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.
背景：本研究旨在评估硼中子俘获疗法（BNCT）联合硼法仑（10B）在日本局部晚期或局部复发性头颈癌（LA/LR-HNC）患者中的真实世界安全性与有效性。方法：这项前瞻性、多中心观察性研究于2020年5月在日本启动，纳入了所有根据监管部门指导接受硼法仑（10B）治疗的患者。患者入组持续至至少150例患者完成登记，并对药物、治疗设备及BNCT相关不良事件进行评估。对LA/LR-HNC患者进行了系统性疗效分析。结果：入组的162例患者包括144例头颈部鳞状细胞癌（SCCHN）、17例非头颈部鳞状细胞癌（NSCCHN）及1例胶质母细胞瘤患者。治疗相关不良事件（TRAEs）中，急性TRAEs包括高淀粉酶血症（84.0%）、口腔炎（51.2%）、唾液腺炎（50.6%）和脱发（49.4%）；较常见的远期TRAEs包括吞咽困难（4.5%）、口渴（2.6%）和皮肤病变（1.9%）。复发性SCCHN患者的1年及2年总生存率分别为78.8%和60.7%。结论：本项上市后监测在真实世界环境中证实了BNCT联合硼法仑（10B）治疗LA/LR-HNC患者的安全性与有效性。
肿瘤(癌症)患者之家