Safety comparison The ddTMZ+mEHT regimen did not display any grade II–IV toxicity, whereas the ddTMZ regimens generated such toxicity events at a rate of 45%–92%, the difference was always highly significant (p<0.001) ( table 9 ).
12 However, a recent phase III randomised controlled trial (RTOG 0525) 16 of ddTMZ 21/28 d versus the standard 5/28 d adjuvant regimen for newly diagnosed patients with GBM after completion of concurred chemoradiotherapy (CRT), failed to show an advantage of ddTMZ in MST (14.9 vs 16.6 months in the standard arm, p=0.63), although it did show an improvement of PFS-6m (6.7 vs 5.5 months) with borderline significance (p=0.06), with somewhat higher toxicity in the ddTMZ arm.