Emerging concepts in biomarker discovery; the US-Japan Workshop on Immunological Molecular Markers in Oncology.
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.
Tahara
Hideaki
H
Department of Surgery and Bioengineering, Advanced Clinical Research Center, Institute of Medical Science, The University of Tokyo, Tokyo, Japan. tahara@ims.u-tokyo.ac.jp
Sato
Marimo
M
Thurin
Magdalena
M
Wang
Ena
E
Butterfield
Lisa H
LH
Disis
Mary L
ML
Fox
Bernard A
BA
Lee
Peter P
PP
Khleif
Samir N
SN
Wigginton
Jon M
JM
Ambs
Stefan
S
Akutsu
Yasunori
Y
Chaussabel
Damien
D
Doki
Yuichiro
Y
Eremin
Oleg
O
Fridman
Wolf Hervé
WH
Hirohashi
Yoshihiko
Y
Imai
Kohzoh
K
Jacobson
James
J
Jinushi
Masahisa
M
Kanamoto
Akira
A
Kashani-Sabet
Mohammed
M
Kato
Kazunori
K
Kawakami
Yutaka
Y
Kirkwood
John M
JM
Kleen
Thomas O
TO
Lehmann
Paul V
PV
Liotta
Lance
L
Lotze
Michael T
MT
Maio
Michele
M
Malyguine
Anatoli
A
Masucci
Giuseppe
G
Matsubara
Hisahiro
H
Mayrand-Chung
Shawmarie
S
Nakamura
Kiminori
K
Nishikawa
Hiroyoshi
H
Palucka
A Karolina
AK
Petricoin
Emanuel F
EF
Pos
Zoltan
Z
Ribas
Antoni
A
Rivoltini
Licia
L
Sato
Noriyuki
N
Shiku
Hiroshi
H
Slingluff
Craig L
CL
Streicher
Howard
H
Stroncek
David F
DF
Takeuchi
Hiroya
H
Toyota
Minoru
M
Wada
Hisashi
H
Wu
Xifeng
X
Wulfkuhle
Julia
J
Yaguchi
Tomonori
T
Zeskind
Benjamin
B
Zhao
Yingdong
Y
Zocca
Mai-Britt
MB
Marincola
Francesco M
FM
D014408:Biomarkers, Tumor / Q000276:immunology*; D035843:Biomedical Research / Q000639:trends*; D006801:Humans; D007564:Japan; D054547:National Cancer Institute (U.S.); D009369:Neoplasms / Q000188:drug therapy*; D015203:Reproducibility of Results; D014481:United States; D014486:United States Food and Drug Administration
D014408:Biomarkers, Tumor