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Phase III randomized trial of autologous cytokine-induced killer cell immunotherapy for newly diagnosed glioblastoma in korea

Authors
Kong, Doo-SikNam, Do-HyunKang, Shin-HyukLee, Jae WonChang, Jong-HeeKim, Jeong-HoonLim, Young-JinKoh, Young-ChoChung, Yong-GuKim, Jae-MinKim, Choong-Hyun
Issue Date
24-1월-2017
Publisher
IMPACT JOURNALS LLC
Keywords
immunotherapy; autologous cytokine-induced killer cell; glioblastoma
Citation
ONCOTARGET, v.8, no.4, pp.7003 - 7013
Indexed
SCIE
SCOPUS
Journal Title
ONCOTARGET
Volume
8
Number
4
Start Page
7003
End Page
7013
URI
https://scholar.korea.ac.kr/handle/2021.sw.korea/84881
DOI
10.18632/oncotarget.12273
ISSN
1949-2553
Abstract
Purpose: Adoptive cell immunotherapy involves an ex vivo expansion of autologous cytokine-induced killer (CIK) cells before their reinfusion into the host. We evaluated the efficacy and safety of CIK cell immunotherapy with radiotherapy-temozolomide (TMZ) for the treatment of newly diagnosed glioblastomas. Experimental design: In this multi-center, open-label, phase 3 study, we randomly assigned patients with newly diagnosed glioblastoma to receive CIK cell immunotherapy combined with standard TMZ chemoradiotherapy (CIK immunotherapy group) or standard TMZ chemoradiotherapy alone (control group). The efficacy endpoints were analyzed in the intention-to-treat set and in the per protocol set. Results: Between December 2008 and October 2012, a total of 180 patients were randomly assigned to the CIK immunotherapy (n = 91) or control group (n = 89). In the intention-to-treat analysis set, median PFS was 8.1 months (95% confidence interval (CI), 5.8 to 8.5 months) in the CIK immunotherapy group, as compared to 5.4 months (95% CI, 3.3 to 7.9 months) in the control group (one-sided log-rank, p = 0.0401). Overall survival did not differ significantly between two groups. Grade 3 or higher adverse events, health-related quality of life and performance status between two groups did not show a significant difference. Conclusions: The addition of CIK cells immunotherapy to standard chemoradiotherapy with TMZ improved PFS. However, the CIK immunotherapy group did not show evidence of a beneficial effect on overall survival.
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