A phase II study of decitabine and gemtuzumab ozogamicin in newly diagnosed and relapsed acute myeloid leukemia and high-risk myelodysplastic syndrome

Leukemia

Volumn 30, Issue 2, 2016, Pages 268-273

  Daver, N ^a   Kantarjian, H ^a   Ravandi, F ^a   Estey, E ^b   Wang, X ^c   Garcia Manero, G ^a   Jabbour, E ^a   Konopleva, M ^a   O'Brien, S ^a   Verstovsek, S ^a   Kadia, T ^a   Dinardo, C ^a   Pierce, S ^a   Huang, X ^a   Pemmaraju, N ^a   Diaz Pines Mateo, M ^a   Cortes, J ^a   Borthakur, G ^a  

^a UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

^b UNIVERSITY OF WASHINGTON SCHOOL OF MEDICINE   (United States)

^c UNIVERSITY OF TEXAS   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AZACITIDINE; DECITABINE; GEMTUZUMAB OZOGAMICIN; VALPROIC ACID; VORINOSTAT; AMINOGLYCOSIDE; ANTINEOPLASTIC AGENT; CD33 ANTIGEN; CD33 PROTEIN, HUMAN; GEMTUZUMAB; MONOCLONAL ANTIBODY;

ACUTE MYELOBLASTIC LEUKEMIA; ADULT; AGED; ALKALINE PHOSPHATASE BLOOD LEVEL; ARTICLE; ATRIAL FIBRILLATION; BLEEDING; CANCER MORTALITY; CANCER PATIENT; CANCER SURVIVAL; CHRONIC MYELOMONOCYTIC LEUKEMIA; COMPARATIVE STUDY; CONTROLLED STUDY; FEBRILE NEUTROPENIA; FEMALE; GASTROINTESTINAL HEMORRHAGE; HIGH RISK PATIENT; HUMAN; HYPOTENSION; INFECTION; LEUKEMIA RELAPSE; LEUKEMIA REMISSION; MAJOR CLINICAL STUDY; MALE; MUCOSA INFLAMMATION; MUCOSAL BLEEDING; MULTIPLE CYCLE TREATMENT; MYELODYSPLASTIC SYNDROME; MYELOFIBROSIS; MYELOPROLIFERATIVE NEOPLASM; NAUSEA; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; SIDE EFFECT; TREATMENT RESPONSE; VERY ELDERLY; ANALOGS AND DERIVATIVES; CLINICAL TRIAL; LEUKEMIA, MYELOID, ACUTE; MIDDLE AGED; MYELODYSPLASTIC SYNDROMES;

ADULT; AGED; AGED, 80 AND OVER; AMINOGLYCOSIDES; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; AZACITIDINE; FEMALE; HUMANS; LEUKEMIA, MYELOID, ACUTE; MALE; MIDDLE AGED; MYELODYSPLASTIC SYNDROMES; SIALIC ACID BINDING IG-LIKE LECTIN 3;

EID: 84959372857     PISSN: 08876924     EISSN: 14765551     Source Type: Journal    
DOI: 10.1038/leu.2015.244     Document Type: Article

References (44)

