415
Views
22
CrossRef citations to date
0
Altmetric
Original Articles: Clinical

A phase I trial of two sequence-specific schedules of decitabine and vorinostat in patients with acute myeloid leukemia

, , , , , , , , , , , , , , , , , , , & show all
Pages 2793-2802 | Received 13 Aug 2014, Accepted 06 Feb 2015, Published online: 30 Mar 2015

References

  • Costello JF, Fruhwald MC, Smiraglia DJ, et al. Aberrant CpG-island methylation has non-random and tumour-type-specific patterns. Nat Genet 2000;24:132–138.
  • Shi H, Wei SH, Leu YW, et al. Triple analysis of the cancer epigenome:an integrated microarray system for assessing gene expression, DNA methylation, and histone acetylation. Cancer Res 2003;63:2164–2171.
  • Jones PA, Baylin SB. The fundamental role of epigenetic events in cancer. Nat Rev Genet 2002;3:415–428.
  • Minucci S, Pelicci PG. Histone deacetylase inhibitors and the promise of epigenetic (and more) treatments for cancer. Nat Rev Cancer 2006;6:38–51.
  • Mizuno S, Chijiwa T, Okamura T, et al. Expression of DNA methyltransferases DNMT1, 3A, and 3B in normal hematopoiesis and in acute and chronic myelogenous leukemia. Blood 2001;97: 1172–1179.
  • Fournel M, Sapieha P, Beaulieu N, et al. Down-regulation of human DNA-(cytosine-5) methyltransferase induces cell cycle regulators p16(ink4A) and p21(WAF/Cip1) by distinct mechanisms. J Biol Chem 1999;274:24250–24256.
  • Bakin AV, Curran T. Role of DNA 5-methylcytosine transferase in cell transformation by fos. Science 1999;283:387–390.
  • Patra SK, Patra A, Zhao H, et al. DNA methyltransferase and demethylase in human prostate cancer. Mol Carcinog 2002;33: 163–171.
  • Kanai Y, Ushijima S, Nakanishi Y, et al. Reduced mRNA expression of the DNA demethylase, MBD2, in human colorectal and stomach cancers. Biochem Biophys Res Commun 1999;264:962–966.
  • Gore SD, Jones C, Kirkpatrick P. Decitabine. Nat Rev Drug Discov 2006;5:891–892.
  • Vardiman JW, Thiele J, Arber DA, et al. The 2008 revision of the World Health Organization (WHO) classification of myeloid neoplasms and acute leukemia: rationale and important changes. Blood 2009;114:937–951.
  • Kantarjian HM, Thomas XG, Dmoszynska A, 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.
  • Lubbert M, Ruter B, Claus R et al. A multicenter phase II trial of decitabine as first-line treatment of older AML patients judged unfit for induction chemotherapy. Haematologica 2012;97:393–401.
  • Cashen AF, Schiller GJ, O’Donnell MR, et al. Multicenter, phase II study of decitabine for the first-line treatment of older patients with acute myeloid leukemia. J Clin Oncol 2010;28:556–561.
  • 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 2007;109:52–57.
  • 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 2009;27:3842–3848.
  • Lubbert M, Suciu S, Baila L, et al. Low-dose decitabine versus best supportive care in elderly patients with intermediate- or high-risk myelodysplastic syndrome (MDS) ineligible for intensive chemotherapy: final results of the randomized phase III study of the European Organisation for Research and Treatment of Cancer Leukemia Group and the German MDS Study Group. J Clin Oncol 2011;29:1987–1996.
  • Kantarjian H, Issa JP, Rosenfeld CS, et al. Decitabine improves patient outcomes in myelodysplastic syndromes:results of a phase III randomized study. Cancer 2006;106:1794–1803.
  • Yang AS, Doshi KD, Choi SW, et al. DNA methylation changes after 5-aza-2’-deoxycytidine therapy in patients with leukemia. Cancer Res 2006;66:5495–5503.
  • Issa JP, 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.
