Fractionated Boron Neutron Capture Therapy in Locally Recurrent Head and Neck Cancer: A Prospective Phase I/II Trial
Fractionated Boron Neutron Capture Therapy in Locally Recurrent Head and Neck Cancer: A Prospective Phase I/II Trial
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DOI：
10.1016/j.ijrobp.2016.02.028
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发表时间：
2016-05-01
影响因子：
7
通讯作者：
Yen, Sang-Hue
中科院分区：
文献类型：
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作者：
Wang, Ling-Wei;Chen, Yi-Wei;Yen, Sang-Hue
目的：探讨分次硼中子俘获治疗（BNCT）的有效性和安全性复发头颈部（H&N）癌后光子放射therapy.Methods和材料：在这个前瞻性的1/2期试验，2-馏分BNCT静脉注射L-硼苯丙氨酸（L-BPA，400 mg/kg），在28天的时间间隔。在每一部分之前，进行氟-18-标记-BPA正电子发射断层扫描以确定单个肿瘤的肿瘤/正常组织比率。通过使用剂量体积直方图，选择每部分20 Gy-Eq的处方剂量（D80）以覆盖80%的总肿瘤体积，同时最小化接受>10 Gy-Eq的口腔粘膜体积。肿瘤反应和不良反应进行了评估，使用反应评价标准在实体瘤v1.1和通用术语标准的不良事件v3.0，respectively.Results：17例患者与以前的累积辐射剂量为63-165戈伊。除2名参与者外，所有参与者均接受了2次BNCT。肿瘤/正常组织比值的中位数第一次为3.4，第二次为2.5，而第一次和第二次的中位数D_（80）分别为19.8和14. 6 Gy-Eq。在中位随访期19.7个月（范围，5.2-52个月）后，6名参与者表现出完全缓解，6名表现出部分缓解。关于急性毒性，5名参与者显示3级粘膜炎，1名参与者显示4级喉水肿和颈动脉出血。关于晚期毒性，2名参与者表现出3级脑神经病变。接受总D80> 40 Gy-Eq的6名参与者中有4名（67%）完全缓解。两年总生存率为47%。结论：2次BNCT适应剂量方案治疗局部复发H&N癌是安全有效的。修改我们的协议可能会产生更令人满意的结果在未来。(C)2016 Elsevier Inc. All rights reserved.
Purpose: To investigate the efficacy and safety of fractionated boron neutron capture therapy (BNCT) for recurrent head and neck (H&N) cancer after photon radiation therapy.Methods and Materials: In this prospective phase 1/2 trial, 2-fraction BNCT with intravenous L-boronophenylalanine (L-BPA, 400 mg/kg) was administered at a 28-day interval. Before each fraction, fluorine-18-labeled-BPAepositron emission tomography was conducted to determine the tumor/normal tissue ratio of an individual tumor. The prescription dose (D80) of 20 Gy-Eq per fraction was selected to cover 80% of the gross tumor volume by using a dose volume histogram, while minimizing the volume of oralmucosa receiving >10 Gy-Eq. Tumor responses and adverse effects were assessed using the Response Evaluation Criteria in Solid Tumors v1.1 and the Common Terminology Criteria for Adverse Events v3.0, respectively.Results: Seventeen patients with a previous cumulative radiation dose of 63-165 Gy were enrolled. All but 2 participants received 2 fractions of BNCT. The median tumor/normal tissue ratio was 3.4 for the first fraction and 2.5 for the second, whereas themedian D80 for the first and second fraction was 19.8 and 14.6Gy-Eq, respectively. After a median follow-up period of 19.7 months (range, 5.2-52 mo), 6 participants exhibited a complete response and 6 exhibited a partial response. Regarding acute toxicity, 5 participants showed grade 3 mucositis and 1 participant showed grade 4 laryngeal edema and carotid hemorrhage. Regarding late toxicity, 2 participants exhibited grade 3 cranial neuropathy. Four of six participants (67%) receiving totalD80> 40 Gy-Eq had a complete response. Two-year overall survival was 47%. Two-year locoregional control was 28%.Conclusions: Our results suggested that 2-fraction BNCTwith adaptive dose prescription was effective and safe in locally recurrent H&N cancer. Modifications to our protocol may yield more satisfactory results in the future. (C) 2016 Elsevier Inc. All rights reserved.