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

Authors
  • Hudeček, Jan1
  • Voorwerk, Leonie1
  • van Seijen, Maartje1
  • Nederlof, Iris1
  • de Maaker, Michiel1
  • van den Berg, Jose1
  • van de Vijver, Koen K.2
  • Sikorska, Karolina1
  • Adams, Sylvia3
  • Demaria, Sandra4, 4
  • Viale, Giuseppe5, 6
  • Nielsen, Torsten O.7
  • Badve, Sunil S.8
  • Michiels, Stefan9, 9
  • Symmans, William Fraser10
  • Sotiriou, Christos11
  • Rimm, David L.12, 13
  • Hewitt, Stephen M.14
  • Denkert, Carsten15, 16
  • Loibl, Sibylle17
  • And 237 more
  • 1 The Netherlands Cancer Institute, Amsterdam, The Netherlands , Amsterdam (Netherlands)
  • 2 Ghent University Hospital, Ghent, Belgium , Ghent (Belgium)
  • 3 New York University School of Medicine, New York, NY, USA , New York (United States)
  • 4 Weill Cornell Medicine, New York, NY, USA , New York (United States)
  • 5 IEO European Institute of Oncology IRCCS, Milan, Italy , Milan (Italy)
  • 6 University of Milan, Milan, Italy , Milan (Italy)
  • 7 University of British Columbia, Vancouver, BC, Canada , Vancouver (Canada)
  • 8 Indiana University Simon Cancer Center, Indianapolis, IN, USA , Indianapolis (United States)
  • 9 Université Paris-Saclay, Villejuif, France , Villejuif (France)
  • 10 M.D. Anderson Cancer Center, Houston, TX, USA , Houston (United States)
  • 11 Université Libre de Bruxelles, Brussels, Belgium , Brussels (Belgium)
  • 12 Yale School of Medicine, New Haven, CT, USA , New Haven (United States)
  • 13 Yale University School of Medicine, New Haven, CT, USA , New Haven (United States)
  • 14 National Cancer Institute, Bethesda, MD, USA , Bethesda (United States)
  • 15 Charité Universitätsmedizin Berlin, Berlin, Germany , Berlin (Germany)
  • 16 Philipps-University Marburg, Marburg, Germany , Marburg (Germany)
  • 17 German Breast Group, Neu-Isenburg, Germany , Neu-Isenburg (Germany)
  • 18 University of Melbourne, Melbourne, VIC, Australia , Melbourne (Australia)
  • 19 Ontario Institute for Cancer Research, Toronto, ON, Canada , Toronto (Canada)
  • 20 IGMM, Edinburgh, UK , Edinburgh (United Kingdom)
  • 21 Western General Hospital, Edinburgh, UK , Edinburgh (United Kingdom)
  • 22 IRCCS Fondazion - Instituto Nazionale Tumori, Milan, Italy , Milan (Italy)
  • 23 Harvard Medical School, Boston, MA, USA , Boston (United States)
  • 24 The Institute of Cancer Research, Surrey, UK , Surrey (United Kingdom)
  • 25 The Institute of Cancer Research, London, UK , London (United Kingdom)
  • 26 Vivactiv Ltd, Chesham, Buckinghamshire, UK , Chesham (United Kingdom)
  • 27 University of Ottawa, Ottawa, ON, Canada , Ottawa (Canada)
  • 28 GZA-ZNA Ziekenhuizen, Antwerp, Belgium , Antwerp (Belgium)
  • 29 Department of Oral and Maxillofacial Diseases, Helsinki, Finland , Helsinki (Finland)
  • 30 Department of Pathology, Matsuyama Shimin Hospital, Matsuyama, Japan , Matsuyama (Japan)
  • 31 Surgical Oncology, Baylor College of Medicine, Houston, TX, USA , Houston (United States)
  • 32 Roche Diagnostics, Mechelen, Belgium , Mechelen (Belgium)
  • 33 Departments of Pathology, Genomic Medicine, Dermatology, and Translational Molecular Pathology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA , Houston (United States)
  • 34 PhenoPath Laboratories, Seattle, WA, USA , Seattle (United States)
  • 35 Research Pathology, Genentech Inc., South San Francisco, CA, USA , South San Francisco (United States)
  • 36 University of Turin/Candiolo Cancer Institute - FPO, IRCCS, Candiolo, Italy , Candiolo (Italy)
