The discovery and development of romidepsin for the treatment of T-cell lymphoma

References

• Swerdlow SH, Campo E, Pileri SA, et al. The 2016 revision of the World Health Organization classification of lymphoid neoplasms. Blood. 2016;127:2375–2390.
   PubMed Web of Science ®Google Scholar
• Jiang M, Bennani NN, Feldman AL. Lymphoma classification update: T-cell lymphomas, Hodgkin lymphomas, and histiocytic/dendritic cell neoplasms. Expert Rev Hematol. 2017 Jan 29:1–11. Epub ahead of print. DOI:10.1080/17474086.2017.1281122
   Web of Science ®Google Scholar
• Bellei M, Chiattone CS, Luminari S, et al. T-Cell Lymphomas in South America and Europe. Rev Bras Hematol Hemoter. 2012;34:42–47.
   PubMedGoogle Scholar
• Hsi ED, Horwitz SM, Carson KR, et al. Analysis of peripheral T-cell lymphoma diagnostic workup in the United States. Clin Lymphoma Myeloma Leuk. 2017;17:113–200.
   PubMed Web of Science ®Google Scholar
• Piekarz R, Bates S. A review of depsipeptide and other histone deacetylase inhibitors in clinical trials. Curr Pharm Des. 2004;10:2289–2298.
   PubMed Web of Science ®Google Scholar
• Richmond TJ, Davey CA. The structure of DNA in the nucleosome core. Nature. 2003;423:145–150.
   PubMed Web of Science ®Google Scholar
• Polo SE, Almouzni G. Cancer lett histone metabolic pathways and chromatin assembly factors as proliferation markers. Cancer Lett. 2005;220:1–9.
   PubMed Web of Science ®Google Scholar
• Litvinov IV, Jones DA, Sasseville D, et al. Transcriptional profiles predict disease outcome in patients with cutaneous T-cell lymphoma. Clin Cancer Res. 2010;16:2106–2114.
   PubMed Web of Science ®Google Scholar
• Prince HM, Dickinson M. Romidepsin for cutaneous T-cell lymphoma. Clin Cancer Res. 2012;18:3509–35015.
   PubMed Web of Science ®Google Scholar
• Willemze R, Jaffe ES, Burg G, et al. WHO-EORTC classification for cutaneous lymphomas. Blood. 2005;105:3768–3785.
   PubMed Web of Science ®Google Scholar
• Whittaker SJ, Marsden JR, Spittle M, et al. Joint British Association of Dermatologists and U.K. Cutaneous Lymphoma Group guidelines for the management of primary cutaneous T-cell lymphomas. Br J Dermatol. 2003;149:1095–1107.
   PubMed Web of Science ®Google Scholar
• Gu W, Roeder RG. Activation of p53 sequence-specific DNA binding by acetylation of the p53 C-terminal domain. Cell. 1997;90:595–606.
   PubMed Web of Science ®Google Scholar
• Boyes J, Byfield P, Nakatani Y, et al. Regulation of activity of the transcription factor GATA-1 by acetylation. Nature. 1998;396:594–598.
   PubMed Web of Science ®Google Scholar
• Kim EJ, Hess S, Richardson SK, et al. Immunopathogenesis and therapy of cutaneous T cell lymphoma. J Clin Invest. 2005;115:798–812.
   PubMed Web of Science ®Google Scholar
• Jenuwein T, Allis CD. Translating the histone code. Science. 2001;293:1074–1080.
   PubMed Web of Science ®Google Scholar
• Zinzani PL, Bonthapally V, Huebner D, et al. Panoptic clinical review of the current and future treatment of relapsed/refractory T-cell lymphomas: peripheral T-cell lymphomas. Crit Rev Oncol Hematol. 2016;99:214–227.
   PubMed Web of Science ®Google Scholar
• Ellin F, Landström J, Jerkeman M, et al. Real-world data on prognostic factors and treatment in peripheral T-cell lymphomas: a study from the Swedish Lymphoma Registry. Blood. 2014;124:1570–1577.
   PubMed Web of Science ®Google Scholar
• d’Amore F, Relander T, Lauritzsen GF, et al. Up-front autologous stem-cell transplantation in peripheral T-cell lymphoma: NLG-T-01. J Clin Oncol. 2012;30:3093–3099.
