Electrocardiographic studies of romidepsin demonstrate its safety and identify a potential role for KATP channel

Clinical Cancer Research

Volumn 19, Issue 11, 2013, Pages 3095-3104

  Noonan, Anne M ^a   Eisch, Robin A ^a   Liewehr, David J ^a   Sissung, Tristan M ^a   Venzon, David J ^a   Flagg, Thomas P ^b   Haigney, Mark C ^b   Steinberg, Seth M ^a   Figg, William D ^a   Piekarz, Richard L ^a   Bates, Susan E ^a  

^a NATIONAL CANCER INSTITUTE   (United States)

^b UNIFORMED SERVICES UNIVERSITY OF THE HEALTH SCIENCES   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADENOSINE TRIPHOSPHATE; BETA ADRENERGIC RECEPTOR BLOCKING AGENT; MAGNESIUM; MULTIDRUG RESISTANCE PROTEIN 1; POTASSIUM; ROMIDEPSIN; TROPONIN;

ADULT; AGED; ARTICLE; CARDIOTOXICITY; CONTROLLED STUDY; CUTANEOUS T CELL LYMPHOMA; DIASTOLIC BLOOD PRESSURE; DRUG EFFICACY; DRUG SAFETY; ECHOCARDIOGRAPHY; ELECTROCARDIOGRAPHY; FEMALE; GENE FREQUENCY; GENE LINKAGE DISEQUILIBRIUM; GENE LOCUS; GENOTYPE; HEART ARRHYTHMIA; HEART ATRIUM FLUTTER; HEART RATE; HOLTER MONITORING; HUMAN; HYPERTENSION; HYPOALBUMINEMIA; HYPOKALEMIA; HYPOMAGNESEMIA; LONG QT SYNDROME; MAJOR CLINICAL STUDY; MALE; PERIPHERAL T CELL LYMPHOMA; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROTEIN ANALYSIS; PROTEIN BLOOD LEVEL; PROTEIN EXPRESSION; PROTEIN FUNCTION; QT INTERVAL; SINGLE NUCLEOTIDE POLYMORPHISM; ST SEGMENT DEPRESSION; ST SEGMENT ELEVATION; SUBSTITUTION THERAPY; SYSTOLIC BLOOD PRESSURE; TELEMETRY;

ADULT; AGED; AGED, 80 AND OVER; ANTIBIOTICS, ANTINEOPLASTIC; DEPSIPEPTIDES; ELECTROCARDIOGRAPHY; FEMALE; GENOTYPE; HEART RATE; HISTONE DEACETYLASE INHIBITORS; HUMANS; LYMPHOMA, T-CELL, CUTANEOUS; LYMPHOMA, T-CELL, PERIPHERAL; MAGNESIUM; MALE; MIDDLE AGED; P-GLYCOPROTEIN; POTASSIUM;

EID: 84878967679     PISSN: 10780432     EISSN: 15573265     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-13-0109     Document Type: Article

References (50)

