- 作者：Ling-Wei Wang ; MD&lowast ; ; &dagger ; ; lwwang@vghtpe.gov.tw" class="auth_mail" title="E-mail the corresponding author ; Yi-Wei Chen ; MD ; PhD&lowast ; ; &dagger ; ; Ching-Yin Ho ; MD&dagger ; ; &Dagger ; ; Yen-Wan Hsueh Liu ; PhD§ ; ; Fong-In Chou ; PhD§ ; ; ‖ ; Yuan-Hao Liu ; PhD¶ ; ; Hong-Ming Liu ; PhD‖ ; Jinn-Jer Peir ; PhD‖ ; Shiang-Huei Jiang ; PhD§ ; ; Chi-Wei Chang ; PhD&dagger ; ; # ; Ching-Sheng Liu ; PhD&lowast ; ; &dagger ; ; Ko-Han Lin ; MD&lowast ; &lowast ; ; Shyh-Jen Wang ; MD&dagger ; ; # ; Pen-Yuan Chu ; MD&dagger ; ; &Dagger ; ; Wen-Liang Lo ; DDS&dagger ; ; &dagger ; &dagger ; ; Shou-Yen Kao ; DDS ; DMSc&dagger ; ; &dagger ; &dagger ; ; Sang-Hue Yen ; MD&lowast ; ; &dagger ;
- 刊名：International Journal of Radiation Oncology*Biology*Physics
- 出版年：2016
- 出版时间：1 May 2016
- 年：2016
- 卷：95
- 期：1
- 页码：396-403
- 全文大小：833 K
Methods and Materials
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.
Results
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%.
Conclusions
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.