   PubMed Web of Science ®Google Scholar
• O’Connor OA, Pro B, Pinter-Brown L, et al. Pralatrexate in patients with relapsed or refractory peripheral T-cell lymphoma: results from the pivotal PROPEL study. J Clin Oncol. 2011;29:1182–1189.
   PubMed Web of Science ®Google Scholar
• Coiffier B, Pro B, Prince HM, 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;30:631–636.
   PubMed Web of Science ®Google Scholar
• O’Connor OA, Horwitz S, Masszi T, et al. Belinostat in patients with relapsed or refractory peripheral T-cell lymphoma: results of the Pivotal Phase II BELIEF (CLN-19) Study. J Clin Oncol. 2015;33:2492–2499.
   PubMed Web of Science ®Google Scholar
• Pro B, Advani R, Brice P, et al. Brentuximab vedotin (SGN-35) in patients with relapsed or refractory systemic anaplastic large-cell lymphoma: results of a phase II study. J Clin Oncol. 2012;30:2190–2196.
   PubMed Web of Science ®Google Scholar
• Ogura M, Ishida T, Hatake K, et al. Multicenter phase II study of mogamulizumab (KW-0761), a defucosylated anti-cc chemokine receptor 4 antibody, in patients with relapsed peripheral T-cell lymphoma and cutaneous T-cell lymphoma. J Clin Oncol. 2014;32:1157–1163.
   PubMed Web of Science ®Google Scholar
• Kuo MH, Allis CD. Roles of histone acetyltransferases and deacetylases in gene regulation. Bioessays. 1998;20:615–626.
   PubMed Web of Science ®Google Scholar
• Ueda H, Manda T, Matsumoto S, et al. FR901228, a novel antitumor bicyclic depsipeptide produced by Chromobacterium violaceum No. 968. III. Antitumor activities on experimental tumors in mice. J Antibiot (Tokyo). 1994;47:315–323.
   PubMed Web of Science ®Google Scholar
• Rosato RR, Grant S. Histone deacetylase inhibitors in clinical development. Expert Opin Investig Drugs. 2004;13:21–38.
   PubMed Web of Science ®Google Scholar
• Huang HC, Liu YC, Liu SH, et al. Geldanamycin inhibits trichostatin A-induced cell death and histone H4 hyperacetylation in COS-7 cells. Life Sci. 2002;70:1763–1775.
   PubMed Web of Science ®Google Scholar
• FDA Approval for Romidepsin. Available from: https://www.cancer.gov/about-cancer/treatment/drugs/fda-romidepsin. Updated: 2013 July 3 .Cited: 2017 June 6.
   Google Scholar
• Chung CG, Poligone B. Cutaneous T cell lymphoma: an update on pathogenesis and systemic therapy. Curr Hematol Malig Rep. 2015;10:468–746.
   PubMed Web of Science ®Google Scholar
• Emanuele S, Lauricella M, Tesoriere G. Histone deacetylase inhibitors: apoptotic effects and clinical implications. Int J Oncol. 2008;33:637–646.
   PubMed Web of Science ®Google Scholar
• Glaser KB. HDAC inhibitors: clinical update and mechanism-based potential. Biochem Pharmacol. 2007;74:659–671.
   PubMed Web of Science ®Google Scholar
• Fukuda H, Sano N, Muto S, et al. Simple histone acetylation plays a complex role in the regulation of gene expression. Brief Funct Genomic Proteomic. 2006;5:190–208.
   PubMedGoogle Scholar
• Mitsiades CS, Mitsiades NS, McMullan CJ, et al. Transcriptional signature of histone deacetylase inhibition in multiple myeloma: biological and clinical implications. Proc Natl Acad Sci U S A. 2004;101:540–545.
   PubMed Web of Science ®Google Scholar
• Mahlknecht U, Hoelzer D. Histone acetylation modifiers in the pathogenesis of malignant disease. Mol Med. 2000;6:623–644.
   PubMed Web of Science ®Google Scholar
• Murugan K, Sangeetha S, Ranjitha S, et al. HDACiDB: a database for histone deacetylase inhibitors. Drug Des Devel Ther. 2015;9:2257–2264.
   Google Scholar
• FDA approves Farydak for treatment of multiple myeloma. U.S. Drug&Food Administration.  Available from: https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm435296.htm. Retrieved 20 March 2017.
