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

Publication date: Available online 13 February 2016
Source:International Journal of Radiation Oncology*Biology*Physics
Author(s): Ling-Wei Wang, Yi-Wei Chen, Ching-Yin Ho, Yen-Wan Hsueh Liu, Fong-In Chou, Yuan-Hao Liu, Hong-Ming Liu, Jinn-Jer Peir, Shiang-Huei Jiang, Chi-Wei Chang, Ching-Sheng Liu, Ko-Han Lin, Shyh-Jen Wang, Pen-Yuan Chu, Lo-Wen Liang, Shou-Yen Kao, Sang-Hue Yen
Purpose/ObjectivesTo investigate the efficacy and safety of fractionated boron neutron capture therapy (BNCT) for recurrent head and neck (H & N) cancer following photon radiotherapy.MethodsIn this prospective phase I/II 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 (T/N) 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.ResultsSeventeen patients with a previous cumulative radiation dose of 63–165 Gy were enrolled. All but 2 participants received 2 fractions of BNCT. The median T/N 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 (CR) and 6 exhibited a partial response. Regarding the acute toxicity, 5 participants showed grade 3 mucositis and 1 participant showed grade 4 laryngeal edema and carotid hemorrhage. Regarding the late toxicity, 2 participants exhibited grade 3 cranial neuropathy. Four of six participants (67 %) receiving total D80 >40 Gy-Eq procured a CR. Two-year overall survival was 47%. Two-year locoregional control was 28 %.ConclusionsOur 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.

Teaser

To investigate the efficacy and safety of boron neutron capture therapy (BNCT), we treated 17 patients with recurrent head and neck (H & N) cancer following photon radiotherapy in a prospective phase I/II trial started in 2010. Two-fraction BNCT with intravenous L-boronophenylalanine at a 28-day interval was conducted. The total response rate was 71%, including 6 complete responses. Toxicity was acceptable. BNCT may be a treatment choice for locally recurrent H & N cancer.


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