CLIN-ONGOING CLINICAL TRIALS

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INTRODUCTION: Bevacizumab has been reported to be an effective treatment for symptomatic radiation necrosis and to decrease focal edema around areas of radiation necrosis.We report our preliminary results and ongoing clinical trial of bevacizumab treatment for radiation necrosis.METHODS: Thirteen patients with symptomatic radiation necrosis were treated with bevacizumab.Radiation necrosis was diagnosed according to the patients' clinical courses, magnetic resonance images, and fluoridelabeled boronophenylalanine-positron emission tomography (F-BPA-PET).Lesion/normal (L/N) ratios less than 2.0 and 2.5 on F-BPA-PET were defined as absolute and relative indications for bevacizumab treatment, respectively.The patients were treated with bevacizumab at a dose of 5 mg/ kg every 2 weeks, 6 cycles in total.RESULTS: Two patients were excluded from analysis because of adverse events.Eleven patients underwent 3 to 6 cycles of bevacizumab treatment.The median rate of the reduction in peri-lesional edema was 65.5% (range: 2.0% to 81.0%).The Karnofsky performance status (KPS) improved in 6 patients after bevacizumab treatment, and in 5 patients the status did not change.The L/N ratio on F-BPA-PET (P ¼ 0.0084) and the improvement of KPS after bevacizumab (P ¼ 0.0228) were significantly associated with the reduction rate of peri-lesional edema after bevacizumab treatment.CONCLUSION: Bevacizumab is a very effective treatment for radiation necrosis, irrespective of the original tumor histology.F-BPA-PET could be useful for diagnosing radiation necrosis and for making the decision as to whether or not to treat symptomatic radiation necrosis with bevacizumab.The clinical trial "Intra-venous administration of bevacizumab for the treatment of radiation necrosis in the brain" has been approved as Investigational Medical Care System by the Japanese Ministry of Health, Labour and Welfare.This trial has been ongoing since April, 2011.

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