   Google Scholar
• FDA approves Beleodaq to treat rare., aggressive form of non-Hodgkin lymphoma. GoodPill Primary Medical Supply. Available from: http://www.goodpillpharmacy.com/health-news/fda-approves-beleodaq-to-treat-rare-aggressive-form-of-non-hodgkin-lymphoma. Retrieved 20 March 2017.
   Google Scholar
• Li KW, Wu J, Xing W, et al. Total synthesis of the antitumor depsipeptide FR-901,228. J Am Chem Soc. 1996;118:7237–7238.
   Web of Science ®Google Scholar
• Nakajima H, Kim YB, Terano H, et al. FR901228, a potent antitumor antibiotic, is a novel histone deacetylase inhibitor. Exp Cell Res. 1998;241:126–133.
   PubMed Web of Science ®Google Scholar
• Thiagalingam S, Cheng KH, Lee HJ, et al. Histone deacetylases: unique players in shaping the epigenetic histone code. Ann N Y Acad Sci. 2003;983:84–100.
   PubMed Web of Science ®Google Scholar
• Sandor V, Robbins AR, Robey R, et al. FR901228 causes mitotic arrest but does not alter microtubule polymerization. Anticancer Drugs. 2000;11:445–454.
   PubMed Web of Science ®Google Scholar
• Manoharan TH, Burgess JA, Ho D, et al. Integration of a mutant c-Ha-ras oncogene into C3H/10T1/2 cells and its relationship to tumorigenic transformation. Carcinogenesis. 1985;6:1295–1301.
   PubMed Web of Science ®Google Scholar
• Lech-Maranda E, Robak E, Robak T. Novel systemic drugs for cutaneous T-cell, lymphoma. Recent Pat Anticancer Drug Discov. 2011;6:70–93.
   PubMed Web of Science ®Google Scholar
• Rajgolikar G, Chan KK, Wang HC. Effects of a novel antitumor depsipeptide, FR901228, on human breast cancer cells. Breast Cancer Res Treat. 1998;51:29–38.
   PubMed Web of Science ®Google Scholar
• Yoshida M, Furumai R, Nishiyama M, et al. Histone deacetylase as a new target for cancer chemotherapy. Cancer Chem Pharm. 2001;48(Suppl 1):S20–S26.
   PubMed Web of Science ®Google Scholar
• Shigematsu N, Ueda H, Takase S, et al. FR901228, a novel antitumor bicyclic depsipeptide produced by Chromobacterium violaceum No. 968. II. Structure determination. J Antibiot. 1994;47:311–314.
   PubMed Web of Science ®Google Scholar
• Barbarotta L, Hurley K. Romidepsin for the treatment of peripheral T-cell lymphoma. J Adv Pract Oncol. 2015;6:22–36.
   PubMedGoogle Scholar
• Rosato RR, Almenara JA, Grant S. The histone deacetylase inhibitor MS-275 promotes differentiation or apoptosis in human leukemia cells through a process regulated by generation of reactive oxygen species and induction of p21CIP1/WAF1 1. Cancer Res. 2003;63:3637–3645.
   PubMed Web of Science ®Google Scholar
• Ueda H, Nakajima H, Hori Y, et al. Action of FR901228, a novel antitumor bicyclic depsipeptide produced by Chromobacterium violaceum no. 968, on Ha-ras transformed NIH3T3 cells-+. Biosci Biotechnol Biochem. 1994;58:1579–1583.
   PubMed Web of Science ®Google Scholar
• Johnstone RW, Ruefli AA, Lowe SW. Apoptosis: a link between cancer genetics and chemotherapy. Cell. 2002;108:153–164.
   PubMed Web of Science ®Google Scholar
• Xiao JJ, Byrd J, Marcucci G, et al. Identification of thiols and glutathione conjugates of depsipeptide FK228 (FR901228), a novel histone protein deacetylase inhibitor, in the blood. Rapid Commun Mass Spectrom. 2003;17:757–766.
   PubMed Web of Science ®Google Scholar
• Marks PA, Richon VM, Breslow R, et al. Histone deacetylase inhibitors as new cancer drugs. Curr Opin Oncol. 2001;13:477–483.
