Randomized phase II trial of bevacizumab/irinotecan therapy vs. standard TMZ therapy in the first-line treatment of patients with newly diagnosed MGMT-non-methylated glioblastoma

2:1 randomization for experimental arm (bevacizumab + irinocetane (BEV/IRI)) and standard arm with temozolomide therapy according to the Stupp regimen. Because the study enrolled only patients with nonmethylated MGMT promoters (ratio < 0.6) and temozolomide is at best only marginally effective in this population, temozolomide therapy was not required in the experimental arm. From June 2010 to August 2012, 182 patients were recruited at 22 German centers. Evaluation of the primary endpoint (PFS-6) and key secondary endpoints (PFS, OS, quality of life) were performed and published in abstract form (ASCO 2014-Abstract; Herrlinger et al, J Clin Oncol 32:5s, 2014 (suppl; abstr 2042)).