JCO Early Release, published online ahead of print Aug 31 2009
Journal of Clinical Oncology, 10.1200/JCO.2008.19.8721
Received September 8, 2008
Accepted March 19, 2009
Bevacizumab Alone and in Combination With Irinotecan in Recurrent Glioblastoma
Henry S. Friedman,* 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, and Timothy Cloughesy
From the Brain Tumor Center, Duke University, Durham, NC; Department of Neurosurgery, University of California, San Francisco, San Francisco; Genetech Inc, South San Francisco; and Department of Neurology, University of California, Los Angeles School of Medicine, Los Angeles, CA; Department of Neurology, Brigham and Women's Hospital and Center for Neuro-Oncology, Dana-Farber Cancer Institute, Boston, MA; Hermelin Brain Tumor Center, Henry Ford Hospital, Detroit, MI; Department of Neurology, University of Virginia, Charlottesville, VA; Department of Neurology, Memorial Sloan-Kettering Cancer Center, New York, NY; Department of Neuro-Oncology, M. D. Anderson Cancer Center, Houston, TX; Division of Neurology, Evanston Northwestern Healthcare, Evanston, IL; Department of Neurology, University of Chicago, Chicago, IL; and University of Utah Hospital, Salt Lake City, UT.
* To whom correspondence should be addressed. E-mail: fried003{at}mc.duke.edu
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/m2 or 125 mg/m2 (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  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.
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