   PubMed Web of Science ®Google Scholar
• Klisovic MI, Maghraby EA, Parthun MR, et al. Depsipeptide (FR 901228) promotes histone acetylation, gene transcription, apoptosis and its activity is enhanced by DNA methyltransferase inhibitors in AML1/ETO-positive leukemic cells. Leukemia. 2003;17:350–358.
   PubMed Web of Science ®Google Scholar
• Furumai R, Matsuyama A, Kobashi N, et al. FK228 (depsipeptide) as a natural prodrug that inhibits class I histone deacetylases. Cancer Res. 2002;62:4916–4921.
   PubMed Web of Science ®Google Scholar
• Archer SY, Meng S, Shei A, et al. RA. p21WAF1 is required for butyrate-mediated growth inhibition of human colon cancer cells. Proc Natl Acad Sci USA. 1998;95:6791–6796.
   PubMed Web of Science ®Google Scholar
• Ueda H, Nakajima H, Hori Y, et al. FR901228, a novel antitumor bicyclic depsipeptide produced by Chromobacterium violaceum No. 968. I. Taxonomy, fermentation, isolation, physicochemical and biological properties, and antitumor activity. J Antibiot. 1994;47:301–310.
   PubMed Web of Science ®Google Scholar
• Sandor V, Senderowicz A, Mertins S, et al. P21-dependent G1 arrest with downregulation of cyclin D1 and upregulation of cyclin E by the histone deacetylase inhibitor FR901228. Br J Cancer. 2000;83:817–825.
   PubMed Web of Science ®Google Scholar
• Peart MJ, Tainton KM, Ruefli AA, et al. Novel mechanisms of apoptosis induced by histone deacetylase inhibitors. Cancer Res. 2003;63:4460–4471.
   PubMed Web of Science ®Google Scholar
• Burgess AJ, Pavey S, Warrener R, et al. Up-regulation of p21WAF1/CIP1 by histone deacetylase inhibitors reduces their cytotoxicity. Mol Pharmacol. 2001;60:828–837.
   PubMed Web of Science ®Google Scholar
• Insinga A, Monestiroli S, Ronzoni S, et al. Inhibitors of histone deacetylases induce tumor-selective apoptosis through activation of the death receptor pathway. Nat Med. 2005;11:71–76.
   PubMed Web of Science ®Google Scholar
• Pelletier G, Stefanovsky VY, Faubladier M, et al. Competitive recruitment of CBP and Rb-HDAC regulates UBF acetylation and ribosomal transcription. Mol Cell. 2000;6:1059–1066.
   PubMed Web of Science ®Google Scholar
• Nebbioso A, Clarke N, Voltz E, et al. Tumor-selective action of HDAC inhibitors involves TRAIL induction in acute myeloid leukemia cells. Nat Med. 2005;11:77–84.
   PubMed Web of Science ®Google Scholar
• Lech-Maranda E, Robak E, Korycka A, et al. Depsipeptide (FK228) as a novel histone deacetylase mechanism of action and anticancer activity. Mini Rev Med Chem. 2007;7:1062–1069.
   PubMed Web of Science ®Google Scholar
• Shao Y, Gao Z, Marks PA, et al. Apoptotic and autophagic cell death induced by histone deacetylase inhibitors. Proc Natl Acad Sci USA. 2004;101:18030–18035.
   PubMed Web of Science ®Google Scholar
• Yu X, Guo ZS, Marcu MG, et al. Modulation of p53, ErbB1, ErbB2, and Raf-1 expression in lung cancer cells by depsipeptide FR901228. Natl Cancer Inst. 2002;94:504–513.
   Google Scholar
• Bali P, Pranpat M, Bradner J, et al. Inhibition of histone deacetylase 6 acetylates and disrupts the chaperone function of heat shock protein 90: a novel basis for antileukemia activity of histone deacetylase inhibitors. J Biol Chem. 2005;280:26729–26734.
   PubMed Web of Science ®Google Scholar
• Sutheesophon K, Kobayashi Y, Takatoku MA, et al. Histone deacetylase inhibitor depsipeptide (FK228) induces apoptosis in leukemic cells by facilitating mitochondrial translocation of Bax, which is enhanced by the proteasome inhibitor bortezomib. Acta Haematol. 2006;115:78–90.
   PubMed Web of Science ®Google Scholar
• Bates SE, Eisch R, Ling A, et al. Romidepsin in peripheral and cutaneous T-cell lymphoma: mechanistic implications from clinical and correlative data. Br J Haematol. 2015;170:96–109.
