Abstract
PurposeThis study reports the first-in-human use of a linear accelerator-based boron neutron capture therapy (BNCT) system and the first treatment of patients with scalp-angiosarcoma with accelerator-based BNCT. Patients and methodsA single-center open-label phase I clinical trial has been conducted using the system since November 2019. Patients with a localized node-negative scalp-angiosarcoma along with the largest diameter of the tumor ≤ 15 cm who refused primary surgery and chemotherapy were enrolled. After administration of boronophenylalanine (BPA), a single treatment of BNCT with the maximum dose delivered to the skin being 12 Gy-Eq was performed. The safety and effectiveness of accelerator-based BNCT therapy for localized scalp angiosarcoma were evaluated. ResultsScalp-angiosarcoma of the two patients did not develop the dose-limiting toxicity in the clinical trial. They reached CR within half a year and did not exhibit in-field failure 20 months after BNCT without any severe treatment-related adverse events. Although a grade 3 adverse event of an asymptomatic but increased serum amylase level was noted in both patients, it relieved without any treatment. Additionally, no severe acute dermatitis was observed for both patients, which is typically seen with conventional primary radiotherapy. ConclusionsIt was suggested that BNCT would be a promising treatment modality for scalp-angiosarcoma, which is difficult to treat.
Highlights
Boron neutron capture therapy (BNCT) utilizing an acceleratorbased neutron source is a recently introduced in radiotherapy that is primarily based on 10B(n, α)7Li reactions
Boronophenylalanine (BPA) is a widely used 10B-containing drug that is taken up by tumor cells via the L-type amino acid transporter 1 (LAT-1) [2], which is expressed at high levels by many tumors [3]
It was noted that the maximum therapeutic field size was 15 cm in diameter on the clinical trial protocol, and the protocol was based on results of the several nonclinical trials in CICS-1
Summary
Boron neutron capture therapy (BNCT) utilizing an acceleratorbased neutron source is a recently introduced in radiotherapy that is primarily based on 10B(n, α)7Li reactions. As the α and 7Li particles released during BNCT exhibit high linear energy transfer, the relative biological effectiveness of BNCT is greater than that of conventional radiotherapies [1]. The high biological effectiveness via boron neutron capture reaction has been experimentally demonstrated [1]. Boronophenylalanine (BPA) is a widely used 10B-containing drug that is taken up by tumor cells via the L-type amino acid transporter 1 (LAT-1) [2], which is expressed at high levels by many tumors [3].
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