Katsumi Hirose

The authors wish to make the following corrections to this paper

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.

Background and purpose: Boron neutron capture therapy (BNCT) has been routinely practiced for treatment of head and neck cancer in Japan. However, differences in contouring the oral and pharyngeal mucosa can lead to discrepancies in treatment. This study aimed to introduce a standardized approach using an MRI-based atlas, aiming to minimize inter-observer error and improve dose precision. Materials and Methods: An MRI atlas of the head and neck mucosa was developed using water/fat-separated images from a healthy man. Using CT images from three patients, seven radiation oncologists performed contouring of the head and neck mucosa twice over a 3-week period. Contouring was first performed using CT alone, then later using fused T2-weighted images with the mucosal atlas for guidance. Contouring errors were assessed and their impacts on tumor dose were evaluated. Results: The introduction of the MRI-based mucosal atlas significantly reduced inter-observer variation in mucosal volume (the coefficient of variation, abbreviated with COV, decreased from 0.61 with CT alone to 0.21 with the MRI atlas; p=0.003). Moreover, the atlas resulted in improved contour homology among observers and reduced variations in tumor dose. For all cases, COVs for maximum, mean, and minimum tumor doses were all below 5%. Conclusion: Utilizing an MRI-based mucosal atlas in BNCT contouring can significantly reduce inter-observer variation, improve contour homology, and decrease variations in tumor dose. These findings suggest strong potential for standardizing and enhancing the quality of BNCT for head and neck cancer.