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Clinical Trial
. 2009 Oct 1;27(28):4733-40.
doi: 10.1200/JCO.2008.19.8721. Epub 2009 Aug 31.

Bevacizumab alone and in combination with irinotecan in recurrent glioblastoma

Henry S Friedman  1 , Michael D Prados, Patrick Y Wen, Tom Mikkelsen, David Schiff, Lauren E Abrey, W K Alfred Yung, Nina Paleologos, Martin K Nicholas, Randy Jensen, James Vredenburgh, Jane Huang, Maoxia Zheng, Timothy Cloughesy
Affiliations
Clinical Trial

Bevacizumab alone and in combination with irinotecan in recurrent glioblastoma

Henry S Friedman et al. J Clin Oncol. .

Abstract

Purpose: We evaluated the efficacy of bevacizumab, alone and in combination with irinotecan, in patients with recurrent glioblastoma in a phase II, multicenter, open-label, noncomparative trial.

Patients and methods: One hundred sixty-seven patients were randomly assigned to receive bevacizumab 10 mg/kg alone or in combination with irinotecan 340 mg/m(2) or 125 mg/m(2) (with or without concomitant enzyme-inducing antiepileptic drugs, respectively) once every 2 weeks. Primary end points were 6-month progression-free survival and objective response rate, as determined by independent radiology review. Secondary end points included safety and overall survival.

Results: In the bevacizumab-alone and the bevacizumab-plus-irinotecan groups, estimated 6-month progression-free survival rates were 42.6% and 50.3%, respectively; objective response rates were 28.2% and 37.8%, respectively; and median overall survival times were 9.2 months and 8.7 months, respectively. There was a trend for patients who were taking corticosteroids at baseline to take stable or decreasing doses over time. Of the patients treated with bevacizumab alone or bevacizumab plus irinotecan, 46.4% and 65.8%, respectively, experienced grade > or = 3 adverse events, the most common of which were hypertension (8.3%) and convulsion (6.0%) in the bevacizumab-alone group and convulsion (13.9%), neutropenia (8.9%), and fatigue (8.9%) in the bevacizumab-plus-irinotecan group. Intracranial hemorrhage was noted in two patients (2.4%) in the bevacizumab-alone group (grade 1) and in three patients (3.8%) patients in the bevacizumab-plus-irinotecan group (grades 1, 2, and 4, respectively).

Conclusion: Bevacizumab, alone or in combination with irinotecan, was well tolerated and active in recurrent glioblastoma.

Trial registration: ClinicalTrials.gov NCT00345163.

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