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.

• DOI: 10.1093/neuonc/noac079.231
• Publication Date: 2022-06-03T11:59:44Z
• Authors: Andrè O von Bueren; Robert Kwiecien; Gerrit H Gielen; Martin Benesch; Thomas Perwein; Gunther Nussbaumer; Dominik Sturm; David T W Jones; Stefan M Pfister; Matthias Eyrich; Stefan Rutkowski; Gudrun Fleischhack; Miriam von Buiren; Michael Karremann; Rolf-Dieter Kortmann; Christian Hagel; Gabriele Calaminus; Andreas Faldum; Brigitte Bison; Torsten Pietsch; Marion Hoffmann; Christof M Kramm
• Keywords: Temozolomide

Abstract The aim of the HIT-HGG-2007 trial (ISRCTN19852453) was to demonstrate therapeutic non-inferiority temozolomide radiochemotherapy for pediatric patients (3-18 years) with high-grade gliomas (pedHGG) in comparison cisplatinum-based two previous clinical trials HIT-GBM-C/-D. Between 06/2009 and 12/2016, 456 were enrolled at 79 centers Germany, Austria, Switzerland (n=18 dropouts, remaining confirmatory analysis: n=438). 438 from HIT-GBM-C/-D served as historical control. All pedHGG diagnoses had been confirmed by central neuroradiological neuropathological review. Primary objective achieved since indicated 6 months event-free survival (EFS) statistically (p=0.0125). Statistical analyses even revealed a better overall (OS) EFS their counterparts (EFS: p<0.0001; OS: p=0.0328). While subgroup pontine non-pontine also showed (median pedHGG: 8.2 (n=152; confidence interval (CI): 7.6-9.4) versus 6.2 (n=170; CI: 5.5-6.9) months, p=0.0079; median 10.7 (n=276; 9.6-12.4) 7.4 (n=267; 6.4-9.2) p<0.0001), OS only improved 19.3 (CI: 16.8-23.3) 16.2 14.2-19.1) months; p=0.0181) but not 11.4 11.3 p=0.4021) Toxicity profile seemed very favorable most CTCAE (common toxicity criteria adverse event) ≥ grade 3 hematological toxicity, hepatotoxicity, neurotoxicity. Less observed during concomitant Further well assessment impact MGMT promoter methylation are ongoing. In conclusion, our data show increased less when compared