Boron neutron capture therapy (BNCT) for glioblastoma multiforme:: A phase II study evaluating a prolonged high-dose of boronophenylalanine (BPA)
Boron neutron capture therapy (BNCT) for glioblastoma multiforme:: A phase II study evaluating a prolonged high-dose of boronophenylalanine (BPA)
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DOI：
10.1016/j.radonc.2006.04.015
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发表时间：
2008-08-01
影响因子：
5.7
通讯作者：
Bergenheim, A. Tommy
中科院分区：
文献类型：
--
作者：
Henriksson, Roger;Capala, Jacek;Bergenheim, A. Tommy
背景和目的：为了评估硼中子俘获治疗（BNCT）的疗效和安全性多形性胶质母细胞瘤（GBM）使用一种新的协议的硼苯丙氨酸-果糖（BPA-F）infration.Patient和方法：这第二阶段的研究包括30例患者，26-69岁，具有良好的性能状态，其中27已经接受了减瘤手术。BPA-F（900 mg BPA/kg体重）静脉注射6 h。在输注完成后2小时开始中子照射。结果：照射期间血硼浓度为15.2-33.7 μ g/g。正常脑平均吸收剂量为3.2-6.1戈伊（W）。肿瘤体积的最小剂量范围为15.4至54.3戈伊（W）。与BNCT密切相关的癫痫发作7例，皮肤粘膜病变8例，血栓栓塞5例，腹部不适4例。4例患者出现9次3-4级事件（WHO）。在至少十个月的随访时，29名可评估患者中有23名死亡。从BNCT治疗到肿瘤进展的中位时间为5.8个月，BNCT后的中位生存时间为14.2个月。进展后，13例患者给予替莫唑胺，2例患者再次放疗，2例再次手术。接受替莫唑胺治疗的患者生存时间明显延长（17.7个月vs. 11.6个月）。生活质量分析显示BNCT后进行性恶化。虽然，BNCT在本方案中的疗效似乎与常规放疗相当，并且治疗时间更短，但观察到的副作用以及对复杂基础设施和更高资源的需求强调了进一步I期和II期研究的需要，特别是针对改善肿瘤细胞中B-10的积累。(C)2008爱思唯尔爱尔兰有限公司保留所有权利。
Background and purpose: To evaluate the efficacy and safety of boron neutron capture therapy (BNCT) for glioblastoma multiforme (GBM) using a novel protocol for the boronophenylalanine-fructose (BPA-F) infusion.Patient and methods: This phase II study included 30 patients, 26-69 years old, with a good performance status of which 27 have undergone debulking surgery. BPA-F (900 mg BPA/kg body weight) was given i.v. over 6 h. Neutron irradiation started 2 h after the completion of the infusion. Follow-up reports were monitored by an independent clinical research institute.Results: The boron-blood concentration during irradiation was 15.2-33.7 mu g/g. The average weighted absorbed dose to normal brain was 3.2-6.1 Gy (W). The minimum dose to the tumour volume ranged from 15.4 to 54.3 Gy (W). Seven patients suffered from seizures, 8 from skin/mucous problem, 5 patients were stricken by thromboembolism and 4 from abdominal disturbances in close relation to BNCT. Four patients displayed 9 episodes of grade 3-4 events (WHO). At the time for follow-up, minimum ten months, 23 out of the 29 evaluable patients were dead. The median time from BNCT treatment to tumour progression was 5.8 months and the median survival time after BNCT was 14.2 months. Following progression, 13 patients were given temozolomide, two patients were re-irradiated, and two were re-operated. Patients treated with temozolomide lived considerably longer (17.7 vs. 11.6 months). The quality of life analysis demonstrated a progressive deterioration after BNCT.Conclusion: Although, the efficacy of BNCT in the present protocol seems to be comparable with conventional radiotherapy and the treatment time is shorter, the observed side effects and the requirement of complex infrastructure and higher resources emphasize the need of further phase I and II studies, especially directed to improve the accumulation of B-10 in tumour cells. (C) 2008 Elsevier Ireland Ltd. All rights reserved.