Author(s): Friedman HS, Prados MD, Wen PY, Mikkelsen T, Schiff D,
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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.
This article was published in J Clin Oncol
and referenced in Journal of Cytology & Histology