Abstract
PurposeAdoptive 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 designIn 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.ResultsBetween 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.ConclusionsThe 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.
Highlights
Glioblastoma (GBM) is the most aggressive primary parenchymal brain tumor, which has a median survival of only 14.6-16 months. [1, 2] The current standard therapy is safe maximal resection followed by concurrent radiotherapy and chemotherapy with temozolomide (TMZ) and subsequent TMZ treatment
In the intention-to-treat analysis set, median progression-free survival (PFS) was 8.1 months (95% confidence interval (CI), 5.8 to 8.5 months) in the Cytokineinduced killer (CIK) immunotherapy group, as compared to 5.4 months in the control group
[12] Recent studies demonstrated that immunotherapy with CIK cells improved clinical outcome and promoted the quality of life (QoL) in cancer patients. [4, 5, 11, 13, 14] Wu, et al reported the result of phase II study that chemotherapy plus CIK cells had potential benefits compared to chemotherapy alone in patients with advanced non-small cell lung cancer and autologous CIK cell transfusion had no obvious sideeffects4
Summary
Glioblastoma (GBM) is the most aggressive primary parenchymal brain tumor, which has a median survival of only 14.6-16 months. [1, 2] The current standard therapy is safe maximal resection followed by concurrent radiotherapy and chemotherapy with temozolomide (TMZ) and subsequent TMZ treatment. [3, 4, 6,7,8,9,10,11] Since the first clinical trial of adoptive immunotherapy using CIK cells in 1999, a growing number of trials have suggested that CIK therapy is associated with a significantly prolonged mean survival time and disease control rate. [12] Recent studies demonstrated that immunotherapy with CIK cells improved clinical outcome and promoted the quality of life (QoL) in cancer patients. [8, 9, 13, 15] there is no clinical evidence for adoptive immunotherapy using CIK cells to prolong the survival and promote the QoL in patients with GBM Retrospective reviews regarding the adverse events by autologous CIK cells immunotherapy revealed that their adverse effects represented minor, selflimiting, and not serious, as most of the adverse events were resolved without additional management within 24 hours. [8, 9, 13, 15] there is no clinical evidence for adoptive immunotherapy using CIK cells to prolong the survival and promote the QoL in patients with GBM
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