Decitabine improves patient outcomes in myelodysplastic syndromes: Results of a phase III randomized study

Cancer

Volumn 106, Issue 8, 2006, Pages 1794-1803

  Kantarjian, Hagop ^a   Issa, Jean Pierre J ^a   Rosenfeld, Craig S ^b   Bennett, John M ^c   Albitar, Maher ^a,d   DiPersio, John ^e   Klimek, Virginia ^f   Slack, James ^g   De Castro, Carlos ^h   Ravandi, Farhad ⁱ   Helmer III, Richard ^j   Shen, Lanlan ^a   Nimer, Stephen D ^f   Leavitt, Richard ^b   Raza, Azra ^k   Saba, Hussain ^l,m  

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

^b University of Rochester Medical Center ^*  (United States)

^c UNIVERSITY OF ROCHESTER MEDICAL CENTER   (United States)

^d QUEST DIAGNOSTICS NICHOLS INSTITUTE   (United States)

^e WASHINGTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

^f MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

^g ROSWELL PARK CANCER INSTITUTE   (United States)

^h DUKE UNIVERSITY MEDICAL CENTER   (United States)

ⁱ UNIVERSITY OF ILLINOIS AT CHICAGO   (United States)

^j Southwest Regional Cancer Center   (United States)

^k RUSH UNIVERSITY MEDICAL CENTER   (United States)

^l VETERANS AFFAIRS MEDICAL CENTER   (United States)

^m H LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE   (United States)

more..

Author keywords

Acute myelogenous leukemia; Azacitidine; Decitabine; Hypomethylating; Myelodysplastic syndrome

Indexed keywords

5 AZA 2' DEOXYCYTIDINE;

ABDOMINAL PAIN; ACUTE GRANULOCYTIC LEUKEMIA; ADULT; AGED; ANEMIA; ARTICLE; CANCER PALLIATIVE THERAPY; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DNA METHYLATION; FEBRILE NEUTROPENIA; FEMALE; FEVER; HUMAN; HYPERBILIRUBINEMIA; LEUKEMOGENESIS; LEUKOPENIA; MAJOR CLINICAL STUDY; MALE; MYELODYSPLASTIC SYNDROME; NAUSEA; NEUTROPENIA; PETECHIA; PHASE 3 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; PROMOTER REGION; RANDOMIZED CONTROLLED TRIAL; THROMBOCYTOPENIA; TREATMENT OUTCOME;

EID: 33646071894     PISSN: 0008543X     EISSN: 10970142     Source Type: Journal    
DOI: 10.1002/cncr.21792     Document Type: Article

References (27)

1. Leone G, Teofili L, Voso MT, et al. DNA methylation and demethylating drugs in myelodysplastic syndromes and secondary leukemias. Haematologica. 2002;87:1324-1341.
2. Bird AP. CpG-rich islands and the function of DNA methylation. Nature. 1986;321:209-213.
3. Herman JG, Baylin SB. Gene silencing in cancer in association with promoter hypermethylation. N Engl J Med. 2003;349:2042-2054.
4. Merlo A, Herman JG, Mao L, et al. 5′ CpG island methylation is associated with transcriptional silencing of the tumour suppressor p16/CDKN2/MTS1 in human cancers. Nat Med. 1995;1:686-692.
5. Wijermans PW, Luebbert M, Verhoef G. Low dose decitabine for elderly high risk MDS patients: who will respond? [abstract 335] Blood. 2002;100:96a.
6. Kantarjian HM, O'Brien S, Cortes J, et al. Results of decitabine (5-aza-2′deoxycytidine) therapy in 130 patients with chronic myelogenous leukemia. Cancer. 2003;98:522-528.
7. Lubbert M, Wijermans P, Kunzmann R, et al. Cytogenetic responses in high-risk myelodysplastic syndrome following low-dose treatment with the DNA methylation inhibitor 5-aza-2′-deoxycytidine. Br J Haematol. 2001;114:349-357.
8. Sacchi S, Kantarjian HM, O'Brien S, et al. Chronic myelogenous leukemia in nonlymphoid blastic phase: analysis of the results of first salvage therapy with three different treatment approaches for 162 patients. Cancer. 1999;86:2632-2641.
9. 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. 2004;103:1635-1640.
10. Saunthararajah Y, Hillery CA, Lavelle D, et al. Effects of 5-aza-2′-deoxycytidine on fetal hemoglobin levels, red cell adhesion, and hematopoietic differentiation in patients with sickle cell disease. Blood. 2003;102:3865-3870.
11. Wijermans PW, Krulder JW, Huijgens PC, et al. Continuous infusion of low-dose 5-Aza-2′-deoxycytidine in elderly patients with high-risk myelodysplastic syndrome. Leukemia. 1997;11:1-5.
12. Wijermans P, Lubbert M, Verhoef G, et al. Low-dose 5-aza-2′- deoxycytidine, a DNA hypomethylating agent, for the treatment of high-risk myelodysplastic syndrome: a multicenter phase II study in elderly patients. J Clin Oncol. 2000;18:956-962.
13. Saba H, Rosenfeld C, Issa J-P, et al. First report of the phase III North American trial of decitabine in advanced myelodysplastic syndrome (MDS) [abstract 67]. Blood. 2004;104:23a.
14. Bennett JM, Catovsky D, Daniel MT, et al. Proposals for the classification of the myelodysplastic syndromes. Br J Haematol. 1982;51:189-199.
15. [no authors listed]. American Society of Clinical Oncology. Recommendations for the use of hematopoietic colony-stimulating factors: evidence-based, clinical practice guidelines. J Clin Oncol. 1994;12:2471-2508.
16. Aaronson NK, Ahmedzai S, Bergman B, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993;85:365-376.
17. 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.
18. Greenberg P, Cox C, LeBeau MM, et al. International scoring system for evaluating prognosis in myelodysplastic syndromes. Blood. 1997;89:2079-2088.
19. Onida F, Kantarjian HM, Smith TL, et al. Prognostic factors and scoring systems in chronic myelomonocytic leukemia: a retrospective analysis of 213 patients. Blood. 2002;99:840-849.
20. Gatto S, Ball G, Onida F, et al. Contribution of beta-2 microglobulin levels to the prognostic stratification of survival in patients with myelodysplastic syndrome (MDS). Blood. 2003;102:1622-1625.
21. Estey E, Keating M, Pierce S, et al. Application of the International Scoring System for myelodysplasia to M. D. Anderson patients. Blood. 1997;90:2843-2846.
22. Saba HI, Wijermans PW. Decitabine in myelodysplastic syndromes. Semin Hematol. 2005;42:S23-S31.
23. 2/course) in myelodysplastic syndrome (MDS). Comparison of 3 different dose schedules [abstract 6545]. Proc Am Soc Clin Oncol. 2005;23:571S.
24. 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 BiolChem. 1982;257:2041-2048.
25. Kaminskas E, Farrell A, Abraham S, et al. Approval summary: azacitidine for treatment of myelodysplastic syndrome subtypes. Clin Cancer Res. 2005 11:3604-3608.
26. 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.
27. Colella S, Shen L, Baggerly KA, et al. Sensitive and quantitative universal pyrosequencing methylation analysis of CpG sites. Biotechniques. 2003;35:146-150.