PuSH - Publication Server of Helmholtz Zentrum München

Butterfield, L.H.* ; Palucka, A.K.* ; Britten, C.M.* ; Dhodapkar, M.V.* ; Håkansson, L.* ; Janetzki, S.* ; Kawakami, Y.* ; Kleen, T.O.* ; Lee, P.P.* ; Maccalli, C.* ; Maecker, H.T.* ; Maino, V.C.* ; Maio, M.* ; Malyguine, A.* ; Masucci, G.* ; Pawelec, G.* ; Potter, D.M.* ; Rivoltini, L.* ; Salazar, L.G.* ; Schendel, D.J. ; Slingluff, C.L. Jr.* ; Song, W.* ; Stroncek, D.F.* ; Tahara, H.* ; Thurin, M.* ; Trinchieri, G.* ; van Der Burg, S.H.* ; Whiteside, T.L.* ; Wigginton, J.M.* ; Marincola, F.* ; Khleif, S.* ; Fox, B.A.* ; Disis, M.L.*

Recommendations from the iSBTc-SITC/FDA/NCI Workshop on Immunotherapy Biomarkers.

Clin. Cancer Res. 17, 3064-3076 (2011)
Open Access Green as soon as Postprint is submitted to ZB.
To facilitate development of innovative immunotherapy approaches, especially for treatment concepts exploiting the potential benefits of personalized therapy, there is a need to develop and validate tools to identify patients who can benefit from immunotherapy. Despite substantial effort, we do not yet know which parameters of antitumor immunity to measure and which assays are optimal for those measurements. The iSBTc-SITC (International Society for Biological Therapy of Cancer-Society for Immunotherapy of Cancer), FDA (Food and Drug Administration), and NCI (National Cancer Institute) partnered to address these issues for immunotherapy of cancer. Here, we review the major challenges, give examples of approaches and solutions, and present our recommendations. Although specific immune parameters and assays are not yet validated, we recommend following standardized (accurate, precise, and reproducible) protocols and use of functional assays for the primary immunologic readouts of a trial; consideration of central laboratories for immune monitoring of large, multi-institutional trials; and standardized testing of several phenotypic and functional potential potency assays specific to any cellular product. When reporting results, the full QA (quality assessment)/QC (quality control) should be conducted and selected examples of truly representative raw data and assay performance characteristics should be included. Finally, to promote broader analysis of multiple aspects of immunity, and gather data on variability, we recommend that in addition to cells and serum, RNA and DNA samples be banked (under standardized conditions) for later testing. We also recommend that sufficient blood be drawn to allow for planned testing of the primary hypothesis being addressed in the trial, and that additional baseline and posttreatment blood is banked for testing novel hypotheses (or generating new hypotheses) that arise in the field.
Additional Metrics?
Edit extra informations Login
Publication type Article: Journal article
Document type Scientific Article
Keywords t-cell immunity; cytokine flow-cytometry; cancer vaccine consortium; colony-stimulating factor; b elispot assay; phase-ii trial; dendritic cells; clinical-trials; hiv vaccine; harmonization guidelines
ISSN (print) / ISBN 1078-0432
e-ISSN 1557-3265
Quellenangaben Volume: 17, Issue: 10, Pages: 3064-3076 Article Number: , Supplement: ,
Publisher American Association for Cancer Research (AACR)
Publishing Place Philadelphia, MA
Reviewing status Peer reviewed