Results of a randomized phase III clinical trial conducted by the Radiation Therapy Oncology Group (RTOG) determined that adding bevacizumab to initial treatment for glioblastoma (GBM) did not improve patient overall survival or progression-free survival,. Results were reported June 2 during the plenary session of the American Society of Clinical Oncology 2013 Annual Meeting.
Chicago, IllinoisGBM is the most common primary malignant brain tumor in adults and, despite treatment advances in recent years, the average survival of patients enrolled in clinical trials is less than 16 months and few patients live beyond five years. GBM is characterized by angiogenesisthe formation of new blood vessels that support tumor growth stimulated by the GBM-produced vascular endothelial growth factor A (VEGF-A). Bevacizumab is a monoclonal antibody that targets VEGF-A production to block the growth of tumor-derived blood vessels. "Clinical trials evaluating the addition of bevacizumab to standard treatment for recurrent glioblastoma demonstrated clinical benefit and led to the drug's FDA approval for this indication," says Mark Gilbert, MD, RTOG 0825 Principal Investigator and professor of neuro-oncology at The University of Texas MD Anderson Cancer Center, Houston, Texas. "Additionally, compelling preclinical data suggest that anti-angiogenic targeted therapies may normalize the tumor's rapidly forming and underdeveloped blood vessels, resulting in improved oxygen and chemotherapy delivery to the tumor and potentially enhancing radiotherapy and chemotherapy treatment," explains Gilbert. The RTOG 0825 study tested this hypothesis.
Six hundred and thirty-seven adult study participants were enrolled in the multicenter trial and randomized into one of two study arms, with treating physicians blinded to treatment assignment. All participants were treated with standard radiotherapy (RT) (60 Gy) and daily temozolomide. Bevacizumab (experimental arm) or a plac
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American College of Radiology