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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,
Language English Country New Zealand
Document type Journal Article
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PubMed
25678833
DOI
10.2147/jbm.s64067
Knihovny.cz E-resources
- Publication type
- Journal Article MeSH
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.
Copernicus Memorial Hospital Lodz Poland
Department of Clinical Hematology University of Nantes Nantes France
Department of Haematology Royal North Shore Hospital Sydney NSW Australia
Department of Hematology Edouard Herriot Hospital Lyon France
Department of Hematology Wrocław Medical University Wrocław Poland
Department of Leukemia University of Texas MD Anderson Cancer Center Houston TX USA
Institute of Hematology and Blood Transfusion Prague Czech Republic
Oncology Product Creation Unit Eisai Inc Woodcliff Lake NJ USA
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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