Randomized double-blind placebo-controlled trial of bevacizumab therapy for radiation necrosis of the central nervous system

Levin, Victor A. and Bidaut, Luc and Hou, Ping and Kumar, Ashok J. and Wefel, Jeffrey S. and Bekele, B. Nebiyou and Prabhu, Sujit and Loghin, Monica and Gilbert, Mark R. and Jackson, Edward F. (2011) Randomized double-blind placebo-controlled trial of bevacizumab therapy for radiation necrosis of the central nervous system. International Journal of Radiation Oncology Biology Physics, 79 (5). pp. 1487-1495. ISSN 0360-3016

Full text not available from this repository.

Item Type:Article
Item Status:Live Archive

Abstract

Purpose: To conduct a controlled trial of bevacizumab for the treatment of symptomatic radiation necrosis of the brain. Methods and Materials: A total of 14 patients were entered into a placebo-controlled randomized double-blind study of bevacizumab for the treatment of central nervous system radiation necrosis. All patients were required to have radiographic or biopsy proof of central nervous system radiation necrosis and progressive neurologic symptoms or signs. Eligible patients had undergone irradiation for head-and-neck carcinoma, meningioma, or low- to mid-grade glioma. Patients were randomized to receive intravenous saline or bevacizumab at 3-week intervals. The magnetic resonance imaging findings 3 weeks after the second treatment and clinical signs and symptoms defined the response or progression. Results: The volumes of necrosis estimated on T2-weighted fluid-attenuated inversion recovery and T1-weighted gadolinium-enhanced magnetic resonance imaging scans demonstrated that although no patient receiving placebo responded (0 of 7), all bevacizumab-treated patients did so (5 of 5 randomized and 7 of 7 crossover) with decreases in T2-weighted fluid-attenuated inversion recovery and T1-weighted gadolinium-enhanced volumes and a decrease in endothelial transfer constant. All bevacizumab-treated patients - and none of the placebo-treated patients - showed improvement in neurologic symptoms or signs. At a median of 10 months after the last dose of bevacizumab in patients receiving all four study doses, only 2 patients had experienced a recurrence of magnetic resonance imaging changes consistent with progressive radiation necrosis; one patient received a single additional dose of bevacizumab and the other patient received two doses. Conclusion: The Class I evidence of bevacizumab efficacy from the present study in the treatment of central nervous system radiation necrosis justifies consideration of this treatment option for people with radiation necrosis secondary to the treatment of head-and-neck cancer and brain cancer. © 2011 Elsevier Inc.

Keywords:Brain edema, Endothelial transfer constant, K<sub>trans</sub>, Neurotoxicity, Volumetric magnetic resonance imaging changes, Diseases, Gadolinium, Magnetism, Radiation, Radiotherapy, Resonance, Self assembly, Magnetic resonance imaging, bevacizumab, dexamethasone, enoxaparin, placebo, prednisone, sodium chloride, vasculotropin inhibitor, warfarin, adult, aged, article, brain biopsy, brain necrosis, cancer grading, cancer radiotherapy, clinical article, controlled study, crossover procedure, deep vein thrombosis, disease course, double blind procedure, drug dose increase, drug dose reduction, drug efficacy, drug substitution, drug withdrawal, female, glioma, head and neck carcinoma, hemiplegia, human, human tissue, male, meningioma, multiple cycle treatment, neurologic disease, nuclear magnetic resonance imaging, priority journal, radiation injury, randomized controlled trial, recurrent disease, sagittal sinus thrombosis, side effect, symptom, treatment response, visual field, Adult, Antibodies, Monoclonal, Brain, Brain Neoplasms, Central Nervous System, Cross-Over Studies, Double-Blind Method, Head and Neck Neoplasms, Humans, Magnetic Resonance Imaging, Meningeal Neoplasms, Middle Aged, Necrosis, Neuroprotective Agents, Placebos, Radiation Injuries
Subjects:F Physical Sciences > F350 Medical Physics
Divisions:College of Science > School of Computer Science
Related URLs:
ID Code:24128
Deposited On:19 Oct 2016 09:54

Repository Staff Only: item control page