Boron neutron capture therapy for newly diagnosed glioblastoma multiforme: an assessment of clinical potential
Boron neutron capture therapy for newly diagnosed glioblastoma multiforme: an assessment of clinical potential
复制标题
DOI：
10.1259/bjr/56953620
复制
发表时间：
2010-07-01
影响因子：
2.6
通讯作者：
Hopewell, J. W.
中科院分区：
文献类型：
--
作者：
Skold, K.;Gorlia, T.;Hopewell, J. W.
本研究的目的是评估硼中子俘获疗法（BNCT）作为新诊断的多形性胶质母细胞瘤（GBM）一线放疗的潜力，该疗法使用硼载体L - 硼苯丙氨酸果糖制剂（BPA - f）进行6小时输注。将一项使用BNCT的II期研究的患者生存数据与一项III期研究的两组回顾性数据进行比较，III期研究的参考组使用常规放疗（RT），实验组使用放疗加替莫唑胺（TMZ）同步和辅助用药，并且还与这些患者中已知MGMT（O(6)-甲基鸟嘌呤 - DNA甲基转移酶）DNA修复基因甲基化状态的小亚组进行比较。还考虑了基线特征、复发后的挽救治疗以及严重不良事件水平的差异。结果表明，BNCT提供的治疗效果至少与单独的常规放疗相同。对于MGMT DNA修复基因未甲基化的患者，提示BNCT可能比RT/TMZ具有临床优势。BNCT是一种单日治疗，对患者方便，副作用轻微，在患者原本需要每日接受RT和TMZ治疗的期间，它能提供最初6周的高质量生活。建议在一项分层随机II期试验中探索使用BPA - f输注6小时的BNCT，在该试验中，MGMT DNA修复基因未甲基化的患者在实验组接受BNCT，在参考组接受RT加TMZ。
The purpose of this study was to assess the potential of boron neutron capture therapy (BNCT), with a 6-h infusion of the boron carrier L-boronophenylalanine as a fructose preparation (BPA-f), as first-line radiotherapy for newly diagnosed glioblastoma multiforme (GBM). Patient survival data from a Phase II study using BNCT were compared with retrospective data from the two arms of a Phase III study using conventional radiotherapy (RT) in the reference arm and using RT plus concomitant and adjuvant medication with temozolomide (TMZ) in the experimental arm, and were also compared with small subgroups of these patients for whom the methylation status of the MGMT (O(6)-methylguanine-DNA methyltransferase) DNA repair gene was known. Differences in the baseline characteristics, salvage therapy after recurrence and levels of severe adverse events were also considered. The results indicate that BNCT offers a treatment that is at least as effective as conventional RT alone. For patients with an unmethylated MGMT DNA repair gene, a possible clinical advantage of BNCT over RT/TMZ was suggested. BNCT is a single-day treatment, which is of convenience to patients, with mild side effects, which would offer an initial 6 weeks of good-quality life during the time when patients would otherwise be undergoing daily treatments with RT and TMZ. It is suggested that the use of BNCT with a 6-h infusion of BPA-f should be explored in a stratified randomised Phase II trial in which patients with the unmethylated MGMT DNA repair gene are offered BNCT in the experimental arm and RT plus TMZ in the reference arm.