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Neurooncol Pract. 2016 Dec;3(4):272-280. Epub 2016 Jan 7.

A prospective, multicentre, single-arm clinical trial of bevacizumab for patients with surgically untreatable, symptomatic brain radiation necrosis.

Author information

1
Department of Neurosurgery , Osaka Medical College , Takatsuki, Osaka , Japan (M.F., N.N., T.K., S.-I.M.); Department of Neurosurgery , Kyoto University Graduate School of Medicine , Kyoto , Japan (S.M., Y.A.); Department of Neurosurgery, Chubu Medical Center for Prolonged Traumatic Brain Dysfunction , Kizawa Memorial Hospital , Minokamo , Japan (J.S., K.M.); Division of Neurological Surgery , Chiba Cancer Center , Chiba , Japan (T.I.); Proton Medical Research Center , University of Tsukuba , Tsukuba , Japan (K.T.); Department of Neurosurgery , Hokkaido University Graduate School of Medicine , Sapporo , Japan (K.H., S.T.); Department of Neurosurgery , Japanese Red Cross Medical Center , Tokyo , Japan (Y.T.); Department of Neurosurgery , Kumamoto University Graduate School of Medical Science , Kumamoto , Japan (H.N.); Department of Neurosurgery , Kyorin University Faculty of Medicine , Mitaka , Japan (M.N.); Department of Clinical Oncology and Neuro-oncology Program , Hiroshima University Hospital , Hiroshima , Japan (K.S.); Department of Neurosurgery , Kurume University School of Medicine , Kurume , Japan (M.T.); Department of Neurosurgery , Oita University Faculty of Medicine , Oita , Japan (T.A.); Department of Neurosurgery and Neuro-Oncology , National Cancer Center Hospital , Tokyo , Japan (Y.N.); Department of Neurosurgery , The University of Tokyo , Tokyo , Japan (N.S., A.M.); Department of Neurosurgery , Iwate Medical University , Morioka , Japan (K.O.); Department of Neurosurgery, Division of Hyperbaric Medicine , Iwate Medical University , Morioka , Japan (T.B.); Department of Neurosurgery , Kitasato University School of Medicine , Sagamihara , Japan (T.Kum); Department of Neurosurgery , Tokyo Medical and Dental University , Tokyo , Japan (T.N.); Department of Neurosurgery , Osaka City University Graduate School of Medicine , Osaka , Japan (N.T.); Translational Research Informatics Center , Foundation for Biomedical Research and Innovation , Kobe , Japan (E.N., S.K., Y.N.).

Abstract

BACKGROUND:

Brain radiation necrosis (BRN) can be a complication of radiotherapy for primary and secondary brain tumors, as well as head and neck tumors. Since vascular endothelial growth factor (VEGF) is also a vascular permeability factor in the brain, bevacizumab, a humanized antibody that inhibits VEGF, would be expected to reduce perilesional edema that often accompanies BRN.

METHODS:

Patients with surgically untreatable, symptomatic BRN refractory to conventional medical treatments (eg, corticosteroid, anticoagulants, or hyperbaric oxygen therapy) were enrolled. We judged that a major cause of perilesional edema with a lesion-to-normal brain ratio ≤1.8 on 11C-methionine or ≤2.5 on 18F-boronophenylalanine PET was BRN, not tumor recurrence, and 6 cycles of biweekly bevacizumab (5 mg/kg) were administered. The primary endpoint was a ≥30% reduction from the patients' registration for perilesional edema continuing for ≥1 month.

RESULTS:

Of the 41 patients enrolled, 38 were fully eligible for the response assessment. The primary endpoint was achieved in 30 of the 38 (78.9%) patients at 3.0 months (median) after enrollment. Sixteen patients (42.1%) experienced improvement of their Karnofsy Performance Score. Corticosteroid use could be reduced in 29 patients (76.3%). Adverse events at grade ≥3 occurred in 10 patients (24.4%).

CONCLUSIONS:

Bevacizumab treatment offers certain clinical benefits for patients with surgically untreatable, symptomatic BRN. The determination of BRN using amino-acid PET, not biopsy, is adequate and less invasive for determining eligibility to receive bevacizumab.

KEYWORDS:

Bevacizumab; brain radiation necrosis; positron emission tomography; vascular endothelial growth factor

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