PMID- 30301187 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20231004 IS - 2072-6694 (Print) IS - 2072-6694 (Electronic) IS - 2072-6694 (Linking) VI - 10 IP - 10 DP - 2018 Oct 5 TI - Audencel Immunotherapy Based on Dendritic Cells Has No Effect on Overall and Progression-Free Survival in Newly Diagnosed Glioblastoma: A Phase II Randomized Trial. LID - 10.3390/cancers10100372 [doi] LID - 372 AB - 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. FAU - Buchroithner, Johanna AU - Buchroithner J AD - University Clinic for Neurosurgery, Kepler University Hospital, Johannes Kepler University, Wagner-Jauregg-Weg 15, 4020 Linz, Austria. johanna.buchroithner@kepleruniklinikum.at. FAU - Erhart, Friedrich AU - Erhart F AD - Department of Neurosurgery, Medical University of Vienna, Wahringer Gurtel 18-20, 1090 Vienna, Austria. friedrich.erhart@meduniwien.ac.at. AD - Institute of Neurology, Medical University of Vienna, Wahringer Gurtel 18-20, 1090 Vienna, Austria. friedrich.erhart@meduniwien.ac.at. FAU - Pichler, Josef AU - Pichler J AD - Department of Internal Medicine and Neurooncology, Kepler University Hospital, Johannes Kepler University, Wagner-Jauregg-Weg 15, 4020 Linz, Austria. Josef.Pichler@kepleruniklinikum.at. FAU - Widhalm, Georg AU - Widhalm G AD - Department of Neurosurgery, Medical University of Vienna, Wahringer Gurtel 18-20, 1090 Vienna, Austria. georg.widhalm@meduniwien.ac.at. FAU - Preusser, Matthias AU - Preusser M AD - Clinical Division of Medical Oncology, Department for Internal Medicine I, Medical University of Vienna, Wahringer Gurtel 18-20, 1090 Vienna, Austria. Matthias.preusser@meduniwien.ac.at. FAU - Stockhammer, Gunther AU - Stockhammer G AD - Department of Neurology, Medical University of Innsbruck, Christoph-Probst-Platz 1, Innrain 52, 6020 Innsbruck, Austria. guenther.stockhammer@i-med.ac.at. FAU - Nowosielski, Martha AU - Nowosielski M AD - Department of Neurology, Medical University of Innsbruck, Christoph-Probst-Platz 1, Innrain 52, 6020 Innsbruck, Austria. Martha.Nowosielski@i-med.ac.at. FAU - Iglseder, Sarah AU - Iglseder S AD - Department of Neurology, Medical University of Innsbruck, Christoph-Probst-Platz 1, Innrain 52, 6020 Innsbruck, Austria. sarah.iglseder@tirol-kliniken.at. FAU - Freyschlag, Christian F AU - Freyschlag CF AUID- ORCID: 0000-0002-8228-8217 AD - Department of Neurosurgery, Medical University of Innsbruck, Christoph-Probst-Platz 1, Innrain 52, 6020 Innsbruck, Austria. christian.freyschlag@i-med.ac.at. FAU - Oberndorfer, Stefan AU - Oberndorfer S AUID- ORCID: 0000-0002-4229-8920 AD - Department of Neurology, University Clinic St. Polten, Karl Landsteiner Privat Universitat, Dunant-Platz 1, 3100 St. Polten, Austria. Stefan.Oberndorfer@stpoelten.lknoe.at. FAU - Bordihn, Karin AU - Bordihn K AD - Department of Neurosurgery, Landeskrankenhaus Salzburg, University Clinic of the Paracelsus Private Medical University, Mullner Hauptstrasse 48, 5020 Salzburg, Austria. k.bordihn@salk.at. FAU - von Campe, Gord AU - von Campe G AD - Department of Neurosurgery, Medical