Incidence rates of treatment-emergent adverse events and related hospitalization are reduced with azacitidine compared with conventional care regimens in older patients with acute myeloid leukemia

References

• Dohner H, Weisdorf DJ, Bloomfield CD. Acute myeloid leukemia. N Engl J Med.2015;373:1136–1152.
   PubMed Web of Science ®Google Scholar
• Vardiman JW, Thiele J, Arber DA, et al. The 2008 revision of the World Health Organization (WHO) classification of myeloid neoplasms and acute leukemia: rationale and important changes. Blood. 2009;114:937–951.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• Estey EH. General approach to, and perspectives on clinical research in, older patients with newly diagnosed acute myeloid leukemia. Sem Hematol. 2006;43:89–95.
   PubMed Web of Science ®Google Scholar
• Estey EH. Acute myeloid leukemia: 2014 update on risk-stratification and management. Am J Hematol. 2014;89:1063–1081.
   PubMed Web of Science ®Google Scholar
• Walter RB, Estey EH. Management of older or unfit patients with acute myeloid leukemia. Leukemia. 2015;29:770–775.
   PubMed Web of Science ®Google Scholar
• Appelbaum FR, Gundacker H, Head DR, et al. Age and acute myeloid leukemia. Blood. 2006;107:3481–3485.
   PubMed Web of Science ®Google Scholar
• Sekeres MA, Stone RM, Zahrieh D, et al. Decision-making and quality of life in older adults with acute myeloid leukemia or advanced myelodysplastic syndrome. Leukemia. 2004;18:809–816.
   PubMed Web of Science ®Google Scholar
• Lefebvre G, Angers JF, Blais L. Estimation of time-dependent rate ratios in case-control studies: comparison of two approaches for exposure assessment. Pharmacoepidemiol. Drug Safety. 2006;15:304–316.
   PubMed Web of Science ®Google Scholar
• Seymour JF, Fenaux P, Silverman LR, et al. Effects of azacitidine compared with conventional care regimens in elderly (>/=75 years) patients with higher-risk myelodysplastic syndromes. Crit Rev Oncol/Hematol. 2010;76:218–227.
   PubMed Web of Science ®Google Scholar
• Santini V, Fenaux P, Mufti GJ, et al. Management and supportive care measures for adverse events in patients with myelodysplastic syndromes treated with azacitidine. Eur J Haematol.2010;85:130–138.
   PubMed Web of Science ®Google Scholar
• Vidaza® summary of product characteristics. Uxbridge, UK: Celgene Europe Limited; 2015.
   Google Scholar
• Dombret H, Seymour JF, Butrym A, et al. International phase 3 study of azacitidine vs conventional care regimens in older patients with newly diagnosed AML with >30% blasts. Blood. 2015;126:291–299.
   PubMed Web of Science ®Google Scholar
• National Comprehensive Cancer Network. 2009 February 25, 2015. NCCN Clinical Practice Guidelines in Oncology. Acute Myeloid Leukemia; [cited 2015 Feb 25]. Available from: http://www.nccn.org/professionals/physician_gls/f_guidelines.asp.
   Google Scholar
• Fenaux P, Mufti GJ, Hellstrom-Lindberg E, et al. Efficacy of azacitidine compared with that of conventional care regimens in the treatment of higher-risk myelodysplastic syndromes: a randomised, open-label, phase III study. Lancet Oncol. 2009;10:223–232.
   PubMed Web of Science ®Google Scholar
• Burnett AK, Milligan D, Prentice AG, et al. A comparison of low-dose cytarabine and hydroxyurea with or without all-trans retinoic acid for acute myeloid leukemia and high-risk myelodysplastic syndrome in patients not considered fit for intensive treatment. Cancer. 2007;109:1114–1124.
   PubMed Web of Science ®Google Scholar
• Brass EP, Hiatt WR. Review of mortality and cardiovascular event rates in patients enrolled in clinical trials for claudication therapies. Vasc Med. 2006;11:141–145.
