Cargando…
Levetiracetam as a sensitizer of concurrent chemoradiotherapy in newly diagnosed glioblastoma: An open‐label phase 2 study
BACKGROUND: An open‐label single‐arm phase 2 study was conducted to evaluate the role of levetiracetam as a sensitizer of concurrent chemoradiotherapy (CCRT) for patients with newly diagnosed glioblastoma. This study aimed to determine the survival benefit of levetiracetam in conjunction with the st...
Autores principales: | , , , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2021
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8729048/ https://www.ncbi.nlm.nih.gov/pubmed/34845868 http://dx.doi.org/10.1002/cam4.4454 |
_version_ | 1784626857634693120 |
---|---|
author | Hwang, Kihwan Kim, Junhyung Kang, Seok‐Gu Jung, Tae‐Young Kim, Jeong Hoon Kim, Se‐Hyuk Kang, Shin‐Hyuk Hong, Yong‐Kil Kim, Tae Min Kim, Yu Jung Choi, Byung Se Chang, Jong Hee Kim, Chae‐Yong |
author_facet | Hwang, Kihwan Kim, Junhyung Kang, Seok‐Gu Jung, Tae‐Young Kim, Jeong Hoon Kim, Se‐Hyuk Kang, Shin‐Hyuk Hong, Yong‐Kil Kim, Tae Min Kim, Yu Jung Choi, Byung Se Chang, Jong Hee Kim, Chae‐Yong |
author_sort | Hwang, Kihwan |
collection | PubMed |
description | BACKGROUND: An open‐label single‐arm phase 2 study was conducted to evaluate the role of levetiracetam as a sensitizer of concurrent chemoradiotherapy (CCRT) for patients with newly diagnosed glioblastoma. This study aimed to determine the survival benefit of levetiracetam in conjunction with the standard treatment for glioblastoma. METHODS: Major eligibility requirements included histologically proven glioblastoma in the supratentorial region, patients 18 years or older, and Eastern Cooperative Oncology Group (ECOG) performance status of 0–2. Levetiracetam was given at 1,000–2,000 mg daily in two divided doses during CCRT and adjuvant chemotherapy thereafter. The primary and the secondary endpoints were 6‐month progression‐free survival (6mo‐PFS) and 24‐month overall survival (24mo‐OS), respectively. Outcomes of the study group were compared to those of an external control group. RESULTS: Between July 2016 and January 2019, 76 patients were enrolled, and 73 patients were included in the final analysis. The primary and secondary outcomes were improved in the study population compared to the external control (6mo‐PFS, 84.9% vs. 72.3%, p = 0.038; 24mo‐OS, 58.0% vs. 39.9%, p = 0.018), but the differences were less prominent in a propensity score‐matched analysis (6mo‐PFS, 88.0% vs. 76.9%, p = 0.071; 24mo‐OS, 57.1% vs. 38.8%, p = 0.054). In exploratory subgroup analyses, some results suggested that patients with ages under 65 years or unmethylated MGMT promoter might have a greater survival benefit from the use of levetiracetam. CONCLUSIONS: The use of levetiracetam during CCRT in patients with newly diagnosed glioblastoma may result in improved outcomes, but further investigations are warranted. |
format | Online Article Text |
id | pubmed-8729048 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-87290482022-01-11 Levetiracetam as a sensitizer of concurrent chemoradiotherapy in newly diagnosed glioblastoma: An open‐label phase 2 study Hwang, Kihwan Kim, Junhyung Kang, Seok‐Gu Jung, Tae‐Young Kim, Jeong Hoon Kim, Se‐Hyuk Kang, Shin‐Hyuk Hong, Yong‐Kil Kim, Tae Min Kim, Yu Jung Choi, Byung Se Chang, Jong Hee Kim, Chae‐Yong Cancer Med Clinical Cancer Research BACKGROUND: An open‐label single‐arm phase 2 study was conducted to evaluate the role of levetiracetam as a sensitizer of concurrent chemoradiotherapy (CCRT) for patients with newly diagnosed glioblastoma. This study aimed to determine the survival benefit of levetiracetam in conjunction with the standard treatment for glioblastoma. METHODS: Major eligibility requirements included histologically proven glioblastoma in the supratentorial region, patients 18 years or older, and Eastern Cooperative Oncology Group (ECOG) performance status of 0–2. Levetiracetam was given at 1,000–2,000 mg daily in two divided doses during CCRT and adjuvant chemotherapy thereafter. The primary and the secondary endpoints were 6‐month progression‐free survival (6mo‐PFS) and 24‐month overall