1. Kantarjian HM. Therapy for elderly patients with acute myeloid leukemia: a problem in search of solutions. Cancer 2007; 109: 1007-1010.
2. Kantarjian H, O'Brien S, Cortes J, Giles F, Faderl S, Jabbour E, et al. Results of intensive chemotherapy in 998 patients age 65 years or older with acute myeloid leukemia or high-risk myelodysplastic syndrome: predictive prognostic models for outcome. Cancer 2006; 106: 1090-1098.
3. Nazha A, Ravandi F. Acute myeloid leukemia in the elderly: do we know who should be treated and how?. Leuk Lymphoma 2014; 55: 979-987.
4. Appelbaum FR, Gundacker H, Head DR, Slovak ML, Willman CL, Godwin JE, et al. Age and acute myeloid leukemia. Blood 2006; 107: 3481-3485.
5. Tallman MS, Gilliland DG, Rowe JM. Drug therapy for acute myeloid leukemia. Blood 2005; 106: 1154-1163.
6. Estey EH. Treatment of relapsed and refractory acute myelogenous leukemia. Leukemia 2000; 14: 476-479.
7. Ravandi F, Cortes J, Faderl S, O'Brien S, Garcia-Manero G, Verstovsek S, et al. Characteristics and outcome of patients with acute myeloid leukemia refractory to 1 cycle of high-Dose cytarabine-based induction chemotherapy. Blood 2010; 116: 5818-5823, quiz 6153.
8. Stanisic S, Kalaycio M. Treatment of refractory and relapsed acute myelogenous leukemia. Expert Rev Anticancer Ther 2002; 2: 287-295.
9. Scheinberg DA, Lovett D, Divgi CR, Graham MC, Berman E, Pentlow K, et al. A phase I trial of monoclonal antibody M195 in acute myelogenous leukemia: specific bone marrow targeting and internalization of radionuclide. J Clin Oncol 1991; 9: 478-490.
10. Appelbaum FR, Matthews DC, Eary JF, Badger CC, Kellogg M, Press OW, et al. The use of radiolabeled anti-CD33 antibody to augment marrow irradiation prior to marrow transplantation for acute myelogenous leukemia. Transplantation 1992; 54: 829-833.
11. Sievers EL, Larson RA, Stadtmauer EA, Estey E, Lowenberg B, Dombret H, et al. Efficacy and safety of gemtuzumab ozogamicin in patients with CD33-positive acute myeloid leukemia in first relapse. J Clin Oncol 2001; 19: 3244-3254.
12. Zein N, Poncin M, Nilakantan R, Ellestad GA. Calicheamicin gamma 1I and DNA: molecular recognition process responsible for site-specificity. Science 1989; 244: 697-699.
13. Burnett AK, Hills RK, Milligan D, Kjeldsen L, Kell J, Russell NH, et al. Identification of patients with acute myeloblastic leukemia who benefit from the addition of gemtuzumab ozogamicin: results of the MRC AML15 trial. J Clin Oncol 2011; 29: 369-377.
14. Castaigne S, Pautas C, Terre C, Raffoux E, Bordessoule D, Bastie JN, et al. Effect of gemtuzumab ozogamicin on survival of adult patients with de-novo acute myeloid leukaemia (ALFA-0701): a randomised, open-label, phase 3 study. Lancet 2012; 379: 1508-1516.
15. Burnett AK, Russell NH, Hills RK, Kell J, Freeman S, Kjeldsen L, et al. Addition of gemtuzumab ozogamicin to induction chemotherapy improves survival in older patients with acute myeloid leukemia. J Clin Oncol 2012; 30: 3924-3931.
16. Delaunay J, Recher C, Pigneux A, Witz F, Vey N, Blanchet O, et al. Addition of gemtuzumab ozogamycin to chemotherapy improves event-free survival but not overall survival of AML patients with intermediate cytogenetics not eligible for allogeneic transplantation. Results of the GOELAMS AML 2006 IR Study. Blood 2011; 118: 37-38.
17. Bross PF, Beitz J, Chen G, Chen XH, Duffy E, Kieffer L, et al. Approval summary: gemtuzumab ozogamicin in relapsed acute myeloid leukemia. Clin Cancer Res 2001; 7: 1490-1496.
18. Christman JK. 5-Azacytidine and 5-Aza-2'-Deoxycytidine as inhibitors of DNA methylation: mechanistic studies and their implications for cancer therapy. Oncogene 2002; 21: 5483-5495.
19. Karpf AR, Jones DA. Reactivating the expression of methylation silenced genes in human cancer. Oncogene 2002; 21: 5496-5503.
20. Jones PA, Taylor SM. Cellular differentiation, cytidine analogs and DNA methylation. Cell 1980; 20: 85-93.
21. Kantarjian HM, Thomas XG, Dmoszynska A, Wierzbowska A, Mazur G, Mayer J, 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.
22. Balaian L, Ball ED. Cytotoxic activity of gemtuzumab ozogamicin (Mylotarg) in acute myeloid leukemia correlates with the expression of protein kinase Syk. Leukemia 2006; 20: 2093-2101.
23. Goodman PA, Burkhardt N, Juran B, Tibbles HE, Uckun FM. Hypermethylation of the spleen tyrosine kinase promoter in T-lineage acute lymphoblastic leukemia. Oncogene 2003; 22: 2504-2514.
24. Yuan Y, Mendez R, Sahin A, Dai JL. Hypermethylation leads to silencing of the SYK gene in human breast cancer. Cancer Res 2001; 61: 5558-5561.
