Multicenter, phase II study of decitabine for the first-line treatment of older patients with Acute Myeloid Leukemia

Journal of Clinical Oncology

Volumn 28, Issue 4, 2010, Pages 556-561

  Cashen, Amanda F ^a   Schiller, Gary J ^a   O'Donnell, Margaret R ^a   DiPersio, John F ^a  

^a WASHINGTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

5 AZA 2' DEOXYCYTIDINE; CYTARABINE; GEMTUZUMAB OZOGAMICIN; HYDROXYUREA; LENALIDOMIDE; ANTINEOPLASTIC ANTIMETABOLITE; AZACITIDINE; DRUG DERIVATIVE;

ACUTE GRANULOCYTIC LEUKEMIA; ADULT; AGED; ANEMIA; ARTICLE; BACTEREMIA; BLAST CELL; BLAST CELL CRISIS; BLEEDING; BLOOD CELL COUNT; BONE MARROW BIOPSY; BONE MARROW SUPPRESSION; CANCER SURVIVAL; CLINICAL TRIAL; CYTOGENETICS; CYTOPENIA; DISEASE COURSE; DRUG ACTIVITY; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG SAFETY; DYSPNEA; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; GROUPS BY AGE; HIGH RISK POPULATION; HUMAN; INFECTION; LOW DRUG DOSE; MAJOR CLINICAL STUDY; MALE; MORTALITY; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; MYELODYSPLASTIC SYNDROME; NEUTROPENIA; PHASE 2 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; THERAPY DELAY; THROMBOCYTOPENIA; TREATMENT DURATION; TREATMENT INDICATION; TREATMENT OUTCOME; TREATMENT RESPONSE; CANCER STAGING; FOLLOW UP; MAXIMUM TOLERATED DOSE; MIDDLE AGED; PATHOLOGY; PROGNOSIS; SURVIVAL RATE; TUMOR RECURRENCE;

AGED; AGED, 80 AND OVER; ANTIMETABOLITES, ANTINEOPLASTIC; AZACITIDINE; FEMALE; FOLLOW-UP STUDIES; HUMANS; LEUKEMIA, MYELOID, ACUTE; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; MYELODYSPLASTIC SYNDROMES; NEOPLASM RECURRENCE, LOCAL; NEOPLASM STAGING; PROGNOSIS; SURVIVAL RATE; TREATMENT OUTCOME;

EID: 77449149374     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2009.23.9178     Document Type: Article

References (31)

