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Assessing Tumor-infiltrating Lymphocytes in Solid Tumors: A Practical Review for Pathologists and Proposal for a Standardized Method From the International Immunooncology Biomarkers Working Group: Part 1: Assessing the Host Immune Response, TILs in Invasive Breast Carcinoma and Ductal Carcinoma In Situ, Metastatic Tumor Deposits and Areas for Further Research

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Assessment of tumor-infiltrating lymphocytes (TILs) in histopathologic specimens can provide important prognostic information in diverse solid tumor types, and may also be of value in predicting response to treatments. However, implementation as a routine clinical biomarker has not yet been achieved. As successful use of immune checkpoint inhibitors and other forms of immunotherapy become a clinical reality, the need for widely applicable, accessible, and reliable immunooncology biomarkers is clear. In part 1 of this review we briefly discuss the host immune response to tumors and different approaches to TIL assessment. We propose a standardized methodology to assess TILs in solid tumors on hematoxylin and eosin sections, in both primary and metastatic settings, based on the International Immuno-Oncology Biomarker Working Group guidelines for TIL assessment in invasive breast carcinoma. A review of the literature regarding the value of TIL assessment in different solid tumor types follows in part 2. The method we propose is reproducible, affordable, easily applied, and has demonstrated prognostic and predictive significance in invasive breast carcinoma. This standardized methodology may be used as a reference against which other methods are compared, and should be evaluated for clinical validity and utility. Standardization of TIL assessment will help to improve consistency and reproducibility in this field, enrich both the quality and quantity of comparable evidence, and help to thoroughly evaluate the utility of TILs assessment in this era of immunotherapy.
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Keywords: biomarkers; cancer; immunotherapy; lymphocytes; pathology; tumor-infiltrating

