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Application of a risk-management framework for integration of stromal tumor-infiltrating lymphocytes in clinical trials.
Hudecek, Jan; Voorwerk, Leonie; van Seijen, Maartje; Nederlof, Iris; de Maaker, Michiel; van den Berg, Jose; van de Vijver, Koen K; Sikorska, Karolina; Adams, Sylvia; Demaria, Sandra; Viale, Giuseppe; Nielsen, Torsten O; Badve, Sunil S; Michiels, Stefan; Symmans, William Fraser; Sotiriou, Christos; Rimm, David L; Hewitt, Stephen M; Denkert, Carsten; Loibl, Sibylle; Loi, Sherene; Bartlett, John M S; Pruneri, Giancarlo; Dillon, Deborah A; Cheang, Maggie C U; Tutt, Andrew; Hall, Jacqueline A; Kos, Zuzana; Salgado, Roberto; Kok, Marleen; Horlings, Hugo M.
Afiliación
  • Hudecek J; 1Department of Research IT, The Netherlands Cancer Institute, Amsterdam, The Netherlands.
  • Voorwerk L; 2Division of Tumor Biology and Immunology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.
  • van Seijen M; 3Division of Molecular Pathology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.
  • Nederlof I; 2Division of Tumor Biology and Immunology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.
  • de Maaker M; 3Division of Molecular Pathology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.
  • van den Berg J; 4Department of Pathology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.
  • van de Vijver KK; 5Department of Pathology, Ghent University Hospital, Ghent, Belgium.
  • Sikorska K; 6Department of Biometrics, The Netherlands Cancer Institute, Amsterdam, The Netherlands.
  • Adams S; 7Department of Medicine, Perlmutter Cancer Center, New York University School of Medicine, New York, NY USA.
  • Demaria S; 8Department of Radiation Oncology, Weill Cornell Medicine, New York, NY USA.
  • Viale G; 9Department of Pathology and Laboratory Medicine, Weill Cornell Medicine, New York, NY USA.
  • Nielsen TO; 10International Breast Cancer Study Group Central Pathology Office, Department of Pathology and Laboratory Medicine, IEO European Institute of Oncology IRCCS, Milan, Italy.
  • Badve SS; 11University of Milan, Milan, Italy.
  • Michiels S; 12Department of Pathology and Laboratory Medicine, Genetic Pathology Evaluation Centre, University of British Columbia, Vancouver, BC Canada.
  • Symmans WF; 13Department of Pathology and Laboratory Medicine, Indiana University Simon Cancer Center, Indianapolis, IN USA.
  • Sotiriou C; 14Service de Biostatistique et d'Epidémiologie, Gustave Roussy, CESP, Université-Paris Sud, Université Paris-Saclay, Villejuif, France.
  • Rimm DL; 15CESP, Fac. de médecine - Univ. Paris-Sud, Fac. de médecine - UVSQ, INSERM, Université Paris-Saclay, Villejuif, France.
  • Hewitt SM; 16Department of Pathology, M.D. Anderson Cancer Center, Houston, TX USA.
  • Denkert C; 17Breast Cancer Translational Research Laboratory, Institut Jules Bordet, U-CRC, Université Libre de Bruxelles, Brussels, Belgium.
  • Loibl S; 18Department of Pathology, Yale School of Medicine, New Haven, CT USA.
  • Loi S; 19Department of Medicine, Yale University School of Medicine, New Haven, CT USA.
  • Bartlett JMS; 20Laboratory of Pathology, Center for Cancer Research, National Cancer Institute, Bethesda, MD USA.
  • Pruneri G; 21Institute of Pathology, Charité Universitätsmedizin Berlin, Berlin, Germany.
  • Dillon DA; 22Institute of Pathology, Philipps-University Marburg, Marburg, Germany.
  • Cheang MCU; 23German Breast Group, Neu-Isenburg, Germany.
  • Tutt A; 24Division of Research and Clinical Medicine, Peter MacCallum Cancer Centre, University of Melbourne, Melbourne, VIC Australia.
  • Hall JA; 25Ontario Institute for Cancer Research, Toronto, ON Canada.
  • Kos Z; 26IGMM, Edinburgh, UK.
  • Salgado R; 27Edinburgh Cancer Research Centre, Western General Hospital, Edinburgh, UK.
  • Kok M; 28Department of Pathology and Laboratory Medicine, IRCCS Fondazion - Instituto Nazionale Tumori, Milan, Italy.
  • Horlings HM; 29School of Medicine, University of Milan, Milan, Italy.
NPJ Breast Cancer ; 6: 15, 2020.
Article en En | MEDLINE | ID: mdl-32436923
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: NPJ Breast Cancer Año: 2020 Tipo del documento: Article País de afiliación: Países Bajos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: NPJ Breast Cancer Año: 2020 Tipo del documento: Article País de afiliación: Países Bajos