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Efficacy and the Adverse Effects of Oral Versus Intravenous Arsenic for Acute Promyelocytic Leukemia: A Meta-Analysis of Randomized-Controlled Studies.
Technol Cancer Res Treat. 2020 Jan-Dec; 19:1533033820937008.TC

Abstract

Acute promyelocytic leukemia, a subtype of acute myeloid leukemia, is highly curable. In subgroup of patients with non-high-risk acute promyelocytic leukemia, intravenous arsenic trioxide plus all-trans-retinoic acid is considered the preferred regimen for acute promyelocytic leukemia. Recently, there are interests in the use of the oral form of arsenic, named the Realgar-Indigo naturalis formula, but the data on its efficacy and safety are still relatively limited. The current study was conducted with the aims to identify and summarize the results of all available randomized-controlled studies. A systematic review was conducted in the 2 major databases, utilizing the terms for arsenic and acute promyelocytic leukemia. Eligible studies had to be randomized-controlled studies that compared efficacy and/or adverse effects of oral arsenic versus intravenous arsenic for treatment of patients with acute promyelocytic leukemia. The Mantel-Haenszel method was used to pool the effect estimates and 95% confidence intervals of the included studies together. A total of 4 randomized controlled studies with 482 patients with acute promyelocytic leukemia (258 in Realgar-Indigo naturalis formula group and 224 in intravenous arsenic trioxide group) were included in the meta-analysis. The chances of achieving complete remission were numerically higher in the Realgar-Indigo naturalis formula group but the difference was not statistically significant (pooled odds ratio: 4.59, 95% CI: 0.74-28.57, I 2 = 0%). Similarly, other efficacy outcomes, including 30-day mortality rate, overall survival, and event-free survival, also tended to favor the Realgar-Indigo naturalis formula group but the difference was not statistically significant. There was no significant difference in the chance of developing differentiation syndrome, cardiac complications, grades 3 to 4 liver toxicity, grades 3 to 4 renal toxicity, and infection between the 2 groups. The results may suggest that all-trans-retinoic acid plus oral Realgar-Indigo naturalis formula regimen is, at minimum, not a worse alternative to the standard all-trans-retinoic acid plus intravenous intravenous arsenic trioxide regimen for treatment of acute promyelocytic leukemia, especially for patients with low-to-intermediate risk.

Authors+Show Affiliations

Division of Medicine, Klang Hospital, Bangkok, Thailand.Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany.Clinical Epidemiology Unit, Department of Research and Development, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.Division of Hematology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

32583728

Citation

Sasijareonrat, Natthaporn, et al. "Efficacy and the Adverse Effects of Oral Versus Intravenous Arsenic for Acute Promyelocytic Leukemia: a Meta-Analysis of Randomized-Controlled Studies." Technology in Cancer Research & Treatment, vol. 19, 2020, p. 1533033820937008.
Sasijareonrat N, Jahn N, Ungprasert P, et al. Efficacy and the Adverse Effects of Oral Versus Intravenous Arsenic for Acute Promyelocytic Leukemia: A Meta-Analysis of Randomized-Controlled Studies. Technol Cancer Res Treat. 2020;19:1533033820937008.
Sasijareonrat, N., Jahn, N., Ungprasert, P., & Owattanapanich, W. (2020). Efficacy and the Adverse Effects of Oral Versus Intravenous Arsenic for Acute Promyelocytic Leukemia: A Meta-Analysis of Randomized-Controlled Studies. Technology in Cancer Research & Treatment, 19, 1533033820937008. https://doi.org/10.1177/1533033820937008
Sasijareonrat N, et al. Efficacy and the Adverse Effects of Oral Versus Intravenous Arsenic for Acute Promyelocytic Leukemia: a Meta-Analysis of Randomized-Controlled Studies. Technol Cancer Res Treat. 2020 Jan-Dec;19:1533033820937008. PubMed PMID: 32583728.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and the Adverse Effects of Oral Versus Intravenous Arsenic for Acute Promyelocytic Leukemia: A Meta-Analysis of Randomized-Controlled Studies. AU - Sasijareonrat,Natthaporn, AU - Jahn,Nikolaus, AU - Ungprasert,Patompong, AU - Owattanapanich,Weerapat, PY - 2020/6/26/entrez PY - 2020/6/26/pubmed PY - 2020/6/26/medline KW - APL KW - acute promyelocytic leukemia KW - arsenic Realgar-Indigo naturalis formula KW - arsenic trioxide SP - 1533033820937008 EP - 1533033820937008 JF - Technology in cancer research & treatment JO - Technol. Cancer Res. Treat. VL - 19 N2 - Acute promyelocytic leukemia, a subtype of acute myeloid leukemia, is highly curable. In subgroup of patients with non-high-risk acute promyelocytic leukemia, intravenous arsenic trioxide plus all-trans-retinoic acid is considered the preferred regimen for acute promyelocytic leukemia. Recently, there are interests in the use of the oral form of arsenic, named the Realgar-Indigo naturalis formula, but the data on its efficacy and safety are still relatively limited. The current study was conducted with the aims to identify and summarize the results of all available randomized-controlled studies. A systematic review was conducted in the 2 major databases, utilizing the terms for arsenic and acute promyelocytic leukemia. Eligible studies had to be randomized-controlled studies that compared efficacy and/or adverse effects of oral arsenic versus intravenous arsenic for treatment of patients with acute promyelocytic leukemia. The Mantel-Haenszel method was used to pool the effect estimates and 95% confidence intervals of the included studies together. A total of 4 randomized controlled studies with 482 patients with acute promyelocytic leukemia (258 in Realgar-Indigo naturalis formula group and 224 in intravenous arsenic trioxide group) were included in the meta-analysis. The chances of achieving complete remission were numerically higher in the Realgar-Indigo naturalis formula group but the difference was not statistically significant (pooled odds ratio: 4.59, 95% CI: 0.74-28.57, I 2 = 0%). Similarly, other efficacy outcomes, including 30-day mortality rate, overall survival, and event-free survival, also tended to favor the Realgar-Indigo naturalis formula group but the difference was not statistically significant. There was no significant difference in the chance of developing differentiation syndrome, cardiac complications, grades 3 to 4 liver toxicity, grades 3 to 4 renal toxicity, and infection between the 2 groups. The results may suggest that all-trans-retinoic acid plus oral Realgar-Indigo naturalis formula regimen is, at minimum, not a worse alternative to the standard all-trans-retinoic acid plus intravenous intravenous arsenic trioxide regimen for treatment of acute promyelocytic leukemia, especially for patients with low-to-intermediate risk. SN - 1533-0338 UR - https://www.unboundmedicine.com/medline/citation/32583728/Efficacy_and_the_Adverse_Effects_of_Oral_Versus_Intravenous_Arsenic_for_Acute_Promyelocytic_Leukemia:_A_Meta-Analysis_of_Randomized-Controlled_Studies L2 - https://journals.sagepub.com/doi/10.1177/1533033820937008?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -
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