A randomized controlled trial of romiplostim in patients with low-or intermediate-risk myelodysplastic syndrome receiving decitabine

Leukemia and Lymphoma

Volumn 54, Issue 2, 2013, Pages 321-328

  Greenberg, Peter L ^a   Garcia Manero, Guillermo ^b   Moore, Michael ^c   Damon, Lloyd ^d   Roboz, Gail ^e   Hu, Kuolung ^f   Yang, Allen S ^f   Franklin, Janet ^f  

^a STANFORD CANCER INSTITUTE   (United States)

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

^c Willis Knighton Medical Center   (United States)

^d UNIVERSITY OF CALIFORNIA   (United States)

^e NEW YORK PRESBYTERIAN HOSPITAL   (United States)

^f AMGEN INC   (United States)

Author keywords

Decitabine; Myelodysplastic syndromes; Romiplostim; Thrombocytopenia; Treatment

Indexed keywords

5 AZA 2' DEOXYCYTIDINE; PLACEBO; ROMIPLOSTIM;

ACUTE GRANULOCYTIC LEUKEMIA; ADULT; AGED; ARTERY THROMBOSIS; ARTICLE; BLEEDING; BRAIN HEMORRHAGE; CLINICAL ARTICLE; CONTROLLED STUDY; DISEASE COURSE; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; DRUG WITHDRAWAL; FEMALE; HUMAN; MALE; MYELODYSPLASTIC SYNDROME; NEUTROPENIA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RISK ASSESSMENT; SEPSIS; THROMBOCYTE; THROMBOCYTE COUNT; THROMBOCYTE TRANSFUSION; TREATMENT RESPONSE;

AGED; AGED, 80 AND OVER; AZACITIDINE; FEMALE; HUMANS; MALE; MIDDLE AGED; MYELODYSPLASTIC SYNDROMES; PLATELET COUNT; RECEPTORS, FC; RECEPTORS, THROMBOPOIETIN; RECOMBINANT FUSION PROTEINS; THROMBOPOIETIN; TREATMENT OUTCOME;

EID: 84872039897     PISSN: 10428194     EISSN: 10292403     Source Type: Journal    
DOI: 10.3109/10428194.2012.713477     Document Type: Article

References (26)

1. Jadersten M, Hellstrom-Lindberg E. Myelodysplastic syndromes: biology and treatment. JIntern Med 2009; 265: 307-328.
2. Kao JM, McMillan A, Greenberg PL. International MDS risk analysis workshop (IMRAW)/IPSS reanalyzed: impact of cytopenias on clinical outcomes in myelodysplastic syndromes. Am JHematol 2008; 83: 765-770.
3. Kantarjian H, Giles F, List A, et al. Theincidence and impact of thrombocytopenia in myelodysplastic syndromes. Cancer 2007; 109: 1705-1714.
4. Hendrickson JE, Hillyer CD. Noninfectious serious hazards of transfusion. Anesth Analg 2009; 108: 759-769.
5. Kuter DJ. Romiplostim. Cancer Treat Res 2 011; 1 57: 2 67-2 88.
6. Wang B, Nichol JL, Sullivan JT. Pharmacodynamics and pharmacokinetics of AMG 531, anovel thrombopoietin receptor ligand. Clin Pharmacol Ther 2004; 76: 628-638.
7. Kuter DJ, Bussel JB, Lyons RM, et al. Efficacy of romiplostim in patients with chronic immune thrombocytopenic purpura: adoubleblind randomised controlled trial. Lancet 2008; 371: 395-403.
8. Bussel JB, Kuter DJ, Pullarkat V, et al. Safety and efficacy of longterm treatment with romiplostim in thrombocytopenic patients with chronic ITP. Blood 2009; 113: 2161-2171.
9. Kantarjian H, Fenaux P, Sekeres MA, et al. Safety and efficacy of romiplostim in patients with lower-risk myelodysplastic syndrome and thrombocytopenia. JClin Oncol 2010; 28: 437-444.
10. Sekeres MA, Kantarjian H, Fenaux P, et al. Subcutaneous or intravenous administration of romiplostim in thrombocytopenic patients with lower risk myelodysplastic syndromes. Cancer 2011; 117: 992-1000.
11. Leone G, Teofili L, Voso MT, Lubbert M. DNA methylation and demethylating drugs in myelodysplastic syndromes and secondary leukemias. Haematologica 2002; 87: 1324-1341.
12. Santini V, Kantarjian HM, Issa JP. Changes in DNA methylation in neoplasia: pathophysiology and therapeutic implications. Ann Intern Med 2001; 134: 573-586.
13. Mund C, Brueckner B, Lyko F. Reactivation of epigenetically silenced genes by DNA methyltransferase inhibitors: basic concepts and clinical applications. Epigenetics 2006; 1: 7-13.
14. Kantarjian H, Oki Y, Garcia-Manero G, et al. Results of arandomized study of 3 schedules of low-dose decitabine in higher-risk myelodysplastic syndrome and chronic myelomonocytic leukemia. Blood 2007; 109: 52-57.
15. Kantarjian H, Issa JP, Rosenfeld CS, et al. Decitabine improves patient outcomes in myelodysplastic syndromes: results of aphase III randomized study. Cancer 2006; 106: 1794-1803.
16. 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. JClin Oncol 2009; 27: 3842-3848.
17. Silverman LR, Demakos EP, Peterson BL, et al. Randomized controlled trial of azacitidine in patients with the myelodysplastic syndrome: astudy of the cancer and leukemia group B. JClin Oncol 2002; 20: 2429-2440.
18. Greenberg P, Cox C, LeBeau MM, et al. International scoring system for evaluating prognosis in myelodysplastic syndromes. Blood 1997; 89: 2079-2088.
19. Kantarjian HM, Giles FJ, Greenberg PL, et al. Phase 2 study of romiplostim in patients with low-or intermediate-risk myelodysplastic syndrome receiving azacitidine therapy. Blood 2010; 116: 3163-3170.
20. Vardiman JW, Harris NL, Brunning RD. TheWorld Health Organization (WHO) classification of the myeloid neoplasms. Blood 2002; 100: 2292-2302.
21. Schiffer CA, Anderson KC, Bennett CL, et al. Platelet transfusion for patients with cancer: clinical practice guidelines of the American Society of Clinical Oncology. JClin Oncol 2001; 19: 1519-1538.
22. Cheson BD, Greenberg PL, Bennett JM, et al. Clinical application and proposal for modification of the International Working Group (IWG) response criteria in myelodysplasia. Blood 2006; 108: 419-425.
23. Abdulhaq H, Rossetti JM. Therole of azacitidine in the treatment of myelodysplastic syndromes. Expert Opin Investig Drugs 2007; 16: 1967-1975.
24. Amgen. Nplate (romiplostim). Prescribing information. 2 012. Available from:-http://pi.amgen.com/united-states/nplate/nplate-pi-hcp-english.pdf-
25. Giagounidis A, Mufti H, Kantarjian H, et al. Treatment with the thrombopoietin (TPO)-receptor agonist romiplostim in thrombocytopenic patients (Pts) with low or intermediate-1 (Int-1) risk myelodysplastic syndrome (MDS): results of arandomized, doubleblind, placebo (PBO)-controlled study. Blood 2011; 118(21 [ASH abstracts]): Abstract 117.
26. Fenaux P, Kantarjian H, Muus, P, et al. Update of an openlabel extension study evaluating the long-term safety and efficacy of romiplostim in thrombocytopenic patients with myelodysplastic syndromes (MDS). Blood 2011; 118(21 [ASH abstracts]): Abstract 2772.