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Emerging concepts in biomarker discovery; The US-Japan workshop on immunological molecular markers in oncology

Hideaki Tahara1 email, Marimo Sato1 email, Magdalena Thurin2 email, Ena Wang3 email, Lisa H Butterfield4 email, Mary L Disis5 email, Bernard A Fox6 email, Peter P Lee7 email, Samir N Khleif8 email, Jon M Wigginton9 email, Stefan Ambs10 email, Yasunori Akutsu11 email, Damien Chaussabel12 email, Yuichiro Doki13 email, Oleg Eremin14 email, Wolf Hervé Fridman15 email, Yoshihiko Hirohashi16 email, Kohzoh Imai16 email, James Jacobson2 email, Masahisa Jinushi1 email, Akira Kanamoto1 email, Mohammed Kashani-Sabet17 email, Kazunori Kato18 email, Yutaka Kawakami19 email, John M Kirkwood4 email, Thomas O Kleen20 email, Paul V Lehmann20 email, Lance Liotta21 email, Michael T Lotze22 email, Michele Maio23,24 email, Anatoli Malyguine25 email, Giuseppe Masucci26 email, Hisahiro Matsubara11 email, Shawmarie Mayrand-Chung27 email, Kiminori Nakamura18 email, Hiroyoshi Nishikawa28 email, A Karolina Palucka12 email, Emanuel F Petricoin21 email, Zoltan Pos3 email, Antoni Ribas29 email, Licia Rivoltini30 email, Noriyuki Sato31 email, Hiroshi Shiku28 email, Craig L Slingluff32 email, Howard Streicher33 email, David F Stroncek34 email, Hiroya Takeuchi35 email, Minoru Toyota36 email, Hisashi Wada13 email, Xifeng Wu37 email, Julia Wulfkuhle21 email, Tomonori Yaguchi19 email, Benjamin Zeskind38 email, Yingdong Zhao39 email, Mai-Britt Zocca40 email and Francesco M Marincola3 email

1  Department of Surgery and Bioengineering, Advanced Clinical Research Center, Institute of Medical Science, The University of Tokyo, Tokyo, Japan

2  Cancer Diagnosis Program, National Cancer Institute (NCI), National Institutes of Health (NIH), Rockville, Maryland, 20852, USA

3  Infectious Disease and Immunogenetics Section (IDIS), Department of Transfusion Medicine, Clinical Center and Center for Human Immunology (CHI), NIH, Bethesda, Maryland, 20892, USA

4  Departments of Medicine, Surgery and Immunology, Division of Hematology Oncology, University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, 15213, USA

5  Tumor Vaccine Group, Center for Translational Medicine in Women's Health, University of Washington, Seattle, Washington, 98195, USA

6  Earle A Chiles Research Institute, Robert W Franz Research Center, Providence Portland Medical Center, and Department of Molecular Microbiology and Immunology, Oregon Health and Science University, Portland, Oregon, 97213, USA

7  Department of Medicine, Division of Hematology, Stanford University, Stanford, California, 94305, USA

8  Cancer Vaccine Section, NCI, NIH, Bethesda, Maryland, 20892, USA

9  Discovery Medicine-Oncology, Bristol-Myers Squibb Inc., Princeton, New Jersey, USA

10  Laboratory of Human Carcinogenesis, Center of Cancer Research, NCI, NIH, Bethesda, Maryland, 20892, USA

11  Department of Frontier Surgery, Graduate School of Medicine, Chiba University, Chiba, Japan

12  Baylor Institute for Immunology Research and Baylor Research Institute, Dallas, Texas, 75204, USA

13  Department of Surgery, Graduate School of Medicine, Osaka University, Osaka, Japan

14  Section of Surgery, Biomedical Research Unit, Nottingham Digestive Disease Centre, University of Nottingham, NG7 2UH, UK

15  Centre de la Reserche des Cordeliers, INSERM, Paris Descarte University, 75270 Paris, France

16  Sapporo Medical University, School of Medicine, Sapporo, Japan

17  Melanoma Clinic, University of California, San Francisco, California, USA

18  Department of Molecular Medicine, Sapporo Medical University, School of Medicine, Sapporo, Japan

19  Division of Cellular Signaling, Institute for Advanced Medical Research, Keio University School of Medicine, Tokyo, Japan

20  Cellular Technology Ltd, Shaker Heights, Ohio, 44122, USA

21  Department of Molecular Pathology and Microbiology, Center for Applied Proteomics and Molecular Medicine, George Mason University, Manassas, Virginia, 10900, USA

