HGG-16. Final analysis of the HIT-HGG-2007 trial (ISRCTN19852453): Significant survival benefit for pontine and non-pontine pediatric high-grade gliomas in comparison to previous HIT-GBM-C/-D trials

• Published in: Neuro-oncology (Charlottesville, Va.) Va.), 2022-06, Vol.24 (Supplement_1), p.i63-i64
• Main Authors: von Bueren, Andrè O, Kwiecien, Robert, Gielen, Gerrit H, Benesch, Martin, Perwein, Thomas, Nussbaumer, Gunther, Sturm, Dominik, Jones, David T W, Pfister, Stefan M, Eyrich, Matthias, Rutkowski, Stefan, Fleischhack, Gudrun, von Buiren, Miriam, Karremann, Michael, Kortmann, Rolf-Dieter, Hagel, Christian, Calaminus, Gabriele, Faldum, Andreas, Bison, Brigitte, Pietsch, Torsten, Hoffmann, Marion, Kramm, Christof M
• Format: Article
• Language: English
• Subjects: High Grade Glioma
• ISSN: 1522-8517; 1523-5866
• DOI: 10.1093/neuonc/noac079.231

The aim of the HIT-HGG-2007 trial (ISRCTN19852453) was to demonstrate therapeutic non-inferiority of temozolomide radiochemotherapy for pediatric patients (3-18 years) with high-grade gliomas (pedHGG) in comparison to the cisplatinum-based radiochemotherapy of the two previous clinical trials HIT-GBM-C/-D. Between 06/2009 and 12/2016, 456 patients were enrolled at 79 centers in Germany, Austria, and Switzerland (n=18 dropouts, remaining patients for confirmatory analysis: n=438). 438 patients from HIT-GBM-C/-D served as historical control. All pedHGG diagnoses had been confirmed by central neuroradiological and neuropathological review. Primary objective was achieved since non-inferiority of HIT-HGG-2007 in comparison to HIT-GBM-C/-D as indicated by 6 months event-free survival (EFS) was statistically confirmed (p=0.0125). Statistical survival analyses even revealed a better overall survival (OS) and EFS for HIT-HGG-2007 patients in comparison to their HIT-GBM-C/-D counterparts (EFS: p