  • Garzon R, Liu S, Fabbri M, et al. MicroRNA-29b induces global DNA hypomethylation and tumor suppressor gene reexpression in acute myeloid leukemia by targeting directly DNMT3A and 3B and indirectly DNMT1. Blood 2009;113:6411–6418.
  • Fabbri M, Garzon R, Cimmino A, et al. MicroRNA-29 family reverts aberrant methylation in lung cancer by targeting DNA methyltransferases 3A and 3B. Proc Natl Acad Sci USA 2007;104:15805–15810.
  • Blum W, Garzon R, Klisovic RB, et al. Clinical response and miR-29b predictive significance in older AML patients treated with a 10-day schedule of decitabine. Proc Natl Acad Sci USA 2010;107:7473–7478.
  • Metzeler KH, Walker A, Geyer S, et al. DNMT3A mutations and response to the hypomethylating agent decitabine in acute myeloid leukemia. Leukemia 2012;26:1106–1107.
  • Garcia-Manero G, Yang H, Bueso-Ramos C, et al. Phase 1 study of the histone deacetylase inhibitor vorinostat (suberoylanilide hydroxamic acid [SAHA]) in patients with advanced leukemias and myelodysplastic syndromes. Blood 2008;111:1060–1066.
  • Schaefer EW, Loaiza-Bonilla A, Juckett M, et al. A phase 2 study of vorinostat in acute myeloid leukemia. Haematologica 2009;94:1375–1382.
  • Giles F, Fischer T, Cortes J, et al. A phase I study of intravenous LBH589, a novel cinnamic hydroxamic acid analogue histone deacetylase inhibitor, in patients with refractory hematologic malignancies. Clin Cancer Res 2006;12:4628–4635.
  • Gojo I, Jiemjit A, Trepel JB, et al. Phase 1 and pharmacologic study of MS–275, a histone deacetylase inhibitor, in adults with refractory and relapsed acute leukemias. Blood 2007;109: 2781–2790.
  • Klimek VM, Fircanis S, Maslak P, et al. Tolerability, pharmacodynamics, and pharmacokinetics studies of depsipeptide (romidepsin) in patients with acute myelogenous leukemia or advanced myelodysplastic syndromes. Clin Cancer Res 2008;14: 826–832.
  • Garcia-Manero G, Assouline S, Cortes J, et al. Phase 1 study of the oral isotype specific histone deacetylase inhibitor MGCD0103 in leukemia. Blood 2008;112:981–989.
  • Mann BS, Johnson JR, He K, et al. Vorinostat for treatment of cutaneous manifestations of advanced primary cutaneous T-cell lymphoma. Clin Cancer Res 2007;13:2318–2322.
  • Mann BS, Johnson JR, Cohen MH, et al. FDA approval summary: vorinostat for treatment of advanced primary cutaneous T-cell lymphoma. Oncologist 2007;12:1247–1252.
  • Cameron EE, Bachman KE, Myohanen S, et al. Synergy of demethylation and histone deacetylase inhibition in the re-expression of genes silenced in cancer. Nat Genet 1999;21:103–107.
  • Zhu WG, Dai Z, Ding H, et al. Increased expression of unmethylated CDKN2D by 5-aza-2’-deoxycytidine in human lung cancer cells. Oncogene 2001;20:7787–7796.
  • Zhu WG, Lakshmanan RR, Beal MD, et al. DNA methyltransferase inhibition enhances apoptosis induced by histone deacetylase inhibitors. Cancer Res 2001;61:1327–1333.
  • Boivin AJ, Momparler LF, Hurtubise A, et al. Antineoplastic action of 5-aza-2’-deoxycytidine and phenylbutyrate on human lung carcinoma cells. Anticancer Drugs 2002;13:869–874.
  • Kikuchi T, Toyota M, Itoh F, et al. Inactivation of p57KIP2 by regional promoter hypermethylation and histone deacetylation in human tumors. Oncogene 2002;21:2741–2749.
