The path to a better biomarker: application of a risk management framework for the implementation of PD‐L1 and TILs as immuno‐oncology biomarkers in breast cancer clinical trials and daily practice-Reference-Cited by-同舟云学术

The path to a better biomarker: application of a risk management framework for the implementation of PD‐L1 and TILs as immuno‐oncology biomarkers in breast cancer clinical trials and daily practice

Published:2020-04 Issue:5 Volume:250 Page:667-684
ISSN:0022-3417
Container-title:The Journal of Pathology
language:en
Short-container-title:J. Pathol.

Author:

Gonzalez‐Ericsson Paula I¹^ORCID,Stovgaard Elisabeth S²,Sua Luz F³,Reisenbichler Emily⁴,Kos Zuzana⁵,Carter Jodi M⁶,Michiels Stefan⁷,Le Quesne John⁸⁹,Nielsen Torsten O¹⁰,Lænkholm Anne‐Vibeke¹¹,Fox Stephen B¹²¹³,Adam Julien¹⁴,Bartlett John MS¹⁵¹⁶,Rimm David L⁴,Quinn Cecily¹⁷,Peeters Dieter¹⁸¹⁹,Dieci Maria V²⁰²¹,Vincent‐Salomon Anne²²,Cree Ian²³^ORCID,Hida Akira I²⁴,Balko Justin M¹²⁵²⁶,Haynes Harry R²⁷²⁸^ORCID,Frahm Isabel²⁹,Acosta‐Haab Gabriela³⁰,Balancin Marcelo³¹^ORCID,Bellolio Enrique³²,Yang Wentao³³,Kirtani Pawan³⁴,Sugie Tomoharu³⁵,Ehinger Anna³⁶^ORCID,Castaneda Carlos A³⁷,Kok Marleen³⁸,McArthur Heather³⁹,Siziopikou Kalliopi⁴⁰,Badve Sunil⁴¹,Fineberg Susan⁴²,Gown Allen⁴³,Viale Giuseppe⁴⁴⁴⁵,Schnitt Stuart J⁴⁶⁴⁷,Pruneri Giancarlo⁴⁵⁴⁸,Penault‐Llorca Frederique⁴⁹⁵⁰,Hewitt Stephen⁵¹,Thompson E Aubrey⁵²,Allison Kimberly H⁵³,Symmans William F⁵⁴,Bellizzi Andrew M⁵⁵,Brogi Edi⁵⁶,Moore David A⁵⁷,Larsimont Denis⁵⁸,Dillon Deborah A⁴⁶,Lazar Alexander⁵⁴^ORCID,Lien Huangchun⁵⁹,Goetz Matthew P⁶⁰,Broeckx Glenn⁶¹^ORCID,El Bairi Khalid⁶²^ORCID,Harbeck Nadia⁶³,Cimino‐Mathews Ashley⁶⁴,Sotiriou Christos⁶⁵,Adams Sylvia⁶⁶,Liu Shi‐wei⁶⁷,Loibl Sibylle⁶⁸,Chen I‐Chun⁶⁹,Lakhani Sunil R⁷⁰,Juco Jonathan W⁷¹,Denkert Carsten⁷²,Blackley Elizabeth F⁷³,Demaria Sandra⁷⁴,Leon‐Ferre Roberto⁶⁰,Gluz Oleg⁷⁵,Zardavas Dimitrios⁷⁶,Emancipator Kenneth⁷¹,Ely Scott⁷⁷,Loi Sherene¹³⁷⁸,Salgado Roberto⁷⁸⁷⁹,Sanders Melinda¹²⁶,

Affiliation:

1. Breast Cancer Research Program Vanderbilt University Medical Center Nashville TN USA

2. Department of Pathology Herlev and Gentofte Hospital, University of Copenhagen Herlev Denmark

3. Department of Pathology and Laboratory Medicine Fundación Valle del Lili, and Faculty of Health Sciences, Universidad ICESI Cali Colombia