  • 37 Case Western Reserve University, Cleveland, OH, USA , Cleveland (United States)
  • 38 Louis Stokes Cleveland Veterans Health Administration Medical Center, Cleveland, OH, USA , Cleveland (United States)
  • 39 Pulmonary Pathology, New York University Center for Biospecimen Research and Development, New York University, New York, NY, USA , New York (United States)
  • 40 Department of Pathology, Johns Hopkins Hospital, Baltimore, MD, USA , Baltimore (United States)
  • 41 Department of Pathology, Istituto Europeo di Oncologia, University of Milan, Milan, Italy , Milan (Italy)
  • 42 PathAI, Inc, Cambridge, MA, USA , Cambridge (United States)
  • 43 Department of Pathology, University of Iowa Hospitals and Clinics, Iowa City, IA, USA , Iowa City (United States)
  • 44 Department of Oncology, IVO, Valencia, Spain , Valencia (Spain)
  • 45 Cancer Bioinformatics Lab, Cancer Centre at Guy’s Hospital, London, UK , London (United Kingdom)
  • 46 School of Life Sciences and Medicine, King’s College London, London, UK , London (United Kingdom)
  • 47 Lund University, Skane University Hospital, Department of Clinical Sciences Lund, Oncology and Pathology, Lund, Sweden , Lund (Sweden)
  • 48 Dana Farber Cancer Institute, Boston, MA, USA , Boston (United States)
  • 49 Institut Curie, Paris Sciences Lettres Université, Inserm U934, Department of Pathology, Paris, France , Paris (France)
  • 50 Department of Surgical Pathology, Zealand University Hospital, Køge, Denmark , Køge (Denmark)
  • 51 Department of Biomedical Informatics, Emory University, GA, USA , Emory University (United States)
  • 52 Departments of Pathology and Oncology, The Johns Hopkins Hospital, Baltimore, MD, USA , Baltimore (United States)
  • 53 National Surgical Adjuvant Breast and Bowel Project Operations Center/NRG Oncology, Pittsburgh, PA, USA , Pittsburgh (United States)
  • 54 Department of Pathology, Karolinska Institutet, Karolinska, Sweden , Karolinska (Sweden)
  • 55 Department of Pathology, New York University Langone Medical Centre, New York, NY, USA , New York (United States)
  • 56 Department of Pathology and Laboratory Medicine, UNC School of Medicine, Chapel Hill, NC, USA , Chapel Hill (United States)
  • 57 Bioinformatics and Computational Genomics Laboratory, Princess Margaret Cancer Center, Toronto, ON, Canada , Toronto (Canada)
  • 58 Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia , Melbourne (Australia)
  • 59 Department of Medicine, University of Melbourne, Parkville, VIC, Australia , Parkville (Australia)
  • 60 Trev & Joyce Deeley Research Centre, British Columbia Cancer Agency, Victoria, BC, Canada , Victoria (Canada)
  • 61 Division of Imaging, Diagnostics, and Software Reliability (DIDSR), Office of Science and Engineering Laboratories (OSEL), Center for Devices and Radiological Health (CDRH), Rockville, MD, USA , Rockville (United States)
  • 62 Department of Research, Instituto Nacional de Enfermedades Neoplásicas, Lima, Peru , Lima (Peru)
  • 63 Department of Research, Instituto Nacional de Enfermedades Neoplásicas, Lima, 15038, Peru , Lima (Peru)
  • 64 Providence Cancer Research Center, Portland, Oregon, USA , Oregon (United States)
  • 65 Department of Medical Oncology, Istituto Europeo di Oncologia, Milan, Italy , Milan (Italy)
  • 66 Department of Pathology, AZ Turnhout, Turnhout, Belgium , Turnhout (Belgium)
  • 67 Department of Pathology, St Vincent’s University Hospital and University College Dublin, Dublin, Ireland , Dublin (Ireland)
