English to Russian Medical Medical: Pharmaceuticals PRAC PSUR assessment repo

• Interventional IIS, T81004/ (NU04C1) - Trisenox® study “A Phase I /II Trial of Arsenic Trioxide and Temozolomide in Combination with Radiation Therapy for Patients with Malignant Gliomas”.
The study was finalized in June 2017.
A total of 42 patients were enrolled in both the Phase I and II trials for this study treatment.
The median age was 54 (24–80); 28 patients had a GBM and 14 had anaplastic glioma (AG).
All patients completed RT/TMZ/ATO and went on to maintenance TMZ.
Median number of post RT cycles of TMZ was 4 (0–12).
Median PFS was 7 m for GBM and 75 m for AG and median OS was 17 m for GBM and NR for AG.
Best response was CR in 2, SD in 28, PR in 5 and PD in 7.