Temozolomide radiochemotherapy appears noninferior to cisplatin-based radiochemotherapy for pediatric patients with high-grade glioma, according to research presented at the 20th International Symposium on Pediatric Neuro-Oncology (ISPNO).
The findings come from the HIT-HGG-2007 study, which was designed to determine whether temozolomide radiochemotherapy yields noninferior event-free survival (EFS) when compared with cisplatin-based radiochemotherapy regimens used in the HIT-GBM-C and HIT-GBM-D trials.
The final analysis from HIT-HGG-2007 included 438 patients who received concomitant radiochemotherapy with temozolomide, matched with 438 historical controls from the HIT-GBM-C/-D trials.
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In the HIT-GBM-C trial, patients received radiation along with a chemotherapy regimen consisting of cisplatin, etoposide, vincristine, and ifosfamide. In the HIT-GBM-D trial, patients received the same chemoradiotherapy regimen, but it was preceded by single-agent methotrexate.
The primary endpoint of the HIT-HGG-2007 trial was noninferior 6-month EFS. To meet criteria for noninferiority, the 6-month EFS rate had to be at least 46% for patients with diffuse intrinsic pontine glioma (DIPG) and at least 53% for non-DIPG patients. Both criteria were met (P <.0125).
In fact, the researchers noted significant EFS benefits in the HIT-HGG-2007 trial for patients with and without DIPG.
Among DIPG patients, the median EFS was 8.1 months in the HIT-HGG-2007 trial and 6.2 months in the HIT-GBM-C/-D trials. In non-DIPG patients, the median EFS was 10.6 months and 7.5 months, respectively.
Among patients with grade IV disease, both EFS and overall survival were improved in the HIT-HGG-2007 trial. The median EFS was 8.5 months in the HIT-HGG-2007 trial and 6.4 months in the HIT-GBM-C/-D trials (P =.00023). The median overall survival was 15.9 months and 13.4 months, respectively (P =.0294).
Reference
von Bueren AO, Kwiecien R, Gielen GH, et al. 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. Presented at ISPNO 2022; June 12-15, 2022. Abstract HGG-16.
