Immuno-Oncology biomarkers 2010 and beyond: Perspectives from the iSBTc/SITC biomarker task force

Journal of Translational Medicine

Volumn 8, Issue , 2010, Pages

  Butterfield, Lisa H ^a   Disis, Mary L ^b   Khleif, Samir N ^c   Balwit, James M ^d   Marincola, Francesco M ^e  

^a UNIVERSITY OF PITTSBURGH SCHOOL OF MEDICINE   (United States)

^b UNIVERSITY OF WASHINGTON SCHOOL OF MEDICINE   (United States)

^c NATIONAL CANCER INSTITUTE   (United States)

^d Society for Immunotherapy of Cancer   (United States)

^e NATIONAL INSTITUTES OF HEALTH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL MARKER; INTERLEUKIN 28B; PEGINTERFERON ALPHA; PROVENGE; RIBAVIRIN; TUMOR MARKER;

ANTIGEN SPECIFICITY; AUTOIMMUNITY; CANCER IMMUNOTHERAPY; CD8+ T LYMPHOCYTE; CELLULAR IMMUNITY; DENDRITIC CELL; FLOW CYTOMETRY; GENETIC VARIABILITY; HEPATITIS C; HUMAN; HUMORAL IMMUNITY; IMMUNOLOGICAL MONITORING; LABORATORY TEST; MATHEMATICAL MODEL; MEDICAL RESEARCH; MEDICAL SOCIETY; NATIONAL HEALTH ORGANIZATION; NOTE; PROSTATE ADENOCARCINOMA; STANDARDIZATION; TREATMENT RESPONSE; TUMOR IMMUNITY; TUMOR MICROENVIRONMENT; VALIDATION PROCESS; ADVISORY COMMITTEE; ANIMAL; CLINICAL TRIAL (TOPIC); CONFERENCE PAPER; HEALTH CARE PLANNING; IMMUNITY; IMMUNOASSAY; IMMUNOLOGY; IMMUNOTHERAPY; MOUSE; NEOPLASM; REPRODUCIBILITY; STANDARD;

ADVISORY COMMITTEES; ANIMALS; CLINICAL TRIALS AS TOPIC; HEALTH PLANNING GUIDELINES; HUMANS; IMMUNITY; IMMUNOASSAY; IMMUNOTHERAPY; MICE; MONITORING, IMMUNOLOGIC; NEOPLASMS; REFERENCE STANDARDS; REPRODUCIBILITY OF RESULTS; SOCIETIES, MEDICAL; TUMOR MARKERS, BIOLOGICAL;

EID: 78649750575     PISSN: None     EISSN: 14795876     Source Type: Journal    
DOI: 10.1186/1479-5876-8-130     Document Type: Note

References (18)