1. Liu F, Levin MD, Petrenko NB, Lu MM, Wang T, Yuan LJ, et al. Histonedeacetylase inhibition reverses atrial arrhythmia inducibility and fibrosis in cardiac hypertrophy independent of angiotensin. J Mol Cell Cardiol 2008;45:715-23.
2. Piekarz RL, Frye AR, Wright JJ, Steinberg SM, Liewehr DJ, Rosing DR, et al. Cardiac studies in patients treated with depsipeptide, FK228, in a phase II trial for T-cell lymphoma. Clin Cancer Res 2006;12:3762-73. (Pubitemid 44000258)
3. Niesvizky R, Ely S, Mark T, Aggarwal S, Gabrilove JL, Wright JJ, et al. Phase 2 trial of the histone deacetylase inhibitor romidepsin for the treatment of refractory multiple myeloma. Cancer 2011;117:336-42.
4. Molife LR, Attard G, Fong PC, Karavasilis V, Reid AHM, Patterson S, et al. Phase II, two-stage, single-arm trial of the histone deacetylase inhibitor (HDACi) romidepsin in metastatic castration-resistant prostate cancer (CRPC). Ann Oncol 2009;21:109-13.
5. Molife R, Fong P, Scurr M, Judson I, Kaye S, de Bono J. HDAC inhibitors and cardiac safety. Clin Cancer Res 2007;13:1068.
6. Lassen U, Molife LR, Sorensen M, Engelholm SA, Vidal L, Sinha R, et al. A phase I study of the safety and pharmacokinetics of the histone deacetylase inhibitor belinostat administered in combination with carboplatin and/or paclitaxel in patients with solid tumours. Br J Cancer 2010;103:12-7.
7. Steele NL, Plumb JA, Vidal L, Tjornelund J, Knoblauch P, Rasmussen A, et al.Aphase 1 pharmacokinetic and pharmacodynamic study of the histone deacetylase inhibitor belinostat in patients with advanced solid tumors. Clin Cancer Res 2008;14:804-10. (Pubitemid 351231163)
8. Sandor V, Bakke S, Robey RW, Kang MH, Blagosklonny MV, Bender J, et al. Phase I trial of the histone deacetylase inhibitor, depsipeptide (FR901228, NSC 630176), in patients with refractory neoplasms. Clin Cancer Res 2002;8:718-28. (Pubitemid 34742100)
9. Marshall JL, Rizvi N, Kauh J, Dahut W, Figuera M, Kang MH, et al. A phase I trial of depsipeptide (FR901228) in patients with advanced cancer. J Exp Ther Oncol 2002;2:325-32. (Pubitemid 35265981)
10. Coiffier B, Pro B, Prince HM, Foss F, Sokol L, Greenwood M, et al. Results from a pivotal, open-label, phase II study of romidepsin in relapsed or refractory peripheral T-cell lymphoma after prior systemic therapy. J Clin Oncol 2012;30:631-6.
11. Piekarz RL, Frye R, Turner M, Wright JJ, Allen SL, Kirschbaum MH, et al. Phase II multi-institutional trial of the histone deacetylase inhibitor romidepsin as monotherapy for patients with cutaneous T-cell lymphoma. J Clin Oncol 2009;27:5410-7.
12. Piekarz RL, Frye R, Prince HM, Kirschbaum MH, Zain J, Allen SL, et al. Phase II trial of romidepsin in patients with peripheral T-cell lymphoma. Blood 2011;117:5827-34.
13. Sissung TM, Gardner ER, Piekarz RL, Howden R, Chen X, Woo S, et al. Impact of ABCB1 allelic variants on QTc interval prolongation. Clin Cancer Res 2011;17:937-46.
14. Engstrom G, Hedblad B, Juul-Moller S, Tyden P, Janzon L. Cardiac arrhythmias and stroke: increased risk in men with high frequency of atrial ectopic beats. Stroke 2000;31:2925-9.
15. Todo K, Moriwaki H, Saito K, Naritomi H. Frequent premature atrial contractions in stroke of undetermined etiology. Eur Neurol 2009;61:285-8.
16. Kwa AT, Li Z, Amsterdam EA, Srivatsa UN. Ventricular ectopy and long-term cardiac function. Crit Pathw Cardiol 2011;10:52-4.
17. O'Mahony D, Peikarz RL, Bandettini WP, Arai AE, Wilson WH, Bates SE. Cardiac involvement with lymphoma: a review of the literature. Clin Lymphoma Myeloma 2008;8:249-52.
