, Volume 57, Issue 3, pp 285-288,
Open Access This content is freely available online to anyone, anywhere at any time.
Date: 25 Aug 2007

Toward the harmonization of immune monitoring in clinical trials: Quo vadis?

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A constantly increasing number of cancer immunotherapies are being investigated in clinical trials but no reliable biomarkers to predict clinical benefit currently exist. For some cancer types, biomarkers have proven to be meaningful predictors of patient outcomes (e.g., BCR-ABL in Chronic Myeloid Leukemia or PSA in prostate cancer) and were established as routine tools. As effects of cancer immunotherapy are mediated through the immune system, immune responses may act as natural biomarkers for clinical efficiency if the right factors can be reliably measured. Following this concept, cancer immunotherapy trials over the last decade have often included measures of tumor-specific cellular immune responses as endpoints to identify reliable surrogates for clinical benefit. Substantial efforts were invested throughout the immunotherapy field in setting up suitable cellular immune assays. However, to date, data from clinical trials do not consistently show that immune responses a

C. M. Britten and S. Janetzki both authors contributed equally to this work.
This commentary refers to the two original articles “The CIMT-Monitoring panel: A two-step approach to harmonize the enumeration of antigen-specific CD8+ T lymphocytes by structural and functional assays” by C. M. Britten et al. and “Results and Harmonization Guidelines from two large-scale international Elispot proficiency panels conducted by the Cancer Vaccine Consortium (CVC/SVI)” by S. Janetzki et al.