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- W2591423002 abstract "6520 Background: Secondary acute myeloid leukemia (sAML; after antecedent histologically documented myelodysplastic syndrome or arising from prior chemo or radiation therapy for another cancer) responds poorly to current therapies and is often multidrug resistant; results with the current standard induction therapy of an anthracycline plus cytarabine are disappointing. Amonafide L-malate (AS1413) is a DNA intercalator and non-ATP-dependent topoisomerase II inhibitor that evades multidrug resistance mechanisms. The ACCEDE trial, one of the largest ever conducted in this subgroup of AML patients, was designed to assess the efficacy and safety of AS1413 plus cytarabine compared with standard remission induction therapy of daunorubicin plus cytarabine in sAML. Methods: In this phase III, multicenter, open-label, study, patients aged ≥ 18 years with newly diagnosed sAML were randomized to cytarabine 200 mg/m2 continuous IV infusion daily on days 1–7 plus either AS1413 600 mg/m2 IV over 4 hours daily on days 1–5 (Arm A) or daunorubicin 45 mg/m2 IV over 30 minutes daily on days 1–3 (Arm B). The primary endpoint was CR rate (± hematopoietic recovery). The planned sample size of 420 patients provided 89% power to detect a 15% difference at the p=0.05 level (two-tailed) between anticipated CR rates. Results: 564 pts were screened and 433 randomized; 216 to arm A, 217 to arm B. Disease etiology, cytogenetics and age were balanced between both arms. CR + CRi: 94/216 (43.5%) Arm A, 94/217 Arm B (43.3%); p=0.966. Thirty-day mortality was 20.4% in arm A, 12.4% in arm B. Serious Adverse Events were balanced between the two arms, and no event occurred in more than 6% of patients in either arm. Subgroup analyses are ongoing. Conclusions: The combination of amonafide and cytarabine does not provide a CR benefit over treatment with daunorubicin and cytarabine in patients with secondary AML. sAML patients should be considered for clinical trials or specific therapies based on molecular profiles." @default.
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- W2591423002 date "2011-05-20" @default.
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- W2591423002 title "A phase III, open-label, randomized comparison of AS1413 (amonafide L-malate) plus cytarabine with daunorubicin plus cytarabine in secondary acute myeloid leukemia (ACCEDE)." @default.
- W2591423002 doi "https://doi.org/10.1200/jco.2011.29.15_suppl.6520" @default.
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