Cancer vaccines: what do we need to measure in clinical trials?

doi:10.4161/hv.27586

Review

. 2014;10(11):3236-40.

doi: 10.4161/hv.27586. Epub 2014 Nov 1.

Cancer vaccines: what do we need to measure in clinical trials?

Alex Kudrin¹

Affiliations

PMID: 25483508
PMCID: PMC4514090
DOI: 10.4161/hv.27586

Review

Cancer vaccines: what do we need to measure in clinical trials?

Alex Kudrin. Hum Vaccin Immunother. 2014.

. 2014;10(11):3236-40.

doi: 10.4161/hv.27586. Epub 2014 Nov 1.

Author

Alex Kudrin¹

Affiliation

¹ a Celltrion Inc ; Incheon , South Korea.

PMID: 25483508
PMCID: PMC4514090
DOI: 10.4161/hv.27586

Abstract

Cancer immunotherapy has seen a tremendous number of failures and only few recent regulatory successes. This review is dedicated to evaluate remaining challenges in capturing clinical response with cancer vaccines. Definition of disease progression in context of clinical rather image-specific criteria and interpretation of efficacy in relation to delayed effect of cancer vaccines should be taken into account in the design of future of immunotherapy trials.

Keywords: cancer vaccines; endpoints; immune response; patient reported outcomes; progression free survival.

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References

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1. Hoos A, Eggermont AM, Janetzki S, Hodi FS, Ibrahim R, Anderson A, Humphrey R, Blumenstein B, Old L, Wolchok J. Improved endpoints for cancer immunotherapy trials. J Natl Cancer Inst 2010; 102:1388-97; PMID:20826737; http://dx.doi.org/10.1093/jnci/djq310 - DOI - PMC - PubMed
1. Di Lorenzo G, Buonerba C. Kidney cancer: Overall Survival is an unsuitable primary clinical endpoint. Nature Urology 2010; 7:367-8; http://dx.doi.org/10.1038/nrurol.2010.84 - DOI - PubMed
1. Wolchok JD, Hoos A, O'Day S, Weber JS, Hamid O, Lebbé C, Maio M, Binder M, Bohnsack O, Nichol G, et al. . Guidelines for the evaluation of immune therapy activity in solid tumors: immune-related response criteria. Clin Cancer Res 2009; 15:7412-20; PMID:19934295; http://dx.doi.org/10.1158/1078-0432.CCR-09-1624 - DOI - PubMed
1. Gomella L, Nabhan C, DeVries T, Whitmore J, Frohlich M. Estimating the overall survival benefit of sipuleucel-T in the IMPACT trial accounting for crossover treatment in control subjects with autologous immunotherapy generated from cryopreserved cell. J Urol 2012; 187:E278-9; http://dx.doi.org/10.1016/j.juro.2012.02.765 - DOI

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[1] Hoos A, Parmiani G, Hege K, Sznol M, Loibner H, Eggermont A, Urba W, Blumenstein B, Sacks N, Keilholz U, et al.; Cancer Vaccine Clinical Trial Working Group. A clinical development paradigm for cancer vaccines and related biologics. J Immunother 2007; 30:1-15; PMID:17198079; http://dx.doi.org/10.1097/01.cji.0000211341.88835.ae - DOI - PubMed

[2] Hoos A, Parmiani G, Hege K, Sznol M, Loibner H, Eggermont A, Urba W, Blumenstein B, Sacks N, Keilholz U, et al.; Cancer Vaccine Clinical Trial Working Group. A clinical development paradigm for cancer vaccines and related biologics. J Immunother 2007; 30:1-15; PMID:17198079; http://dx.doi.org/10.1097/01.cji.0000211341.88835.ae - DOI - PubMed

[3] Hoos A, Eggermont AM, Janetzki S, Hodi FS, Ibrahim R, Anderson A, Humphrey R, Blumenstein B, Old L, Wolchok J. Improved endpoints for cancer immunotherapy trials. J Natl Cancer Inst 2010; 102:1388-97; PMID:20826737; http://dx.doi.org/10.1093/jnci/djq310 - DOI - PMC - PubMed

[4] Hoos A, Eggermont AM, Janetzki S, Hodi FS, Ibrahim R, Anderson A, Humphrey R, Blumenstein B, Old L, Wolchok J. Improved endpoints for cancer immunotherapy trials. J Natl Cancer Inst 2010; 102:1388-97; PMID:20826737; http://dx.doi.org/10.1093/jnci/djq310 - DOI - PMC - PubMed

[5] Di Lorenzo G, Buonerba C. Kidney cancer: Overall Survival is an unsuitable primary clinical endpoint. Nature Urology 2010; 7:367-8; http://dx.doi.org/10.1038/nrurol.2010.84 - DOI - PubMed

[6] Di Lorenzo G, Buonerba C. Kidney cancer: Overall Survival is an unsuitable primary clinical endpoint. Nature Urology 2010; 7:367-8; http://dx.doi.org/10.1038/nrurol.2010.84 - DOI - PubMed

[7] Wolchok JD, Hoos A, O'Day S, Weber JS, Hamid O, Lebbé C, Maio M, Binder M, Bohnsack O, Nichol G, et al. . Guidelines for the evaluation of immune therapy activity in solid tumors: immune-related response criteria. Clin Cancer Res 2009; 15:7412-20; PMID:19934295; http://dx.doi.org/10.1158/1078-0432.CCR-09-1624 - DOI - PubMed

[8] Wolchok JD, Hoos A, O'Day S, Weber JS, Hamid O, Lebbé C, Maio M, Binder M, Bohnsack O, Nichol G, et al. . Guidelines for the evaluation of immune therapy activity in solid tumors: immune-related response criteria. Clin Cancer Res 2009; 15:7412-20; PMID:19934295; http://dx.doi.org/10.1158/1078-0432.CCR-09-1624 - DOI - PubMed

[9] Gomella L, Nabhan C, DeVries T, Whitmore J, Frohlich M. Estimating the overall survival benefit of sipuleucel-T in the IMPACT trial accounting for crossover treatment in control subjects with autologous immunotherapy generated from cryopreserved cell. J Urol 2012; 187:E278-9; http://dx.doi.org/10.1016/j.juro.2012.02.765 - DOI

[10] Gomella L, Nabhan C, DeVries T, Whitmore J, Frohlich M. Estimating the overall survival benefit of sipuleucel-T in the IMPACT trial accounting for crossover treatment in control subjects with autologous immunotherapy generated from cryopreserved cell. J Urol 2012; 187:E278-9; http://dx.doi.org/10.1016/j.juro.2012.02.765 - DOI

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Cancer vaccines: what do we need to measure in clinical trials?

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Cancer vaccines: what do we need to measure in clinical trials?

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