1. Godwin JE, Kopecky KJ, Head DR, et al: A double-blind, placebo-controlled trial of granulocyte colony-stimulating factor in elderly patients with previously untreated acute myeloid leukemia: A Southwest Oncology Group Study (9031). Blood 91:3607-3615, 1998
2. Goldstone AH, Burnett AK, Wheatley K, et al: Attempts to improve treatment outcomes in acute myeloid leukemia (AML) in older patients: The results of the United Kingdom Medical Research Council AML11 trial. Blood 98:1302-1311, 2001
3. Estey E: Acute myeloid leukemia and myelodysplastic syndromes in older patients. J Clin Oncol 25:1908-1915, 2007
4. Menzin J, Boulanger L, Karsten V, et al: Effects of initial treatment on survival among elderly AML patients: Findings from the SEER-Medicare Database. ASH Annual Meeting Abstracts 108:1973, 2006
5. Issa J-P, Baylin S, Herman J: DNA methylation changes in hematologic malignancies: Biologic and clinical implications. Leukemia 11:S7-S11, 1997 (Pubitemid 27197352)
6. Santini V, Kantarjian HM, Issa J-P: Changes in DNA methylation in neoplasia: Pathophysiology and therapeutic implications. Ann Intern Med 134:573-586, 2001 (Pubitemid 32245319)
7. Leone G, Teofili L, Voso M, et al: DNA methylation and demethylating drugs in myelodysplastic syndromes and secondary leukemias. Haematologica 87:1324-1341, 2002 (Pubitemid 36005306)
8. Attadia V: Effects of 5-aza-2′-deoxycytidine on differentiation and oncogene expression in the human monoblastic leukemia cell line U-937. Leukemia 7:9-16, 1993 (suppl 1)
9. Pinto A, Attadia V, Fusco A, et al: 5-Aza-2′-deoxycytidine induces terminal differentiation of leukemic blasts from patients with acute myeloid leukemias. Blood 64:922-929, 1984 (Pubitemid 14003616)
10. Christman JK: 5-Azacytidine and 5-aza-2′-deoxycytidine as inhibitors of DNA methylation: Mechanistic studies and their implications for cancer therapy. Oncogene 21:5483-5495, 2002
11. Kantarjian H, Issa J-PJ, Rosenfeld CS, et al: Decitabine improves patient outcomes in myelodysplastic syndromes. Cancer 106:1794-1803, 2006
12. Lubbert M, Ruter B, Claus R, et al: Continued low-dose decitabine (DAC) is an active first-line treatment in all cytogenetic subgroups of older AML patients: Results of the FR00331 multicenter phase II study. ASH Annual Meeting Abstracts 110:300, 2007
13. Blum W, Klisovic RB, Hackanson B, et al: Phase I study of decitabine alone or in combination with valproic acid in acute myeloid leukemia. J Clin Oncol 25:3884-3891, 2007 (Pubitemid 47477265)
14. Issa J-PJ, 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 103:1635-1640, 2004 (Pubitemid 38268953)
15. Garcia-Manero G, Kantarjian HM, Sanchez-Gonzalez B, et al: Phase 1/2 study of the combination of 5-aza-2′-deoxycytidine with valproic acid in patients with leukemia. Blood 108:3271-3279, 2006
16. Kantarjian H, Oki Y, Garcia-Manero G, et al: Results of a randomized study of 3 schedules of low-dose decitabine in higher-risk myelodysplastic syndrome and chronic myelomonocytic leukemia. Blood 109:52-57, 2007 (Pubitemid 46053042)
17. Steensma DP, Baer MR, Slack JL, et al: Multicenter study of decitabine administered daily for 5 days every 4 weeks to adults with myelodysplastic syndromes: The alternative dosing for outpatient treatment (ADOPT) trial. J Clin Oncol 27:3842-3848, 2009
18. Slovak ML, Kopecky KJ, Cassileth PA, et al: Karyotypic analysis predicts outcome of preremission and postremission therapy in adult acute myeloid leukemia: A Southwest Oncology Group/ Eastern Cooperative Oncology Group study. Blood 96:4075-4083, 2000
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 21:4642-4649, 2003
20. Stone RM, Berg DT, George SL, et al: Granulocyte-macrophage colony-stimulating factor after initial chemotherapy for elderly patients with primary acute myelogenous leukemia. N Engl J Med 332:1671-1677, 1995
21. Grimwade D, Walker H, Harrison G, et al: The predictive value of hierarchical cytogenetic classification in older adults with acute myeloid leukemia (AML): Analysis of 1,065 patients entered into the United Kingdom Medical Research Council AML11 trial. Blood 98:1312-1320, 2001
22. Anderson JE, Kopecky KJ, Willman CL, et al: Outcome after induction chemotherapy for older patients with acute myeloid leukemia is not improved with mitoxantrone and etoposide compared to cytarabine and daunorubicin: A Southwest Oncology Group study. Blood 100:3869-3876, 2002
23. 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 109:1114-1124, 2007 (Pubitemid 46435390)
24. Tilly H, Castaigne S, Bordessoule D, et al: Low-dose cytarabine versus intensive chemotherapy in the treatment of acute nonlymphocytic leukemia in the elderly. J Clin Oncol 8:272-279, 1990 (Pubitemid 20056558)
25. Giles F, Rizzieri D, Karp J, et al: Cloretazine (VNP40101M), a novel sulfonylhydrazine alkylating agent, in patients age 60 years or older with previously untreated acute myeloid leukemia. J Clin Oncol 25:25-31, 2007 (Pubitemid 350003047)
26. Erba HP, Kopecky KJ, Kirschbaum MH, et al: Phase II studies of different schedules and doses of the farnesyl transferase inhibitor tipifarnib (R115777, Zarnestra, NSC-702818) for patients of age 70 or older with previously untreated acute myeloid leukemia (AML): A North American Intergroup Study (S0432). ASH Annual Meeting Abstracts 110:440, 2007
27. Erba HP, Kantarjian H, Claxton DF, et al: Phase II study of single agent clofarabine in previously untreated older adult patients with acute myelogenous leukemia (AML) unlikely to benefit from standard induction chemotherapy. ASH Annual Meeting Abstracts 112:558, 2008
28. Fehniger TA, Nelson A, Trinkaus K, et al: Phase II study of high dose lenalidomide as initial treatment for older acute myeloid leukemia patients: Early results show a significant reduction of bone marrow blasts after 14 days of therapy. ASH Annual Meeting Abstracts 110:916, 2007
29. Baron F, Storb R: Hematopoietic cell transplantation after reduced-intensity conditioning for older adults with acute myeloid leukemia in complete remission. Curr Opin Hematol 14:145-151, 2007 (Pubitemid 46175099)
30. Nabhan C, Rundhaugen LM, Riley MB, et al: Phase II pilot trial of gemtuzumab ozogamicin (GO) as first line therapy in acute myeloid leukemia patients age 65 or older. Leuk Res 29:53-57, 2005 (Pubitemid 39487909)
31. Blum W, Klisovic R, Liu S, et al: Preliminary results of a phase II study of low dose decitabine as a single agent in older patients (age ≥ 60) with previously untreated acute myeloid leukemia (AML). ASH Annual Meeting Abstracts 112:2957, 2008