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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...

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Autores principales: 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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Impact Journals LLC 2016
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.
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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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