⟩
Accession number :
edsair.doi.dedup.....5cc0eed7935fac67e7046bd597e941f6

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