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Drug Evaluations

Sapacitabine in acute myelogenous leukemia

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•Phase III study that demonstrated improved overall survival in patients over the age of 65 with AML treated with decitabine compared to best supportive care

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• This paper provides evidence for a β-elimination reaction following incorporation into the DNA of a cell, and introduces the investigation of sapacitabine, the prodrug of CNDAC

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•• First phase I trial in hematological malignancies and their precursors (AMS, MDS). The recommended phase II dose was determined for two dosing schedules

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  • Green SR, Choudhary AK, Fleming IN, et al. Combination of sapacitabine and HDAC inhibitors stimulates cell death in AML and other tumour types. Br J Cancer. 2010;103(9):1391–1399.
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•• First phase II study of sapacitabine in patients with AML. Three dosing schedules were evaluated, ultimately identifying an optimal dosing schema for combination with other agents

  • Ravandi F, Faderl S, Cortes JE, et al. Phase 1/2 study of sapacitabine and decitabine administered sequentially in elderly patients with newly diagnosed AML. Blood (ASH Annual Meeting Abstracts). 2011;29:118. Abstract 3630.

•• Phase 1/2 study evaluating alternating cycles of sapacitabine and decitabine given to untreated elderly patients with AML. The acceptable toxicity profile and promising response rate and overall survival of enrolled patients have led to a phase III trial comparing this treatment regimen against single-agent decitabine in the treatment of elderly AML

  • Burnett AK, Russell RK, Hills N, et al. A randomized comparison of the novel nucleoside analogue sapacitabine with low-dose cytarabine in older patients with acute myeloid leukaemia. Leukemia. 2015;29: 1312–1319.

•• Phase III trial comparing sapacitabine as a single agent with low-dose cytarabine in untreated older patients who were not considered suitable for intensive therapy. No benefits with regard to remission rate, relapse-free survival or overall survival were seen

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