18. Morgan M, Maloney D, Duvic M. Hypomagnesemia and hypocalcemia in mycosis fungoides: a retrospective case series. Leuk Lymphoma 2002;43:1297-302. (Pubitemid 34537976)
19. Cho YS, Whitehead L, Li J, Chen CH, Jiang L, Vogtle M, et al. Conformational refinement of hydroxamate-based histone deacetylase inhibitors and exploration of 3-piperidin-3-ylindole analogues of dacinostat (LAQ824). J Med Chem 2010;53:2952-63.
20. Shultz MD, Cao X, Chen CH, Cho YS, Davis NR, Eckman J, et al. Optimization of the in vitro cardiac safety of hydroxamate-based histone deacetylase inhibitors. J Med Chem 2011;54:4752-72.
21. Cabell C, Bates S, Piekarz R, Whittaker S, Kim Youn H, Currie M, et al. Systematic assessment of potential cardiac effects of the novel histone deacetylase (HDAC) inhibitor romidepsin. American Society of Hematology Annual Meeting Blood 2009;114 (suppl; abstr 3709).
22. Godfrey CJ, Cabell C, Balser B, Wolfson J, Nichols J, Burris HA. Exposure-QTc response analysis of class 1 selective histone deacetylase inhibitor. American Society of Hematology Annual Meeting. Blood 2011;118 (suppl; abstr 2680).
23. Giles F, Fischer T, Cortes J, Garcia-Manero G, Beck J, Ravandi F, 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;12:4628-35. (Pubitemid 44297814)
24. Stadler WM, Margolin K, Ferber S, McCulloch W, Thompson JA. A phase II study of depsipeptide in refractory metastatic renal cell cancer. Clin Genitourin Cancer 2006;5:57-60.
25. de Bono JS, Kristeleit R, Tolcher A, Fong P, Pacey S, Karavasilis V, et al. Phase I pharmacokinetic and pharmacodynamic study of LAQ824, a hydroxamate histone deacetylase inhibitor with a heat shock protein-90 inhibitory profile, in patients with advanced solid tumors. Clin Cancer Res 2008;14:6663-73.
26. Ramalingam SS, Kummar S, Sarantopoulos J, Shibata S, LoRusso P, Yerk M, et al. Phase I study of vorinostat in patients with advanced solid tumors and hepatic dysfunction: a National Cancer Institute Organ Dysfunction Working Group study. J Clin Oncol 2010;28:4507-12.
27. Banerji U, van Doorn L, Papadatos-Pastos D, Kristeleit R, Debnam P, Tall M, et al. A phase I pharmacokinetic and pharmacodynamic study of CHR-3996, an oral class I selective histone deacetylase inhibitor in refractory solid tumors. Clin Cancer Res 2012;18:2687-94.
28. Rowinsky EK, de Bono J, Deangelo DJ, van Oosterom A, Morganroth J, Laird GH, et al. Cardiac monitoring in phase I trials of a novel histone deacetylase (HDAC) inhibitor LAQ824 in patients with advanced solid tumors and hematologic malignancies. J Clin Oncol (Meeting Abstracts) 23(16), 2005 (suppl; abstr 3131).
29. Shah MH, Binkley P, Chan K, Xiao J, Arbogast D, Collamore M, et al. Cardiotoxicity of histone deacetylase inhibitor depsipeptide in patients with metastatic neuroendocrine tumors. Clin Cancer Res 2006;12:3997-4003. (Pubitemid 44078086)
30. Olsen EA, Kim YH, Kuzel TM, Pacheco TR, Foss FM, Parker S, et al. Phase IIb multicenter trial of vorinostat in patients with persistent, progressive, or treatment refractory cutaneous T-cell lymphoma. J Clin Oncol 2007;25:3109-15. (Pubitemid 47218059)
31. Gojo I, Jiemjit A, Trepel JB, Sparreboom A, Figg WD, Rollins S, et al. Phase 1 and pharmacologic study of MS-275, a histone deacetylase inhibitor, in adults with refractory and relapsed acute leukemias. Blood 2007;109:2781-90. (Pubitemid 46482071)
32. Galli M, Salmoiraghi S, Golay J, Gozzini A, Crippa C, Pescosta N, et al. A phase II multiple dose clinical trial of histone deacetylase inhibitor ITF2357 in patients with relapsed or progressive multiple myeloma. Ann Hematol 2010;89:185-90.
