Journal
CANCER IMMUNOLOGY IMMUNOTHERAPY
Volume 61, Issue 11, Pages 2033-2044Publisher
SPRINGER
DOI: 10.1007/s00262-012-1261-1
Keywords
Dendritic cell; Vaccine; Glioblastoma; Radiochemoimmunotherapy
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Funding
- Olivia Hendrickx Research Fund
- Herman Memorial Research Fund
- James E. Kearney Memorial Foundation
- CAF Belgium
- Baxter
- Stichting tegen Kanker
- IWT (TBM projects)
- Stem Cell Institute Leuven
- Emmanuel van der Schueren Fund
- International Union against Cancer
- Klinisch Onderzoeksfonds UZ Leuven
- Fund for Scientific Research-Flanders (FWO-V)
- Klinisch onderzoeksfonds from the University Hospital Leuven
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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.
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