  • 68 Department of Computational and Systems Biology, University of Pittsburgh, Pittsburgh, PA, USA , Pittsburgh (United States)
  • 69 Cancer Research UK Lung Cancer Centre of Excellence, University College London Cancer Institute, University College London, London, UK , London (United Kingdom)
  • 70 Azienda AUSL, Regional Hospital of Aosta, Aosta, Italy , Aosta (Italy)
  • 71 Université Paris-Sud, Institut National de la Santé et de la Recherche Médicale, Villejuif, France , Villejuif (France)
  • 72 Gustave Roussy, Universite Paris-Saclay, Villejuif, France , Villejuif (France)
  • 73 University Hospital Halle (Saale), Institute of Pathology, Halle, (Saale), Germany , Halle (Germany)
  • 74 Department of Pathology, UCL Cancer Institute, UCL, London, UK , London (United Kingdom)
  • 75 University College Hospitals NHS Trust, London, UK , London (United Kingdom)
  • 76 Department of Pathology, Jules Bordet Institute, Brussels, Belgium , Brussels (Belgium)
  • 77 Department of Clinical Medicine, Macquarie University, Sydney, Australia , Sydney (Australia)
  • 78 HistoGeneX NV, Antwerp, Belgium and AZ Sint-Maarten Hospital, Mechelen, Belgium , Mechelen (Belgium)
  • 79 Oncology Clinical Development, Bristol-Myers Squibb, Princeton, NJ, USA , Princeton (United States)
  • 80 Institut für Pathologie, UK Hamburg, Germany , UK Hamburg (Germany)
  • 81 Department of Medicine, Vanderbilt University Medical Centre, Nashville, TN, USA , Nashville (United States)
  • 82 Department of Cancer CV, Jacksonville, FL, USA , Jacksonville (United States)
  • 83 Department of Pathology, Memorial Sloan Kettering Cancer Center, New York, NY, USA , New York (United States)
  • 84 Department of Oncology, Mayo Clinic, Rochester, MN, USA , Rochester (United States)
  • 85 Roche, Tucson, AZ, USA , Tucson (United States)
  • 86 Department of Pathology, Herlev and Gentofte Hospital, Gentofte, Denmark , Gentofte (Denmark)
  • 87 Université Paris-Saclay, Univ. Paris-Sud, Villejuif, France , Villejuif (France)
  • 88 Service de biostatistique et d’épidémiologie, Gustave Roussy, Villejuif, France , Villejuif (France)
  • 89 Department of Pathology, Universidad de La Frontera, Temuco, Chile , Temuco (Chile)
  • 90 Departamento de Anatomía Patológica, Universidad de La Frontera, Temuco, Chile , Temuco (Chile)
  • 91 Tumor Pathology Department, Maria Sklodowska-Curie Memorial Cancer Center, Gliwice, Poland , Gliwice (Poland)
  • 92 Pathology and Tissue Analytics, Roche, Neuherberg, Germany , Neuherberg (Germany)
  • 93 Department of Medical Oncology, Gustave Roussy, Villejuif, France , Villejuif (France)
  • 94 Sunnybrook Health Sciences Centre, Toronto, ON, Canada , Toronto (Canada)
  • 95 Tehran University of Medical Sciences, Tehran, Iran , Tehran (Iran)
  • 96 Pathology Department, Instituto de Investigación Sanitaria Fundación Jiménez Díaz (IIS-FJD), Madrid, Spain , Madrid (Spain)
  • 97 GEICAM-Spanish Breast Cancer Research Group, Madrid, Spain , Madrid (Spain)
  • 98 Translational Research, Montreal, Canada , Montreal (Canada)
  • 99 Computational Pathology Group, Department of Pathology, Nijmegen, Radboud University Medical Center, The Netherlands , Nijmegen (Netherlands)
  • 100 Oncology Biomarker Development, Genentech-Roche, Neuherberg, Germany , Neuherberg (Germany)
  • 101 Division of Medical Oncology, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, USA , Aurora (United States)
  • 102 Centre de Lutte Contre le cancer - Centre Jean Perrin, Clermont-Ferrand, France , Clermont-Ferrand (France)
  • 103 Department of Pathology, Hospital de Oncología Maria Curie, Buenos Aires, Argentina , Buenos Aires (Argentina)
