{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,11]],"date-time":"2026-10-11T13:10:39Z","timestamp":1791724239490,"version":"4.3.4"},"reference-count":45,"publisher":"Journal of Neurosurgery Publishing Group (JNSPG)","issue":"6","license":[{"start":{"date-parts":[[2022,12,1]],"date-time":"2022-12-01T00:00:00Z","timestamp":1669852800000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2022,12,1]]},"abstract":"\nOBJECTIVE<\/jats:title>\nThere is an unmet need for safe and rapidly effective therapies for refractory brain radiation necrosis (RN). The aim of this prospective single-arm phase II trial was to evaluate the safety and efficacy of a single low-dose targeted bevacizumab infusion after blood-brain barrier disruption (BBBD) in adult patients with steroid-refractory brain RN.<\/jats:p>\n<\/jats:sec>\n\nMETHODS<\/jats:title>\nTen adults with steroid-refractory, imaging-confirmed brain RN were enrolled between November 2016 and January 2018 and followed for 12 months after treatment. Bevacizumab 2.5 mg\/kg was administered as a one-time targeted intra-arterial infusion immediately after BBBD. Primary outcomes included safety and > 25% decrease in lesion volume. Images were analyzed by a board-certified neuroradiologist blinded to pretrial diagnosis and treatment status. Secondary outcomes included changes in headache, steroid use, and functional status and absence of neurocognitive sequelae. Comparisons were analyzed using the Fisher exact test, Mann-Whitney U-test, linear mixed models, Wilcoxon signed-rank test, and repeated-measures 1-way ANOVA.<\/jats:p>\n<\/jats:sec>\n\nRESULTS<\/jats:title>\nTen adults (mean \u00b1 SD [range] age 35 \u00b1 15 [22\u201362] years) participated in this study. No patients died or exhibited serious adverse effects of systemic bevacizumab. At 3 months, 80% (95% CI 44%\u201398%) and 90% (95% CI 56%\u2013100%) of patients demonstrated > 25% decrease in RN and vasogenic edema volume, respectively. At 12 months, RN volume decreased by 74% (median [range] 76% [53%\u201396%], p = 0.012), edema volume decreased by 50% (median [range] 70% [\u221211% to 83%], p = 0.086), and headache decreased by 84% (median [range] 92% [58%\u2013100%], p = 0.022) among the 8 patients without RN recurrence. Only 1 (10%) patient was steroid dependent at the end of the trial. Scores on 12 of 16 (75%) neurocognitive indices increased, thereby supporting a pattern of cerebral white matter recovery. Two (20%) patients exhibited RN recurrence that required further treatment at 10 and 11 months, respectively, after bevacizumab infusion.<\/jats:p>\n<\/jats:sec>\n\nCONCLUSIONS<\/jats:title>\nFor the first time, to the authors\u2019 knowledge, the authors demonstrated that a single low-dose targeted bevacizumab infusion resulted in durable clinical and imaging improvements in 80% of patients at 12 months after treatment without adverse events attributed to bevacizumab alone. These findings highlight that targeted bevacizumab may be an efficient one-time treatment for adults with brain RN. Further confirmation with a randomized controlled trial is needed to compare the intra-arterial approach with the conventional multicycle intravenous regimen.<\/jats:p>\nClinical trial registration no.: NCT02819479 (ClinicalTrials.gov<\/jats:ext-link>)<\/jats:p>\n<\/jats:sec>","DOI":"10.3171\/2022.2.jns212006","type":"journal-article","created":{"date-parts":[[2022,4,15]],"date-time":"2022-04-15T13:39:40Z","timestamp":1650029980000},"page":"1676-1686","source":"Crossref","is-referenced-by-count":23,"title":["Single low-dose targeted bevacizumab infusion in adult patients with steroid-refractory radiation necrosis of the brain: a phase II open-label prospective clinical trial"],"prefix":"10.3171","volume":"137","author":[{"given":"Shervin R.","family":"Dashti","sequence":"first","affiliation":[{"name":"Cerebrovascular & Endovascular Neurosurgery Institute, Norton Neuroscience Institute, Norton Healthcare, Louisville, Kentucky;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert J.","family":"Kadner","sequence":"additional","affiliation":[{"name":"DXP Imaging, Louisville, Kentucky;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bradley S.","family":"Folley","sequence":"additional","affiliation":[{"name":"Norton Neuroscience Institute, Norton Healthcare, Louisville, Kentucky;"},{"name":"Department of Neurosurgery, University of Kentucky College of Medicine, Lexington, Kentucky;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jason P.","family":"Sheehan","sequence":"additional","affiliation":[{"name":"Department of Neurological Surgery, University of Virginia, Charlottesville, Virginia;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dong Y.","family":"Han","sequence":"additional","affiliation":[{"name":"Department of Neurology, University of Kentucky College of Medicine, Lexington, Kentucky;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard J.","family":"Kryscio","sequence":"additional","affiliation":[{"name":"Department of Statistics, University of Kentucky, Lexington, Kentucky;"},{"name":"Sanders Brown Center on Aging, University of Kentucky, Lexington, Kentucky;"},{"name":"Center for Clinical and Translational Sciences, University of Kentucky, Lexington, Kentucky;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mary B.","family":"Carter","sequence":"additional","affiliation":[{"name":"Doctor Talk, LLC, Louisville, Kentucky;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lisa B. 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