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 journalArticle

29 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 Jan 1

Keywords

  • Autologous cytokine-induced killer cell
  • Glioblastoma
  • Immunotherapy

ASJC Scopus subject areas

  • Oncology

Fingerprint Dive into the research topics of 'Phase III randomized trial of autologous cytokine-induced killer cell immunotherapy for newly diagnosed glioblastoma in korea'. Together they form a unique fingerprint.

  • Cite this

    Kong, D. S., Nam, D. H., Kang, S-H., Lee, J. W., Chang, J. H., Kim, J. H., Lim, Y. J., Koh, Y. C., Chung, Y. G., Kim, J. M., & Kim, C. H. (2017). Phase III randomized trial of autologous cytokine-induced killer cell immunotherapy for newly diagnosed glioblastoma in korea. Oncotarget, 8(4), 7003-7013. https://doi.org/10.18632/oncotarget.12273