Abstract
Advanced myelodysplastic syndrome (MDS) carries a poor prognosis. In this phase I/II study, arsenic trioxide was combined with low-dose cytarabine in 49 previously untreated patients with intermediate-2 and high-risk MDS. Complete remission was achieved in 8 (17%) patients, including 3/14 (21%) with treatment-related disease, 4/31 (13%) with unfavorable cytogenetics and 2/36 (6%) with baseline poor performance status. Mortality within the first 4 weeks was 8%. The regimen was active and had a tolerable extramedullary toxicity profile, but it was cumbersome and intensive compared to other currently available treatments.
Copyright © 2010 Elsevier Ltd. All rights reserved.
Publication types
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Clinical Trial, Phase I
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Clinical Trial, Phase II
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Research Support, Non-U.S. Gov't
MeSH terms
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Aged
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Aged, 80 and over
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Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
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Arsenic Trioxide
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Arsenicals / administration & dosage
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Arsenicals / adverse effects
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Cytarabine / administration & dosage
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Cytarabine / adverse effects
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Diarrhea / chemically induced
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Dose-Response Relationship, Drug
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Fatigue / chemically induced
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Female
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Humans
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Karyotyping
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Male
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Middle Aged
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Myelodysplastic Syndromes / drug therapy*
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Myelodysplastic Syndromes / genetics
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Myelodysplastic Syndromes / mortality
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Nausea / chemically induced
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Oxides / administration & dosage
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Oxides / adverse effects
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Risk Factors
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Survival Analysis
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Survival Rate
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Time Factors
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Treatment Outcome
Substances
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Arsenicals
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Oxides
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Cytarabine
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Arsenic Trioxide