   PubMed Web of Science ®Google Scholar
• Kwon HJ, Kim MS, Kim MJ, et al. Histone deacetylase inhibitor FK228 inhibits tumor angiogenesis. Int J Cancer. 2002;97:290–296.
   PubMed Web of Science ®Google Scholar
• Sasakawa Y, Naoe Y, Noto T, et al. Antitumor efficacy of FK228, a novel histone deacetylase inhibitor, depends on the effect on expression of angiogenesis factors. Biochem Pharmacol. 2003;66:897–906.
   PubMed Web of Science ®Google Scholar
• Woo S, Gardner ER, Chen X, et al. Population pharmacokinetics of romidepsin in patients with cutaneous T-cell lymphoma and relapsed peripheral T-cell lymphoma. Clin Cancer Res. 2009;15:1496–1503.
   PubMed Web of Science ®Google Scholar
• Sandor V, Bakke S, Robey RW, et al. Phase I trial of the histone deacetylase inhibitor, depsipeptide (FR901228, NSC 630176), in patients with refractory neoplasms. Clin Cancer Res. 2002;8:718–728.
   PubMed Web of Science ®Google Scholar
• Marshall JL, Rizvi N, Kauh J, et al. A phase I trial of romidepsin (FR901228) in patients with advanced cancer. J Exp Ther Oncol. 2002;2:325–332.
   PubMedGoogle Scholar
• Byrd JC, Marcucci G, Parthun MR, et al. A phase 1 and pharmacodynamic study of depsipeptide (FK228) in chronic lymphocytic leukemia and acute myeloid leukemia. Blood. 2005;105:959–967.
   PubMed Web of Science ®Google Scholar
• Fouladi M, Furman WL, Chin T, et al. Phase I study of depsipeptide in pediatric patients with refractory solid tumors: a Children’s Oncology Group report. J Clin Oncol. 2006;24:3678–3685.
   PubMed Web of Science ®Google Scholar
• Poligone B, Lin J, Chung C. Romidepsin: evidence for its potential use to manage previously treated cutaneous T cell lymphoma. Core Evid. 2011;6:1–12.
   PubMedGoogle Scholar
• Bates SE, Zhan Z, Steadman K, et al. Laboratory correlates for a phase II trial of romidepsin in cutaneous and peripheral T-cell lymphoma. Br J Haematol. 2010;148:256–267.
   PubMed Web of Science ®Google Scholar
• Grant C, Rahman F, Piekarz R, 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.
   PubMed Web of Science ®Google Scholar
• Fronsdal K, Saatcioglu F. Histone deacetylase inhibitors differentially mediate apoptosis in prostate cancer cells. Prostate. 2005;62:299–306.
   PubMed Web of Science ®Google Scholar
• Ito T, Ouchida M, Morimoto Y, et al. Significant growth suppression of synovial sarcomas by the histone deacetylase inhibitor FK228 in vitro and in vivo. Cancer Lett. 2005;224:311–319.
   PubMed Web of Science ®Google Scholar
• Piekarz RL, Robey RW, Zhan Z, et al. T-cell lymphoma as a model for the use of histone deacetylase inhibitors in cancer therapy: impact of depsipeptide on molecular markers, therapeutic targets, and mechanisms of resistance. Blood. 2004;103:4636–4643.
   PubMed Web of Science ®Google Scholar
• Wei DG, Chiang V, Fyne E, et al. Histone deacetylase inhibitor romidepsin induces HIV expression in CD4 T cells from patients on suppressive antiretroviral therapy at concentrations achieved by clinical dosing. PLoS Pathog. 2014;10:e1004071.
   PubMed Web of Science ®Google Scholar
• Sun WJ, Huang H, He B, et al. Romidepsin induces G2/M phase arrest via Erk/cdc25C/cdc2/cyclinB pathway and apoptosis induction through JNK/c-Jun/caspase3 pathway in hepatocellular carcinoma cells. Biochem Pharmacol. 2016;127:90–100.
   Web of Science ®Google Scholar
• Tiffon C, Adams J, Van Der Fits L, et al. The histone deacetylase inhibitors vorinostat and romidepsin downmodulate IL-10 expression in cutaneous T-cell lymphoma cells. Br J Pharmacol. 2011;162:1590–1602.
