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Multicenter randomized trial of arsenic trioxide and Realgar‐Indigo naturalis formula in pediatric patients with acute promyelocytic leukemia: Interim results of the SCCLG‐APL clinical study
Intravenous arsenic trioxide (ATO) has been adopted as the first‐line treatment for acute promyelocytic leukemia (APL). Another arsenic compound named the Realgar‐Indigo naturalis formula (RIF), an oral traditional Chinese medicine containing As(4)S(4), has been shown to be highly effective in treat...
Autores principales: | , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley & Sons, Inc.
2018
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6282847/ https://www.ncbi.nlm.nih.gov/pubmed/30160789 http://dx.doi.org/10.1002/ajh.25271 |
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author | Yang, Ming‐Hua Wan, Wu‐Qing Luo, Jie‐Si Zheng, Min‐Cui Huang, Ke Yang, Li‐Hua Mai, Hui‐Rong Li, Jian Chen, Hui‐Qin Sun, Xiao‐Fei Liu, Ri‐Yang Chen, Guo‐Hua Feng, Xiaoqin Ke, Zhi‐Yong Li, Bin Tang, Yan‐Lai Huang, Li‐Bin Luo, Xue‐Qun |
author_facet | Yang, Ming‐Hua Wan, Wu‐Qing Luo, Jie‐Si Zheng, Min‐Cui Huang, Ke Yang, Li‐Hua Mai, Hui‐Rong Li, Jian Chen, Hui‐Qin Sun, Xiao‐Fei Liu, Ri‐Yang Chen, Guo‐Hua Feng, Xiaoqin Ke, Zhi‐Yong Li, Bin Tang, Yan‐Lai Huang, Li‐Bin Luo, Xue‐Qun |
author_sort | Yang, Ming‐Hua |
collection | PubMed |
description | Intravenous arsenic trioxide (ATO) has been adopted as the first‐line treatment for acute promyelocytic leukemia (APL). Another arsenic compound named the Realgar‐Indigo naturalis formula (RIF), an oral traditional Chinese medicine containing As(4)S(4), has been shown to be highly effective in treating adult APL. In the treatment of pediatric APL, the safety and efficacy of RIF remains to be confirmed. This randomized, multicenter, and noninferiority trial was conducted to determine whether intravenous ATO can be substituted by oral RIF in the treatment of pediatric APL. From September 2011 to January 2017, among 92 patients who were 16 years old or younger with newly diagnosed PML‐RARa positive APL, 82 met eligible criteria and were randomly assigned to ATO (n = 42) or RIF (n = 40) group. The remaining 10 patients did not fulfilled eligible criteria because five did not accept randomization, four died and one had hemiplegia prior to arsenic randomization due to intracranial hemorrhage or cerebral thrombosis. Induction and consolidation treatment contained ATO or RIF, all‐trans‐retinoic acid and low intensity chemotherapy. End points included event‐free survival (EFS), adverse events and hospital days. After a median 3‐year follow‐up, the estimated 5‐year EFS was 100% in both groups, and adverse events were mild. However, patients in the RIF group had significantly less hospital stay than those in the ATO group. This interim analysis shows that oral RIF is as effective and safe as intravenous ATO for the treatment of pediatric APL, with the advantage of reducing hospital stay. Final trial analysis will reveal mature outcome data. |
format | Online Article Text |
id | pubmed-6282847 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | John Wiley & Sons, Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-62828472018-12-11 Multicenter randomized trial of arsenic trioxide and Realgar‐Indigo naturalis formula in pediatric patients with acute promyelocytic leukemia: Interim results of the SCCLG‐APL clinical study Yang, Ming‐Hua Wan, Wu‐Qing Luo, Jie‐Si Zheng, Min‐Cui Huang, Ke Yang, Li‐Hua Mai, Hui‐Rong Li, Jian Chen, Hui‐Qin Sun, Xiao‐Fei Liu, Ri‐Yang Chen, Guo‐Hua Feng, Xiaoqin Ke, Zhi‐Yong Li, Bin Tang, Yan‐Lai Huang, Li‐Bin Luo, Xue‐Qun Am J Hematol Research Articles Intravenous arsenic trioxide (ATO) has been adopted as the first‐line