  • 104 Directorate of Surgical Pathology, SA Pathology, Adelaide, Australia , Adelaide (Australia)
  • 105 Department of Pathology, GZA-ZNA Ziekenhuizen, Wilrijk, Belgium , Wilrijk (Belgium)
  • 106 University of Milano, Instituto Europeo di Oncologia, IRCCS, Milano, Italy , Milano (Italy)
  • 107 Division of Early Drug Development for Innovative Therapy, IEO, European Institute of Oncology IRCCS, Milan, Italy , Milan (Italy)
  • 108 Department of Imaging and Pathology, Laboratory of TranslCal Cell & Tissue Research, Leuven, Belgium , Leuven (Belgium)
  • 109 KU Leuven- University Hospitals Leuven, Department of Pathology, Leuven, Belgium , Leuven (Belgium)
  • 110 Department of Pathology, University Hospital of Antwerp, Antwerp, Belgium , Antwerp (Belgium)
  • 111 Paula I, Breast Cancer Research Program, Vanderbilt University Medical Center, Nashville, TN, USA , Nashville (United States)
  • 112 Translational Health Sciences, Department of Cellular Pathology, North Bristol NHS Trust, University of Bristol, Bristol, UK , Bristol (United Kingdom)
  • 113 Medical Oncology, Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, CA, USA , Los Angeles (United States)
  • 114 Helsinki University Central Hospital, Helsinki, Finland , Helsinki (Finland)
  • 115 Department of Clinical Pathology, Akademiska University Hospital, Uppsala, Sweden , Uppsala (Sweden)
  • 116 Department of Pathology, National Taiwan University Hospital, Taipei, Taiwan , Taipei (Taiwan)
  • 117 Department of Oncology, National Taiwan University Cancer Center, Taipei, Taiwan , Taipei (Taiwan)
  • 118 Graduate Institute of Oncology, College of Medicine, National Taiwan University, Taipei, Taiwan , Taipei (Taiwan)
  • 119 International Agency for Research on Cancer (IARC), World Health Organization, Lyon, France , Lyon (France)
  • 120 Department of Pathology, Sanatorio Mater Dei, Buenos Aires, Argentina , Buenos Aires (Argentina)
  • 121 Institute of Pathology, Medical University of Graz, Graz, Austria , Graz (Austria)
  • 122 Department of Oncology, National Cancer Centre Singapore, Singapore, Singapore , Singapore (Singapore)
  • 123 Department of Pathology, Brigham and Women’s Hospital, Boston, MA, USA , Boston (United States)
  • 124 Department of Pathology, Netherlands Cancer Institute, Amsterdam, The Netherlands , Amsterdam (Netherlands)
  • 125 PathAI Inc, Cambridge, MA, USA , Cambridge (United States)
  • 126 Visiopharm A/S, Hørsholm, Denmark , Hørsholm (Denmark)
  • 127 DTU Compute, Department of Applied Mathematics, Technical University of Denmark, Lyngby, Denmark , Lyngby (Denmark)
  • 128 Nuffield Department of Population Health, University of Oxford, Oxford, UK , Oxford (United Kingdom)
  • 129 Department of Medical Oncology, University Hospitals Bristol NHS Foundation Trust, Bristol, UK , Bristol (United Kingdom)
  • 130 R&D UNICANCER, Paris, France , Paris (France)
  • 131 Translational Sciences, MedImmune, Gaithersberg, MD, USA , Gaithersberg (United States)
  • 132 Breast Unit, Champalimaud Clinical Centre, Lisboa, Portugal , Lisboa (Portugal)
  • 133 Department of Pathology, Massachusetts General Hospital, Boston, MA, USA , Boston (United States)
  • 134 Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN, USA , Rochester (United States)
  • 135 Biomedical Informatics Department, Stony Brook University, Stony Brook, NY, USA , Stony Brook (United States)
  • 136 Department of Oncology and Pathology, Karolinska Institutet and University Hospital, Solna, Sweden , Solna (Sweden)
