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Post hoc analysis of the relationship between baseline white blood cell count and survival outcome in a randomized Phase III trial of decitabine in older patients with newly diagnosed acute myeloid leukemia

C. Arthur, J. Cermak, J. Delaunay, J. Mayer, G. Mazur, X. Thomas, A. Wierzbowska, MM. Jones, E. Berrak, H. Kantarjian,

. 2015 ; 6 (-) : 25-9.

Language English Country New Zealand

Document type Journal Article

BACKGROUND: In a Phase III trial, 485 patients (≥65 years) with newly diagnosed acute myeloid leukemia received decitabine 20 mg/m(2) intravenously for 5 days every 4 weeks or a treatment choice (supportive care or cytarabine 20 mg/m(2) subcutaneously for 10 days every 4 weeks). MATERIALS AND METHODS: We summarized overall and progression-free survival by baseline white blood cell count using two analyses: <1, 1-5, >5×10(9)/L; ≤10 or >10×10(9)/L. RESULTS: There were 446 deaths (treatment choice, n=227; decitabine, n=219). Median overall survival was 5.0 (treatment choice) versus 7.7 months (decitabine; nominal P=0.037). Overall survival differences between white blood cell groups were not significant; hazard ratios (HRs) favored decitabine. Significant progression-free survival differences favored decitabine for groups 1-5×10(9)/L (P=0.005, HR =0.67), greater than 5×10(9)/L (P=0.027, HR =0.71), and up to 10×10(9)/L (P=0.003, HR =0.72). CONCLUSION: There was a trend toward improved outcome with decitabine, regardless of baseline white blood cell count.

References provided by Crossref.org

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$a BACKGROUND: In a Phase III trial, 485 patients (≥65 years) with newly diagnosed acute myeloid leukemia received decitabine 20 mg/m(2) intravenously for 5 days every 4 weeks or a treatment choice (supportive care or cytarabine 20 mg/m(2) subcutaneously for 10 days every 4 weeks). MATERIALS AND METHODS: We summarized overall and progression-free survival by baseline white blood cell count using two analyses: <1, 1-5, >5×10(9)/L; ≤10 or >10×10(9)/L. RESULTS: There were 446 deaths (treatment choice, n=227; decitabine, n=219). Median overall survival was 5.0 (treatment choice) versus 7.7 months (decitabine; nominal P=0.037). Overall survival differences between white blood cell groups were not significant; hazard ratios (HRs) favored decitabine. Significant progression-free survival differences favored decitabine for groups 1-5×10(9)/L (P=0.005, HR =0.67), greater than 5×10(9)/L (P=0.027, HR =0.71), and up to 10×10(9)/L (P=0.003, HR =0.72). CONCLUSION: There was a trend toward improved outcome with decitabine, regardless of baseline white blood cell count.
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$a Mazur, Grzegorz $u Department of Hematology, Wrocław Medical University, Wrocław, Poland.
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