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Phase I/II trial of local interstitial chemotherapy with arsenic trioxide in patients with newly diagnosed glioma

BACKGROUND: Glioma is the most common primary brain tumor in adults with poor prognosis. The glioma patients benefit from STUPP strategy, including maximum and safe resection and adjuvant radiotherapy and chemotherapy. Arsenic trioxide could inhibit various tumors. However, it is a challenge to eval...

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Autores principales: Han, Dayong, Teng, Lei, Wang, Xiaoxiong, Zhen, Yunbo, Chen, Xiaofeng, Yang, Mingchun, Gao, Ming, Yang, Guang, Han, Mingyang, Wang, Ligang, Xu, Jiajun, Li, Yue, Shumadalova, Alina, Zhao, Shiguang
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9535358/
https://www.ncbi.nlm.nih.gov/pubmed/36212657
http://dx.doi.org/10.3389/fneur.2022.1001829
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author Han, Dayong
Teng, Lei
Wang, Xiaoxiong
Zhen, Yunbo
Chen, Xiaofeng
Yang, Mingchun
Gao, Ming
Yang, Guang
Han, Mingyang
Wang, Ligang
Xu, Jiajun
Li, Yue
Shumadalova, Alina
Zhao, Shiguang
author_facet Han, Dayong
Teng, Lei
Wang, Xiaoxiong
Zhen, Yunbo
Chen, Xiaofeng
Yang, Mingchun
Gao, Ming
Yang, Guang
Han, Mingyang
Wang, Ligang
Xu, Jiajun
Li, Yue
Shumadalova, Alina
Zhao, Shiguang
author_sort Han, Dayong
collection PubMed
description BACKGROUND: Glioma is the most common primary brain tumor in adults with poor prognosis. The glioma patients benefit from STUPP strategy, including maximum and safe resection and adjuvant radiotherapy and chemotherapy. Arsenic trioxide could inhibit various tumors. However, it is a challenge to evaluate the efficiency and safety of srsenic trioxide in glioma patients. OBJECTIVE: The arsenic trioxide has the potent therapeutic effect on glioma. However, the safety and efficacy of local interstitial chemotherapy with arsenic trioxide in newly diagnosed glioma patients is unclear. METHODS: All patients received partial or complete tumor resection and intraoperative implantation of Ommaya reservoirs followed by standard radiotherapy. Arsenic trioxide with the starting dose 0.3 mg was administered via an Ommaya reservoir catheter inserted into the tumor cavity for 5 consecutive days every 3 months for a total of eight cycles unless tumor progression or excessive toxicity was observed. RESULTS: No hematological or grade 4 non-hematological toxicity was observed in any patient during arsenic trioxide treatment. The maximum tolerated dose of 1.5 mg of arsenic trioxide was safe and well tolerated. The median overall survival for WHO grade 3 glioma was 33.6 months, and for glioblastoma was 13.9 months. The median progression-free survival for WHO grade 2 glioma was 40.3 months, for grade 3 glioma was 21.5 months, and for glioblastoma was 9.5 months. CONCLUSION: These results suggest that arsenic trioxide is safe and well tolerated with local delivery into the tumor cavity of the brain, and the dose recommended for a phase II trial is 1.5 mg.
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spelling pubmed-95353582022-10-07 Phase I/II trial of local interstitial chemotherapy with arsenic trioxide in patients with newly diagnosed glioma Han, Dayong Teng, Lei Wang, Xiaoxiong Zhen, Yunbo Chen, Xiaofeng Yang, Mingchun Gao, Ming Yang, Guang Han, Mingyang Wang, Ligang Xu, Jiajun Li, Yue Shumadalova, Alina Zhao, Shiguang Front Neurol Neurology BACKGROUND: Glioma is the most common primary brain tumor in adults with poor prognosis. The glioma patients benefit from STUPP strategy, including maximum and safe resection and adjuvant radiotherapy and chemotherapy. Arsenic trioxide could inhibit various tumors. However, it is a challenge to evaluate the efficiency and safety of srsenic trioxide in glioma patients. OBJECTIVE: The arsenic trioxide has the potent therapeutic effect on glioma. However, the safety and efficacy of local interstitial chemotherapy with arsenic trioxide in newly diagnosed glioma patients is unclear. METHODS: All patients received partial or complete tumor resection and intraoperative implantation of Ommaya reservoirs followed by standard radiotherapy. Arsenic trioxide with the starting dose 0.3 mg was administered via an Ommaya reservoir catheter inserted into the tumor cavity for 5 consecutive days every 3 months for a total of eight cycles unless tumor progression or excessive toxicity was observed. RESULTS: No hematological or grade 4 non-hematological toxicity was observed in any patient during arsenic trioxide treatment. The maximum tolerated dose of 1.5 mg of arsenic trioxide was safe and well tolerated. The median overall survival for WHO grade 3 glioma was 33.6 months, and for glioblastoma was 13.9 months. The median progression-free survival for WHO grade 2 glioma was 40.3 months, for grade 3 glioma was 21.5 months, and for glioblastoma was 9.5 months. CONCLUSION: These results suggest that arsenic trioxide is safe and well tolerated with local delivery into the tumor cavity of the brain, and the dose recommended for a phase II trial is 1.5 mg. Frontiers Media S.A. 2022-08-30 /pmc/articles/PMC9535358/ /pubmed/36212657 http://dx.doi.org/10.3389/fneur.2022.1001829 Text en Copyright © 2022 Han, Teng, Wang, Zhen, Chen, Yang, Gao, Yang, Han, Wang, Xu, Li, Shumadalova and Zhao. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Neurology
Han, Dayong
Teng, Lei
Wang, Xiaoxiong
Zhen, Yunbo
Chen, Xiaofeng
Yang, Mingchun
Gao, Ming
Yang, Guang
Han, Mingyang
Wang, Ligang
Xu, Jiajun
Li, Yue
Shumadalova, Alina
Zhao, Shiguang
Phase I/II trial of local interstitial chemotherapy with arsenic trioxide in patients with newly diagnosed glioma
title Phase I/II trial of local interstitial chemotherapy with arsenic trioxide in patients with newly diagnosed glioma
title_full Phase I/II trial of local interstitial chemotherapy with arsenic trioxide in patients with newly diagnosed glioma
title_fullStr Phase I/II trial of local interstitial chemotherapy with arsenic trioxide in patients with newly diagnosed glioma
title_full_unstemmed Phase I/II trial of local interstitial chemotherapy with arsenic trioxide in patients with newly diagnosed glioma
title_short Phase I/II trial of local interstitial chemotherapy with arsenic trioxide in patients with newly diagnosed glioma
title_sort phase i/ii trial of local interstitial chemotherapy with arsenic trioxide in patients with newly diagnosed glioma
topic Neurology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9535358/
https://www.ncbi.nlm.nih.gov/pubmed/36212657
http://dx.doi.org/10.3389/fneur.2022.1001829
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