  • 137 Department of Medicine, Clinical Division of Oncology, Comprehensive Cancer Centre Vienna, Medical University of Vienna, Vienna, Austria , Vienna (Austria)
  • 138 Leicester Cancer Research Centre, University of Leicester, Leicester, and MRC Toxicology Unit, University of Cambridge, Cambridge, UK , Cambridge (United Kingdom)
  • 139 Merck & Co., Inc, Kenilworth, USA , Kenilworth (United States)
  • 140 Human Oncology and Pathogenesis Program, Memorial Sloan Kettering Cancer Center, New York, NY, USA , New York (United States)
  • 141 Department of Research, Instituto Nacional de Enfermedades Neoplasicas, Lima, 15038, Peru , Lima (Peru)
  • 142 Department of Medicine, Department of Obstetrics and Gynecology and Women’s Health, Albert Einstein Medical Center, Bronx, USA , Bronx (United States)
  • 143 GHI Le Raincy-Montfermeil, Chelles, Île-de-France, France , Île-de-France (France)
  • 144 Department of Pathology, Gustave Roussy, Grand Paris, France , Grand Paris (France)
  • 145 Departments of Medicine and Cancer Biology, Vanderbilt University Medical Centre, Nashville, TN, USA , Nashville (United States)
  • 146 VMscope GmbH, Berlin, Germany , Berlin (Germany)
  • 147 Department of Pathology, Breast Pathology Section, Northwestern University, Chicago, IL, USA , Chicago (United States)
  • 148 Molecular Immunology Unit, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium , Brussels (Belgium)
  • 149 NSABP/NRG Oncology, Pittsburgh, PA, USA , Pittsburgh (United States)
  • 150 Division of Molecular Pathology, Centre for Evolution and Cancer, The Institute of Cancer Research, London, UK , London (United Kingdom)
  • 151 Cancer Biomarkers Working Group, Faculty of Medicine and Pharmacy, Université Mohamed Premier, Oujda, Morocco , Oujda (Morocco)
  • 152 Yale Cancer Center Genetics, Genomics and Epigenetics Program, Yale School of Medicine, New Haven, CT, USA , New Haven (United States)
  • 153 Pathology Department, Stanford University Medical Centre, Stanford, CA, USA , Stanford (United States)
  • 154 Pathology and Tissue Analytics, Roche Innovation Centre Munich, Penzberg, Germany , Penzberg (Germany)
  • 155 Pathology Department, Hospital del Mar, Parc de Salut Mar, Barcelona, Spain , Barcelona (Spain)
  • 156 Department of Pathology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA , Chicago (United States)
  • 157 Center for Pharmacogenomics and Fudan-Zhangjiang, Center for Clinical Genomics School of Life Sciences and Shanghai Cancer Center, Fudan University, Fudan, China , Fudan (China)
  • 158 GROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre and Department of Pathology, Maastricht University Medical Centre, Maastricht, The Netherlands , Maastricht (Netherlands)
  • 159 Biorepository and Tissue Technology Shared Resources, University of California San Diego, San Diego, CA, USA , San Diego (United States)
  • 160 Department of Pathology, Gustave Roussy, Villejuif, France , Villejuif (France)
  • 161 Departments of Epigenetics and Molecular Carcinogenesis, The University of Texas MD Anderson Cancer Center, Houston, TX, USA , Houston (United States)
  • 162 Department of Pathology, Academic Medical Center, Amsterdam, The Netherlands , Amsterdam (Netherlands)
  • 163 Department of Pathology, University of São Paulo, São Paulo, Brazil , São Paulo (Brazil)
  • 164 Hospital das Clínicas, Sao Paulo, Brasil , Sao Paulo (Brazil)
  • 165 Department of Surgery, Oncology and Gastroenterology, University of Padova, Padua, Italy , Padua (Italy)
