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
Katsumi Hirose, Akiyoshi Konno, Junichi Hiratsuka, Seiichi Yoshimoto, Takahiro Katō, Koji Ono, Naoki Otsuki, Jun Hatazawa, Hiroki Tanaka, Kanako Takayama, Hitoshi Wada, Motohisa Suzuki, Mariko Sato, H. Yamaguchi, Ichiro Seto, Yuji Ueki, Susumu Iketani, Shigeki Imai, Tatsuya Nakamura, Takashi Ono, Hiromasa Endo, Yusuke Azami, Yasuhiro Kikuchi, Masao Murakami, Yoshihiro Takai
Abstract
BACKGROUND AND PURPOSE: B) for recurrent or locally advanced head and neck cancer. MATERIALS AND METHODS: B), 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: B) is a promising treatment option for patients with R-SCC or R/LA-nSCC of the head and neck.