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@ARTICLE{Oster:284612,
author = {C. Oster$^*$ and T. Schmidt$^*$ and S. Agkatsev$^*$ and L.
Lazaridis$^*$ and C. Kleinschnitz and U. Sure$^*$ and B.
Scheffler$^*$ and S. Kebir$^*$ and M. Glas$^*$},
title = {{A}re we providing best-available care to newly diagnosed
glioblastoma patients? {S}ystematic review of phase {III}
trials in newly diagnosed glioblastoma 2005-2022.},
journal = {Neuro-oncology advances},
volume = {5},
number = {1},
issn = {2632-2498},
address = {Oxford},
publisher = {Oxford University Press},
reportid = {DKFZ-2023-02031},
pages = {1-14},
year = {2023},
abstract = {Glioblastoma is the most aggressive primary brain cancer
with a poor prognosis. Despite numerous studies in the past
17 years, effective treatment options for glioblastoma
remain limited. In this study, we aimed to identify and
compare phase III clinical trials for glioblastoma in terms
of efficacy and baseline characteristics.A systematic
literature search was conducted using PubMed and
ClinicalTrials.gov to identify phase III clinical trials for
glioblastoma in adult patients. The target population
included adult patients aged 18 years and above (younger
cohort) and patients ≥60 years of age (elderly cohort).
The search results were screened based on predefined
inclusion criteria, and the included trials were analyzed
for their study design, baseline characteristics, and
survival results.Eleven trials met the inclusion criteria in
the younger cohort. Of these, three reported a statistically
significant improvement in overall survival (OS), including
the EORTC/NCIC study (NCT00006353), EF-14 (NCT00916409), and
CeTeG (NCT01149109). Of the 11 trials, eight were open-label
randomized trials, including all of the positive ones, while
three negative trials employed treatment blinding and a
placebo control. The baseline characteristics of the trials
[such as extent of resection, age, gender, and
O(6)-methylguanine-DNA-methyltransferase (MGMT) promoter
methylation status] did not significantly differ between
positive and negative trials. Isocitrate dehydrogenase (IDH)
mutation status was analyzed in only two trials, with a
small percentage of IDH-mutated tumors in each.
Additionally, three more trials in the elderly cohort showed
a statistically significant improvement of OS, the NOA-08
trial, the ISRCTN81470623-trial by Malmström et al. and
NCT00482677-trial by Perry et al. Their baseline
characteristics and implications are also analyzed.This
analysis of phase III clinical trials for glioblastoma
conducted since 2005 showed that the majority of trials did
not result in a significant improvement in OS. Among the
trials included in this analysis, only the EORTC/NCIC,
EF-14, and CeTeG studies demonstrated a positive OS outcome
in the younger cohort.},
subtyp = {Review Article},
keywords = {CeTeG (Other) / EF-14 (Other) / glioblastoma (Other) /
meta-analysis (Other) / phase III trials (Other)},
cin = {ED01},
ddc = {610},
cid = {I:(DE-He78)ED01-20160331},
pnm = {899 - ohne Topic (POF4-899)},
pid = {G:(DE-HGF)POF4-899},
typ = {PUB:(DE-HGF)16},
pubmed = {pmid:37811538},
pmc = {pmc:PMC10558397},
doi = {10.1093/noajnl/vdad105},
url = {https://inrepo02.dkfz.de/record/284612},
}