Document Type: Research Article

Affiliations: 1: Departments of Pathology, The Sir Peter MacCallum Department of Oncology 2: Breast Cancer Translational Research Laboratory/Breast International Group, Institut Jules Bordet, Department of Pathology and TCRU, GZA 3: Laboratory of Experimental Urology, Department of Development and Regeneration, KU Leuven, Department of Pathology, AZ Klina, Brasschaat 4: Department of Anatomical Pathology, St Vincent’s Hospital Melbourne, Fitzroy, Departments of Pathology 5: Department of Medical Oncology, Austin Health, Olivia Newton-John Cancer Research Institute, Heidelberg, School of Cancer Medicine, La Trobe University, Bundoora 6: Olivia Newton-John Cancer Research Institute, Heidelberg, Medicine, University of Melbourne 7: Department of Anatomical Pathology, Royal Melbourne Hospital, Parkville 8: Divisions of Diagnostic Oncology & Molecular Pathology, Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, The Netherlands 9: Department of Pathology, School of Medicine, University of California, San Diego 10: Breast Cancer Research Program, Vanderbilt Ingram Cancer Center, Vanderbilt University 11: Departments of Pathology, Microbiology and Immunology 12: Medical Oncology, Peter MacCallum Cancer Centre, Melbourne 13: Molecular Immunology Unit 14: Molecular Immunology Unit, Department of Pathology, GZA Ziekenhuizen, Antwerp 15: Université Paris-Est, INSERM, UMR 955, Département de pathologie, APHP, Hôpital Henri-Mondor, Créteil 16: Department of Medicine, Clinical Division of Oncology 17: Institute of Neurology, Comprehensive Cancer Centre Vienna, Medical University of Vienna, Vienna 18: European Institute of Oncology, School of Medicine 19: Departments of Radiation Oncology and Pathology, Weill Cornell Medicine, New York, NY 20: Department of Pathology, University of Texas M.D. Anderson Cancer Center, Houston, TX 21: Molecular Oncology Group, Vall d’Hebron Institute of Oncology, Barcelona 22: Department of Cancer Biology, Mayo Clinic, Jacksonville, FL 23: Centre for Clinical Research and School of Medicine, The University of Queensland, Pathology Queensland, Royal Brisbane and Women’s Hospital, Brisbane 24: National Surgical Adjuvant Breast and Bowel Project Operations Center/NRG Oncology, Pittsburgh, PA 25: Cancer Research Institute and Department of Pathology, Beth Israel Deaconess Cancer Center, Harvard Medical School 26: Department of Pathology, GZA Ziekenhuizen, Sint-Augustinus, Wilrijk 27: Department of Medical Oncology, Institut Jules Bordet, Université Libre de Bruxelles 28: Academic Medical Innovation, Novartis Pharmaceuticals Corporation, East Hanover 29: Department of Pathology and Laboratory Medicine, Indiana University, Indianapolis, IN 30: Cancer Immunotherapy Trials Network, Central Laboratory and Program in Immunology, Fred Hutchinson Cancer Research Center, Seattle, WA 31: Department of Pathology, Istituto Europeo di Oncologia, University of Milan, Milan 32: Department of Pathology, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium 33: Department of Surgical Pathology and Biopathology, Jean Perrin Comprehensive Cancer Centre, University of Auvergne UMR1240, Clermont-Ferrand, France 34: Department of Surgery, Kansai Medical School, Hirakata, Japan 35: Montefiore Medical Center, The Albert Einstein College of Medicine, Bronx, NY 36: National Surgical Adjuvant Breast and Bowel Project Operations Center/NRG Oncology, Pittsburgh, PA, Severance Biomedical Science Institute and Department of Medical Oncology, Yonsei University College of Medicine, Seoul, South Korea 37: Harvard Medical School, Department of Pathology, Brigham and Women’s Hospital, Department of Cancer Biology 38: Department of Pathology and Laboratory Medicine, Rhode Island Hospital and Lifespan Medical Center, Warren Alpert Medical School of Brown University, Providence 39: Tumor Pathology Department, Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology, Gliwice Branch, Gliwice, Poland 40: Harvard Medical School, Department of Pathology, Brigham and Women’s Hospital 41: Department of Medicine, Vanderbilt University Medical Centre, Vanderbilt Ingram Cancer Center, Nashville 42: Institute of Pathology, Charité Universitätsmedizin Berlin, VMscope GmbH, Berlin 43: Department of Pathology, Yale University School of Medicine, New Haven 44: Service de Biostatistique et d’Epidémiologie, Gustave Roussy, CESP, Inserm U1018, Université-Paris Sud, Université Paris-Saclay 45: German Breast Group GmbH, Neu-Isenburg, Germany 46: The Sir Peter MacCallum Department of Oncology, Medical Oncology, Peter MacCallum Cancer Centre, Melbourne 47: Institute of Pathology, Charité Universitätsmedizin Berlin 48: Pathology and Laboratory Medicine, Trev & Joyce Deeley Research Centre, British Columbia Cancer Agency 49: Trev & Joyce Deeley Research Centre, British Columbia Cancer Agency, Department of Biochemistry and Microbiology, University of Victoria, Victoria, Departments of Medical Genetics 50: European Institute of Oncology 51: The Cancer Research Program, Garvan Institute of Medical Research, Darlinghurst, Australian Clinical Labs, Bella Vista 52: INSERM Unit U981, and Department of Medical Oncology, Gustave Roussy, Villejuif, Faculté de Médecine, Université Paris Sud, Kremlin-Bicêtre 53: INSERM Unit U981, and Department of Medical Oncology, Gustave Roussy, Villejuif 54: Department of Surgical Oncology, Netherlands Cancer Institute 55: Pathology Department, IIS-Fundacion Jimenez Diaz, UAM, Madrid, Spain 56: Department of Pathology, University Hospital Leuven, Leuven, Belgium 57: Department of Pathology and Laboratory Medicine, Weill Cornell Medical College, Doha, Qatar 58: Department of Oncology, Montefiore Medical Centre, Albert Einstein College of Medicine 59: Department of Pathology and Laboratory Medicine, Genetic Pathology Evaluation Centre, University of British Columbia, Vancouver, BC 60: Department of Pathology and Laboratory Medicine, University of Ottawa, Ottawa, Canada 61: Laboratory of Pathology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda 62: Department of Pathology, New York University Langone Medical Centre 63: Directorate of Surgical Pathology, SA Pathology, Discipline of Medicine, Adelaide University, Adelaide, Australia 64: Pathology Department, Stanford University Medical Centre, Stanford 65: Division of Hematology-Oncology, Beth Israel Deaconess Medical Center 66: New York University Medical School, Perlmutter Cancer Center 67: Department of Pathology 68: Perlmutter Cancer Center, Dana-Farber Cancer Institute, Boston, MA 69: Pulmonary Pathology, New York University Center for Biospecimen Research and Development, New York University 70: Department of Medicine, Division of Medical Oncology, University of Colorado Anschutz Medical Campus, Aurora, CO 71: Department of Surgery, Oncology and Gastroenterology, University of Padova, Medical Oncology 2, Veneto Institute of Oncology IOV-IRCCS, Padua, Italy 72: European Organisation for Research and Treatment of Cancer (EORTC) Headquarters 73: Institute of Pathology, Medical University of Graz, Austria 74: Pathology and Tissue Analytics, Roche Innovation Centre Munich, Penzberg 75: Research Pathology, Genentech Inc., South San Francisco, CA 76: Research Pathology, Genentech Inc., South San Francisco, CA, Department of Pathology, Stanford University, Palo Alto 77: Translational Sciences, MedImmune, Gaithersberg, MD 78: Translational Medicine, Merck & Co. Inc., Kenilworth, NJ 79: Department of Pathology, Memorial Sloan-Kettering Cancer Center

Publication date: September 1, 2017

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