Mark R. Gilbert, MD, reviews the trial design and findings from the RTOG 0825 phase III trial evaluating bevacizumab in patients with newly diagnosed glioblastoma.
Mark R. Gilbert, MD, a professor of neuro-oncology at the University of Texas MD Anderson Cancer Center in Houston, Texas, reviews the trial design and findings from the RTOG 0825 phase III study that evaluated bevacizumab in patients with newly diagnosed glioblastoma.
Bevacizumab is approved for the treatment of patients with recurrent glioblastoma. The RTOG 0825 trial sought to move bevacizumab to the frontline setting, based on the angiogenic nature of the disease.
The trial was randomized and double blinded, to remove bias, Gilbert notes. Additionally, a crossover was provided as part of the trial design warranting the need to have co-primary endpoints, which included progression-free survival (PFS) and overall survival (OS). Ultimately, 637 patients with newly diagnosed glioblastoma were randomized to receive standard chemoradiation with or without bevacizumab.
In total, the OS goal was not reached and PFS was not statistically significant. Specifically, OS was 16.1 months versus 15.7 and PFS was 7.3 months versus 10.7 months, respectively for placebo and bevacizumab.