  • 166 Department of Medical Biology and Pathology, Gustave Roussy Cancer Campus, Villejuif, France , Villejuif (France)
  • 167 Institut Jules Bordet, Universite Libre de Bruxelles, Brussels, Belgium , Brussels (Belgium)
  • 168 Roche Tissue Diagnostics, Digital Pathology, Santa Clara, CA, USA , Santa Clara (United States)
  • 169 Department of Pathology, Microbiology and Immunology, Vanderbilt University Medical Centre, Nashville, TN, USA , Nashville (United States)
  • 170 Division of Biostatistics, Dana-Farber Cancer Institute, Boston, MA, USA , Boston (United States)
  • 171 Roche Diagnostics Information Solutions, Belmont, CA, USA , Belmont (United States)
  • 172 Department of Anatomical Pathology, Royal Melbourne Hospital, Parkville, VIC, Australia , Parkville (Australia)
  • 173 Vernon Cancer Center, Newton-Wellesley Hospital, Newton, MA, USA , Newton (United States)
  • 174 Department of Medical Oncology, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium , Brussels (Belgium)
  • 175 Service de pathologique, Cliniques universitaires Saint-Luc, Bruxelles, Belgique , Bruxelles (Belgium)
  • 176 Department of Biomedical Informatics, Emory University School of Medicine, Atlanta, GA, USA , Atlanta (United States)
  • 177 Breast Center, Dept. OB&GYN and CCC (LMU), University of Munich, Munich, Germany , Munich (Germany)
  • 178 Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Boston, MA, USA , Boston (United States)
  • 179 University of Leuven, Leuven, Belgium , Leuven (Belgium)
  • 180 Department of Pathology, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium , Brussels (Belgium)
  • 181 Department of Surgical Pathology and Biopathology, Jean Perrin Comprehensive Cancer Centre, Clermont-Ferrand, France , Clermont-Ferrand (France)
  • 182 Johanniter GmbH - Evangelisches Krankenhaus Bethesda Mönchengladbach, West German Study Group, Mönchengladbach, Germany , Mönchengladbach (Germany)
  • 183 Molecular Oncology Group, Vall d’Hebron Institute of Oncology, Barcelona, Spain , Barcelona (Spain)
  • 184 Department of Pathology, University of Marburg, Marburg, Germany , Marburg (Germany)
  • 185 Breast Cancer Program, Vanderbilt-Ingram Cancer Center, Vanderbilt University Medical Center, Nashville, TN, USA , Nashville (United States)
  • 186 Department of Histopathology, Manipal Hospitals Dwarka, New Delhi, India , New Delhi (India)
  • 187 Department of Pathology and Laboratory Medicine, University of British Columbia, Vancouver, BC, Canada , Vancouver (Canada)
  • 188 The Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia , Melbourne (Australia)
  • 189 Peter MacCallum Cancer Centre, Melbourne, VIC, Australia , Melbourne (Australia)
  • 190 Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia , Melbourne (Australia)
  • 191 Department of Anatomical Pathology, St Vincent’s Hospital Melbourne, Fitzroy, VIC, Australia , Fitzroy (Australia)
  • 192 Icahn School of Medicine at Mt. Sinai, New York, NY, USA , New York (United States)
  • 193 NRG Oncology/NSABP, Pittsburgh, PA, USA , Pittsburgh (United States)
  • 194 Cancer Immunotherapy Trials Network, Central Laboratory and Program in Immunology, Fred Hutchinson Cancer Research Center, Seattle, WA, USA , Seattle (United States)
  • 195 Clinical Trial Service Unit & Epidemiological Studies Unit, University of Oxford, Oxford, UK , Oxford (United Kingdom)
  • 196 Department of Pathology, Fudan University Cancer Center, Shanghai, China , Shanghai (China)
  • 197 Department of Pathology, GZA-ZNA Hospitals, Antwerp, Belgium , Antwerp (Belgium)
