Article
Boron neutron capture therapy for glioblastoma. Phase I/II clinical trial at JRR-4
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Published: | June 4, 2012 |
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Objective: High dose irradiation to glioblastomas may improve the survival rate for glioblastomas. We have applied boron neutron capture therapy (BNCT) for newly diagnosed glioblastomas. BNCT is a cell selective alpha particle therapy produced by the nuclear reaction of 10B and the thermal neutron. BNCT could provide over 100 Gy-Eq b.e.d dose to the tumor. The BNCT irradiation was performed at the JRR-4 research reactor and the whole irradiation time was 20 to 30 min in a single session.
Methods: From 2002 until 2009, 11 cases of newly diagnosed glioblastoma were enrolled in this study. The most critical inclusion criteria are that the tumor is not deeper than 6 cm from the skin surface in order to achieve the application of an effective dose to the deepest intracranial region. The irradiation was done in a single session for BNCT using 100 mg/kg of sodium borocaptate (BSH) only in the early phase and later in the BSH and an additional 250 mg/kg boronophenyl-alainine (BPA) were used. In the final protocol, conventional 30 Gy (2 Gy/Eq) X-ray was added to BNCT to the broader area surrounding CTV-2 cm. The data were compared with the conventional X-ray group in our same institution as a historical control. The maximum normal brain dose was limited to 13 Gy-Eq in this BNCT protocol. The mean minimum tumor dose (of CTV-2cm) was 15.1 Gy-Eq in this study.
Results: The median progression free survival (PFS) was 12.0 months in the BNCT and 5.1 months in the control group. The median overall survival (Median OS) in the BNCT group was 25.7 months and 12.5 months in the control group. There were statistically significant differences in PFS and in median OS.
Conclusions: This preliminary pilot study proved the survival benefit for glioblastoma cases compared to standard therapy. A larger phase II study or randomized clinical study is required to finally prove the efficacy of BNCT for glioblastomas.