Fractionated Boron Neutron Capture Therapy in Locally Recurrent Head and Neck Cancer: A Prospective Phase I/II Trial

医学 不良事件通用术语标准 粘膜炎 核医学 不利影响 头颈部癌 放射治疗 毒性 前瞻性队列研究 癌症 水肿 放射科 内科学
作者
Ling-Wei Wang,Yi‐Wei Chen,Ching‐Yin Ho,Yen-Wan Hsueh Liu,Fong‐In Chou,Yuan-Hao Liu,Hongming Liu,Jinn-Jer Peir,Shiang‐Huei Jiang,Chi‐Wei Chang,Ching-Sheng Liu,Ko-Han Lin,Shyh‐Jen Wang,Pen‐Yuan Chu,Wen‐Liang Lo,Shou‐Yen Kao,Sang‐Hue Yen
出处
期刊:International Journal of Radiation Oncology Biology Physics [Elsevier]
卷期号:95 (1): 396-403 被引量:74
标识
DOI:10.1016/j.ijrobp.2016.02.028
摘要

To investigate the efficacy and safety of fractionated boron neutron capture therapy (BNCT) for recurrent head and neck (H&N) cancer after photon radiation therapy.In this prospective phase 1/2 trial, 2-fraction BNCT with intravenous L-boronophenylalanine (L-BPA, 400 mg/kg) was administered at a 28-day interval. Before each fraction, fluorine-18-labeled-BPA-positron emission tomography was conducted to determine the tumor/normal tissue ratio of an individual tumor. The prescription dose (D80) of 20 Gy-Eq per fraction was selected to cover 80% of the gross tumor volume by using a dose volume histogram, while minimizing the volume of oral mucosa receiving >10 Gy-Eq. Tumor responses and adverse effects were assessed using the Response Evaluation Criteria in Solid Tumors v1.1 and the Common Terminology Criteria for Adverse Events v3.0, respectively.Seventeen patients with a previous cumulative radiation dose of 63-165 Gy were enrolled. All but 2 participants received 2 fractions of BNCT. The median tumor/normal tissue ratio was 3.4 for the first fraction and 2.5 for the second, whereas the median D80 for the first and second fraction was 19.8 and 14.6 Gy-Eq, respectively. After a median follow-up period of 19.7 months (range, 5.2-52 mo), 6 participants exhibited a complete response and 6 exhibited a partial response. Regarding acute toxicity, 5 participants showed grade 3 mucositis and 1 participant showed grade 4 laryngeal edema and carotid hemorrhage. Regarding late toxicity, 2 participants exhibited grade 3 cranial neuropathy. Four of six participants (67%) receiving total D80 > 40 Gy-Eq had a complete response. Two-year overall survival was 47%. Two-year locoregional control was 28%.Our results suggested that 2-fraction BNCT with adaptive dose prescription was effective and safe in locally recurrent H&N cancer. Modifications to our protocol may yield more satisfactory results in the future.
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