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• W2762193297 abstract "Background: Progress in the treatment of acute myeloid leukemia (AML) in older patients (pts) is still limited. In the randomized part of the AMLSG 06-04 trial, valproic acid (VPA) was evaluated in combination with intensive therapy plus all-trans retinoic acid (ATRA) in older pts (>60 years) with newly diagnosed AML. The randomized part of the study (cohort-1) was terminated due to excessive VPA-induced toxicity (Tassara et al, Blood 2014;123:4027-36.). The study was amended thereafter (cohort-2) to evaluate a cytarabine dose-intensifcation in first consolidation therapy. Here we report on the comparison of the two cohorts. Methods: Between 2004 and 2008, patients were treated in cohort-1 (n = 186) and cohort-2 (n = 376). 2 cycles of induction therapy (ATRA, idarubicin, cytarabine, n = 93 with VPA) were followed by consolidation-1 (mitoxantrone, ATRA, cytarabine [cohort-1, 0.5g/m2; cohort-2, 1g/m2] bid, days 1-3) and consoldation-2 (idarubicin, etoposide, ATRA). Results: Median age was 68 (range, 60-84) years without difference between the cohorts (p = 0.49). Complete remission (CR) rates after induction therapy were 45% and 48% (p = 0.59) in cohort-1 and -2, respectively. There were no significant differences in the cumulative incidences of relapse (CIR, p = 0.26) and death (p = 0.51) between cohort-1 and -2 with CIR of 63% (SE, 4.8%) in cohort-1 compared to 51% (SE, 6.3%) in cohort-2. A Cox regression model on overall survival revealed older age (hazard ratio (HR) for a 10 years difference, 1.97, p < 0.0001), 2010 European LeukemiaNet (ELN) unfavorable risk (HR, 1.57, p = 0.0003) as well as cohort-1 (HR, 1.31, p = 0.02) as unfavorable parameters and ELN favorable risk (HR 0.55, p < 0.0001) as favorable prognostic parameter. Survival was inferior (p = 0.03) in cohort-1 with 21% (95%-CI, 16-28%) compared to cohort-2 with 28% (95%-CI, 23-33%) at 2 years. In an age-adjusted analysis the molecular marker FLT3-ITD was associated with an unfavorable prognosis. Conclusions: Although evaluated in a cohort- rather than a randomized study, intensification of cytarabine dosage in consolidation therapy seems to improve survival. Clinical trial identification: NCT00151255 Legal entity responsible for the study: University Hospital Ulm Funding: University Ulm, Pfizer Disclosure: R. Schlenk: Research funding: Novartis, Pfizer, Amgen, AstraZeneca, PharmaMar; Speakers bureau: Novartis, Pfizer; Advisory board: Daiichi Sankyo, Novartis, Pfizer. All other authors have declared no conflicts of interest." @default.
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• W2762193297 date "2017-09-01" @default.
• W2762193297 modified "2023-09-26" @default.
• W2762193297 title "Evaluation of dose intensification of cytarabine in postremission therapy in older AML patients within the prospective phase II AMLSG 06-04 study" @default.
• W2762193297 doi "https://doi.org/10.1093/annonc/mdx373.036" @default.
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