Bevacizumab (Avastin) alone or in combination with irinotecan, was well tolerated and active in recurrent glioblastoma, according to phase II trial results. The multicenter, open-label, noncomparative trial evaluated 167 patients randomly assigned to receive bevacizumab (10 mg/kg) alone or in combination with irinotecan (340 mg/m2 or 125 mg/m2), with or without concomitant enzyme-inducing antiepileptic drugs, respectively, once every two weeks.
Primary endpoints were six-month progression-free survival (PFS) and objective response rate (ORR) based on independent radiology review. Secondary endpoints included safety and overall survival (OS). Henry S. Friedman, MD, led the study.
For bevacizumab alone, PFS was 42.6%. The ORR was 28.7% while median OS was 9.2 months. For bevacizumab plus irinotecan, PFS was 50.3%, the ORR was 37.8%, and median OS was 8.7 months (J Clin Oncol online, August 31, 2009).