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

被引：77

作者：

Butterfield, Lisa H. ^{[1
,2
,3
]}

Palucka, A. Karolina ^{[7
,8
]}

Britten, Cedrik M. ^{[25
,26
]}

Dhodapkar, Madhav V. ^{[9
]}

Hakansson, Leif ^{[32
]}

Janetzki, Sylvia ^{[10
]}

Kawakami, Yutaka ^{[33
]}

Kleen, Thomas-Oliver ^{[12
]}

Lee, Peter P. ^{[13
]}

Maccalli, Cristina ^{[35
]}

Maecker, Holden T. ^{[14
]}

Maino, Vernon C. ^{[15
]}

Maio, Michele ^{[37
,38
]}

Malyguine, Anatoli

Masucci, Giuseppe ^{[30
,31
]}

Pawelec, Graham ^{[27
]}

Potter, Douglas M. ^{[4
,5
]}

Rivoltini, Licia ^{[36
]}

Salazar, Lupe G.

Schendel, Dolores J. ^{[28
,29
]}

Slingluff, Craig L., Jr. ^{[22
]}

Song, Wenru ^{[23
]}

Stroncek, David F. ^{[17
]}

Tahara, Hideaki ^{[34
]}

Thurin, Magdalena ^{[20
]}

Trinchieri, Giorgio ^{[16
]}

van Der Burg, Sjoerd H. ^{[39
]}

Whiteside, Theresa L. ^{[6
]}

Wigginton, Jon M. ^{[11
]}

Marincola, Francesco ^{[18
]}

Khleif, Samir ^{[19
]}

Fox, Bernard A. ^{[24
]}

Disis, Mary L. ^{[21
]}

机构：

[1] Univ Pittsburgh, Dept Med, Pittsburgh, PA 15213 USA

[2] Univ Pittsburgh, Dept Surg, Pittsburgh, PA 15213 USA

[3] Univ Pittsburgh, Dept Immunol, Pittsburgh, PA 15213 USA

[4] Univ Pittsburgh, Grad Sch Publ Hlth, Dept Biostat, Pittsburgh, PA 15213 USA

[5] Biostat Facil, Pittsburgh, PA USA

[6] Univ Pittsburgh, Inst Canc, Dept Pathol, Pittsburgh, PA 15213 USA

[7] Baylor Inst Immunol Res, Dallas, TX USA

[8] Mt Sinai Sch Med, Inst Immunol, Dept Gene & Cell Med, New York, NY USA

[9] Yale Univ, Dept Hematol & Immunobiol, New Haven, CT USA

[10] ZellNet Consulting Inc, Ft Lee, NJ USA

[11] Bristol Myers Squibb Co, Discovery Med Clin Oncol, Princeton, NJ USA

[12] Cellular Technol Ltd, Shaker Hts, OH USA

[13] Stanford Univ, Sch Med, Dept Med Hematol, Stanford, CA USA

[14] Stanford Univ, Sch Med, Inst Immun Transplantat & Infect, Human Immune Monitoring Ctr, Stanford, CA USA

[15] BD Biosci, San Jose, CA USA

[16] NCI, Canc & Inflammat Program, CCR, NIH, Frederick, MD 21701 USA

[17] NCI, Dept Transfus Med, Ctr Clin, NIH, Bethesda, MD 20892 USA

[18] NCI, Dept Translat Med, NIH, Bethesda, MD 20892 USA

[19] NCI, Canc Vaccine Sect, NIH, Bethesda, MD 20892 USA

[20] NCI, Canc Diag Program, Div Canc Treatment & Diag, NIH, Rockville, MD USA

[21] Univ Washington, Tumor Vaccine Grp, Div Oncol, Ctr Translat Med Womens Hlth, Seattle, WA 98109 USA

[22] Univ Virginia, Dept Surg, Charlottesville, VA USA

[23] Pfizer Oncol, New London, CT USA

[24] Providence Portland Med Ctr, Robert W Franz Canc Ctr, Earle A Chiles Res Inst, Lab Mol & Tumor Immunol, Portland, OR USA

[25] Johannes Gutenberg Univ Mainz, Univ Med Ctr, Dept Internal Med, D-6500 Mainz, Germany

[26] BioNTech AG, Clin Dev, Mainz, Germany

[27] Univ Tubingen, Sch Med, Dept Internal Med 2, Tubingen, Germany

[28] Helmholth Zentrum, Inst Mol Immunol, Munich, Germany

[29] Helmholth Zentrum, Immune Monitoring Grp, Munich, Germany

[30] Karolinska Inst, Dept Oncol Pathol, Stockholm, Sweden

[31] NCEV Nord Network Centrum Excellence Antitumour V, Stockholm, Sweden

[32] CamImGuide Therapeut AB, Hollviken, Sweden

[33] Keio Univ, Inst Adv Med Res, Div Cellular Signaling, Sch Med, Tokyo, Japan

[34] Univ Tokyo, Inst Med Sci, Adv Clin Res Ctr, Dept Surg & Bioengn,Minato Ku, Tokyo, Japan

[35] Ist Sci San Raffaele, Div Mol Oncol, Unit Immunobiotherapy Melanoma & Solid Tumors, Milan, Italy

[36] Fdn IRCCS Ist Nazl Tumori, Unit Immunotherapy Human Tumors, Milan, Italy

[37] Univ Hosp Siena, Ist Toscano Tumori, Siena, Italy

[38] Ctr Riferimento Oncol, Canc Bioimmunotherapy Unit, I-33081 Aviano, Italy

[39] Leiden Univ, Med Ctr, Dept Clin Oncol, Leiden, Netherlands

来源：

CLINICAL CANCER RESEARCH | 2011年 / 17卷 / 10期

基金：

美国国家卫生研究院;

关键词：

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;

D O I：

10.1158/1078-0432.CCR-10-2234

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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. (C) 2011 AACR.

引用

页码：3064 / 3076

页数：13

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