000K utf8 1100 2023$c2023-09-04 1500 eng 2050 urn:nbn:de:hbz:465-20231011-083400-7 2051 10.1093/noajnl/vdad105 3000 Oster, Christoph 3010 Agkatsev, Sarina 3010 Glas, Martin 3010 Kebir, Sied 3010 Kleinschnitz, Christoph 3010 Lazaridis, Lazaros 3010 Scheffler, Björn 3010 Schmidt, Teresa 3010 Sure, Ulrich 4000 Are we providing best available care to newly diagnosed glioblastoma patients? Systematic review of phase III trials in newly diagnosed glioblastoma 2005-2022 [Oster, Christoph] 4209 Background: 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. Methods: 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. 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. Conclusion: 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. 4950 https://doi.org/10.1093/noajnl/vdad105$xR$3Volltext$534 4950 https://nbn-resolving.org/urn:nbn:de:hbz:465-20231011-083400-7$xR$3Volltext$534 4961 https://duepublico2.uni-due.de/receive/duepublico_mods_00079030 5051 610 5550 CeTeG 5550 EF-14 5550 Glioblastoma 5550 Metaanalysis 5550 phase III trials