33. Kjeldsen K. Hypokalemia and sudden cardiac death. Exp Clin Cardiol 2010;15:e96-9.
34. Peacock JM, Ohira T, Post W, Sotoodehnia N, Rosamond W, Folsom AR. Serum magnesium and risk of sudden cardiac death in the Atherosclerosis Risk in Communities (ARIC) Study. Am Heart J 2010;160:464-70.
35. Chiuve SE, Korngold EC, Januzzi JL Jr, Gantzer ML, Albert CM. Plasma and dietary magnesium and risk of sudden cardiac death in women. Am J Clin Nutr 2011;93:253-60.
36. Santoro A, Mancini E, London G, Mercadal L, Fessy H, Perrone B, et al. Patients with complex arrhythmias during and after haemodialysis suffer from different regimens of potassium removal. Nephrol Dial Transplant 2008;23:1415-21. (Pubitemid 351767479)
37. Osadchii OE. Mechanisms of hypokalemia-induced ventricular arrhythmogenicity. Fundam Clin Pharmacol 2010;24:547-59.
38. Mosseri M, Fingert HJ, Varticovski L, Chokshi S, Isner JM. In vitro evidence that myocardial ischemia resulting from 5-fluorouracil chemotherapy is due to protein kinase C-mediated vasoconstriction of vascular smooth muscle. Cancer Res 1993;53:3028-33. (Pubitemid 23210307)
39. Li RA, Leppo M, Miki T, Seino S, Marban E. Molecular basis of electrocardiographic ST-segment elevation. Circ Res 2000;87:837-9.
40. Shaw RM, Rudy Y. Electrophysiologic effects of acute myocardial ischemia: a theoretical study of altered cell excitability and action potential duration. Cardiovasc Res 1997;35:256-72. (Pubitemid 27372038)
41. Nichols CG, Ripoll C, Lederer WJ. ATP-sensitive potassium channel modulation of the guinea pig ventricular action potential and contraction. Circ Res 1991;68:280-7.
42. Di Diego JM, Antzelevitch C. Cellular basis for ST-segment changes observed during ischemia. J Electrocardiol 2003;36 Suppl:1-5. (Pubitemid 38049755)
43. Flagg TP, Enkvetchakul D, Koster JC, Nichols CG. Muscle KATP channels: recent insights to energy sensing and myoprotection. Physiol Rev 2010;90:799-829.
44. Fatima N SJ, Flagg TP. Evidence for epigenetic regulation of chamber-specific structure of cardiac ATP-sensitive potassium (KATP) channels. Circulation 2011;124:A13506.
45. Basseville A, Tamaki A, Ierano C, Trostel S, Ward Y, Robey RW, et al. Histone deacetylase inhibitors influence chemotherapy transport by modulating expression and trafficking of a common polymorphic variant of the ABCG2 efflux transporter. Cancer Res 2012;72:3642-51.
46. Flagg TP, KurataHT, Masia R, Caputa G,Magnuson MA, Lefer DJ, et al. Differential structure of atrial and ventricular KATP: atrial KATP channels require SUR1. Circ Res 2008;103:1458-65.
47. Glukhov AV, Flagg TP, Fedorov VV, Efimov IR, Nichols CG. Differential K(ATP) channel pharmacology in intact mouse heart. J Mol Cell Cardiol 2010;48:152-60.
48. Fedorov VV, Glukhov AV, Ambrosi CM, Kostecki G, Chang R, Janks D, et al. Effects of KATP channel openers diazoxide and pinacidil in coronary-perfused atria and ventricles from failing and non-failing human hearts. J Mol Cell Cardiol 2011;51:215-25.
49. Meissner K, Jedlitschky G, Meyer zu Schwabedissen H, Dazert P, Eckel L, Vogelgesang S, et al. Modulation of multidrug resistance P-glycoprotein 1 (ABCB1) expression in human heart by hereditary polymorphisms. Pharmacogenetics 2004;14:381-5.
50. Grant C, Rahman F, Piekarz R, Peer C, Frye R, Robey RW, et al. Romidepsin: a new therapy for cutaneous T-cell lymphoma and a potential therapy for solid tumors. Expert Rev Anticancer Ther 2010;10:997-1008.