症候性脳放射線壊死の核医学的診断とベバシズマブによる治療:—先進医療Bからの薬事承認に向けて—  [in Japanese] Intravenous Administration of Bevacizumab for the Treatment of Symptomatic Radiation Necrosis in the Brain with the Diagnosis based on Amino Acid PET—Advanced Therapy of Type B for NDA Approval—  [in Japanese]

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Abstract

 脳腫瘍に対する高線量放射線治療後の症候性脳放射線壊死は重篤な問題である. われわれは12名の症候性脳放射線壊死の患者に対して, アミノ酸トレーサーによるPETでの診断後, 抗血管内皮増殖因子 (VEGF) 抗体であるベバシズマブを2週に1度, 5mg/kgのスケジュールで静脈内投与を行うという臨床研究を大阪医科大学単一施設で行ったところ, 全例で脳浮腫の軽減を認めた. 以上の結果に基づき, 「脳放射線壊死に対する核医学的診断とベバシズマブの静脈内投与による治療」を高度医療 (先進医療B) として厚生労働省に申請し2011年4月1日に認可され, 薬事承認を目指した多施設臨床試験として施行した. 最終的には16施設が参加し, 41例の症例が登録され, 観察期間も終了し, 現在その結果の公表を準備中である.

  Symptomatic radiation necrosis in the brain is a serious problem after high-dose irradiation for brain tumors. We used amino-acid positron emission tomography (PET) for the diagnosis of radiation necrosis and examined the treatment of radiation necrosis with bevacizumab, an anti-vascular endothelial growth factor antibody. In a single-institute clinical study, we administered multiple times of intravenous injection of bevacizumab, 5 mg/kg biweekly to 12 consecutive patients with symptomatic radiation necrosis in the brain, diagnosed using PET. All patients responded well to this treatment, with marked shrinkage of perilesional edema. This treatment was effective irrespective of the original tumor type and radiation modality. Based on these observations, we applied for an Investigational Medical Care System grant from Japan's Ministry of Health, Labor, and Welfare (MHLW) to study the “Intravenous administration of bevacizumab for the treatment of symptomatic radiation necrosis in the brain with the diagnosis based on amino acid PET.” The MHLW approved the grant on April 1, 2011, and the clinical trial was begun. Sixteen institutes were included and 41 cases were enrolled in this nationwide clinical trial. The final goal of the clinical trial is to determine the optimal on-label use of bevacizumab for the treatment of symptomatic radiation necrosis in the brain. We will present the results of the clinical trial in the near future.

Journal

  • Japanese Journal of Neurosurgery

    Japanese Journal of Neurosurgery 24(6), 399-406, 2015

    The Japanese Congress of Neurological Surgeons

Codes

  • NII Article ID (NAID)
    130005083634
  • Text Lang
    JPN
  • ISSN
    0917-950X
  • Data Source
    J-STAGE 
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