Safety and clinical activity of 5-aza-2'-deoxycytidine (decitabine) with or without Hyper-CVAD in relapsed/refractory acute lymphocytic leukaemia

British Journal of Haematology

Volumn 167, Issue 3, 2014, Pages 356-365

  Benton, Christopher B ^a   Thomas, Deborah A ^a   Yang, Hui ^a   Ravandi, Farhad ^a   Rytting, Michael ^a   O'Brien, Susan ^a   Franklin, Anna R ^a   Borthakur, Gautam ^a   Dara, Samuel ^a   Kwari, Monica ^a   Pierce, Sherry R ^a   Jabbour, Elias ^a   Kantarjian, Hagop ^a   Garcia Manero, Guillermo ^a  

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

Author keywords

Clinical trial; Decitabine; DNA methylation; Precursor cell lymphoblastic leukaemia Lymphoma

Indexed keywords

5 AZA 2' DEOXYCYTIDINE; CYCLOPHOSPHAMIDE; CYTARABINE; DEXAMETHASONE; DOXORUBICIN; METHOTREXATE; VINCRISTINE; ANTINEOPLASTIC AGENT; ANTINEOPLASTIC ANTIMETABOLITE; AZACITIDINE; DNA;

ACUTE LYMPHOBLASTIC LEUKEMIA; ADOLESCENT; ADULT; AGED; ANOREXIA; ARTICLE; CHILD; CLINICAL ARTICLE; DIARRHEA; DISEASE FREE SURVIVAL; DNA METHYLATION; DRUG ACTIVITY; DRUG DOSE ESCALATION; DRUG MEGADOSE; DRUG RESPONSE; DRUG SAFETY; DRUG SENSITIVITY; DRUG TOLERABILITY; FEMALE; HUMAN; HYPERGLYCEMIA; KIDNEY FAILURE; LEUKEMIA RELAPSE; LIVER TOXICITY; MALE; MULTIPLE CYCLE TREATMENT; OUTCOME ASSESSMENT; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; SURVIVAL RATE; TREATMENT DURATION; VOMITING; ANALOGS AND DERIVATIVES; BONE MARROW; CHEMICALLY INDUCED; CHEMISTRY; CLINICAL TRIAL; COMPARATIVE STUDY; DRUG ADMINISTRATION; DRUG EFFECTS; DRUG-INDUCED LIVER INJURY; GASTROINTESTINAL DISEASE; INTRAVENOUS DRUG ADMINISTRATION; KAPLAN MEIER METHOD; MIDDLE AGED; PATHOLOGY; PRECURSOR CELL LYMPHOBLASTIC LEUKEMIA-LYMPHOMA; PRESCHOOL CHILD; RECURRENT DISEASE; REMISSION; SALVAGE THERAPY; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; ANTIMETABOLITES, ANTINEOPLASTIC; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; AZACITIDINE; BONE MARROW; CHILD; CHILD, PRESCHOOL; CYCLOPHOSPHAMIDE; CYTARABINE; DEXAMETHASONE; DNA METHYLATION; DNA, NEOPLASM; DOXORUBICIN; DRUG ADMINISTRATION SCHEDULE; DRUG-INDUCED LIVER INJURY; FEMALE; GASTROINTESTINAL DISEASES; HUMANS; HYPERGLYCEMIA; INFUSIONS, INTRAVENOUS; KAPLAN-MEIER ESTIMATE; MALE; METHOTREXATE; MIDDLE AGED; PRECURSOR CELL LYMPHOBLASTIC LEUKEMIA-LYMPHOMA; RECURRENCE; REMISSION INDUCTION; SALVAGE THERAPY; VINCRISTINE; YOUNG ADULT;

EID: 84911995813     PISSN: 00071048     EISSN: 13652141     Source Type: Journal    
DOI: 10.1111/bjh.13050     Document Type: Article

References (39)

