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  3. 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

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

  • Radiother Oncol. 2021 Feb;155:182-187. doi: 10.1016/j.radonc.2020.11.001.
Katsumi Hirose 1,  Akiyoshi Konno 2,  Junichi Hiratsuka 3,  Seiichi Yoshimoto 4,  Takahiro Kato 5,  Koji Ono 6,  Naoki Otsuki 7,  Jun Hatazawa 8,  Hiroki Tanaka 9,  Kanako Takayama 10,  Hitoshi Wada 10,  Motohisa Suzuki 10,  Mariko Sato 11,  Hisashi Yamaguchi 10,  Ichiro Seto 10,  Yuji Ueki 2,  Susumu Iketani 12,  Shigeki Imai 13,  Tatsuya Nakamura 10,  Takashi Ono 10,  Hiromasa Endo 10,  Yusuke Azami 14,  Yasuhiro Kikuchi 10,  Masao Murakami 10,  Yoshihiro Takai 15
Affiliations

Affiliations

  • 1 Southern Tohoku BNCT Research Center, Koriyama, Japan; Department of Radiation Oncology, Southern Tohoku General Hospital, Koriyama, Japan; Department of Radiation Oncology, Hirosaki University Graduate School of Medicine, Japan. Electronic address: [email protected].
  • 2 Department of Otorhinolaryngology, Southern Tohoku General Hospital, Koriyama, Japan.
  • 3 Department of Radiation Oncology, Kawasaki Medical School, Kurashiki, Japan.
  • 4 Department of Head and Neck Surgery, National Cancer Center Hospital, Tokyo, Japan.
  • 5 Southern Tohoku BNCT Research Center, Koriyama, Japan; Department of Radiation Oncology, Southern Tohoku General Hospital, Koriyama, Japan; Southern Tohoku Proton Therapy Center, Koriyama, Japan; Preparing Section for New Faculty of Medical Science, Fukushima Medical University, Japan.
  • 6 Kansai BNCT Medical Center, Osaka Medical College, Japan.
  • 7 Department of Otolaryngology, Kindai University, Faculty of Medicine, Osaka, Japan.
  • 8 Department of Nuclear Medicine and Tracer Kinetics, Osaka University Graduate School of Medicine, Japan.
  • 9 Institute for Integrated Radiation and Nuclear Science, Kyoto University, Kumatori, Japan.
  • 10 Department of Radiation Oncology, Southern Tohoku General Hospital, Koriyama, Japan; Southern Tohoku Proton Therapy Center, Koriyama, Japan.
  • 11 Southern Tohoku BNCT Research Center, Koriyama, Japan; Department of Radiation Oncology, Southern Tohoku General Hospital, Koriyama, Japan; Department of Radiation Oncology, Hirosaki University Graduate School of Medicine, Japan.
  • 12 Department of Oral and Maxillofacial Surgery, Southern Tohoku General Hospital, Koriyama, Japan.
  • 13 Department of Radiology, Southern Tohoku General Hospital, Koriyama, Japan.
  • 14 Department of Radiation Oncology, Southern Tohoku General Hospital, Koriyama, Japan; Southern Tohoku Proton Therapy Center, Koriyama, Japan; Department of Medical Oncology, School of Medicine, Fukushima Medical University, Japan.
  • 15 Southern Tohoku BNCT Research Center, Koriyama, Japan; Department of Radiation Oncology, Southern Tohoku General Hospital, Koriyama, Japan.
PMID: 33186684 DOI: 10.1016/j.radonc.2020.11.001
Abstract

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 (10B) 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 (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).

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 (10B) is a promising treatment option for patients with R-SCC or R/LA-nSCC of the head and neck.

Keywords

Borofalan ((10)B); Boron neutron capture therapy (BNCT); C-BENS; Head and neck cancer; Phase II study.

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