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

Doo Sik Kong, Do Hyun Nam, Shin Hyuk Kang, Jae Won Lee, Jong Hee Chang, Jeong Hoon Kim, Young Jin Lim, Young Cho Koh, Yong Gu Chung, Jae Min Kim, Choong Hyun Kim

    Research output: Contribution to journalArticlepeer-review

    41 Citations (Scopus)

    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 radiotherapytemozolomide (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.

    Original languageEnglish
    Pages (from-to)7003-7013
    Number of pages11
    JournalOncotarget
    Volume8
    Issue number4
    DOIs
    Publication statusPublished - 2017

    Keywords

    • Autologous cytokine-induced killer cell
    • Glioblastoma
    • Immunotherapy

    ASJC Scopus subject areas

    • Oncology

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