1. Appleton, K., Mackay, H.J., Judson, I., Plumb, J.A., McCormick, C., Strathdee, G., Lee, C., Barrett, S., Reade, S., Jadayel, D., Tang, A., Bellenger, K., Mackay, L., Setanoians, A., Schätzlein, A., Twelves, C., Kaye, S.B. & Brown, R. (2007) Phase I and pharmacodynamic trial of the DNA methyltransferase inhibitor decitabine and carboplatin in solid tumors. Journal of Clinical Oncology, 25, 4603-4609.
2. Baylin, S.B. (2005) DNA methylation and gene silencing in cancer. Nature Clinical Practice Oncology, 2, S4-S11.
3. Blum, W., Garzon, R., Klisovic, R.B., Schwind, S., Walker, A., Geyer, S., Liu, S., Havelange, V., Becker, H., Schaaf, L., Mickle, J., Devine, H., Kefauver, C., Devine, S.M., Chan, K.K., Heerema, N.A., Bloomfield, C.D., Grever, M.R., Byrd, J.C., Villalona-Calero, M., Croce, C.M. & Marcucci, G. (2010) Clinical response and miR-29b predictive significance in older AML patients treated with a 10-day schedule of decitabine. Proceedings of the National Academy of Sciences of the United States of America, 107, 7473-7478.
4. Cedar, H. & Bergman, Y. (2011) Epigenetics of haematopoietic cell development. Nature Reviews Immunology, 11, 478-488.
5. Clevers, H. (2006) Wnt/beta-catenin signaling in development and disease. Cell, 127, 469-480.
6. Estécio, M.R.H. & Issa, J.-P.J. (2011) Dissecting DNA hypermethylation in cancer. FEBS Letters, 585, 2078-2086.
7. Florean, C., Schnekenburger, M., Grandjenette, C., Dicato, M. & Diederich, M. (2011) Epigenomics of leukemia: from mechanisms to therapeutic applications. Epigenomics, 3, 581-609.
8. Garcia-Manero, G., Daniel, J., Smith, T.L., Kornblau, S.M., Lee, M.-S., Kantarjian, H.M. & Issa, J.-P.J. (2002) DNA methylation of multiple promoter-associated CpG islands in adult acute lymphocytic leukemia. Clinical Cancer Research: An Official Journal of the American Association for Cancer Research, 8, 2217-2224.
9. Garcia-Manero, G., Jeha, S., Daniel, J., Williamson, J., Albitar, M., Kantarjian, H.M. & Issa, J.-P.J. (2003) Aberrant DNA methylation in pediatric patients with acute lymphocytic leukemia. Cancer, 97, 695-702.
10. Garcia-Manero, G., Kantarjian, H.M., Sanchez-Gonzalez, B., Yang, H., Rosner, G., Verstovsek, S., Rytting, M., Wierda, W.G., Ravandi, F., Koller, C., Xiao, L., Faderl, S., Estrov, Z., Cortes, J., O'Brien, S., Estey, E., Bueso-Ramos, C., Fiorentino, J., Jabbour, E. & Issa, J.-P. (2006) Phase 1/2 study of the combination of 5-aza-2'-deoxycytidine with valproic acid in patients with leukemia. Blood, 108, 3271-3279.
11. Garcia-Manero, G., Yang, H., Kuang, S.-Q., O'Brien, S., Thomas, D. & Kantarjian, H. (2009) Epigenetics of acute lymphocytic leukemia. Seminars in Hematology, 46, 24-32.
12. Geng, H., Brennan, S., Milne, T.A., Chen, W.-Y., Li, Y., Hurtz, C., Kweon, S.-M., Zickl, L., Shojaee, S., Neuberg, D., Huang, C., Biswas, D., Xin, Y., Racevskis, J., Ketterling, R.P., Luger, S.M., Lazarus, H., Tallman, M.S., Rowe, J.M., Litzow, M.R., Guzman, M.L., Allis, C.D., Roeder, R.G., Müschen, M., Paietta, E., Elemento, O. & Melnick, A.M. (2012) Integrative epigenomic analysis identifies biomarkers and therapeutic targets in adult B-acute lymphoblastic leukemia. Cancer Discovery, 2, 1004-1023.