   PubMed Web of Science ®Google Scholar
• Akilov OE, Grant C, Frye R, et al. Low-dose electron beam radiation and romidepsin therapy for symptomatic cutaneous T-cell lymphoma lesions. Br J Dermatol. 2012;167:194–197.
   PubMed Web of Science ®Google Scholar
• Kano Y, Akutsu M, Tsunoda S, et al. Cytotoxic effects of histone deacetylase inhibitor FK228 (depsipeptide, formally named FR901228) in combination with conventional anti-leukemia/lymphoma agents against human leukemia/lymphoma cell lines. Invest New Drugs. 2007;25:31–40.
   PubMed Web of Science ®Google Scholar
• Zheng H, Zhao W, Yan C, et al. HDAC inhibitors enhance T-cell chemokine expression and augment response to PD-1 immunotherapy in lung adenocarcinoma. Clin Cancer Res. 2016;22:4119–4132.
   PubMed Web of Science ®Google Scholar
• Chakraborty AR, Robey RW, Luchenko VL, et al. MAPK pathway activation leads to Bim loss and histone deacetylase inhibitor resistance: rationale to combine romidepsin with an MEK inhibitor. Blood. 2013;121:4115–4125.
   PubMed Web of Science ®Google Scholar
• Valdez BC, Brammer JE, Li Y, et al. Romidepsin enhances the cytotoxicity of fludarabine, clofarabine and busulfan combination in malignant T-cells. Leuk Res. 2016;47:100–118.
   PubMed Web of Science ®Google Scholar
• Rozati S, Cheng PF, Widmer DS, et al. Romidepsin and azacitidine synergize in their epigenetic modulatory effects to induce apoptosis in CTCL. Clin Cancer Res. 2016;22:2020–2031.
   PubMed Web of Science ®Google Scholar
• Cosenza M, Civallero M, Fiorcari S, et al. The histone deacetylase inhibitor romidepsin synergizes with lenalidomide and enhances tumor cell death in T-cell lymphoma cell lines. Cancer Biol Ther. 2016;12:1–13.
   Google Scholar
• Beg AA, Gray JE. HDAC inhibitors with PD-1 blockade: a promising strategy for treatment of multiple cancer types? Epigenomics. 2016;8:1015–1017.
   PubMed Web of Science ®Google Scholar
• Makena MR, Koneru B, Nguyen TH, et al. Reactive oxygen species-mediated synergism of fenretinide and romidepsin in preclinical models of T-cell lymphoid malignancies. Mol Cancer Ther. 2017 Jan 23;pii: molcanther.0749. Epub ahead of print. Doi: 10.1158/1535-7163.MCT-16-0749
   PubMed Web of Science ®Google Scholar
• Reddy SA. Romidepsin for the treatment of relapsed/refractory cutaneous T-cell lymphoma (mycosis fungoides/Sézary syndrome): use in a community setting. Crit Rev Oncol Hematol. 2016;106:99–107.
   PubMed Web of Science ®Google Scholar
• Kim M, Thompson LA, Wenger SD, et al. Romidepsin: a histone deacetylase inhibitor for refractory cutaneous T-cell lymphoma. Ann Pharmacother. 2012;46:1340–1348.
   PubMed Web of Science ®Google Scholar
• Kim EJ, Kim YH, Rook AH, et al. Clinically significant responses achieved with romidepsin across disease compartments in patients with cutaneous T-cell lymphoma. Leuk Lymphoma. 2015;56:2847–2854.
   PubMed Web of Science ®Google Scholar
• Foss F, Duvic M, Lerner A, et al. Clinical efficacy of romidepsin in tumor stage and folliculotropic mycosis fungoides. Clin Lymphoma Myeloma Leuk. 2016;16:637–643.
   PubMed Web of Science ®Google Scholar
• Foss F, Pro B, Miles Prince H, et al. Responses to romidepsin by line of therapy in patients with relapsed or refractory peripheral T-cell lymphoma. Cancer Med. 2017;6:36–44.
   PubMed Web of Science ®Google Scholar
• Piekarz RL, Robey R, Sandor V, et al. Inhibitor of histone deacetylation, depsipeptide (FR901228), in the treatment of peripheral and cutaneous T-cell lymphoma: a case report. Blood. 2001;98:2865–2868.
