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Tytuł:
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Comparative Safety and Pharmacokinetic Evaluation of Three Oral Selenium Compounds in Cancer Patients.
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Autorzy:
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Evans SO; Department of Biological Sciences, University of Waikato, Hamilton, New Zealand.; Waikato Clinical Campus, University of Auckland, Hamilton, New Zealand.
Jacobson GM; Department of Biological Sciences, University of Waikato, Hamilton, New Zealand.
Goodman HJB; Regional Cancer Centre, Waikato Hospital, Private Bag 3200, Hamilton, 3240, New Zealand.
Bird S; Department of Biological Sciences, University of Waikato, Hamilton, New Zealand.
Jameson MB; Waikato Clinical Campus, University of Auckland, Hamilton, New Zealand. .; Regional Cancer Centre, Waikato Hospital, Private Bag 3200, Hamilton, 3240, New Zealand. .
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Źródło:
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Biological trace element research [Biol Trace Elem Res] 2019 Jun; Vol. 189 (2), pp. 395-404. Date of Electronic Publication: 2018 Sep 05.
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Typ publikacji:
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Clinical Trial, Phase I; Journal Article; Randomized Controlled Trial
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Język:
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English
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Imprint Name(s):
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Original Publication: [London, Clifton, N. J.] Humana Press.
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MeSH Terms:
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Leukemia, Lymphocytic, Chronic, B-Cell/*drug therapy
Leukemia, Lymphocytic, Chronic, B-Cell/*metabolism
Selenium Compounds/*pharmacokinetics
Selenocysteine/*analogs & derivatives
Selenomethionine/*pharmacokinetics
Aged ; Aged, 80 and over ; DNA Damage/drug effects ; DNA Damage/genetics ; Double-Blind Method ; Female ; Humans ; Male ; Middle Aged ; Selenium Compounds/adverse effects ; Selenocysteine/adverse effects ; Selenocysteine/pharmacokinetics ; Selenomethionine/adverse effects
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Contributed Indexing:
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Keywords: Cancer; Chronic lymphocytic leukaemia; Clinical trial; Double-blinded; Methylselenocysteine; Pharmacokinetics; Selenium
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Substance Nomenclature:
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0 (Selenium Compounds)
0CH9049VIS (Selenocysteine)
964MRK2PEL (Selenomethionine)
TWK220499Z (selenomethylselenocysteine)
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Entry Date(s):
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Date Created: 20180907 Date Completed: 20190802 Latest Revision: 20190802
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Update Code:
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20240104
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DOI:
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10.1007/s12011-018-1501-0
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PMID:
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30187284
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Selenium (Se) compounds have demonstrated anticancer properties in both preclinical and clinical studies, with particular promise in combination therapy where the optimal form and dose of selenium has yet to be established. In a phase I randomised double-blinded study, the safety, tolerability and pharmacokinetic (PK) profiles of sodium selenite (SS), Se-methylselenocysteine (MSC) and seleno-l-methionine (SLM) were compared in patients with chronic lymphocytic leukaemia and a cohort of patients with solid malignancies. Twenty-four patients received 400 μg of elemental Se as either SS, MSC or SLM for 8 weeks. None of the Se compounds were associated with any significant toxicities, and the total plasma Se AUC of SLM was markedly raised in comparison to MSC and SS. DNA damage assessment revealed negligible genotoxicity, and some minor reductions in lymphocyte counts were observed. At the dose level used, all three Se compounds are well-tolerated and non-genotoxic. Further analyses of the pharmacodynamic effects of Se on healthy and malignant peripheral blood mononuclear cells will inform the future evaluation of higher doses of these Se compounds. The study is registered under the Australian and New Zealand Clinical Trials Registry No: ACTRN12613000118707.
