Title: Integration of autologous dendritic cell-based immunotherapy in the standard of care treatment for patients with newly diagnosed glioblastoma: results of the HGG-2006 phase I/II trial
Authors: Ardon, Hilko ×
Van Gool, Stefaan
Verschuere, Tina
Maes, Wim
Fieuws, Steffen
Sciot, Raf
Wilms, Guy
Demaerel, Philippe
Goffin, Jan
Van Calenbergh, Frank
Menten, Joannes
Clement, Paul
Debiec-Rychter, Maria
De Vleeschouwer, Steven #
Issue Date: Nov-2012
Publisher: Springer-Verlag
Series Title: Cancer Immunology, Immunotherapy vol:61 issue:11 pages:2033-2044
Abstract: PURPOSE: Dendritic cell (DC)-based tumor vaccination has rendered promising results in relapsed high-grade glioma patients. In the HGG-2006 trial (EudraCT 2006-002881-20), feasibility, toxicity, and clinical efficacy of the full integration of DC-based tumor vaccination into standard postoperative radiochemotherapy are studied in 77 patients with newly diagnosed glioblastoma. PATIENTS AND METHODS: Autologous DC are generated after leukapheresis, which is performed before the start of radiochemotherapy. Four weekly induction vaccines are administered after the 6-week course of concomitant radiochemotherapy. During maintenance chemotherapy, 4 boost vaccines are given. Feasibility and progression-free survival (PFS) at 6 months (6mo-PFS) are the primary end points. Overall survival (OS) and immune profiling, rather than monitoring, as assessed in patients' blood samples, are the secondary end points. Analysis has been done on intent-to-treat basis. RESULTS: The treatment was feasible without major toxicity. The 6mo-PFS was 70.1 % from inclusion. Median OS was 18.3 months. Outcome improved significantly with lower EORTC RPA classification. Median OS was 39.7, 18.3, and 10.7 months for RPA classes III, IV, and V, respectively. Patients with a methylated MGMT promoter had significantly better PFS (p = 0.0027) and OS (p = 0.0082) as compared to patients with an unmethylated status. Exploratory "immunological profiles" were built to compare to clinical outcome, but no statistical significant evidence was found for these profiles to predict clinical outcome. CONCLUSION: Full integration of autologous DC-based tumor vaccination into standard postoperative radiochemotherapy for newly diagnosed glioblastoma seems safe and possibly beneficial. These results were used to power the currently running phase IIb randomized clinical trial.
ISSN: 0340-7004
Publication status: published
KU Leuven publication type: IT
Appears in Collections:Department of Human Genetics - miscellaneous
Laboratory of Pediatric Immunology
Laboratory of Experimental Radiotherapy
Laboratory of Clinical Immunology
Translational Cell & Tissue Research
Translational MRI (+)
Laboratory for Genetics of Malignant Disorders
Laboratory of Experimental Oncology
Leuven Biostatistics and Statistical Bioinformatics Centre (L-BioStat)
× corresponding author
# (joint) last author

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