   PubMed Web of Science ®Google Scholar
• Piekarz RL, Frye R, Turner M, 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;27:5410–5417.
   PubMed Web of Science ®Google Scholar
• Kim YH, Demierre MF, Kim EJ, et al. Clinically meaningful reduction in pruritus in patients with cutaneous T-cell lymphoma treated with romidepsin. Leuk Lymphoma. 2013;54:284–289.
   PubMed Web of Science ®Google Scholar
• Whittaker SJ, Demierre MF, Kim EJ, et al. Final results from a multicenter, international, pivotal study of romidepsin in refractory cutaneous T-cell lymphoma. J Clin Oncol. 2010;28:4485–4491.
   PubMed Web of Science ®Google Scholar
• Martinez-Escala ME, Kuzel TM, Kaplan JB, et al. Durable responses with maintenance dose-sparing regimens of romidepsin in cutaneous T-cell lymphoma. JAMA Oncol. 2016;2:790–793.
   PubMed Web of Science ®Google Scholar
• Lemchak DM, Akilov OE. Romidepsin controls chronic lymphocytic leukemia in a patient with mycosis fungoides. Hematol Rep. 2016;8:6840.
   PubMed Web of Science ®Google Scholar
• Piekarz RL, Frye R, Prince HM, et al. Phase 2 trial of romidepsin in patients with peripheral T-cell lymphoma. Blood. 2011 Jun 2;117:5827–5834.
   PubMed Web of Science ®Google Scholar
• Dupuis J, Morschhauser F, Ghesquières H, et al. Combination of romidepsin with cyclophosphamide, doxorubicin, vincristine, and prednisone in previously untreated patients with peripheral T-cell lymphoma: a non-randomised, phase 1b/2 study. Lancet Haematol. 2015;2:e160–165.
   PubMed Web of Science ®Google Scholar
• Pellegrini C, Dodero A, Chiappella A, et al. Italian Lymphoma Foundation (Fondazione Italiana Linfomi Onlus, FIL). A phase II study on the role of gemcitabine plus romidepsin (GEMRO regimen) in the treatment of relapsed/refractory peripheral T-cell lymphoma patients. J Hematol Oncol. 2016;9:38.
   PubMed Web of Science ®Google Scholar
• Foss F, Horwitz S, Pro B, et al. Romidepsin for the treatment of relapsed/refractory peripheral T cell lymphoma: prolonged stable disease provides clinical benefits for patients in the pivotal trial. J Hematol Oncol. 2016;9:22.
   PubMed Web of Science ®Google Scholar
• Chan KL, Van Der Weyden C, Khoo C, et al. Durable clinical remission induced by romidepsin for chemotherapy-refractory peripheral T-cell lymphoma with central nervous system involvement. Leuk Lymphoma. 2017;58:996–998.
   PubMed Web of Science ®Google Scholar
• Chihara D, Fanale MA, Miranda RN, et al. The survival outcome of patients with relapsed/refractory peripheral T-cell lymphoma-not otherwise specified and angioimmunoblastic T-cell lymphoma. Br J Haematol. 2016;176:750–758.
   PubMed Web of Science ®Google Scholar
• Fanale MA, Fredrick B, Hagemeister FB, et al. A phase I trial of alisertib plus romidepsin for relapsed/refractory aggressive B- and T-cell lymphomas. Blood. 2014;124(supplement):abstract1744.
   Google Scholar
• Holkova B, Kmieciak M, Bose P, et al. Phase 1 study of bortezomib and romidepsin in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma, indolent B-cell lymphoma, peripheral T-cell lymphoma, or cutaneous T-cell lymphoma: updated results. Blood. 2014;124(supplement):abstract3050.
   Google Scholar
• Northwestern University; Amgen. Dose-escalation trial of carfilzomib with and without romidepsin in cutaneous T-Cell Lymphoma. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US); 2012. cited 2017June 6. Available from: https://clinicaltrials.gov/ct2/show/NCT01738594. NML Identifier: NCT01738594.
   Google Scholar
• Lunning MA, Ruan J, Nair S, et al. A phase I/II trial of the combination of romidepsin and lenalidomide in patients with relapsed/refractory lymphoma and myeloma: phase 1 results. J Clin Oncol. 2014;32(supplement):abstract8582.