  • 198 Department of Radiation Oncology, Odette Cancer Centre, Sunnybrook Research Institute, Toronto, ON, Canada , Toronto (Canada)
  • 199 Merck Oncology, Kenilworth, NJ, USA , Kenilworth (United States)
  • 200 The Cancer Research Program, Garvan Institute of Medical Research, Darlinghurst, NSW, Australia , Darlinghurst (Australia)
  • 201 Georgetown University Medical Center, Washington, DC, USA , Washington (United States)
  • 202 FDA/CDRH/OSEL/Division of Imaging, Diagnostics, and Software Reliability, Silver Spring, MD, USA , Silver Spring (United States)
  • 203 Department of Molecular and Experimental Medicine, Avera Cancer Institute, Sioux Falls, SD, USA , Sioux Falls (United States)
  • 204 Translational Medicine, Bristol-Myers Squibb, Princeton, NJ, USA , Princeton (United States)
  • 205 Anatomic Pathology, Boston, MA, USA , Boston (United States)
  • 206 Guy’s Hospital, London, UK , London (United Kingdom)
  • 207 King’s College London, London, UK , London (United Kingdom)
  • 208 Peking University First Hospital Breast Disease Center, Beijing, China , Beijing (China)
  • 209 Department of Pathology, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia , Melbourne (Australia)
  • 210 Dipartimento di Scienze della Salute (DSS), Firenze, Italy , Firenze (Italy)
  • 211 Department of Oncology, Champalimaud Clinical Centre, Lisbon, Portugal , Lisbon (Portugal)
  • 212 Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Pathology, Berlin, Germany , Berlin (Germany)
  • 213 Department of Pathology and Laboratory Medicine, Tufts Medical Center, Boston, MA, USA , Boston (United States)
  • 214 Dana-Farber Cancer Institute, Boston, MA, USA , Boston (United States)
  • 215 Department of Pathology, Fundación Valle del Lili, Cali, Valle del Cauca, Colombia , Cali, Valle del Cauca (Colombia)
  • 216 The University of Queensland Centre for Clinical Research and Pathology Queensland, Brisbane, QLD, Australia , Brisbane (Australia)
  • 217 Department of Pathology, Montefiore Medical Center and the Albert Einstein College of Medicine, Bronx, NY, USA , Bronx (United States)
  • 218 Department of Pathology, University Hospital of Bellvitge, Oncobell, IDIBELL, L’Hospitalet del Llobregat, Barcelona, Catalonia, 08908, Spain , Barcelona (Spain)
  • 219 Department of Development and Regeneration, Laboratory of Experimental Urology, KU Leuven, Leuven, Belgium , Leuven (Belgium)
  • 220 Department of Medical Oncology, Austin Health, Heidelberg, VIC, Australia , Heidelberg (Australia)
  • 221 Department of Surgery, Kansai Medical School, Hirakata, Japan , Hirakata (Japan)
  • 222 Pathology Department, H.U. Vall d’Hebron, Barcelona, Spain , Barcelona (Spain)
  • 223 Division of Bioinformatics and Biostatistics, US Food and Drug Administration, Silver Spring, MD, USA , Silver Spring (United States)
  • 224 Department of Pathology and Laboratory Medicine, Rhode Island Hospital and Lifespan Medical Center, Providence, RI, USA , Providence (United States)
  • 225 Université Paris-Est, Créteil, France , Créteil (France)
  • 226 Praava Health, Dhaka, Bangladesh , Dhaka (Bangladesh)
  • 227 Department of Pathology, Medical University of Vienna, Vienna, Austria , Vienna (Austria)
Type
Published Article
Journal
npj Breast Cancer
Publisher
Nature Publishing Group UK
Publication Date
May 12, 2020
Volume
6
Issue
1
Identifiers
DOI: 10.1038/s41523-020-0155-1
Source
Springer Nature
License
Green

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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