   PubMed Web of Science ®Google Scholar
• Sandberg-Wollheim M, Kornmann G, Bischof D, et al. The risk of malignancy is not increased in patients with multiple sclerosis treated with subcutaneous interferon beta-la: analysis of data from clinical trial and post-marketing surveillance settings. Multiple Scleros. 2011;17:431–440.
   PubMed Web of Science ®Google Scholar
• Silverman LR, Fenaux P, Mufti GJ, et al. Continued azacitidine therapy beyond time of first response improves quality of response in patients with higher-risk myelodysplastic syndromes. Cancer. 2011;117:2697–2702.
   PubMed Web of Science ®Google Scholar
• Li LH, Olin EJ, Fraser TJ, et al. Phase specificity of 5-azacytidine against mammalian cells in tissue culture. Cancer Res. 1970;30:2770–2775.
   PubMed Web of Science ®Google Scholar
• Li LH, Olin EJ, Buskirk HH, et al. Cytotoxicity and mode of action of 5-azacytidine on L1210 leukemia. Cancer Res. 1970;30:2760–2769.
   PubMed Web of Science ®Google Scholar
• Momparler RL, Goodman J. In vitro cytotoxic and biochemical effects of 5-aza-2'-deoxycytidine. Cancer Res. 1977;37:1636–1639.
   PubMed Web of Science ®Google Scholar
• Stresemann C, Brueckner B, Musch T, et al. Functional diversity of DNA methyltransferase inhibitors in human cancer cell lines. Cancer Res. 2006;66:2794–2800.
   PubMed Web of Science ®Google Scholar
• Flotho C, Claus R, Batz C, et al. The DNA methyltransferase inhibitors azacitidine, decitabine and zebularine exert differential effects on cancer gene expression in acute myeloid leukemia cells. Leukemia. 2009;23:1019–1028.
   PubMed Web of Science ®Google Scholar
• Laille E, Shi T, Garcia-Manero G, et al. Pharmacokinetics and Pharmacodynamics with Extended Dosing of CC-486 in Patients with Hematologic Malignancies. PloS One. 2015;10:e0135520.
   PubMed Web of Science ®Google Scholar
• DiNardo CD, Cortes JE. New treatment for acute myelogenous leukemia. Exp Opin Pharmacother. 2015;16:95–106.
   PubMed Web of Science ®Google Scholar
• Stein EM, DiNardo C, Altman JK, et al. Safety and efficacy of AG-221, a potent inhibitor of mutant IDH2 that promotes differentiation of myeloid cells in patients with advanced hematologic malignancies: results of a phase 1/2 trial. Blood. 2015;126:323.
   Google Scholar
• Wander SA, Levis MJ, Fathi AT. The evolving role of FLT3 inhibitors in acute myeloid leukemia: quizartinib and beyond. Ther Adv Hematol. 2014;5:65–77.
   PubMedGoogle Scholar
• Kampa-Schittenhelm KM, Heinrich MC, Akmut F, et al. Quizartinib (AC220) is a potent second generation class III tyrosine kinase inhibitor that displays a distinct inhibition profile against mutant-FLT3, -PDGFRA and -KIT isoforms. Mol Cancer. 2013;12:1–15.
   PubMed Web of Science ®Google Scholar
• Zeidan AM, Mahmoud D, Kucmin-Bemelmans IT, et al. Economic burden associated with acute myeloid leukemia treatment. Exp Rev Hematol. 2016;9:79–89.
   PubMed Web of Science ®Google Scholar
• Alibhai SM, Leach M, Gupta V, et al. Quality of life beyond 6 months after diagnosis in older adults with acute myeloid leukemia. Crit Rev Oncol/Hematol. 2009;69:168–174.
   PubMed Web of Science ®Google Scholar
• Dohner H, Selleslag D, Cavenagh J, et al. Overall survival (OS) and clinical outcomes in older patients with acute myeloid leukemia (AML) treated with azacitidine (AZA) or intensive chemotherapy (IC) in the AZA-AML-001 study. Haematologica. 2015;100(s1):P566.
   Google Scholar
• Kuderer NM, Dale DC, Crawford J, et al. Mortality, morbidity, and cost associated with febrile neutropenia in adult cancer patients. Cancer. 2006;106:2258–2266.
   PubMed Web of Science ®Google Scholar