Report of a phase 1/2 study of a combination of azacitidine and cytarabine in acute myelogenous leukemia and high-risk myelodysplastic syndromes

References

• Teodoridis JM, Strathdee G, Brown R. Epigenetic silencing mediated by CpG island methylation: potential as a therapeutic target and as a biomarker. Drug Resist Update 2004;7:267–278.
   PubMed Web of Science ®Google Scholar
• Fojo T, Bates S. Strategies for reversing drug resistance. Oncogene 2003;22:7512–7523.
   PubMed Web of Science ®Google Scholar
• Kroeger H, Jelinek J, Estecio MR, et al Aberrant CpG island methylation in acute myeloid leukemia is accentuated at relapse. Blood 2008;112:1366–1373.
   PubMed Web of Science ®Google Scholar
• Agrawal S, Unterberg M, Koschmieder S, et al DNA methylation of tumor suppressor genes in clinical remission predicts the relapse risk in acute myeloid leukemia. Cancer Res 2007;67:1370–1377.
   PubMed Web of Science ®Google Scholar
• Issa JP. DNA methylation as a therapeutic target in cancer. Clin Cancer Res 2007;13:1634–1637.
   PubMed Web of Science ®Google Scholar
• Lee T, Karon M, Momparler RL. Kinetic studies on phosphorylation of 5-azacytidine with the purified uridine-cytidine kinase from calf thymus. Cancer Res 1974;34:2482–2488.
   PubMed Web of Science ®Google Scholar
• Grant S, Cadman E. Altered 5-azacytidine metabolism following 3-deazauridine treatment of L5178Y and human myeloblasts. Cancer Res 1980;40:4000–4006.
   PubMed Web of Science ®Google Scholar
• Plagemann PG, Behrens M, Abraham D. Metabolism and cytotoxicity of 5-azacytidine in cultured Novikoff rat hepatoma and P388 mouse leukemia cells and their enhancement by preincubation with pyrazofurin. Cancer Res 1978;38:2458–2466.
   PubMed Web of Science ®Google Scholar
• Cihak A, Vesely J, Skoda J. Azapyrimidine nucleosides: metabolism and inhibitory mechanisms. Adv Enzyme Regul 1985;24:335–354.
   PubMedGoogle Scholar
• Cihak A, Vesely J, Sorm F. Incorporation of 5-azacytidine into liver ribonucleic acids of leukemic mice sensitive and resistant to 5-azacytidine. Biochim Biophys Acta 1965;108:516–518.
   PubMed Web of Science ®Google Scholar
• Weiss JW, Pitot HC. Effects of 5-azacytidine on nucleolar RNA and the preribosomal particles in Novikoff hepatoma cells. Biochemistry 1975;14:316–326.
   PubMed Web of Science ®Google Scholar
• Cihak A. Biological effects of 5-azacytidine in eukaryotes. Oncology 1974;30:405–422.
   PubMed Web of Science ®Google Scholar
• Mohandas T, Sparkes RS, Shapiro LJ. Reactivation of an inactive human X chromosome: evidence for X inactivation by DNA methylation. Science 1981;211:393–396.
   PubMed Web of Science ®Google Scholar
• Jones PA, Taylor SM. Cellular differentiation, cytidine analogs and DNA methylation. Cell 1980;20:85–93.
   PubMed Web of Science ®Google Scholar
• Creusot F, Acs G, Christman JK. Inhibition of DNA methyltransferase and induction of friend erythroleukemia cell differentiation by 5-azacytidine and 5-aza-2′-deoxycytidine. J Biol Chem 1982;257:2041–2048.
   PubMed Web of Science ®Google Scholar
• Silverman LR, McKenzie DR, Peterson BL, et al Further analysis of trials with azacitidine in patients with myelodysplastic syndrome: studies 8421, 8921, and 9221 by the Cancer and Leukemia Group B. J Clin Oncol 2006;24:3895–3903.
