Azacitidine in patients with acute myeloid leukemia medically unfit for or resistant to chemotherapy: a multicenter phase I/II study

References

• Lowenberg B. Prognostic factors in acute myeloid leukemia. Best Pract Res Clin Haematol 2001;14:65–75.
   PubMed Web of Science ®Google Scholar
• Stone RM. The difficult problem of acute myeloid leukemia in the older adult. CA Cancer J Clin 2002;52:363–371.
   PubMed Web of Science ®Google Scholar
• Leith CP, Kopecky KJ, Godwin J, . Acute myeloid leukemia in the elderly: assessment of multidrug resistance (MDR1) and cytogenetics distinguishes biologic subgroups with remarkably distinct responses to standard chemotherapy. A Southwest Oncology Group study. Blood 1997;89:3323–3329.
   PubMed Web of Science ®Google Scholar
• Tilly H, Castaigne S, Bordessoule D, . Low-dose cytarabine versus intensive chemotherapy in the treatment of acute nonlymphocytic leukemia in the elderly. J Clin Oncol 1990;8:272–279.
   PubMed Web of Science ®Google Scholar
• Aul C, Schneider W. The role of low-dose cytosine arabinoside and aggressive chemotherapy in advanced myelodysplastic syndromes. Cancer 1989;64:1812–1818.
   PubMed Web of Science ®Google Scholar
• Deschler B, de Witte T, Mertelsmann R, . Treatment decision-making for older patients with high-risk myelodysplastic syndrome or acute myeloid leukemia:problems and approaches. Haematologica 2006;91:1513–1522.
   PubMed Web of Science ®Google Scholar
• Burnett AK, Milligan D, Prentice AG, . A comparison of low-dose cytarabine and hydroxyurea with or without all-trans retinoic acid for acute myeloid leukaemia and high-risk myelodysplastic syndrome in patients not considered fit for intensive treatment. Cancer 2007;109:1114–1124.
   PubMed Web of Science ®Google Scholar
• Estey E, Kornblau S, Pierce S, . A stratification system for evaluating and selecting therapies in patients with relapsed or primary refractory acute myelogenous leukemia. Blood 1996;88:756.
   PubMed Web of Science ®Google Scholar
• Leopold LH, Willemze R. The treatment of acute myeloid leukemia in first relapse: a comprehensive review of the literature. Leuk Lymphoma 2002;43:1715–1727.
   PubMed Web of Science ®Google Scholar
• Estey E. Treatment of refractory AML. Leukemia 1996;10:932–936.
   PubMed Web of Science ®Google Scholar
• Estey E, Döhner H. Acute myeloid leukaemia. Lancet 2006;368: 1894–1907.
   PubMed Web of Science ®Google Scholar
• Stone RM, O'Donnell MR, Sekeres MA. Acute myeloid leukemia. Hematology Am Soc Hematol Educ Program 2004:98–117.
   Google Scholar
• Davis CL, Rohatiner AZ, Lim J, . The management of recurrent acute myelogenous leukemia at a single center over a fifteen-year period. Br J Haematol 1993;83:404–411.
   PubMed Web of Science ®Google Scholar
• Raj K, John A, Ho A, . CDKN2B methylation status and isolated chromosome 7 abnormalities predict responses to treatment with 5-azacytidine. Leukemia 2007;21:1937–1944.
   PubMed Web of Science ®Google Scholar
• Khan R, Schmidt-Mende J, Karimi M, . Hypomethylation and apoptosis in 5-azacytidine-treated myeloid cells. Exp Hematol 2008;36:149–157.
   PubMed Web of Science ®Google Scholar
• Stresemann C, Lyko F. Modes of action of the DNA methyltransferase inhibitors azacytidine and decitabine. Int J Cancer 2008; 123:>8–13.
   PubMed Web of Science ®Google Scholar
• Kroeger H, Jelinek J, Estécio MR, . Aberrant CpG island methylation in acute myeloid leukemia is accentuated at relapse. Blood 2008;112:1366–1373.
