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Open Access Green möglich sobald Postprint bei der ZB eingereicht worden ist.
Recommendations from the iSBTc-SITC/FDA/NCI Workshop on Immunotherapy Biomarkers.
Clin. Cancer Res. 17, 3064-3076 (2011)
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.
Impact Factor
Scopus SNIP
Web of Science
Times Cited
Times Cited
Scopus
Cited By
Cited By
Altmetric
7.338
1.834
61
90
Anmerkungen
Besondere Publikation
Auf Hompepage verbergern
Publikationstyp
Artikel: Journalartikel
Dokumenttyp
Wissenschaftlicher Artikel
Schlagwörter
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
Sprache
englisch
Veröffentlichungsjahr
2011
HGF-Berichtsjahr
2011
ISSN (print) / ISBN
1078-0432
e-ISSN
1557-3265
Zeitschrift
Clinical Cancer Research
Quellenangaben
Band: 17,
Heft: 10,
Seiten: 3064-3076
Verlag
American Association for Cancer Research (AACR)
Verlagsort
Philadelphia, MA
Begutachtungsstatus
Peer reviewed
POF Topic(s)
30504 - Mechanisms of Genetic and Environmental Influences on Health and Disease
Forschungsfeld(er)
Immune Response and Infection
PSP-Element(e)
G-501700-001
G-501700-002
G-501790-001
G-520400-001
G-501790-002
G-501790-003
G-501700-002
G-501790-001
G-520400-001
G-501790-002
G-501790-003
PubMed ID
21558394
Erfassungsdatum
2011-11-07