treatment for acute promyelocytic leukemia (APL). Another arsenic compound named the Realgar‐Indigo naturalis formula (RIF), an oral traditional Chinese medicine containing As(4)S(4), has been shown to be highly effective in treating adult APL. In the treatment of pediatric APL, the safety and efficacy of RIF remains to be confirmed. This randomized, multicenter, and noninferiority trial was conducted to determine whether intravenous ATO can be substituted by oral RIF in the treatment of pediatric APL. From September 2011 to January 2017, among 92 patients who were 16 years old or younger with newly diagnosed PML‐RARa positive APL, 82 met eligible criteria and were randomly assigned to ATO (n = 42) or RIF (n = 40) group. The remaining 10 patients did not fulfilled eligible criteria because five did not accept randomization, four died and one had hemiplegia prior to arsenic randomization due to intracranial hemorrhage or cerebral thrombosis. Induction and consolidation treatment contained ATO or RIF, all‐trans‐retinoic acid and low intensity chemotherapy. End points included event‐free survival (EFS), adverse events and hospital days. After a median 3‐year follow‐up, the estimated 5‐year EFS was 100% in both groups, and adverse events were mild. However, patients in the RIF group had significantly less hospital stay than those in the ATO group. This interim analysis shows that oral RIF is as effective and safe as intravenous ATO for the treatment of pediatric APL, with the advantage of reducing hospital stay. Final trial analysis will reveal mature outcome data. John Wiley & Sons, Inc. 2018-10-20 2018-12 /pmc/articles/PMC6282847/ /pubmed/30160789 http://dx.doi.org/10.1002/ajh.25271 Text en © 2018 The Authors. American Journal of Hematology published by Wiley Periodicals, Inc. This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes. |
spellingShingle | Research Articles Yang, Ming‐Hua Wan, Wu‐Qing Luo, Jie‐Si Zheng, Min‐Cui Huang, Ke Yang, Li‐Hua Mai, Hui‐Rong Li, Jian Chen, Hui‐Qin Sun, Xiao‐Fei Liu, Ri‐Yang Chen, Guo‐Hua Feng, Xiaoqin Ke, Zhi‐Yong Li, Bin Tang, Yan‐Lai Huang, Li‐Bin Luo, Xue‐Qun Multicenter randomized trial of arsenic trioxide and Realgar‐Indigo naturalis formula in pediatric patients with acute promyelocytic leukemia: Interim results of the SCCLG‐APL clinical study |
title | Multicenter randomized trial of arsenic trioxide and Realgar‐Indigo naturalis formula in pediatric patients with acute promyelocytic leukemia: Interim results of the SCCLG‐APL clinical study |
title_full | Multicenter randomized trial of arsenic trioxide and Realgar‐Indigo naturalis formula in pediatric patients with acute promyelocytic leukemia: Interim results of the SCCLG‐APL clinical study |
title_fullStr | Multicenter randomized trial of arsenic trioxide and Realgar‐Indigo naturalis formula in pediatric patients with acute promyelocytic leukemia: Interim results of the SCCLG‐APL clinical study |
title_full_unstemmed | Multicenter randomized trial of arsenic trioxide and Realgar‐Indigo naturalis formula in pediatric patients with acute promyelocytic leukemia: Interim results of the SCCLG‐APL clinical study |
title_short | Multicenter randomized trial of arsenic trioxide and Realgar‐Indigo naturalis formula in pediatric patients with acute promyelocytic leukemia: Interim results of the SCCLG‐APL clinical study |
title_sort | multicenter randomized trial of arsenic trioxide and realgar‐indigo naturalis formula in pediatric patients with acute promyelocytic leukemia: interim results of the scclg‐apl clinical study |
topic | Research Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6282847/ https://www.ncbi.nlm.nih.gov/pubmed/30160789 http://dx.doi.org/10.1002/ajh.25271 |
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