University of Graz, Auenbruggerplatz 29, 8036 Graz, Austria. gord.von-campe@medunigraz.at. FAU - Hoffermann, Markus AU - Hoffermann M AD - Department of Neurosurgery, Medical University of Graz, Auenbruggerplatz 29, 8036 Graz, Austria. markus.hoffermann@lkhf.at. FAU - Ruckser, Reinhard AU - Ruckser R AD - Department of Internal Medicine 2, Donauspital, Langobardenstrasse 122, 1220 Vienna, Austria. reinhard.ruckser@aon.at. FAU - Rossler, Karl AU - Rossler K AD - Department of Neurosurgery, Friedrich-Alexander-Universitat Erlangen-Nurnberg, Schwabachanlage 6, 91054 Erlangen, Germany. Karl.roessler@uk.erlangen.de. FAU - Spiegl-Kreinecker, Sabine AU - Spiegl-Kreinecker S AD - University Clinic for Neurosurgery, Kepler University Hospital, Johannes Kepler University, Wagner-Jauregg-Weg 15, 4020 Linz, Austria. Sabine.Spiegl-Kreinecker@kepleruniklinikum.at. FAU - Fischer, Michael B AU - Fischer MB AD - Department of Blood Group Serology and Transfusion Medicine, Medical University of Vienna, Wahringer Gurtel 18-20, 1090 Vienna, Austria. michael.b.fischer@meduniwien.ac.at. FAU - Czech, Thomas AU - Czech T AD - Department of Neurosurgery, Medical University of Vienna, Wahringer Gurtel 18-20, 1090 Vienna, Austria. thomas.czech@meduniwien.ac.at. FAU - Visus, Carmen AU - Visus C AD - Activartis Biotech GmbH, Wilhelminenstrasse 91/IIf, 1160 Vienna, Austria. maria-carmen.visus-miguel@aoporphan.com. FAU - Krumpl, Gunther AU - Krumpl G AD - Activartis Biotech GmbH, Wilhelminenstrasse 91/IIf, 1160 Vienna, Austria. g.krumpl@medresnet.com. FAU - Felzmann, Thomas AU - Felzmann T AD - Activartis Biotech GmbH, Wilhelminenstrasse 91/IIf, 1160 Vienna, Austria. tfelzm@gmail.com. FAU - Marosi, Christine AU - Marosi C AD - Clinical Division of Medical Oncology, Department for Internal Medicine I, Medical University of Vienna, Wahringer Gurtel 18-20, 1090 Vienna, Austria. christine.marosi@meduniwien.ac.at. LA - eng GR - GBM-Vax / Audencel clinical trial/Activartis Biotech GmbH/ PT - Journal Article DEP - 20181005 PL - Switzerland TA - Cancers (Basel) JT - Cancers JID - 101526829 PMC - PMC6210090 OTO - NOTNLM OT - active immunotherapy OT - clinical trial OT - dendritic cells OT - glioblastoma OT - phase II OT - randomized OT - tumor vaccine COIS- F.E. was formerly a (part-time) employee of Activartis Biotech. The funding organization (Activartis Biotech GmbH) participated in the design of the study. The funder had no role in the collection, analyses, or interpretation of data; in the writing of the manuscript, and in the decision to publish the results. EDAT- 2018/10/12 06:00 MHDA- 2018/10/12 06:01 PMCR- 2018/10/05 CRDT- 2018/10/11 06:00 PHST- 2018/08/24 00:00 [received] PHST- 2018/09/22 00:00 [revised] PHST- 2018/09/30 00:00 [accepted] PHST- 2018/10/11 06:00 [entrez] PHST- 2018/10/12 06:00 [pubmed] PHST- 2018/10/12 06:01 [medline] PHST- 2018/10/05 00:00 [pmc-release] AID - cancers10100372 [pii] AID - cancers-10-00372 [pii] AID - 10.3390/cancers10100372 [doi] PST - epublish SO - Cancers (Basel). 2018 Oct 5;10(10):372. doi: 10.3390/cancers10100372.