Efficacy evaluation criteria for immunotherapy in solid tumors

Abstract

Abstract:Immunotherapy has become an important therapy for solid tumors, which is in addition to surgery, radiotherapy, chemotherapy and targeted therapy. However immune treatment mechanism is different from those previous treatment. The effect of immunotherapies is on the immune system and not directly on the tumor. The kinetics of immunotherapy is characterized by a cellular immune response followed by potential changes in tumor burden and survival period. They are not captured by the traditional World Health Organization (WHO) or the Response Evaluation Criteria in Solid Tumors (RECIST). New immunerelated response criteria are defined which more comprehensively capture all response patters and gradually applied in clinical practice.

Key words:Neoplasms,Immunotherapy,Response evaluation

Zhang Ping, Ai Bin. Efficacy evaluation criteria for immunotherapy in solid tumors[J]. Journal of International Oncology, 2016, 43(11): 848-851.

References

［1］ Kerkar SP, Restifo NP. Cellular constituents of immune escape within the tumor microenvironment［J］. Cancer Res, 2012, 72(13): 3125-3130. DOI: 10.1158/0008-5472.CAN-11-4094. ［2］ Di Giacomo AM, Danielli R, Guidoboni M, et al. Therapeutic efficacy of ipilimumab, an antiCTLA4 monoclonal antibody, in patients with metastatic melanoma unresponsive to prior systemic treatments: clinical and immunological evidence from three patient cases［J］. Cancer Immunol Immunother, 2009, 58(8): 12971306. DOI: 10.1007/s002620080642y. ［3］ Rizvi NA, Mazières J, Planchard D, et al. Activity and safety of nivolumab, an antiPD1 immune checkpoint inhibitor, for patients with advanced, refractory squamous non-small-cell lung cancer (CheckMate 063): a phase 2, singlearm trial［J］. Lancet Oncol, 2015, 16(3): 257265. DOI: 10.1016/S14702045(15)700549. ［4］ Hodi FS, Butler M, Oble DA, et al. Immunologic and clinical effects of antibody blockade of cytotoxic T lymphocyteassociated antigen 4 in previously vaccinated cancer patients［J］. Proc Natl Acad Sci USA, 2008, 105(8): 3005-3010. DOI: 10.1073/pnas.0712237105. ［5］ Cohen JV, Alomari AK, Vortmeyer AO, et al. Melanoma brain metastasis pseudoprogression after pembrolizumab treatment［J］. Cancer Immunol Res, 2016, 4(3): 179-182. DOI: 10.1158/2326-6066.CIR-15-0160. ［6］ Hodi FS, Ribas A, Daud A, et al. Evaluation of immunerelated response criteria (irRC) in patients (pts) with advanced melanoma (MEL) treated with the antiPD-1 monoclonal antibody MK3475［J］. J Clin Oncol, 2014, 32(5s): abstr 3006. ［7］ F.Stephen Hodi, Mario Sznol, Harriet M. Kluger, et al. Longterm survival of ipilimumabnaive patients (pts) with advanced melanoma (MEL) treated with nivolumab (antiPD-1, BMS936558, ONO4538) in a phase Ⅰ trial［J］. J Clin Oncol, 2014, 32(5s): abstr 9002. ［8］ Wolchok JD, Hoos A, O′day S, et al. Guidelines for the evaluation of immune therapy activity in solid tumors: immunerelated response criteria［J］. Clin Cancer Res, 2009, 15(23): 7412-7420. DOI: 10.1158/1078-0432.CCR-09-1624. ［9］ Hoos A, Parmiani G, Hege K, et al. A clinical development paradigm for cancer vaccines and related biologics［J］. J Immunother, 2007, 30(1): 1-15. DOI: 10.1097/01.cji.0000211341.88835.ae. ［10］ Ribas A, Chmielowski B, Glaspy JA. Do we need a different set of response assessment criteria for tumor immunotherapy?［J］. Clin Cancer Res, 2009, 15(23): 7116-7118. DOI: 10.1158/1078-0432.CCR-09-2376. ［11］ Chiou VL, Burotto M. Pseudoprogression and immunerelated response in solid tumors［J］.J Clin oncol, 2015, 33(31): 35413543. DOI:10.1200/JCO.2015.61.6870. ［12］ O′day SJ, Maio M, ChiarionSileni V, et al. Efficacy and safety of ipilimumab monotherapy in patients with pretreated advanced melanoma: a multicenter singlearm phase Ⅱ study［J］. Ann Oncol, 2010, 21(8): 17121717. DOI: 10.1093/annonc/mdq013. ［13］ Hodi FS, Hoos A, Ibrahim R, et al. Novel efficacy criteria for antitumor activity to immunotherapt using the example of ipilimumab, and antiCTLA-4 monoclonal antibody［J］. J Clin Oncol, 2008, 26 Suppl: S19. ［14］ Hodi FS, Hwu WJ, Kefford R, et al. Evaluation of immunerelated response criteria and RECIST v1.1 in patients with advanced melanoma treated with pembrolizumab［J］. J Clin Oncol, 2016, 34(13):1510-1517. DOI: 10.1200/JCO.2015.64.0391. ［15］ Hoos A, Wolchok JD, Humphrey RW, et al. CCR 20th anniversary commentary: immunerelated response criteriacapturing clinical activity in immunooncology［J］. Clin Cancer Res, 2015, 21(22): 4989-4991. DOI: 10.1158/10780432.CCR143128. ［16］ Lynch TJ, Bondarenko I, Luft A, et al. Ipilimumab in combination with paclitaxel and carboplatin as firstline treatment in stage IIIB/IV nonsmallcell lung cancer: results from a randomized, doubleblind, multicenter phase Ⅱ study［J］. J Clin Oncol, 2012, 30(17): 2046-2054. DOI: 10.1200/JCO.2011.38.4032. ［17］ Nishino M, GiobbieHurder A, Gargano M, et al. Developing a common language for tumor response to immunotherapy: immunerelated response criteria using unidimensional measurements［J］. Clin Cancer Res, 2013, 19(14): 3936-3943. DOI: 10.1158/1078-0432.CCR-13-0895. ［18］ Nishino M, Gargano M, Suda M, et al. Optimizing immunerelated tumor response assessment: does reducing the number of lesions impact response assessment in melanoma patients treated with ipilimumab?［J］. J Immunother Cancer, 2014, 2: 17. DOI: 10.1186/2051-1426-2-17. ［19］ Bohnsack O, Ludajic K. Adaptation of the immunerelated response criteria: irRECIST［C］. ESMO, 2014: abstract 4958. ［20］ Rosenberg JE, HoffmanCensits J, Powles T, et al. Atezolizumab in patients with locally advanced and metastatic urothelial carcinoma who have progressed following treatment with platinumbased chemotherapy: a singlearm, multicentre, phase 2 trial［J］. Lancet, 2016, 387(10031): 1909-1920. DOI: 10.1016/S01406736(16)00561-4. ［21］ Tuomela M, Stanescu I, Krohn K. Validation overview of bioanalytical methods［J］. Gene Ther, 2005, 12 Suppl 1: S131S138. DOI: 10.1038/sj.gt.3302627. ［22］ Britten CM, Janetzki S, van der Burg SH, et al. Toward the harmonization of immune monitoring in clinical trials: quo vadis［J］. Cancer Immunol Immunother, 2008, 57(3): 285-288.

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