Decitabine reduces transfusion dependence in older patients with acute myeloid leukemia: Results from a post hoc analysis of a randomized phase III study

Leukemia and Lymphoma

Volumn 56, Issue 4, 2015, Pages 1033-1042

  He, Jianming ^a   Xiu, Liang ^b   De Porre, Peter ^c   Dass, Ramesh ^d   Thomas, Xavier ^e  

^a LLC   (United States)

^b Hepat R and D Section   (United States)

^c JANSSEN RESEARCH AND DEVELOPMENT   (Belgium)

^d Janssen EMEA Business Intelligence   (United Kingdom)

^e CENTRE HOSPITALIER LYON SUD   (France)

Author keywords

Decitabine; Myeloid leukemias and dysplasias; Survival; Transfusion dependence

Indexed keywords

CYTARABINE; DECITABINE; ANTINEOPLASTIC ANTIMETABOLITE; AZACITIDINE;

ACUTE MYELOBLASTIC LEUKEMIA; AGED; ARTICLE; CANCER CHEMOTHERAPY; CANCER SURVIVAL; CONTROLLED STUDY; ERYTHROCYTE TRANSFUSION; GERIATRIC DISORDER; HUMAN; LEUKEMIA REMISSION; MAJOR CLINICAL STUDY; MULTICENTER STUDY (TOPIC); PATIENT DECISION MAKING; PHASE 3 CLINICAL TRIAL (TOPIC); POST HOC ANALYSIS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); THROMBOCYTE TRANSFUSION; ACUTE DISEASE; ANALOGS AND DERIVATIVES; DISEASE FREE SURVIVAL; LEUKEMIA, MYELOID; MULTIMODALITY CANCER THERAPY; MULTIVARIATE ANALYSIS; OUTCOME ASSESSMENT; PROCEDURES; REMISSION; STATISTICS AND NUMERICAL DATA;

ACUTE DISEASE; AGED; ANTIMETABOLITES, ANTINEOPLASTIC; AZACITIDINE; CLINICAL TRIALS, PHASE III AS TOPIC; COMBINED MODALITY THERAPY; DISEASE-FREE SURVIVAL; ERYTHROCYTE TRANSFUSION; HUMANS; LEUKEMIA, MYELOID; MULTICENTER STUDIES AS TOPIC; MULTIVARIATE ANALYSIS; OUTCOME ASSESSMENT (HEALTH CARE); PLATELET TRANSFUSION; RANDOMIZED CONTROLLED TRIALS AS TOPIC; REMISSION INDUCTION;

EID: 84929069698     PISSN: 10428194     EISSN: 10292403     Source Type: Journal    
DOI: 10.3109/10428194.2014.951845     Document Type: Article

References (27)