  • Bovenzi V, Momparler RL. Antineoplastic action of 5-aza- 2’-deoxycytidine and histone deacetylase inhibitor and their effect on the expression of retinoic acid receptor beta and estrogen receptor alpha genes in breast carcinoma cells. Cancer Chemother Pharmacol 2001;48:71–76.
  • Takai N, Kawamata N, Walsh CS, et al. Discovery of epigenetically masked tumor suppressor genes in endometrial cancer. Mol Cancer Res 2005;3:261–269.
  • Zhu WG, Otterson GA. The interaction of histone deacetylase inhibitors and DNA methyltransferase inhibitors in the treatment of human cancer cells. Curr Med Chem Anticancer Agents 2003;3: 187–199.
  • Suzuki H, Gabrielson E, Chen W, et al. A genomic screen for genes upregulated by demethylation and histone deacetylase inhibition in human colorectal cancer. Nat Genet 2002;31:141–149.
  • Yang H, Hoshino K, Sanchez-Gonzalez B, et al. Antileukemia activity of the combination of 5-aza-2’-deoxycytidine with valproic acid. Leuk Res 2005;29:739–748.
  • Fiskus W, Buckley K, Rao R et al. Panobinostat treatment depletes EZH2 and DNMT1 levels and enhances decitabine mediated de-repression of JunB and loss of survival of human acute leukemia cells. Cancer Biol Ther 2009;8:939–950.
  • 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 2003;21:4642–4649.
  • Liu Z, Marcucci G, Byrd JC, et al. Characterization of decomposition products and preclinical and low dose clinical pharmacokinetics of decitabine (5-aza-2’-deoxycytidine) by a new liquid chromatography/tandem mass spectrometry quantification method. Rapid Commun Mass Spectrom 2006;20:1117–1126.
  • Parise RA, Holleran JL, Beumer JH, et al. A liquid chromatography-electrospray ionization tandem mass spectrometric assay for quantitation of the histone deacetylase inhibitor, vorinostat (suberoylanilide hydroxamicacid, SAHA), and its metabolites in human serum. J Chromatogr B Analyt Technol Biomed Life Sci 2006;840: 108–115.
  • 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 2007;25:3884–3891.
  • Stathis A, Hotte SJ, Chen EX, et al. Phase I study of decitabine in combination with vorinostat in patients with advanced solid tumors and non-Hodgkin's lymphomas. Clin Cancer Res 2011;17: 1582–1590.
  • Kelly WK, O’Connor OA, Krug LM, et al. Phase I study of an oral histone deacetylase inhibitor, suberoylanilide hydroxamic acid, in patients with advanced cancer. J Clin Oncol 2005;23:3923–3931.
  • Fenaux P, Mufti GJ, Hellstrom-Lindberg E, et al. Efficacy of azacitidine compared with that of conventional care regimens in the treatment of higher-risk myelodysplastic syndromes: a randomised, open-label, phase III study. Lancet Oncol 2009;10:223–232.
  • Ravandi F, Faderl S, Thomas D, et al. Phase I study of suberoylanilide hydroxamic acid (SAHA) and decitabine in patients with relapsed, refractory or poor prognosis leukemia. Blood 2007;110(Suppl. 1): Abstract 897.
  • Garcia-Manero G, Kantarjian HM, Sanchez-Gonzalez B, et al. Phase study of the combination of 5-aza-2’-deoxycytidine with valproic acid in patients with leukemia. Blood 2006;108: 3271–3279.
  • Maslak P, Chanel S, Camacho LH, et al. Pilot study of combination transcriptional modulation therapy with sodium phenylbutyrate and 5-azacytidine in patients with acute myeloid leukemia or myelodysplastic syndrome. Leukemia 2006;20:212–217.
  • Gore SD, Baylin S, Sugar E, et al. Combined DNA methyltransferase and histone deacetylase inhibition in the treatment of myeloid neoplasms. Cancer Res 2006;66:6361–6369.
  • Kirschbaum M, Gojo I, Goldberg SL, et al. A phase 1 clinical trial of vorinostat in combination with decitabine in patients with acute myeloid leukaemia or myelodysplastic syndrome. Br J Haematol 2014;167:185–193.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.