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Audencel Immunotherapy Based on Dendritic Cells Has No Effect on Overall and Progression-Free Survival in Newly Diagnosed Glioblastoma: A Phase II Randomized Trial.

Authors:
Johanna Buchroithner Friedrich Erhart Josef Pichler Georg Widhalm Matthias Preusser Günther Stockhammer Martha Nowosielski Sarah Iglseder Christian F Freyschlag Stefan Oberndorfer Karin Bordihn Gord von Campe Markus Hoffermann Reinhard Ruckser Karl Rössler Sabine Spiegl-Kreinecker Michael B Fischer Thomas Czech Carmen Visus Günther Krumpl Thomas Felzmann Christine Marosi

Cancers (Basel) 2018 Oct 5;10(10). Epub 2018 Oct 5.

Clinical Division of Medical Oncology, Department for Internal Medicine I, Medical University of Vienna, Währinger Gürtel 18-20, 1090 Vienna, Austria.

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%, = 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; = 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.

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Source
http://dx.doi.org/10.3390/cancers10100372DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6210090PMC
October 2018

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