25. Kurimoto M, Matsuoka H, Hanaoka N, Uneda S, Murayama T, Sonoki T, et al. Pretreatment of leukemic cells with low-Dose decitabine markedly enhances the cytotoxicity of gemtuzumab ozogamicin. Leukemia 2013; 27: 233-235.
26. Nand S, Othus M, Godwin JE, Willman CL, Norwood TH, Howard DS, et al. A phase 2 trial of azacitidine and gemtuzumab ozogamicin therapy in older patients with acute myeloid leukemia. Blood 2013; 122: 3432-3439.
27. Greenberg P, Cox C, LeBeau MM, Fenaux P, Morel P, Sanz G, et al. International scoring system for evaluating prognosis in myelodysplastic syndromes. Blood 1997; 89: 2079-2088.
28. Passamonti F, Cervantes F, Vannucchi AM, Morra E, Rumi E, Pereira A, et al. A dynamic prognostic model to predict survival in primary myelofibrosis: a study by the IWG-MRT (International Working Group for Myeloproliferative Neoplasms Research and Treatment). Blood 2010; 115: 1703-1708.
29. Cheson BD, Bennett JM, Kopecky KJ, Buchner T, Willman CL, Estey EH, 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.
30. Sievers EL, Larson RA, Stadtmauer EA, Estey E, Lowenberg B, Dombret H, et al. Efficacy and safety of gemtuzumab ozogamicin in patients with CD33-positive acute myeloid leukemia in first relapse. J Clin Oncol 2001; 19: 3244-3254.
31. Wathen JK, Thall PF, Cook JD, Estey EH. Accounting for patient heterogeneity in phase II clinical trials. Stati Med 2008; 27: 2802-2815.
32. Kaplan EL, Meier P. Nonparametric-Estimation from incomplete observations. J Am Stat Assoc 1958; 53: 457-481.
33. Petersdorf SH, Kopecky KJ, Slovak M, Willman C, Nevill T, Brandwein J, et al. A phase 3 study of gemtuzumab ozogamicin during induction and postconsolidation therapy in younger patients with acute myeloid leukemia. Blood 2013; 121: 4854-4860.
34. Larson RA, Boogaerts M, Estey E, Karanes C, Stadtmauer EA, Sievers EL, et al. Antibody-Targeted chemotherapy of older patients with acute myeloid leukemia in first relapse using Mylotarg (gemtuzumab ozogamicin). Leukemia 2002; 16: 1627-1636.
35. Larson RA, Sievers EL, Stadtmauer EA, Lowenberg B, Estey EH, Dombret H, et al. Final report of the efficacy and safety of gemtuzumab ozogamicin (Mylotarg) in patients with CD33-positive acute myeloid leukemia in first recurrence. Cancer 2005; 104: 1442-1452.
36. Burnett AK, Hills RK, Hunter AE, Milligan D, Kell WJ, Wheatley K, et al. The addition of gemtuzumab ozogamicin to low-Dose Ara-C improves remission rate but does not significantly prolong survival in older patients with acute myeloid leukaemia: results from the LRF AML14 and NCRI AML16 pick-A-winner comparison. Leukemia 2013; 27: 75-81.
37. Nand S, Godwin J, Smith S, Barton K, Michaelis L, Alkan S, et al. Hydroxyurea, azacitidine and gemtuzumab ozogamicin therapy in patients with previously untreated non-M3 acute myeloid leukemia and high-risk myelodysplastic syndromes in the elderly: results from a pilot trial. Leuk Lymphoma 2008; 49: 2141-2147.
38. Walter RB, Raden BW, Hong TC, Flowers DA, Bernstein ID, Linenberger ML. Multidrug resistance protein attenuates gemtuzumab ozogamicin-induced cytotoxicity in acute myeloid leukemia cells. Blood 2003; 102: 1466-1473.
39. Walter RB, Gooley TA, van der Velden VH, Loken MR, van Dongen JJ, Flowers DA, et al. CD33 expression and P-glycoprotein-mediated drug efflux inversely correlate and predict clinical outcome in patients with acute myeloid leukemia treated with gemtuzumab ozogamicin monotherapy. Blood 2007; 109: 4168-4170.
40. Kantarjian H, Oki Y, Garcia-Manero G, Huang X, O'Brien S, Cortes J, et al. Results of a randomized study of 3 schedules of low-Dose decitabine in higher-risk myelodysplastic syndrome and chronic myelomonocytic leukemia. Blood 2007; 109: 52-57.
41. Kantarjian H, Issa JP, Rosenfeld CS, Bennett JM, Albitar M, DiPersio J, et al. Decitabine improves patient outcomes in myelodysplastic syndromes: results of a phase III randomized study. Cancer 2006; 106: 1794-1803.
42. Silverman LR, Demakos EP, Peterson BL, Kornblith AB, Holland JC, Odchimar-Reissig R, 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.
43. Estey E, Kornblau S, Pierce S, Kantarjian H, Beran M, Keating M. A stratification system for evaluating and selecting therapies in patients with relapsed or primary refractory acute myelogenous leukemia. Blood 1996; 88: 756.
44. Malfuson JV, Konopacki J, Thepenier C, Eddou H, Foissaud V, de Revel T. Fractionated doses of gemtuzumab ozogamicin combined with 3+7 induction chemotherapy as salvage treatment for young patients with acute myeloid leukemia in first relapse. Ann Hematol 2012; 91: 1871-1877.