Journal
RADIOTHERAPY AND ONCOLOGY
Volume 155, Issue -, Pages 182-187Publisher
ELSEVIER IRELAND LTD
DOI: 10.1016/j.radonc.2020.11.001
Keywords
Boron neutron capture therapy (BNCT); Head and neck cancer; Phase II study; C-BENS; Borofalan (B-10)
Funding
- Sumitomo Heavy Industries, Ltd.
- Fukushima Prefectural Subsidy for Development and Testing of Global Cutting-Edge Medical Devices
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The study aimed to evaluate the efficacy and safety of cyclotron-based BNCT with borofalan for treating head and neck cancer, demonstrating promising treatment outcomes for patients with R-SCC or R/LA-nSCC.
Background and purpose: Boron neutron capture therapy (BNCT) can be performed without reactors due to development of cyclotron-based epithermal neutron source (C-BENS), which is optimized for treatment for deeper-seated tumors. The purpose of this study was to evaluate efficacy and safety of cyclotron-based BNCT with borofalan (B-10) for recurrent or locally advanced head and neck cancer. Materials and methods: In this open-label, phase II JHN002 trial of BNCT using C-BENS with borofalan (B-10), patients with recurrent squamous cell carcinoma (R-SCC) or with recurrent/locally advanced non-squamous cell carcinoma (R/LA-nSCC) of the head and neck were intravenously administered 400 mg/kg borofalan (B-10), followed by neutron irradiation. The tumor dose was determined passively as the mucosal maximum dose of 12 Gy-Eq. The primary endpoint was the objective response rate (ORR). Post-trial observational JHN002 Look Up study was planned for evaluating locoregional progression-free survival (LRPFS). Results: Eight R-SCC and 13 R/LA-nSCC patients were enrolled. All R-SCC patients had prior radiotherapy with a median dose of 65.5 Gy (range, 59.4-76.0 Gy). The ORR for all patients was 71%, and complete response/partial response were 50%/25% in R-SCC and 8%/62% in R/LA-nSCC. The 2-year overall survival for R-SCC and R/LA-nSCC were 58% and 100%, respectively. The median LRPFS was 11.5 months for R-SCC. Frequently observed adverse events included alopecia (95%), hyperamylasemia (86%), and nausea (81%). Conclusion: These data suggest that BNCT using C-BENS with borofalan (B-10) is a promising treatment option for patients with R-SCC or R/LA-nSCC of the head and neck. (C) 2020 The Authors. Published by Elsevier B.V.
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