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

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; Wen Liang Lo; Shou Yen Kao; Sang Hue Yen

doi:10.1016/j.ijrobp.2016.02.028

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

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, Wen Liang Lo, Shou Yen Kao, Sang Hue Yen

^*Corresponding author for this work

Department of Dentistry

Research output: Contribution to journal › Article › peer-review

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Abstract

Purpose 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. 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.

Original language	English
Pages (from-to)	396-403
Number of pages	8
Journal	International Journal of Radiation Oncology Biology Physics
Volume	95
Issue number	1
DOIs	https://doi.org/10.1016/j.ijrobp.2016.02.028
State	Published - 1 May 2016

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Wang, L. W., Chen, Y. W., Ho, C. Y., Hsueh Liu, Y. W., Chou, F. I., Liu, Y. H., Liu, H. M., Peir, J. J., Jiang, S. H., Chang, C. W., Liu, C. S., Lin, K. H., Wang, S. J., Chu, P. Y., Lo, W. L., Kao, S. Y., & Yen, S. H. (2016). Fractionated Boron Neutron Capture Therapy in Locally Recurrent Head and Neck Cancer: A Prospective Phase I/II Trial. International Journal of Radiation Oncology Biology Physics, 95(1), 396-403. https://doi.org/10.1016/j.ijrobp.2016.02.028

@article{d7997227a401495b96ac1c528a8bc7ab,

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

abstract = "Purpose 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. 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.",

author = "Wang, {Ling Wei} and Chen, {Yi Wei} and Ho, {Ching Yin} and {Hsueh Liu}, {Yen Wan} and Chou, {Fong In} and Liu, {Yuan Hao} and Liu, {Hong Ming} and Peir, {Jinn Jer} and Jiang, {Shiang Huei} and Chang, {Chi Wei} and Liu, {Ching Sheng} and Lin, {Ko Han} and Wang, {Shyh Jen} and Chu, {Pen Yuan} and Lo, {Wen Liang} and Kao, {Shou Yen} and Yen, {Sang Hue}",

note = "Publisher Copyright: {\textcopyright} 2016 Elsevier Inc.",

year = "2016",

month = may,

day = "1",

doi = "10.1016/j.ijrobp.2016.02.028",

language = "English",

volume = "95",

pages = "396--403",

journal = "International Journal of Radiation Oncology Biology Physics",

issn = "0360-3016",

publisher = "Elsevier Inc.",

number = "1",

}

Wang, LW, Chen, YW, Ho, CY, Hsueh Liu, YW, Chou, FI, Liu, YH, Liu, HM, Peir, JJ, Jiang, SH, Chang, CW, Liu, CS, Lin, KH, Wang, SJ, Chu, PY, Lo, WL, Kao, SY & Yen, SH 2016, 'Fractionated Boron Neutron Capture Therapy in Locally Recurrent Head and Neck Cancer: A Prospective Phase I/II Trial', International Journal of Radiation Oncology Biology Physics, vol. 95, no. 1, pp. 396-403. https://doi.org/10.1016/j.ijrobp.2016.02.028

TY - JOUR

T1 - Fractionated Boron Neutron Capture Therapy in Locally Recurrent Head and Neck Cancer

T2 - A Prospective Phase I/II Trial

AU - Wang, Ling Wei

AU - Chen, Yi Wei

AU - Ho, Ching Yin

AU - Hsueh Liu, Yen Wan

AU - Chou, Fong In

AU - Liu, Yuan Hao

AU - Liu, Hong Ming

AU - Peir, Jinn Jer

AU - Jiang, Shiang Huei

AU - Chang, Chi Wei

AU - Liu, Ching Sheng

AU - Lin, Ko Han

AU - Wang, Shyh Jen

AU - Chu, Pen Yuan

AU - Lo, Wen Liang

AU - Kao, Shou Yen

AU - Yen, Sang Hue

PY - 2016/5/1

Y1 - 2016/5/1

N2 - Purpose 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. 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.

AB - Purpose 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. 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.

UR - http://www.scopus.com/inward/record.url?scp=84963507373&partnerID=8YFLogxK

U2 - 10.1016/j.ijrobp.2016.02.028

DO - 10.1016/j.ijrobp.2016.02.028

M3 - Article

C2 - 27084657

AN - SCOPUS:84963507373

SN - 0360-3016

VL - 95

SP - 396

EP - 403

JO - International Journal of Radiation Oncology Biology Physics

JF - International Journal of Radiation Oncology Biology Physics

IS - 1

ER -

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

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