Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
Gewählte Publikation:
SHR Neuro Krebs Kardio Lipid Stoffw Microb
Buchroithner, J; Erhart, F; Pichler, J; Widhalm, G; Preusser, M; Stockhammer, G; Nowosielski, M; Iglseder, S; Freyschlag, CF; Oberndorfer, S; Bordihn, K; von Campe, G; Hoffermann, M; Ruckser, R; Rössler, K; Spiegl-Kreinecker, S; Fischer, MB; Czech, T; Visus, C; Krumpl, G; Felzmann, T; Marosi, C.
Audencel Immunotherapy Based on Dendritic Cells Has No Effect on Overall and Progression-Free Survival in Newly Diagnosed Glioblastoma: A Phase II Randomized Trial.
Cancers (Basel). 2018; 10(10):
Doi: 10.3390/cancers10100372
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- Hoffermann Markus
- von Campe Gord
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- Abstract:
- Dendritic cells (DCs) are antigen-presenting cells that are capable of priming anti-tumor immune responses, thus serving as attractive tools to generate tumor vaccines. In this multicentric randomized open-label phase II study, we investigated the efficacy of vaccination with tumor lysate-charged autologous DCs (Audencel) in newly diagnosed glioblastoma multiforme (GBM). Patients aged 18 to 70 years with histologically proven primary GBM and resection of at least 70% were randomized 1:1 to standard of care (SOC) or SOC plus vaccination (weekly intranodal application in weeks seven to 10, followed by monthly intervals). The primary endpoint was progression-free survival at 12 months. Secondary endpoints were overall survival, safety, and toxicity. Seventy-six adult patients were analyzed in this study. Vaccinations were given for seven (3⁻20) months on average. No severe toxicity was attributable to vaccination. Seven patients showed flu-like symptoms, and six patients developed local skin reactions. Progression-free survival at 12 months did not differ significantly between the control and vaccine groups (28.4% versus 24.5%, p = 0.9975). Median overall survival was similar with 18.3 months (vaccine: 564 days, 95% CI: 436⁻671 versus control: 568 days, 95% CI: 349⁻680; p = 0.89, harzard ratio (HR) 0.99). Hence, in this trial, the clinical outcomes of patients with primary GBM could not be improved by the addition of Audencel to SOC.
- Find related publications in this database (Keywords)
- glioblastoma
- active immunotherapy
- dendritic cells
- tumor vaccine
- phase II
- randomized
- clinical trial