22  Illman Cancer Center, University of Pittsburgh, Pittsburgh, Pennsylvania, 15213, USA

23  Medical Oncology and Immunotherapy, Department. of Oncology, University, Hospital of Siena, Istituto Toscano Tumori, Siena, Italy

24  Cancer Bioimmunotherapy Unit, Department of Medical Oncology, Centro di Riferimento Oncologico, IRCCS, Aviano, 53100, Italy

25  Laboratory of Cell Mediated Immunity, SAIC-Frederick, Inc. NCI-Frederick, Frederick, Maryland, 21702, USA

26  Department of Oncology-Pathology, Karolinska Institute, Stockholm, 171 76, Sweden

27  The Biomarkers Consortium (BC), Public-Private Partnership Program, Office of the Director, NIH, Bethesda, Maryland, 20892, USA

28  Department of Cancer Vaccine, Department of Immuno-gene Therapy, Mie University Graduate School of Medicine, Mie, Japan

29  Department of Medicine, Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, 90095, USA

30  Unit of Immunotherapy of Human Tumors, IRCCS Foundation, Istituto Nazionale Tumori, Milan, 20100, Italy

31  Department of Pathology, Sapporo Medical University School of Medicine, Sapporo, Japan

32  Department of Surgery, Division of Surgical Oncology, University of Virginia School of Medicine, Charlottesville, Virginia, 22908, USA

33  Cancer Therapy Evaluation Program, DCTD, NCI, NIH, Rockville, Maryland, 20892, USA

34  Cell Therapy Section (CTS), Department of Transfusion Medicine, Clinical Center, NIH, Bethesda, Maryland, 20892, USA

35  Department of Surgery, Keio University School of Medicine, Tokyo, Japan

36  Department of Biochemistry, Sapporo Medical University, School of Medicine, Sapporo, Japan

37  Department of Epidemiology, University of Texas, MD Anderson Cancer Center, Houston, Texas, 77030, USA

38  Immuneering Corporation, Boston, Massachusetts, 02215, USA

39  Biometric Research Branch, NCI, NIH, Bethesda, Maryland, 20892, USA

40  DanDritt Biotech A/S, Copenhagen, 2100, Denmark

author email corresponding author email

Journal of Translational Medicine 2009, 7:45doi:10.1186/1479-5876-7-45

Published: 17 June 2009

Abstract

Supported by the Office of International Affairs, National Cancer Institute (NCI), the "US-Japan Workshop on Immunological Biomarkers in Oncology" was held in March 2009. The workshop was related to a task force launched by the International Society for the Biological Therapy of Cancer (iSBTc) and the United States Food and Drug Administration (FDA) to identify strategies for biomarker discovery and validation in the field of biotherapy. The effort will culminate on October 28th 2009 in the "iSBTc-FDA-NCI Workshop on Prognostic and Predictive Immunologic Biomarkers in Cancer", which will be held in Washington DC in association with the Annual Meeting. The purposes of the US-Japan workshop were a) to discuss novel approaches to enhance the discovery of predictive and/or prognostic markers in cancer immunotherapy; b) to define the state of the science in biomarker discovery and validation. The participation of Japanese and US scientists provided the opportunity to identify shared or discordant themes across the distinct immune genetic background and the diverse prevalence of disease between the two Nations.

Converging concepts were identified: enhanced knowledge of interferon-related pathways was found to be central to the understanding of immune-mediated tissue-specific destruction (TSD) of which tumor rejection is a representative facet. Although the expression of interferon-stimulated genes (ISGs) likely mediates the inflammatory process leading to tumor rejection, it is insufficient by itself and the associated mechanisms need to be identified. It is likely that adaptive immune responses play a broader role in tumor rejection than those strictly related to their antigen-specificity; likely, their primary role is to trigger an acute and tissue-specific inflammatory response at the tumor site that leads to rejection upon recruitment of additional innate and adaptive immune mechanisms.

Other candidate systemic and/or tissue-specific biomarkers were recognized that might be added to the list of known entities applicable in immunotherapy trials. The need for a systematic approach to biomarker discovery that takes advantage of powerful high-throughput technologies was recognized; it was clear from the current state of the science that immunotherapy is still in a discovery phase and only a few of the current biomarkers warrant extensive validation. It was, finally, clear that, while current technologies have almost limitless potential, inadequate study design, limited standardization and cross-validation among laboratories and suboptimal comparability of data remain major road blocks. The institution of an interactive consortium for high throughput molecular monitoring of clinical trials with voluntary participation might provide cost-effective solutions.

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