방사선의학 웹진

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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.

Author information​

Kong DS1, Nam DH1, Kang SH2, Lee JW3, Chang JH4, Kim JH5, Lim YJ6, Koh YC7, Chung YG2, Kim JM8, Kim CH8.

1Department of Neurosurgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.

2Department of Neurosurgery, College of Medicine, Korea University, Seoul, Korea.

3Department of Statistics, Korea University, Seoul, Korea.

4Department of Neurosurgery, Yonsei University College of Medicine, Seoul, Korea.

5Department of Neurosurgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.

6Department of Neurosurgery, Kyunghee University Hospital, Seoul, Korea.

7Department of Neurosurgery, Konkuk University Medical Center, Seoul, Korea.

8Department of Neurosurgery, Hanyang University Guri Hospital, Hanyang University College of Medicine, Guri, Korea.