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Poster Display session 3

4703 - Updated results of a phase II study evaluating accelerator-based boron neutron capture therapy (AB-BNCT) with borofalan(10B) (SPM-011) in recurrent squamous cell carcinoma (R-SCC-HN) and recurrent and locally advanced non-SCC (R/LA-nSCC-HN) of the head and neck


30 Sep 2019


Poster Display session 3


Tumour Site

Head and Neck Cancers


Katsumi Hirose


Annals of Oncology (2019) 30 (suppl_5): v449-v474. 10.1093/annonc/mdz252


K. Hirose1, A. Konno2, S. Yoshimoto3, K. Ono4, N. Otsuki5, J. Hatazawa6, J. Hiratsuka7, Y. Takai1

Author affiliations

  • 1 Department Of Radiation Oncology, Southern Tohoku BNCT Research Center, 9638052 - Koriyama/JP
  • 2 Department Of Otorhinolaryngology, Southern Tohoku General Hospital, 9638052 - Koriyama/JP
  • 3 Department Of Head And Neck Surgery, National Cancer Center Hospital, 1040045 - Tokyo/JP
  • 4 Department Of Radiation Oncology, Osaka Medical College, Kansai BNCT Medical Center, 5698686 - Takatsuki/JP
  • 5 Department Of Otolaryngology Head And Neck Surgery, Kobe University Graduate School of Medicine, 6500017 - Kobe/JP
  • 6 Department Of Nuclear Medicine And Tracer Kinetics, Osaka University Graduate School of Medicine, 5650871 - Osaka/JP
  • 7 Department Of Radiation Oncology, Kawasaki Medical School, 7010192 - Kurashiki/JP


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Abstract 4703


BNCT is a unique cancer treatment technique in which tumor cells are irradiated from the inside with heavy particles produced by 10B(n,α)7Li nuclear transmutation reaction of boron atom and neutron. A next-generation AB-BNCT system that does not require a nuclear reactor has been developed, and it has become possible to perform BNCT in urban hospitals along with stable supply of borofalan (10B) supported by high 10B concentration technology.


In this world-first, open-label phase II trial of AB-BNCT, patients (pts) with previously irradiated, platinum-resistant R-SCC-HN or with R/LA-nSCC-HN were administered with borofalan(10B) at 200 mg/kg/h intravenously for 2 hours, followed by neutron irradiation with continuous infusion at 100 mg/kg/h. The irradiated dose for tumor was determined passively as a mucosal maximum dose was given 12 Gy-Eq. Primary endpoint was objective response rate (ORR) by central review. Updated efficacy and safety analysis are presented here (data cut off: 5 April 2019).


Eight R-SCC-HN and thirteen R/LA-nSCC-HN pts were enrolled. All R-SCC-HN pts had prior radiotherapy with a dose of 65.5 Gy (range, 59.4–76.0). The tumor minimum dose was 31.0 Gy-Eq (range, 16.1–42.6). ORR for all pts were 71.4%, and CR/PR were 50.0%/25.0% in R-SCC-HN and 7.7%/61.5% in R/LA-nSCC-HN. With a median follow up of 21.3 months (range 9.2–30.6), 1-year PFS by investigator review were 70.6%. Other ecacy data are shown in the table. For adverse event, nausea (81%), dysgeusia (71%), acute parotitis (67%) were observed frequently.Table: 1135P

All (N = 21)R-SCC-HN (N = 8)R/LA-nSCC-HN (N = 13)
Overall response rate, n (%) (95% CI)15 (71.4) (47.8–88.8)6 (75) (34.9–96.8)9 (69.2) (38.6–90.9)
Disease control rate, n (%) (95% CI)20 (95.2) (76.2–99.9)7 (87.5) (47.3–99.7)13 (100) (79.4–100)
Median progression-free survival, monthsNR10.4NR
1-y / 2-y progression-free survival rate, %70.6 / 65.530.0 / 15.092.3 / 92.3
1-y / 2-y overall survival rate, %94.7 / 85.383.3 / 55.6100 / 100

NR, Not reached.


These data suggest that AB-BNCT with borofalan(10B) emerges as a promising treatment option for pts with R –SCC- HN or R/LA-nSCC-HN with no other treatment option.

Clinical trial identification


Editorial acknowledgement

Legal entity responsible for the study

Sumitomo Heavy Industries, Ltd, Stella Pharma Corporation.


Fukushima prefectural subsidy for development and testing of global cutting-edge medical devices.


K. Hirose: Research grant / Funding (self), Travel / Accommodation / Expenses: Sumitomo Heavy Industries, Ltd; Travel / Accommodation / Expenses: Stella Pharma Corporation. K. Ono: Advisory / Consultancy: Stella Pharma Corporation; Advisory / Consultancy: Sumitomo Heavy Industries, Ltd. Y. Takai: Travel / Accommodation / Expenses: Stella Pharma Corporation; Travel / Accommodation / Expenses: Sumitomo Heavy Industries, Ltd. All other authors have declared no conflicts of interest.

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