1. Butterfield LH, Disis ML, Fox BA, Lee PP, Khleif SN, Thurin M, Trinchieri G, Wang E, Wigginton J, Chaussabel D, Coukos G, Dhodapkar M, Hakansson L, Janetzki S, Kleen TO, Kirkwood JM, Maccalli C, Maecker H, Maio M, Malyguine A, Masucci G, Palucka AK, Potter DM, Ribas A, Rivoltini L, Schendel D, Seliger B, Selvan S, Slingluff CL, Stroncek DF, Streicher H, Wu X, Zeskind B, Zhao Y, Zocca MB, Zwierzina H, Marincola FM. A systematic approach to biomarker discovery; Preamble to "the iSBTc-FDA taskforce on immunotherapy biomarkers. J Transl Med 2008, 6:81. 10.1186/1479-5876-6-81, 2630944, 19105846.
2. Tahara H, Sato M, Thurin M, Wang E, Butterfield LH, Disis ML, Fox BA, Lee PP, Khleif SN, Wigginton JM, Ambs S, Akutsu Y, Chaussabel D, Doki Y, Eremin O, Fridman WH, Hirohashi Y, Imai K, Jacobson J, Jinushi1 M, Kanamoto A, Kashani-Sabet M, Kato K, Kawakami Y, Kirkwood JM, Kleen TO, Lehmann PV, Liotta L, Lotze MT, Malyguine A, Masucci G, Matsubara H, Nakamura K, Palucka AK, Petricoin EF, Pos Z, Ribas A, Rivoltini L, Sato N, Shiku H, Slingluff CL, Streicher H, Stroncek DF, Takeuchi H, Toyota M, Wada H, Wu X, Wulfkuhle J, Yaguchi T, Zeskind B, Zhao Y, Zocca MB, Marincola FM. Emerging concepts in biomarker discovery: The US-Japan workshop on immunological molecular markers in oncology. J Transl Med 2009, 7:45. 10.1186/1479-5876-7-45, 2724494, 19534815.
3. Butterfield LH, Palucka AK, Britten CM, Dhodapkar MV, Hakansson L, Janetzki S, Kawakami Y, Kleen TO, Lee PP, Maccalli C, Maecker HT, Maino VC, Maio M, Malyguine A, Masucci G, Pawelec G, Potter DM, Rivoltini L, Salazar LG, Schendel DJ, Slingluff CL, Song W, Stroncek DF, Tahara H, Thurin M, Trinchieri G, van Der Burg SH, Whiteside TL, Wigginton JM, Marincola F, Khleif S, Fox BA, Disis ML. Recommendations from the iSBTc-SITC/FDA/NCI Workshop on Immunotherapy Biomarkers. Clin Cancer Res 2010,
4. Khleif SN, Doroshow JH, Hait WN, . AACR-FDA-NCI Cancer Biomarkers Collaborative AACR-FDA-NCI Cancer Biomarkers Collaborative Consensus Report: advancing the use of biomarkers in cancer drug development. Clin Cancer Res 2010, 16:3299-3318. 10.1158/1078-0432.CCR-10-0880, 20501613, AACR-FDA-NCI Cancer Biomarkers Collaborative.
5. Miata Reporting Framework. , http://www.miataproject.org
6. Draft Guidance for Industry-Potency Tests for Cellular and Gene Therapy Products. , http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/ucm072571.htm
7. FDA US Food and Drug Administration. Vaccines, Blood & Biologics. , http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/ucm182443.htm
8. FDA US Food and Drug Administration. Vaccines, Blood & Biologics. , http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/OtherRecommendationsforManufacturers/ucm094338.htm
9. Galon J, Costes A, Sanchez-Cabo F, Kirilovsky A, Mlecnik B, Lagorce-Pages C, Tosolini M, Camus M, Berger A, Wind P, Zinzindohoue F, Bruneval P, Cugnenc PH, Trajanoski Z, Fridman WH, Pages F. Type, density, and location of immune cells within human colorectal tumors predict clinical outcome. Science 2006, 313:1960-1964. 10.1126/science.1129139, 17008531.
10. Zhang L, Conejo-Garcia JR, Katsaros D, Gimotty PA, Massobrio M, Regnani G, Makrigiannakis A, Gray H, Schlienger K, Liebman MN, Rubin SC, Coukos G. Intratumoral T cells, recurrence, and survival in epithelial ovarian cancer. N Engl J Med 2003, 348:203-213. 10.1056/NEJMoa020177, 12529460.
11. Sato E, Olson SH, Ahn J, Bundy B, Nishikawa H, Qian F, Jungbluth AA, Frosina D, Gnjatic S, Ambrosone C, Kepner J, Odunsi T, Ritter G, Lele S, Chen YT, Ohtani H, Old LJ, Odunsi K. Intraepithelial CD8+ tumor-infiltrating lymphocytes and a high CD8+/regulatory T cell ratio are associated with favorable prognosis in ovarian cancer. Proc Natl Acad Sci USA 2005, 102:18538-18543. 10.1073/pnas.0509182102, 1311741, 16344461.
12. Bates GJ, Fox SB, Han C, Leek RD, Garcia JF, Harris AL, Banham AH. Quantification of regulatory T cells enables the identification of high-risk breast cancer patients and those at risk of late relapse. J Clin Oncol 2006, 24:5373-5380. 10.1200/JCO.2006.05.9584, 17135638.
13. Hamanishi J, Mandai M, Iwasaki M, Okazaki T, Tanaka Y, Yamaguchi K, Higuchi T, Yagi H, Takakura K, Minato N, Honjo T, Fujii S. Programmed cell death 1 ligand 1 and tumor-infiltrating CD8+ T lymphocytes are prognostic factors of human ovarian cancer. Proc Natl Acad Sci USA 2007, 104:3360-3365. 10.1073/pnas.0611533104, 1805580, 17360651.
14. Desruisseau S, Palmari J, Giusti C, Romain S, Martin PM, Berthois Y. Determination of TGFbeta1 protein level in human primary breast cancers and its relationship with survival. Br J Cancer 2006, 94:239-246. 10.1038/sj.bjc.6602920, 2361106, 16404434.
15. Pages F, Berger A, Camus M, Sanchez-Cabo F, Costes A, Molidor R, Mlecnik B, Kirilovsky A, Nilsson M, Damotte D, Meatchi T, Bruneval P, Cugnenc PH, Trajanoski Z, Fridman WH, Galon J. Effector memory T cells, early metastasis, and survival in colorectal cancer. N Engl J Med 2005, 353:2654-2666. 10.1056/NEJMoa051424, 16371631.
16. Kantoff PW, Higano CS, Shore ND, Berger ER, Small EJ, Penson DF, Redfern CH, Ferrari AC, Dreicer R, Sims RB, Xu Y, Frohlich MW, Schellhammer PF, . IMPACT Study Investigators Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med 2010, 363:411-422. 10.1056/NEJMoa1001294, 20818862, IMPACT Study Investigators.
17. Maecker HT, McCoy JP, . FOCIS Human Immunophenotyping Consortium A model for harmonizing flow cytometry in clinical trials. Nat Immunol 2010, 11:975-978. 10.1038/ni1110-975, 20959798, FOCIS Human Immunophenotyping Consortium.
18. Biomarkers Symposium Slides. , http://www.isbtc.org/meetings/am10/biomarkers10/65