13. Grabher, C., von Boehmer, H. & Look, A.T. (2006) Notch 1 activation in the molecular pathogenesis of T-cell acute lymphoblastic leukaemia. Nature Reviews Cancer, 6, 347-359.
14. Hoshino, K., Quintás-Cardama, A., Yang, H., Sanchez-Gonzalez, B. & Garcia-Manero, G. (2007) Aberrant DNA methylation of the Src kinase Hck, but not of Lyn, in Philadelphia chromosome negative acute lymphocytic leukemia. Leukemia, 21, 906-911.
15. Issa, J.-P.J., Garcia-Manero, G., Giles, F.J., Mannari, R., Thomas, D., Faderl, S., Bayar, E., Lyons, J., Rosenfeld, C.S., Cortes, J. & Kantarjian, H.M. (2004) 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.
16. Issa, J.-P.J., Gharibyan, V., Cortes, J., Jelinek, J., Morris, G., Verstovsek, S., Talpaz, M., Garcia-Manero, G. & Kantarjian, H.M. (2005) Phase II study of low-dose decitabine in patients with chronic myelogenous leukemia resistant to imatinib mesylate. Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology, 23, 3948-3956.
17. Jabbour, E., Issa, J.-P., Garcia-Manero, G. & Kantarjian, H. (2008) Evolution of decitabine development: accomplishments, ongoing investigations, and future strategies. Cancer, 112, 2341-2351.
18. Jones, P.A. & Taylor, S.M. (1980) Cellular differentiation, cytidine analogs and DNA methylation. Cell, 20, 85-93.
19. Kalac, M., Scotto, L., Marchi, E., Amengual, J., Seshan, V.E., Bhagat, G., Ulahannan, N., Leshchenko, V.V., Temkin, A.M., Parekh, S., Tycko, B. & O'Connor, O.A. (2011) HDAC inhibitors and decitabine are highly synergistic and associated with unique gene-expression and epigenetic profiles in models of DLBCL. Blood, 118, 5506-5516.
20. Kantarjian, H.M., O'Brien, S., Smith, T.L., Cortes, J., Giles, F.J., Beran, M., Pierce, S., Huh, Y., Andreeff, M., Koller, C., Ha, C.S., Keating, M.J., Murphy, S. & Freireich, E.J. (2000) Results of treatment with hyper-CVAD, a dose-intensive regimen, in adult acute lymphocytic leukemia. Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology, 18, 547-561.
21. Keating, G.M. (2009) Azacitidine: a review of its use in higher-risk myelodysplastic syndromes/acute myeloid leukaemia. Drugs, 69, 2501-2518.
22. Klimek, V.M. & Tallman, M.S. (2011) Hypomethylating agents in acute lymphoblastic leukemia: untapped potential? Leukemia & Lymphoma, 52, 7-8.
23. Kuang, S.-Q., Ling, X., Sanchez-Gonzalez, B., Yang, H., Andreeff, M. & Garcia-Manero, G. (2007) Differential tumor suppressor properties and transforming growth factor-beta responsiveness of p57KIP2 in leukemia cells with aberrant p57KIP2 promoter DNA methylation. Oncogene, 26, 1439-1448.
24. Kuang, S.-Q., Fang, Z., Zweidler-McKay, P.A., Yang, H., Wei, Y., Gonzalez-Cervantes, E.A., Boumber, Y. & Garcia-Manero, G. (2013) Epigenetic inactivation of Notch-Hes pathway in human B-cell acute lymphoblastic leukemia. PLoS ONE, 8, e61807.
