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Originally published as JCO Early Release 10.1200/JCO.2008.19.8721 on August 31 2009 © 2009 American Society of Clinical Oncology.
Bevacizumab Alone and in Combination With Irinotecan in Recurrent Glioblastoma
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. Corresponding author: Henry S. Friedman, MD, Duke University Medical Center, 047 Baker House, Trent Dr, DUMC Box 3624, Durham, NC 27710; 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 Conclusion Bevacizumab, alone or in combination with irinotecan, was well tolerated and active in recurrent glioblastoma. Both H.S.F. and T.C. contributed equally to data collection and interpretation and manuscript preparation. Genentech Inc provided support for manuscript preparation. Presented in part at the 12th Annual Meeting of the Society for Neuro-Oncology, November 15-18, 2007, Dallas, TX, and at the 44th Annual Meeting of the American Society of Clinical Oncology, May 30-June 3, 2008, Chicago, IL. Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article. Clinical Trials repository link available on JCO.org. Clinical trial information can be found for the following: NCT00345163 [ClinicalTrials.gov] .
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Copyright © 2009 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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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). 
