The Society for Biological Therapy held a Workshop last fall devoted to immune monitoring for cancer immunotherapy trials. Participants included members of the academic and pharmaceutical communities as well as the National Cancer Institute and the Food and Drug Administration. Discussion focused on the relative merits and appropriate use of various immune monitoring tools. General conclusions included: (1) future vaccine studies should be designed to determine whether T-cell dysfunction (tumor-specific and nonspecific) correlated with clinical outcome; (2) tetramer-based assays yield quantitative but not functional data (3) enzyme-linked immunospot assays have the lowest limit of detection (4) cytokine flow cytometry have a higher limit of detection than enzyme-linked immunospot assay, but offer the advantages of speed and the ability to identify subsets of reactive cells; (5) antibody tests are simple and accurate and should be incorporated to a greater extent in monitoring plans; (6) proliferation assays are imprecise and should not be emphasized in future studies; (7) the reverse transcription polymerase chain reaction assay is a promising research approach that is not ready for widespread application; and (8) there is a critical need to validate these assays as surrogates for vaccine potency and clinical effect.Authors: Ulrich Keilholz, Jeffrey Weber, James H. Finke, Dmitry I. Gabrilovich, Martin W. Kast, Mary L. Disis, John M. Kirkwood, Carmen Scheibenbogen, Jeff Schlom, Vernon C. Maino, Kim H. Lyerly, Peter P. Lee, Walter Storkus, Franceso Marincola, Alexandra Worobec, Michael B. AtkinsPublished in the Journal of Immunotherapy (2002) 25:2.#SITCPublication