Details

Autor(en) / Beteiligte

• Hirose, Katsumi
• Konno, Akiyoshi
• Hiratsuka, Junichi
• Yoshimoto, Seiichi
• Kato, Takahiro
• Ono, Koji
• Otsuki, Naoki
• Hatazawa, Jun
• Tanaka, Hiroki
• Takayama, Kanako
• Wada, Hitoshi
• Suzuki, Motohisa
• Sato, Mariko
• Yamaguchi, Hisashi
• Seto, Ichiro
• Ueki, Yuji
• Iketani, Susumu
• Imai, Shigeki
• Nakamura, Tatsuya
• Ono, Takashi
• Endo, Hiromasa
• Azami, Yusuke
• Kikuchi, Yasuhiro
• Murakami, Masao
• Takai, Yoshihiro

Titel

Boron neutron capture therapy using cyclotron-based epithermal neutron source and borofalan (10B) for recurrent or locally advanced head and neck cancer (JHN002): An open-label phase II trial

Ist Teil von

• Radiotherapy and oncology, 2021-02, Vol.155, p.182-187

Ort / Verlag

Ireland: Elsevier B.V

Erscheinungsjahr

2021

Link zum Volltext

Quelle

Elsevier ScienceDirect Journals Complete

Beschreibungen/Notizen

• •Accelerator-BNCT produced tumor response in 71% of head and neck patients.•BNCT showed no serious adverse events such as grade 4 or 5, except hyperamylasemia.•The results support a pivotal role of accelerator BNCT in cancer treatment. 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 (10B) for recurrent or locally advanced head and neck cancer. In this open-label, phase II JHN002 trial of BNCT using C-BENS with borofalan (10B), 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 (10B), 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). 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%). These data suggest that BNCT using C-BENS with borofalan (10B) is a promising treatment option for patients with R-SCC or R/LA-nSCC of the head and neck.