Recommendations from the iSBTc-SITC/FDA/NCI Workshop on Immunotherapy Biomarkers
| Autor: | Cedrik M. Britten, Vernon C. Maino, Peter P. Lee, Madhav V. Dhodapkar, Sylvia Janetzki, Jon M. Wigginton, Giorgio Trinchieri, Samir N. Khleif, Francesco M. Marincola, Dolores J. Schendel, Yutaka Kawakami, Bernard A. Fox, Lisa H. Butterfield, Hideaki Tahara, Licia Rivoltini, Craig L. Slingluff, Cristina Maccalli, Douglas M. Potter, Giuseppe Masucci, Anatoli Malyguine, A. Karolina Palucka, Holden T. Maecker, Sjoerd H. van der Burg, Graham Pawelec, Lupe G. Salazar, Wenru Song, Leif Håkansson, Thomas O. Kleen, Theresa L. Whiteside, Mary L. Disis, Magdalena Thurin, David F. Stroncek, Michele Maio |
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| Jazyk: | angličtina |
| Rok vydání: | 2011 |
| Předmět: |
Cancer Research
Pathology medicine.medical_specialty Health Planning Guidelines medicine.medical_treatment Consensus Development Conferences as Topic Standardized test Immune monitoring 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 Medical Oncology Article Food and drug administration Neoplasms medicine Biomarkers Tumor Humans Medical physics Personalized therapy Societies Medical Antitumor immunity business.industry Quality assessment United States Food and Drug Administration Cancer International Agencies Immunotherapy medicine.disease National Cancer Institute (U.S.) United States Oncology Practice Guidelines as Topic business |
| Zdroj: | Clinical Cancer Research, 17(10), 3064-3076 |
| Popis: | Purpose: 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. Experimental Design: 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. Results and Conclusions: 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. Clin Cancer Res; 17(10); 3064–76. ©2011 AACR. |
| Databáze: | OpenAIRE |
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