Randomized double-blind placebo-controlled trial of bevacizumab therapy for radiation necrosis of the central nervous system.
Randomized double-blind placebo-controlled trial of bevacizumab therapy for radiation necrosis of the central nervous system.
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DOI：
10.1016/j.ijrobp.2009.12.061
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发表时间：
2011-04-01
影响因子：
7
通讯作者：
Jackson, Edward F.
中科院分区：
文献类型：
--
作者：
Levin, Victor A.;Bidaut, Luc;Hou, Ping;Kumar, Ashok J.;Wefel, Jeffrey S.;Bekele, B. Nebiyou;Prabhu, Sujit;Loghin, Monica;Gilbert, Mark R.;Jackson, Edward F.
关键词：
进行贝伐单抗治疗症状性放射性脑坏死的对照试验。14例患者进入了一项安慰剂对照的随机双盲贝伐珠单抗治疗中枢神经系统（CNS）放射性坏死研究。所有患者均需要有CNS放射性坏死和进行性神经系统症状或体征的放射学或活检证据。符合条件的患者接受头颈部癌、脑膜瘤或低至中等级别胶质瘤的放射治疗。患者随机接受静脉注射生理盐水或贝伐单抗，间隔3周。第二次治疗后3周的MRI和临床体征和症状定义了缓解或进展。T2 FLAIR和T1加权钆增强MRI估计的坏死体积表明，虽然安慰剂组患者无应答（0/7），但所有贝伐珠单抗治疗患者均应答（5/5例随机化和7/7例交叉），T2 FLAIR和T1加权钆增强体积减小，Ktranss减小。所有接受贝伐珠单抗治疗的患者-而没有接受安慰剂治疗的患者-均显示神经系统症状或体征改善。在接受所有4种研究剂量的患者中，在贝伐珠单抗末次给药后中位10个月时，仅2例患者发生了与进行性放射性坏死一致的MRI变化复发，这是唯一一例仅接受2次贝伐珠单抗治疗的患者。贝伐珠单抗治疗CNS放射性坏死疗效的I类证据证明，对于继发于头颈癌和脑癌治疗的放射性坏死患者，可考虑使用该治疗方案。
To conduct a controlled trial of bevacizumab for the treatment of symptomatic radiation necrosis of the brain. Fourteen patients were entered into a placebo-controlled randomized double-blind study of bevacizumab for the treatment of central nervous system (CNS) radiation necrosis. All patients were required to have radiographic or biopsy proof of CNS radiation necrosis and progressive neurological symptoms or signs. Eligible patients received irradiation for head and neck carcinomas, meningioma, or low- to mid-grade gliomas. Patients were randomized to receive IV saline or bevacizumab at 3-week intervals. MRI 3-weeks after the second treatment and clinical signs and symptoms defined response or progression. The volumes of necrosis estimated on T2FLAIR and T1-weighted gadolinium-enhanced MRI demonstrated that, while no patient receiving placebo responded (0/7), all bevacizumab-treated patients did (5/5 randomized and 7/7 cross-over) with decreases in T2FLAIR and T1-weighted gadolinium-enhanced volumes and decrease Ktrans. All bevacizumab-treated patients – and none of the placebo-treated patients - showed improvement in neurological symptoms or signs. At a median of 10 months after the last dose of bevacizumab in patients receiving all 4 study doses, only 2 patients had experienced a recurrence of MRI changes consistent with progressive radiation necrosis, and this was the only patient to receive only 2 treatments with bevacizumab. This class I evidence of bevacizumab efficacy in the treatment of CNS radiation necrosis justifies consideration of this treatment option for people who suffer radiation necrosis secondary to the treatment of head and neck and brain cancers.
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DOI：
10.1084/jem.174.5.1275
发表时间：
1991-11-01
期刊：
The Journal of experimental medicine
影响因子：
--
作者：
Dvorak HF;Sioussat TM;Brown LF;Berse B;Nagy JA;Sotrel A;Manseau EJ;Van de Water L;Senger DR
通讯作者：
Senger DR
影响因子：
3.9
作者：
Benedict, RHB;Schretlen, D;Brandt, J
通讯作者：
Brandt, J
影响因子：
56.9
作者：
SENGER, DR;GALLI, SJ;DVORAK, HF
通讯作者：
DVORAK, HF
影响因子：
4.5
作者：
Kim JH;Chung YG;Kim CY;Kim HK;Lee HK
通讯作者：
Lee HK
影响因子：
1.2
作者：
Giglio, P;Gilbert, MR
通讯作者：
Gilbert, MR