Emerging concepts in biomarker discovery; the US-Japan Workshop on Immunological Molecular Markers in Oncology.

Hideaki Tahara 1, * Marimo Sato 1, * Magdalena Thurin 2, * Ena Wang 3, * Lisa Butterfield 4, * Mary Disis 5 Bernard Fox 6 Peter Lee 7 Samir Khleif 8 Jon Wigginton 9 Stefan Ambs 10 Yasunori Akutsu 11 Damien Chaussabel 12 Yuichiro Doki 13 Oleg Eremin 14 Wolf Fridman 15 Yoshihiko Hirohashi 16 Kohzoh Imai 16 James Jacobson 2 Masahisa Jinushi 1 Akira Kanamoto 1 Mohammed Kashani-Sabet 17 Kazunori Kato 18 Yutaka Kawakami 19 John Kirkwood 4 Thomas Kleen 20 Paul Lehmann 20 Lance Liotta 21 Michael Lotze 22 Michele Maio 23, 24 Anatoli Malyguine 25 Giuseppe Masucci 26 Hisahiro Matsubara 11 Shawmarie Mayrand-Chung 27 Kiminori Nakamura 18 Hiroyoshi Nishikawa 28 A Karolina Palucka 12 Emanuel Petricoin 21 Zoltan Pos 3 Antoni Ribas 29 Licia Rivoltini 30 Noriyuki Sato 31 Hiroshi Shiku 28 Craig Slingluff 32 Howard Streicher 33 David Stroncek 34 Hiroya Takeuchi 35 Minoru Toyota 36 Hisashi Wada 13 Xifeng Wu 37 Julia Wulfkuhle 21 Tomonori Yaguchi 19 Benjamin Zeskind 38 Yingdong Zhao 39 Mai-Britt Zocca 40 Francesco Marincola 3, *
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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Journal of Translational Medicine, BioMed Central, 2009, 7 (1), pp.45. 〈10.1186/1479-5876-7-45〉
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Hideaki Tahara, Marimo Sato, Magdalena Thurin, Ena Wang, Lisa Butterfield, et al.. Emerging concepts in biomarker discovery; the US-Japan Workshop on Immunological Molecular Markers in Oncology.. Journal of Translational Medicine, BioMed Central, 2009, 7 (1), pp.45. 〈10.1186/1479-5876-7-45〉. 〈inserm-00585733〉

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