survival (24mo‐OS), respectively. Outcomes of the study group were compared to those of an external control group. RESULTS: Between July 2016 and January 2019, 76 patients were enrolled, and 73 patients were included in the final analysis. The primary and secondary outcomes were improved in the study population compared to the external control (6mo‐PFS, 84.9% vs. 72.3%, p = 0.038; 24mo‐OS, 58.0% vs. 39.9%, p = 0.018), but the differences were less prominent in a propensity score‐matched analysis (6mo‐PFS, 88.0% vs. 76.9%, p = 0.071; 24mo‐OS, 57.1% vs. 38.8%, p = 0.054). In exploratory subgroup analyses, some results suggested that patients with ages under 65 years or unmethylated MGMT promoter might have a greater survival benefit from the use of levetiracetam. CONCLUSIONS: The use of levetiracetam during CCRT in patients with newly diagnosed glioblastoma may result in improved outcomes, but further investigations are warranted. John Wiley and Sons Inc. 2021-11-30 /pmc/articles/PMC8729048/ /pubmed/34845868 http://dx.doi.org/10.1002/cam4.4454 Text en © 2021 The Authors. Cancer Medicine published by John Wiley & Sons Ltd. https://creativecommons.org/licenses/by/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Clinical Cancer Research Hwang, Kihwan Kim, Junhyung Kang, Seok‐Gu Jung, Tae‐Young Kim, Jeong Hoon Kim, Se‐Hyuk Kang, Shin‐Hyuk Hong, Yong‐Kil Kim, Tae Min Kim, Yu Jung Choi, Byung Se Chang, Jong Hee Kim, Chae‐Yong Levetiracetam as a sensitizer of concurrent chemoradiotherapy in newly diagnosed glioblastoma: An open‐label phase 2 study |
title | Levetiracetam as a sensitizer of concurrent chemoradiotherapy in newly diagnosed glioblastoma: An open‐label phase 2 study |
title_full | Levetiracetam as a sensitizer of concurrent chemoradiotherapy in newly diagnosed glioblastoma: An open‐label phase 2 study |
title_fullStr | Levetiracetam as a sensitizer of concurrent chemoradiotherapy in newly diagnosed glioblastoma: An open‐label phase 2 study |
title_full_unstemmed | Levetiracetam as a sensitizer of concurrent chemoradiotherapy in newly diagnosed glioblastoma: An open‐label phase 2 study |
title_short | Levetiracetam as a sensitizer of concurrent chemoradiotherapy in newly diagnosed glioblastoma: An open‐label phase 2 study |
title_sort | levetiracetam as a sensitizer of concurrent chemoradiotherapy in newly diagnosed glioblastoma: an open‐label phase 2 study |
topic | Clinical Cancer Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8729048/ https://www.ncbi.nlm.nih.gov/pubmed/34845868 http://dx.doi.org/10.1002/cam4.4454 |
work_keys_str_mv | AT hwangkihwan levetiracetamasasensitizerofconcurrentchemoradiotherapyinnewlydiagnosedglioblastomaanopenlabelphase2study AT kimjunhyung levetiracetamasasensitizerofconcurrentchemoradiotherapyinnewlydiagnosedglioblastomaanopenlabelphase2study AT kangseokgu levetiracetamasasensitizerofconcurrentchemoradiotherapyinnewlydiagnosedglioblastomaanopenlabelphase2study AT jungtaeyoung levetiracetamasasensitizerofconcurrentchemoradiotherapyinnewlydiagnosedglioblastomaanopenlabelphase2study AT kimjeonghoon levetiracetamasasensitizerofconcurrentchemoradiotherapyinnewlydiagnosedglioblastomaanopenlabelphase2study AT kimsehyuk levetiracetamasasensitizerofconcurrentchemoradiotherapyinnewlydiagnosedglioblastomaanopenlabelphase2study AT kangshinhyuk levetiracetamasasensitizerofconcurrentchemoradiotherapyinnewlydiagnosedglioblastomaanopenlabelphase2study AT hongyongkil levetiracetamasasensitizerofconcurrentchemoradiotherapyinnewlydiagnosedglioblastomaanopenlabelphase2study AT kimtaemin levetiracetamasasensitizerofconcurrentchemoradiotherapyinnewlydiagnosedglioblastomaanopenlabelphase2study AT kimyujung levetiracetamasasensitizerofconcurrentchemoradiotherapyinnewlydiagnosedglioblastomaanopenlabelphase2study AT choibyungse levetiracetamasasensitizerofconcurrentchemoradiotherapyinnewlydiagnosedglioblastomaanopenlabelphase2study AT changjonghee levetiracetamasasensitizerofconcurrentchemoradiotherapyinnewlydiagnosedglioblastomaanopenlabelphase2study AT kimchaeyong levetiracetamasasensitizerofconcurrentchemoradiotherapyinnewlydiagnosedglioblastomaanopenlabelphase2study |