Hammercap Medical AB, Stockholm, Sweden.
Acta Neurol Scand. 2010 Jul;122(1):58-62. doi: 10.1111/j.1600-0404.2009.01267.x. Epub 2009 Nov 26.
To assess possible improved efficacy of Boron Neutron Capture Therapy (BNCT) for glioblastoma multiforme (GBM) using prolonged infusion and a correspondingly higher dose of l-boronophenylalanine, as the fructose complex (BPA-f).
The benefit of prolonged infusion was analyzed by comparing the results from a Phase II study using 6 h infusion of BPA-f with those obtained from a Phase I/II study using 2 h of infusion. Median survival time (MST) from diagnosis, patient baseline characteristics, salvage treatment and severe adverse events were considered in the comparison.
MST increased significantly, from 12.8 (95% confidence interval or CI: 10.3-14.0) months with 2 h infusion to 17.7 (95% CI: 13.6-19.9) months with 6 h of infusion. The fraction of patients with WHO grade 3-4 adverse events was similar in the two studies at 13% and 14%, respectively.
Prolonged infusion was found to be beneficial for the efficacy of BNCT and it is suggested that 6 h infusion of BPA-f should be used in future trials of BNCT for GBM. BNCT, which is a single-day treatment with mild side effects, should be assessed in a controlled trial, as an alternative to 30 daily fractions of conventional fractionated photon therapy over a period of 6 weeks.
评估延长硼中子俘获治疗（BNCT）中 l-硼苯丙氨酸（作为果糖复合物的 BPA-f）输注时间和相应提高剂量，对多形性胶质母细胞瘤（GBM）可能产生的更好疗效。
通过比较使用 6 小时 BPA-f 输注的 II 期研究结果与使用 2 小时输注的 I/II 期研究结果，分析延长输注的益处。比较考虑了从诊断开始的中位生存时间（MST）、患者基线特征、挽救治疗和严重不良事件。
MST 显著增加，从 2 小时输注的 12.8 个月（95%置信区间或 CI：10.3-14.0）增加到 6 小时输注的 17.7 个月（95% CI：13.6-19.9）。在这两项研究中，出现 WHO 3-4 级不良事件的患者比例分别为 13%和 14%，相似。
延长输注被发现对 BNCT 的疗效有益，建议在未来的 GBM BNCT 试验中使用 6 小时的 BPA-f 输注。BNCT 是一种单日治疗，副作用轻微，应在对照试验中评估，作为 6 周内每天 30 次常规分割光子治疗的替代方案。