   PubMed Web of Science ®Google Scholar
• Celgene Corporation. Vidaza® prescribing information [Internet]. 2010. Available from: http://www.vidaza.com/pdf/PI_FINAL.pdf
   Google Scholar
• Celgene Corporation. Azacitidine summary of product characteristics [Internet]. 2010. Available from: http://www.medicines.org. uk/EMC/medicine/21508/SPC/Vidaza+25+mg+ml+powder+ for+suspension+for+injection/
   Google Scholar
• Fenaux P, Mufti GJ, Hellstrom-Lindberg E, . Efficacy of azacitidine compared with that of conventional care regimens in the treatment of higher-risk myelodysplastic syndromes: a randomized, open-label, phase III study. Lancet Oncol 2009;10:223–232.
   PubMed Web of Science ®Google Scholar
• Fenaux P, Mufti GJ, Hellström-Lindberg E, . Azacitidine prolongs overall survival compared with conventional care regimens in elderly patients with low bone marrow blast count acute myeloid leukemia. J Clin Oncol 2010;28:562–569.
   PubMed Web of Science ®Google Scholar
• Brunning RD, Orazi A, Germing U, . Myelodysplastic syndromes. In: Swerdlow S, Campo E, Harris NL, . World Health Organization classification of tumours of haematopoietic and lymphoid tissue. 4th Lyon: IARC Press; 2008. 88–103.
   Google Scholar
• Cheson BD, Bennett JM, Kopecky KJ, . 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
• Oken MM, Creech RH, Tormey DC, . Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol 1982;5:649–655.
   PubMed Web of Science ®Google Scholar
• Lowenberg B, Ossenkoppele GJ, van Putten W, . High-dose daunorubicin in older patients with acute myeloid leukemia. N Engl J Med 2009;361:1235–1248.
   PubMed Web of Science ®Google Scholar
• Juliusson G, Antunovic P, Derolf A. Age and acute myeloid leukaemia: real world data on decision to treat and outcomes from the Swedish Acute Leukemia Registry. Blood 2009;113:4179–4187.
   PubMed Web of Science ®Google Scholar
• List AF, Fenaux P, Mufti GJ, . Effect of azacitidine (AZA) on overall survival in higher-risk myelodysplastic syndromes (MDS) without complete remission. J Clin Oncol 2008;26(Suppl.): Abstract 7006.
   PubMed Web of Science ®Google Scholar
• Hollenbach PW, Nguyen AN, Brady H, . A comparison of azacitidine and decitabine activities in acute myeloid leukemia cell lines. PLoS One 2010;5:e9001.
   PubMed Web of Science ®Google Scholar
• Lyons RM, Cosgriff TM, Modi SS, . Hematologic response to three alternative dosing schedules of azacitidine in patients with myelodysplastic syndromes. J Clin Oncol 2009;27:1850–1856.
   PubMed Web of Science ®Google Scholar
• Blum W, Klisovic RB, Hackanson B, Phase I study of decitabine alone or in combination with valproic acid in acute myeloid leukaemia. J Clin Oncol 2007;25:3884–3891.
   PubMed Web of Science ®Google Scholar
• Lubbert M, Ruter B, Claus R, . Continued low-dose decitabine (DAC) is an effective first-line treatment in all cytogenetic subgroups of older AML patients: results of the FR00331 multicenter phase II study. Blood 2007;110(Suppl. 1): Abstract 300.
   Google Scholar
• Cashen AF, Schiller GJ, O'Donnell MR, . Multicenter, phase II study of decitabine for the first-line treatment of older patients with acute myeloid leukaemia. J Clin Oncol 2010;28:556–561.
   PubMed Web of Science ®Google Scholar
• Thomas XG, Dmoszynska A, Wierzbowska A, . Results from a randomized phase III trial of decitabine versus supportive care or low-dose cytarabine for the treatment of older patients with newly diagnosed AML. J Clin Oncol 2011;29(Suppl.): Abstract 6504.
   Google Scholar
• Kantarjian HM, Erba HP, Claxton D, . Phase II study of clofarabine monotherapy in previously untreated older adults with acute myeloid leukaemia and unfavourable prognostic factors. J Clin Oncol 2010;28:549–555.
   PubMed Web of Science ®Google Scholar
• Faderl S, Ravandi F, Huang X, . A randomised study of clofarabine versus clofarabine plus low-dose cytarabine as front-line therapy for patients aged 60 years and older with acute myeloid leukaemia and high-risk myelodysplastic syndrome. Blood 2008;112:1638–1645.
   PubMed Web of Science ®Google Scholar