{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,12]],"date-time":"2026-10-12T20:19:26Z","timestamp":1791836366439,"version":"4.3.4"},"reference-count":28,"publisher":"MDPI AG","issue":"5","license":[{"start":{"date-parts":[[2024,2,21]],"date-time":"2024-02-21T00:00:00Z","timestamp":1708473600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["www.mdpi.com"],"crossmark-restriction":true},"short-container-title":["Cancers"],"abstract":"<jats:p>Background: This study was conducted to evaluate the real-world safety and efficacy of boron neutron capture therapy (BNCT) with borofalan(10B) in Japanese patients with locally advanced or locally recurrent head and neck cancer (LA\/LR-HNC). Methods: This prospective, multicenter observational study was initiated in Japan in May 2020 and enrolled all patients who re-ceived borofalan(10B) as directed by regulatory authorities. Patient enrollment continued until at least 150 patients were enrolled, and adverse events attributable to drugs, treatment devices, and BNCT were evaluated. The patients with LA\/LR-HNC were systematically evaluated to determine efficacy. Results: The 162 patients enrolled included 144 patients with squamous cell carcinoma of the head and neck (SCCHN), 17 patients with non-SCCHN (NSCCHN), and 1 patient with glioblastoma. Treatmentrelated adverse events (TRAEs) were hyperamylasemia (84.0%), stomatitis (51.2%), sialoadenitis (50.6%), and alopecia (49.4%) as acute TRAEs and dysphagia (4.5%), thirst (2.6%), and skin disorder (1.9%) as more common late TRAEs. One- and two-year OS rates in patients with recurrent SCCHN were 78.8% and 60.7%, respectively. Conclusions: This post-marketing surveillance confirmed the safety and efficacy of BNCT with borofalan(10B) in patients with LA\/LR-HNC in a real-world setting.<\/jats:p>","DOI":"10.3390\/cancers16050869","type":"journal-article","created":{"date-parts":[[2024,2,21]],"date-time":"2024-02-21T11:35:04Z","timestamp":1708515304000},"page":"869","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":51,"title":["Safety of Boron Neutron Capture Therapy with Borofalan(10B) and Its Efficacy on Recurrent Head and Neck Cancer: Real-World Outcomes from Nationwide Post-Marketing Surveillance"],"prefix":"10.3390","volume":"16","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0478-6971","authenticated-orcid":false,"given":"Mariko","family":"Sato","sequence":"first","affiliation":[{"name":"Department of Radiation Oncology, Hirosaki University Graduate School of Medicine, 5 Zaifu-cho, Hirosaki 036-8562, Japan"},{"name":"Department of Radiation Oncology, Southern Tohoku BNCT Research Center, 7-10 Yatsuyamada, Koriyama 963-8052, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7582-8537","authenticated-orcid":false,"given":"Katsumi","family":"Hirose","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology, Hirosaki University Graduate School of Medicine, 5 Zaifu-cho, Hirosaki 036-8562, Japan"},{"name":"Department of Radiation Oncology, Southern Tohoku BNCT Research Center, 7-10 Yatsuyamada, Koriyama 963-8052, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Satoshi","family":"Takeno","sequence":"additional","affiliation":[{"name":"Kansai BNCT Medical Center, Osaka Medical and Pharmaceutical University, 2-7 Daigaku-machi, Takatsuki 569-8686, Japan"},{"name":"Department of Radiation Oncology, Osaka Medical and Pharmaceutical University, 2-7 Daigaku-machi, Takatsuki 569-8686, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Teruhito","family":"Aihara","sequence":"additional","affiliation":[{"name":"Kansai BNCT Medical Center, Osaka Medical and Pharmaceutical University, 2-7 Daigaku-machi, Takatsuki 569-8686, Japan"},{"name":"Department of Otolaryngology Head and Neck Surgery, Osaka Medical and Pharmaceutical University, 2-7 Daigaku-machi, Takatsuki 569-8686, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9603-0567","authenticated-orcid":false,"given":"Keiji","family":"Nihei","sequence":"additional","affiliation":[{"name":"Kansai BNCT Medical Center, Osaka Medical and Pharmaceutical University, 2-7 Daigaku-machi, Takatsuki 569-8686, Japan"},{"name":"Department of Radiation Oncology, Osaka Medical and Pharmaceutical University, 2-7 Daigaku-machi, Takatsuki 569-8686, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoshihiro","family":"Takai","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology, Southern Tohoku BNCT Research Center, 7-10 Yatsuyamada, Koriyama 963-8052, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toshimitsu","family":"Hayashi","sequence":"additional","affiliation":[{"name":"Stella Pharma Corporation, ORIX Kouraibashi Building, 3-2-7 Kouraibashi, Chuo-ku, Osaka 541-0043, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kosuke","family":"Bando","sequence":"additional","affiliation":[{"name":"Stella Pharma Corporation, ORIX Kouraibashi Building, 3-2-7 Kouraibashi, Chuo-ku, Osaka 541-0043, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hitomi","family":"Kimura","sequence":"additional","affiliation":[{"name":"Stella Pharma Corporation, ORIX Kouraibashi Building, 3-2-7 Kouraibashi, Chuo-ku, Osaka 541-0043, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Keisuke","family":"Tsurumi","sequence":"additional","affiliation":[{"name":"Sumitomo Heavy Industries, Ltd., 5-2 Soubirakichou, Niihama 792-0001, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Koji","family":"Ono","sequence":"additional","affiliation":[{"name":"BNCT Joint Clinical Institute, Osaka Medical and Pharmaceutical University, 2-7 Daigaku-machi, Takatsuki 569-8686, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2024,2,21]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","unstructured":"Sauerwein, W.A., Wittig, A., Moss, R., and Nakagawa, Y. 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