   Web of Science ®Google Scholar
• Mehta-Shah N, Lunning MA, Ruan J, et al. A phase I/II trial of the combination of romidepsin and lenalidomide in patients with relapsed/refractory lymphoma and myeloma. Hematol Oncol. 2015;33(abstract):016.
   Google Scholar
• Buckstein R, Fraser G, Cheung M, et al. Alemtuzumab and CHOP chemotherapy for the treatment of aggressive histology peripheral T cell lymphomas: a multi-center phase I study. Clin Lymphoma Myeloma Leuk. 2016;16:18–28.
   PubMed Web of Science ®Google Scholar
• Johnston PB, Cashen AF, Nikolinakos PG, et al. Safe and effective treatment of patients with peripheral T-cell lymphoma (PTCL) with the novel HDAC inhibitor, belinostat, in combination with CHOP: results of the Bel-CHOP Phase 1 Trial. Blood. 2015;124(supplement):abstract253.
   Google Scholar
• Advani RH, Ansell SM, Lechowicz MJ, et al. A phase II study of cyclophosphamide, etoposide, vincristine and prednisone (CEOP) alternating with pralatrexate (P) as front line therapy for patients with peripheral T-cell lymphoma (PTCL): final results from the T- cell consortium trial. Br J Haematol. 2016;172:535–544.
   PubMed Web of Science ®Google Scholar
• Molife LR, Attard G, Fong PC, 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. 2010;21:109–113.
   PubMed Web of Science ®Google Scholar
• Nettersheim D, Jostes S, Fabry M, et al. A signaling cascade including ARID1A, GADD45B and DUSP1 induces apoptosis and affects the cell cycle of germ cell cancers after romidepsin treatment. Oncotarget. 2016;7:74931–74946.
   PubMed Web of Science ®Google Scholar
• Amiri-Kordestani L, Luchenko V, Peer CJ, et al. Phase I trial of a new schedule of romidepsin in patients with advanced cancers. Clin Cancer Res. 2013;19:4499–4507.
   PubMed Web of Science ®Google Scholar
• Holkova B, Yazbeck V, Kmieciak M, et al. A phase 1 study of bortezomib and romidepsin in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma, indolent B-cell lymphoma, peripheral T-cell lymphoma, or cutaneous T-cell lymphoma. Leuk Lymphoma. 2017 Jan;19:1–9. Epub ahead of print. Doi:10.1080/10428194.2016.1276287
   Web of Science ®Google Scholar
• Piekarz RL, Frye AR, Wright JJ, et al. Cardiac studies in patients treated with romidepsin, FK228, in a phase II trial for T-cell lymphoma. Clin Cancer Res. 2006;12:3762–3773.
   PubMed Web of Science ®Google Scholar
• Rivers ZT, Oostra DR, Westholder JS, et al. Romidepsin-associated cardiac toxicity and ECG changes: a case report and review of the literature. J Oncol Pharm Pract. 2016 Oct 5;pii: 1078155216673229. Epub ahead of print.
   PubMed Web of Science ®Google Scholar
• Noonan AM, Eisch RA, Liewehr DJ, et al. Electrocardiographic studies of romidepsin demonstrate its safety and identify a potential role for K(ATP) channel. Clin Cancer Res. 2013;19:3095–3104.
   PubMed Web of Science ®Google Scholar
• Moskowitz AJ, Horwitz SM. Targeting histone deacetylases in T-cell lymphoma. Leuk Lymphoma. 2017;58:1306–1319.
   Web of Science ®Google Scholar
• Cooper MR, Brewer S, Broketa G. Reversible ageusia associated with romidepsin therapy. Am J Health Syst Pharm. 2013;70:1502–1505.
   PubMed Web of Science ®Google Scholar
• Brian Scott B, Wickless H. Romidepsin-induced neutrophilic urticaria. JAAD Case Rep. 2016;2:261–263.
   PubMedGoogle Scholar
• Battistuzzi G, Giannini G. Synthesis of ST7612AA1, a novel oral HDAC inhibitor, via radical thioacetic acid addition. Curr Bioact Compd. 2016;12:282–288.
   PubMedGoogle Scholar
• Rajski SR, Wassarman DA, Restituyo JA FK228 analogs and methods of making and using the same. U.S. 20060128660 A1 (2006). Available from: https://www.google.com/patents/US20060128660. Retrieved 21 March 2017
   Google Scholar