Bevacizumab safe, effective in phase II glioblastoma study

NEW YORK (Reuters Health) - Bevacizumab, alone and in combination with irinotecan, is useful in a substantial proportion of patients with recurrent glioblastoma, researchers report in an advance on-line publication in the Journal of Clinical Oncology.

As lead investigator Dr. Henry Friedman told Reuters Health, "Bevacizumab produced marked benefit in a large fraction of patients with recurrent glioblastoma."

Dr. Friedman of Duke University Medical Center, Durham, North Carolina, and colleagues came to this conclusion after conducting an open-label phase II noncomparative study in 167 patients with first or second relapses.

They were randomized to receive bevacizumab 10 mg/kg alone or in combination with irinotecan with or without concomitant enzyme-inducing antiepileptic drugs once every 2 weeks.

The estimated 6-month progression-free survival rate was 42.6% in the bevacizumab alone group and 50.3% in the combination groups. The researchers note that this rate "far exceeded the 15% rate assumed for salvage chemotherapy" and irinotecan alone.

Objective response rates were 28.2% with bevacizumab and 37.8% with the combination therapy.

Overall survival times after randomization were 9.2 months in the bevacizumab group and 8.7 months in the combination patients. The authors note that patients were randomized between June 2006 and February 2007, and by November 2007, 57.6% of bevacizumab patients and 64.6% of combination therapy patients had died.

Grade 3 or greater adverse events were seen in 46.4% of the bevacizumab patients and 65.8% of those on combination therapy.

"We are optimistic that the new trials using this agent in patients with newly diagnosed glioblastoma," Dr. Friedman concluded, "will lead to increased survival for patients with this grim disease."

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