   PubMed Web of Science ®Google Scholar
• Silverman LR, Demakos EP, Peterson BL, et al Randomized controlled trial of azacitidine in patients with the myelodysplastic syndrome: a study of the cancer and leukemia group B. J Clin Oncol 2002;20:2429–2440.
   PubMed Web of Science ®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
• Schroder JK, Kirch C, Seeber S, Schutte J. Structural and functional analysis of the cytidine deaminase gene in patients with acute myeloid leukaemia. Br J Haematol 1998;103:1096–1103.
   PubMed Web of Science ®Google Scholar
• Steuart CD, Burke PJ. Cytidine deaminase and the development of resistance to arabinosyl cytosine. Nat New Biol 1971;233:109–110.
   PubMedGoogle Scholar
• Gati WP, Paterson AR, Larratt LM, Turner AR, Belch AR. Sensitivity of acute leukemia cells to cytarabine is a correlate of cellular es nucleoside transporter site content measured by flow cytometry with SAENTA-fluorescein. Blood 1997;90:346–353.
   PubMed Web of Science ®Google Scholar
• Colly LP, Peters WG, Richel D, Arentsen-Honders MW, Starrenburg CW, Willemze R. Deoxycytidine kinase and deoxycytidine deaminase values correspond closely to clinical response to cytosine arabinoside remission induction therapy in patients with acute myelogenous leukemia. Semin Oncol 1987;14(2 Suppl 1):257–261.
   PubMed Web of Science ®Google Scholar
• Bhalla K, Nayak R, Grant S. Isolation and characterization of a deoxycytidine kinase-deficient human promyelocytic leukemic cell line highly resistant to 1-β-d-arabinofuranosylcytosine. Cancer Res 1984;44:5029–5037.
   PubMed Web of Science ®Google Scholar
• Qin T, Youssef EM, Jelinek J, et al Effect of cytarabine and decitabine in combination in human leukemic cell lines. Clin Cancer Res 2007;13:4225–4232.
   PubMed Web of Science ®Google Scholar
• Qin T, Jelinek J, Si J, Shu J, Issa JP. Mechanisms of resistance to 5-aza-2′-deoxycytidine in human cancer cell lines. Blood 2009;113:659–667.
   PubMed Web of Science ®Google Scholar
• Huang X, Biswas S, Oki Y, Issa JP, Berry DA. A parallel phase I/II clinical trial design for combination therapies. Biometrics 2007;63:429–436.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• Cheson BD, Bennett JM, Kantarjian H, et al Report of an international working group to standardize response criteria for myelodysplastic syndromes. Blood 2000;96:3671–3674.
   PubMed Web of Science ®Google Scholar
• Avramis VI, Mecum RA, Nyce J, Steele DA, Holcenberg JS. Pharmacodynamic and DNA methylation studies of high-dose 1-β-d-arabinofuranosyl cytosine before and after in vivo 5-azacytidine treatment in pediatric patients with refractory acute lymphocytic leukemia. Cancer Chemother Pharmacol 1989;24:203–210.
   PubMed Web of Science ®Google Scholar
• Neil GL, Berger AE, Bhuyan BK, DeSante DC. Combination chemotherapy of L1210 leukemia with 1-β-d-arabinofuranosylcytosine and 5-azacytidine. Cancer Res 1976;36:1114–1120.
   PubMed Web of Science ®Google Scholar
• Momparler RL, Goodman J, Karon M. In vitro biochemical and cytotoxicity studies with 1-β-d-arabinofuranosylcytosine and 5-azacytidine in combination. Cancer Res 1975;35:2853–2857.
   PubMed Web of Science ®Google Scholar
• Issa JP, Garcia-Manero G, Giles FJ, et al Phase 1 study of low-dose prolonged exposure schedules of the hypomethylating agent 5-aza-2′-deoxycytidine (decitabine) in hematopoietic malignancies. Blood 2004;103:1635–1640.
   PubMed Web of Science ®Google Scholar