The safety and efficacy of boron neutron capture therapy (BNCT) in the treatment of recurrent malignant tumors
10.3760/cma.j.cn113030-20250517-00194
- VernacularTitle:硼中子俘获疗法治疗复发恶性肿瘤的安全性和有效性研究
- Author:
Junqiang HONG
1
;
Xiaoyi LIN
;
Youqun LAI
;
Ye CAO
;
Xiangquan KONG
;
Yuanhao LIU
;
Shuiying LUO
;
Zhicheng XIONG
;
Mei GONG
;
Yalai LIN
;
Qiaoyun CHEN
;
Mingang YING
;
Li HUO
;
Xiaohua ZHU
;
Xiaoping SUN
;
Yiqiao DENG
;
Diyun SHU
;
Haige ZHANG
;
Cheng HUANG
;
Jianji PAN
Author Information
1. 福建医科大学附属厦门弘爱医院放疗科，厦门 316006
- Publication Type:Journal Article
- Keywords:
Radiotherapy;
Boron neutron capture therapy;
Head and neck malignancies;
Brain malignancies;
Neoplasm recurrence;
Safety;
Efficacy
- From:
Chinese Journal of Radiation Oncology
2025;34(10):985-992
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To evaluate the safety and efficacy of accelerator-based boron neutron capture therapy (AB-BNCT) in the treatment of recurrent and refractory malignant tumors.Methods:The data of 14 patients admitted to Xiamen Humanity Hospital from September 2022 to April 2023 were prospectively collected, including 7 patients with primary brain malignancies and 7 patients with locally recurrent inoperable head and neck malignancies. All patients received intravenous infusion of boron drug (NBB-001, p-dihydroxyborylphe nylalanine, a patented freeze-dried formulation) at a total nominal dosage of 500 mg/kg (11 patients) or 750 mg/kg (3 patients), and were irradiated with neutrons (operating with NeuPex system). Adverse events after treatment were recorded and assessed. The primary efficacy endpoint was the 90 d objective response rate (ORR), while the secondary endpoints included progression-free survival (PFS) and complete response rate (CRR). Data were compiled and analyzed by SAS 9.4 software. The rate and 95% CI were calculated using Clopper-Pearson method. Results:The median dose delivered to 80% of the target volume (D 80%) was 16.80 GyE (range: 8.93-23.79 GyE). The most common adverse reactions were hyperamylasemia, alopecia, and hyperprolactinemia. Five patients experienced 8 cases of grade 3 or above adverse events, including 1 case of grade 4 acute kidney injury and 7 cases of grade 3 adverse events. All adverse events were recovered after observation or treatment. At 90 d after treatment, the ORR of all patients was 9/14 (64%, 95% CI: 35%-87%), disease control rate (DCR) was 10/14 (71%, 95% CI: 42%-92%), CRR was 2/14 (14%, 95% CI: 2%-42%); and the best overall response during the entire course included an ORR of 10/14 (71% ,95% CI: 42%-92%), DCR of 13/14 (93%, 95% CI: 66%-100%), and CRR of 3/14 (21% ,95% CI: 5%-51%). The 1-year survival rate for head and neck malignancies was 71.4%, and the 2-year survival rate was 42.8%. The 1-year survival rate for recurrent brain malignancies was 42.8%. Conclusion:AB-BNCT demonstrates favorable safety and promising efficacy in treating primary brain malignancies and recurrent/refractory head and neck malignancies, representing a potential therapeutic option.
