Yong Zhong, Song Zewen, Zhou Yongmao, Liu Tong, Zhang Zizhu, Zhao Yanzhong, Chen Yang, Jin Congjun, Chen Xiang, Lu Jianyun, Han Rui, Li Pengzhou, Sun Xulong, Wang Guohui, Shi Guangqing, Zhu Shaihong
Department of Nuclear Medicine, the Third Xiangya Hospital of Central South University, Changsha 410013, China.
Department of Oncology, the Third Xiangya Hospital of Central South University, Changsha 410013, China.
Chin J Cancer Res. 2016 Dec;28(6):634-640. doi: 10.21147/j.issn.1000-9604.2016.06.10.
A phase I/II clinical trial for treating malignant melanoma by boron neutron capture therapy (BNCT) was designed to evaluate whether the world's first in-hospital neutron irradiator (IHNI) was qualified for BNCT. In this clinical trial planning to enroll 30 patients, the first case was treated on August 19, 2014. We present the protocol of this clinical trial, the treating procedure, and the clinical outcome of this first case. Only grade 2 acute radiation injury was observed during the first four weeks after BNCT and the injury healed after treatment. No late radiation injury was found during the 24-month follow-up. Based on positron emission tomography-computed tomography (PET/CT) scan, pathological analysis and gross examination, the patient showed a complete response to BNCT, indicating that BNCT is a potent therapy against malignant melanoma and IHNI has the potential to enable the delivery of BNCT in hospitals.
一项关于硼中子俘获疗法（BNCT）治疗恶性黑色素瘤的I/II期临床试验旨在评估世界上首个医院内中子辐照器（IHNI）是否符合BNCT的要求。在这项计划招募30名患者的临床试验中，首例患者于2014年8月19日接受治疗。我们介绍了该临床试验的方案、治疗过程以及首例患者的临床结果。在BNCT后的前四周仅观察到2级急性放射损伤，治疗后损伤愈合。在24个月的随访中未发现晚期放射损伤。基于正电子发射断层扫描-计算机断层扫描（PET/CT）、病理分析和大体检查，患者对BNCT显示出完全缓解，这表明BNCT是一种有效的恶性黑色素瘤治疗方法，且IHNI有潜力在医院实现BNCT治疗。