4. Department of Pathology Yale School of Medicine New Haven CT USA

5. Department of Pathology BC Cancer Agency Vancouver Canada

6. Department of Laboratory Medicine and Pathology Mayo Clinic Rochester MN USA

7. Biostatistics and Epidemiology Service Centre de Recherche en Epidémiologie et Santé des Populations, Gustave Roussy, Université Paris‐Sud Villejuif France

8. Leicester Cancer Research Centre University of Leicester Leicester UK

9. MRC Toxicology Unit University of Cambridge Leicester UK

10. Department of Pathology and Laboratory Medicine University of British Columbia Vancouver Canada

11. Department of Surgical Pathology Zealand University Hospital Roskilde Denmark

12. Department of Pathology Peter MacCallum Cancer Centre Melbourne Australia

13. Sir Peter MacCallum Department of Oncology University of Melbourne Parkville Australia

14. Department of Pathology Gustave Roussy Grand Paris France

15. Ontario Institute for Cancer Research Toronto Canada

16. Edinburgh Cancer Research Centre Institute of Genetics and Molecular Medicine Edinburgh UK

17. Department of Pathology St Vincent's University Hospital and University College Dublin Dublin Ireland

18. HistoGeneX NV Antwerp Belgium

19. AZ Sint‐Maarten Hospital Mechelen Belgium

20. Department of Surgery, Oncology and Gastroenterology University of Padova Padova Italy

21. Medical Oncology 2 Istituto Oncologico Veneto – IRCCS Padova Italy

22. Department of Pathology Insitut Curie Paris France

23. International Agency for Research on Cancer (IARC) World Health Organization Lyon France

24. Department of Pathology Matsuyama Shimin Hospital Matsuyama Japan

25. Department of Medicine Vanderbilt University Medical Center Nashville TN USA

26. Department of Pathology, Microbiology and Immunology Vanderbilt University Medical Center Nashville TN USA

27. Department of Cellular Pathology North Bristol NHS Trust Bristol UK

28. Translational Health Sciences University of Bristol Bristol UK

29. Department of Pathology Sanatorio Mater Dei Buenos Aires Argentina

30. Department of Pathology Hospital de Oncología Maria Curie Buenos Aires Argentina

31. Department of Pathology, Faculty of Medicine University of São Paulo São Paulo Brazil

32. Department of Pathology Universidad de La Frontera Temuco Chile

33. Department of Pathology Fudan University Shanghai Cancer Centre Shanghai PR China

34. Department of Histopathology Manipal Hospitals Dwarka New Delhi India

35. Breast Surgery Kansai Medical University Hospital Hirakata Japan

36. Department of Clinical Genetics and Pathology, Skane University Hospital Lund University Lund Sweden

37. Department of Medical Oncology Instituto Nacional de Enfermedades Neoplásicas Lima Peru

38. Divisions of Medical Oncology, Tumor Biology & Immunology The Netherlands Cancer Institute Amsterdam The Netherlands

39. Medical Oncology, Department of Medicine Cedars‐Sinai Medical Center Los Angeles CA USA

40. Department of Pathology, Breast Pathology Section Northwestern University Chicago IL USA

41. Department of Pathology and Laboratory Medicine Indiana University Indianapolis IN USA

42. Department of Pathology Montefiore Medical Center and the Albert Einstein College of Medicine Bronx NY USA

43. PhenoPath Laboratories Seattle WA USA

44. Department of Pathology Istituto Europeo di Oncologia IRCCS Milan Italy

45. University of Milan Milan Italy

46. Department of Pathology Dana‐Farber Cancer Institute Boston MA USA

47. Department of Pathology Brigham and Women's Hospital and Harvard Medical School Boston MA USA

48. Department of Pathology IRCCS Fondazione Instituto Nazionale Tumori Milan Italy

49. Department of Biology and Pathology Centre Jean Perrin Clermont Ferrand France

50. UMR INSERM 1240, Université Clermont Auvergne Clermont Ferrand France

51. Experimental Pathology Laboratory, Laboratory of Pathology, Center for Cancer Research National Cancer Institute, National Institutes of Health Bethesda MD USA

