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Phase III randomized trial of autologous cytokine-induced killer cell immunotherapy for newly diagnosed glioblastoma in korea
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 gliobla...
Autores principales: | , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Impact Journals LLC
2016
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5351686/ https://www.ncbi.nlm.nih.gov/pubmed/27690294 http://dx.doi.org/10.18632/oncotarget.12273 |
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author | Kong, Doo-Sik Nam, Do-Hyun Kang, Shin-Hyuk Lee, Jae Won Chang, Jong-Hee Kim, Jeong-Hoon Lim, Young-Jin Koh, Young-Cho Chung, Yong-Gu Kim, Jae-Min Kim, Choong-Hyun |
author_facet | Kong, Doo-Sik Nam, Do-Hyun Kang, Shin-Hyuk Lee, Jae Won Chang, Jong-Hee Kim, Jeong-Hoon Lim, Young-Jin Koh, Young-Cho Chung, Yong-Gu Kim, Jae-Min Kim, Choong-Hyun |
author_sort | Kong, Doo-Sik |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-5351686 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2016 |
publisher | Impact Journals LLC |
record_format | MEDLINE/PubMed |
spelling | pubmed-53516862017-04-13 Phase III randomized trial of autologous cytokine-induced killer cell immunotherapy for newly diagnosed glioblastoma in korea Kong, Doo-Sik Nam, Do-Hyun Kang, Shin-Hyuk Lee, Jae Won Chang, Jong-Hee Kim, Jeong-Hoon Lim, Young-Jin Koh, Young-Cho Chung, Yong-Gu Kim, Jae-Min Kim, Choong-Hyun Oncotarget Clinical Research Paper 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. Impact Journals LLC 2016-09-27 /pmc/articles/PMC5351686/ /pubmed/27690294 http://dx.doi.org/10.18632/oncotarget.12273 Text en Copyright: © 2017 Kong et al. http://creativecommons.org/licenses/by/3.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. |
spellingShingle | Clinical Research Paper Kong, Doo-Sik Nam, Do-Hyun Kang, Shin-Hyuk Lee, Jae Won Chang, Jong-Hee Kim, Jeong-Hoon Lim, Young-Jin Koh, Young-Cho Chung, Yong-Gu Kim, Jae-Min Kim, Choong-Hyun Phase III randomized trial of autologous cytokine-induced killer cell immunotherapy for newly diagnosed glioblastoma in korea |
title | Phase III randomized trial of autologous cytokine-induced killer cell immunotherapy for newly diagnosed glioblastoma in korea |
title_full | Phase III randomized trial of autologous cytokine-induced killer cell immunotherapy for newly diagnosed glioblastoma in korea |
title_fullStr | Phase III randomized trial of autologous cytokine-induced killer cell immunotherapy for newly diagnosed glioblastoma in korea |
title_full_unstemmed | Phase III randomized trial of autologous cytokine-induced killer cell immunotherapy for newly diagnosed glioblastoma in korea |
title_short | Phase III randomized trial of autologous cytokine-induced killer cell immunotherapy for newly diagnosed glioblastoma in korea |
title_sort | phase iii randomized trial of autologous cytokine-induced killer cell immunotherapy for newly diagnosed glioblastoma in korea |
topic | Clinical Research Paper |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5351686/ https://www.ncbi.nlm.nih.gov/pubmed/27690294 http://dx.doi.org/10.18632/oncotarget.12273 |
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