25. Le Tourneau, C., Lee, J.J. & Siu, L.L. (2009) Dose escalation methods in phase I cancer clinical trials. Journal of the National Cancer Institute, 101, 708-720.
26. Lubbert, M. & Minden, M. (2005) Decitabine in acute myeloid leukemia. Seminars in Hematology, 42, S38-S42.
27. Momparler, R.L. (2005) Pharmacology of 5-Aza-2'-deoxycytidine (decitabine). Seminars in Hematology, 42, S9-S16.
28. Narayan, G., Freddy, A.J., Xie, D., Liyanage, H., Clark, L., Kisselev, S., Un Kang, J., Nandula, S.V., McGuinn, C., Subramaniyam, S., Alobeid, B., Satwani, P., Savage, D., Bhagat, G. & Murty, V.V. (2011) Promoter methylation-mediated inactivation of PCDH10 in acute lymphoblastic leukemia contributes to chemotherapy resistance. Genes, chromosomes & cancer, 50, 1043-1053.
29. Paulson, K., Kumar, R., Ahsanuddin, A. & Seftel, M.D. (2011) Azacytidine as a novel agent in the treatment of acute lymphoblastic leukemia. Leukemia & Lymphoma, 52, 134-136.
30. Pui, C.-H., Relling, M.V. & Downing, J.R. (2004) Acute lymphoblastic leukemia. New England Journal of Medicine, 350, 1535-1548.
31. Qin, T., Youssef, E.M., Jelinek, J., Chen, R., Yang, A.S., Garcia-Manero, G. & Issa, J.-P.J. (2007) Effect of cytarabine and decitabine in combination in human leukemic cell lines. Clinical Cancer Research: An Official Journal of the American Association for Cancer Research, 13, 4225-4232.
32. Ren, J., Singh, B.N., Huang, Q., Li, Z., Gao, Y., Mishra, P., Hwa, Y.L., Li, J., Dowdy, S.C. & Jiang, S.-W. (2011) DNA hypermethylation as a chemotherapy target. Cellular Signalling, 23, 1082-1093.
33. Reya, T., Morrison, S.J., Clarke, M.F. & Weissman, I.L. (2001) Stem cells, cancer, and cancer stem cells. Nature, 414, 105-111.
34. Saba, H.I. & Wijermans, P.W. (2005) Decitabine in myelodysplastic syndromes. Seminars in Hematology, 42, S23-S31.
35. Shen, L., Toyota, M., Kondo, Y., Obata, T., Daniel, S., Pierce, S., Imai, K., Kantarjian, H.M., Issa, J.-P.J. & Garcia-Manero, G. (2003) Aberrant DNA methylation of p57KIP2 identifies a cell-cycle regulatory pathway with prognostic impact in adult acute lymphocytic leukemia. Blood, 101, 4131-4136.
36. Storer, B.E. (1989) Design and analysis of phase I clinical trials. Biometrics, 45, 925-937.
37. Willemze, R., Archimbaud, E. & Muus, P. (1993) Preliminary results with 5-aza-2'-deoxycytidine (DAC)-containing chemotherapy in patients with relapsed or refractory acute leukemia. The EORTC Leukemia Cooperative Group. Leukemia, 7 (Suppl. 1), 49-50.
38. Wong, N.C., Ashley, D., Chatterton, Z., Parkinson-Bates, M., Ng, H.K., Halemba, M.S., Kowalczyk, A., Bedo, J., Wang, Q., Bell, K., Algar, E., Craig, J.M. & Saffery, R. (2012) A distinct DNA methylation signature defines pediatric pre-B cell acute lymphoblastic leukemia. Epigenetics: Official Journal of the DNA Methylation Society, 7, 535-541.
39. Yánez, L., Bermúdez, A., Richard, C., Bureo, E. & Iriondo, A. (2009) Successful induction therapy with decitabine in refractory childhood acute lymphoblastic leukemia. Leukemia, 23, 1342-1343.