52. Department of Cancer Biology Mayo Clinic Jacksonville FL USA

53. Department of Pathology Stanford University Stanford CA USA

54. Department of Pathology, Division of Pathology and Laboratory Medicine The University of Texas, MD Anderson Cancer Center Houston TX USA

55. Department of Pathology University of Iowa Hospitals and Clinics Iowa City IA USA

56. Department of Pathology Memorial Sloan Kettering Cancer Center New York NY USA

57. CRUK Lung Cancer Centre of Excellence, UCL Cancer Institute, and Department of Cellular Pathology UCLH London UK

58. Department of Pathology, Institut Jules Bordet Université Libre de Bruxelles Brussels Belgium

59. Graduate Institute of Pathology National Taiwan University Taipei Taiwan

60. Department of Oncology Mayo Clinic Rochester MN USA

61. Department of Pathology University Hospital Antwerp Edegem Belgium

62. Cancer Biomarkers Working Group, Faculty of Medicine and Pharmacy Mohamed Ist University Oujda Morocco

63. Breast Center, Department of OB&GYN and CCC (LMU) University of Munich Munich Germany

64. Department of Pathology and Oncology The Johns Hopkins Hospital Baltimore MD USA

65. Department of Medical Oncology, Institut Jules Bordet Université Libre de Bruxelles Brussels Belgium

66. Perlmutter Cancer Center New York University Medical School New York NY USA

67. Sichuan Cancer Hospital Chengdu PR China

68. German Breast Group Neu‐Isenburg Germany

69. Department of Medical Oncology National Taiwan University Cancer Center Taipei Taiwan

70. The University of Queensland, Centre for Clinical Research, and Pathology Queensland, Royal Brisbane and Women's Hospital Herston Australia

71. Translational Medicine, Merck & Co, Inc Kenilworth NJ USA

72. Institute of Pathology Universitätsklinikum Gießen und Marburg GmbH, Standort Marburg and Philipps‐Universität Marburg Marburg Germany

73. Department of Medical Oncology Peter MacCallum Cancer Centre Melbourne Australia

74. Department of Radiation Oncology, Department of Pathology and Laboratory Medicine Weill Cornell Medicine New York NY USA

75. Johanniter GmbH ‐ Evangelisches Krankenhaus Bethesda Mönchengladbach, West German Study Group Mönchengladbach Germany

76. Oncology Clinical Development Bristol‐Myers Squibb Princeton NJ USA

77. Translational Medicine Bristol‐Myers Squibb Princeton NJ USA

78. Division of Research Peter MacCallum Cancer Centre Melbourne Australia

79. Department of Pathology GZA‐ZNA Hospitals Antwerp Belgium

Funder

National Breast Cancer Foundation

Breast Cancer Research Foundation

Publisher

Wiley

Subject

Pathology and Forensic Medicine

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/path.5406

Reference99 articles.

1. Comparison of Biomarker Modalities for Predicting Response to PD-1/PD-L1 Checkpoint Blockade

2. 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

3. Assessing Tumor-Infiltrating Lymphocytes in Solid Tumors: A Practical Review for Pathologists and Proposal for a Standardized Method from the International Immuno-Oncology Biomarkers Working Group: Part 2: TILs in Melanoma, Gastrointestinal Tract Carcinomas, Non–Small Cell Lung Carcinoma and Mesothelioma, Endometrial and Ovarian Carcinomas, Squamous Cell Carcinoma of the Head and Neck, Genitourinary Carcinomas, and Primary Brain Tumors

4. Addressing the dichotomy between individual and societal approaches to personalised medicine in oncology

5. A risk-management approach for effective integration of biomarkers in clinical trials: perspectives of an NCI, NCRI, and EORTC working group

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