Clinical Research Papers:
Phase III randomized trial of autologous cytokine-induced killer cell immunotherapy for newly diagnosed glioblastoma in korea
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Doo-Sik Kong1,*, Do-Hyun Nam1,*, Shin-Hyuk Kang2, Jae Won Lee3, Jong-Hee Chang4, Jeong-Hoon Kim5, Young-Jin Lim6, Young-Cho Koh7, Yong-Gu Chung2, Jae-Min Kim8 and Choong-Hyun Kim8
1 Department of Neurosurgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
2 Department of Neurosurgery, College of Medicine, Korea University, Seoul, Korea
3 Department of Statistics, Korea University, Seoul, Korea
4 Department of Neurosurgery, Yonsei University College of Medicine, Seoul, Korea
5 Department of Neurosurgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
6 Department of Neurosurgery, Kyunghee University Hospital, Seoul, Korea
7 Department of Neurosurgery, Konkuk University Medical Center, Seoul, Korea
8 Department of Neurosurgery, Hanyang University Guri Hospital, Hanyang University College of Medicine, Guri, Korea
* These authors have contributed equally to this work
Choong Hyun Kim, email:
Keywords: immunotherapy, autologous cytokine-induced killer cell, glioblastoma
Received: August 05, 2016 Accepted: September 23, 2016 Published: September 27, 2016
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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