1. NCCN Clinical Practice Guidelines in Oncology. A cute myeloid leukemia. National Comprehensive Cancer Network. Available from: www.nccn.org
2. Appelbaum FR, Gundacker H, Head DR, et al. Age and acute myeloid leukemia. Blood 2006;107:3481-3485.
3. SEER Stat Fact Sheets: Leukemia. National Cancer Institute. Available from: http://seer.cancer.gov/statfacts/html/leuks.html
4. Visser O, Trama A, Maynadie M, et al. Incidence, survival and prevalence of myeloid malignancies in Europe. Eur J Cancer 2012;48:3257-3266.
5. Fast Stats [an interactive tool for quick access to key SEER and US cancer statistics]. Surveillance Research Program - National Cancer Institute. Available from: http://seer.cancer.gov/faststats
6. Sekeres MA, Steensma DP. Boulevard of broken dreams: drug approval for older adults with acute myeloid leukemia. J Clin Oncol 2012;30:4061-4063.
7. Luger SM. Treating the elderly patient with acute myelogenous leukemia. Hematology Am Soc Hematol Educ Program 2010;2010:62-69.
8. Sekeres MA, Lancet JE, Wood BL, et al. Randomized, phase IIb study of low-dose cytarabine and lintuzumab versus low-dose cytarabine and placebo in older adults with untreated acute myeloid leukemia. Haematologica 2013;98:119-128.
9. Dohner H, Estey EH, Amadori S, et al. Diagnosis and management of acute myeloid leukemia in adults: recommendations from an international expert panel, on behalf of the European LeukemiaNet. Blood 2010;115:453-474.
10. Kantarjian HM, Thomas XG, Dmoszynska A, et al. Multicenter, randomized, open-label, phase III trial of decitabine versus patient choice, with physician advice, of either supportive care or low-dose cytarabine for the treatment of older patients with newly diagnosed acute myeloid leukemia. J Clin Oncol 2012;30:2670-2677.
11. US Food and Drug Administration. Dacogen ® (decitabine) for injection. 2-5-2006. Available from: www.accessdata.fda.gov/drugsatfda-docs/label/2006/021790lbl.pdf
12. European Medicines Agency. Assessment report-Dacogen, EMEA/H/C/002221. 19-7-2012. Available from: www.ema.europa.eu/docs/de-DE/document-library/EPAR---Summary-for-the-public/human/002221/WC500133572.pdf
13. Balducci L. Transfusion independence in patients with myelodysplastic syndromes: impact on outcomes and quality of life. Cancer 2006;106:2087-2094.
14. Cazzola M, Anderson JE, Ganser A, et al. A patient-oriented approach to treatment of myelodysplastic syndromes. Haematologica 1998;83:910-935.
15. Malcovati L, Porta MG, Pascutto C, et al. Prognostic factors and life expectancy in myelodysplastic syndromes classified according to WHO criteria: a basis for clinical decision making. J Clin Oncol 2005;23:7594-7603.
16. Platzbecker U, Bornhauser M, Germing U, et al. Red blood cell transfusion dependence and outcome after allogeneic peripheral blood stem cell transplantation in patients with de novo myelodysplastic syndrome (MDS). Biol Blood Marrow Transplant 2008;14:1217-1225.
17. Kuendgen A, Lauseker M, List AF, et al. Lenalidomide does not increase AML progression risk in RBC transfusion-dependent patients with Low- or Intermediate-1-risk MDS with del(5q): a comparative analysis. Leukemia 2013;27:1072-1079.
18. Vardiman JW, Harris NL, Brunning RD. The World Health Organization (WHO) classification of the myeloid neoplasms. Blood 2002;100:2292-2302.
19. Cheson BD, Bennett JM, Kopecky KJ, et al. Revised recommendations of the International Working Group for Diagnosis, Standardization of Response Criteria, Treatment Outcomes, and Reporting Standards for Therapeutic Trials in Acute Myeloid Leukemia. J Clin Oncol 2003;21:4642-4649.
20. Wheatley K, Brookes CL, Howman AJ, et al. Prognostic factor analysis of the survival of elderly patients with AML in the MRC AML11 and LRF AML14 trials. Br J Haematol 2009;145:598-605.
21. Gavillet M, Noetzli J, Blum S, et al. Transfusion independence and survival in patients with acute myeloid leukemia treated with 5-azacytidine. Haematologica 2012;97:1929-1931.
22. Dombret H, Seymour JF, Butrym A, et al. Results of a phase 3, multicenter, randomized, open-label study of azacitidine (AZA) vs conventional care regimens (CCR) in older patients with newly diagnosed acute myeloid leukemia (AML). Presented at the 19th Congress of the European Hematology Association (EHA), 12-15 June 2014, Milan, Italy.
23. Pardanani A, Tefferi A. Prognostic relevance of anemia and transfusion dependency in myelodysplastic syndromes and primary myelofibrosis. Haematologica 2011;96:8-10.
24. Tefferi A, Mesa RA, Pardanani A, et al. Red blood cell transfusion need at diagnosis adversely affects survival in primary myelofibrosis-increased serum ferritin or transfusion load does not. Am J Hematol 2009;84:265-267.
25. List AF. Iron overload in myelodysplastic syndromes: diagnosis and management. Cancer Control 2010;17:S2-S8.
26. Bennett J M; MDS Foundation's Working Group on Transfusional Iron Overload. Consensus statement on iron overload in myelodysplastic syndromes. Am J Hematol 2008;83:858-861.
27. Wang J, Yi Z, Wang S, et al. The effect of decitabine on megakaryocyte maturation and platelet release. Thromb Haemost 2011;106:337-343.