Clinically significant responses achieved with romidepsin across disease compartments in patients with cutaneous T-cell lymphoma

References

• 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
• Agar NS, Wedgeworth E, Crichton S, et al. Survival outcomes and prognostic factors in mycosis fungoides/sezary syndrome: validation of the revised International Society for Cutaneous Lymphomas/European Organisation for Research and Treatment of Cancer staging proposal. J Clin Oncol 2010;28:4730–4739.
   PubMed Web of Science ®Google Scholar
• Criscione VD, Weinstock MA. Incidence of cutaneous T-cell lymphoma in the United States, 1973–2002. Arch Dermatol 2007;143:854–859.
   PubMed Web of Science ®Google Scholar
• Korgavkar K, Xiong M, Weinstock M. Changing incidence trends of cutaneous T-cell lymphoma. JAMA Dermatol 2013;149:1295–1299.
   PubMed Web of Science ®Google Scholar
• NCCN clinical practice guidelines in oncology: Non-Hodgkin's lymphoma. V.2.2015. Available from: nccn.org
   Google Scholar
• Olsen E, Vonderheid E, Pimpinelli N, et al. Revisions to the staging and classification of mycosis fungoides and Sézary syndrome: a proposal of the International Society for Cutaneous Lymphomas (ISCL) and the Cutaneous Lymphoma Task Force of the European Organization of Research and Treatment of Cancer (EORTC). Blood 2007;110:1713–1722.
   PubMed Web of Science ®Google Scholar
• Klemke CD, Mansmann U, Poenitz N, et al. Prognostic factors and prediction of prognosis by the CTCL severity index in mycosis fungoides and Sézary syndrome. Br J Dermatol 2005;153: 118–124.
   PubMed Web of Science ®Google Scholar
• Talpur R, Singh L, Daulat S, et al. Long-term outcomes of 1,263 patients with mycosis fungoides and Sézary syndrome from 1982 to 2009. Clin Cancer Res 2012;18:5051–5060.
   PubMed Web of Science ®Google Scholar
• Parker SR, Bradley B. Treatment of cutaneous T-cell lymphoma/mycosis fungoides. Dermatol Nurs 2006;18:566–570, 573–575.
   PubMedGoogle Scholar
• Demierre M. Mycosis fungoides and Sézary syndrome: the burden of pruritus. Community Oncol 2010;7:399–403.
   Google Scholar
• Ahern K, Gilmore ES, Poligone B. Pruritus in cutaneous T-cell lymphoma: a review. J Am Acad Dermatol 2012;67:760–768.
   PubMed Web of Science ®Google Scholar
• Demierre MF, Gan S, Jones J, et al. Significant impact of cutaneous T-cell lymphoma on patients’ quality of life: results of a 2005 national Cutaneous Lymphoma Foundation survey. Cancer 2006;107:2504–2511.
   PubMed Web of Science ®Google Scholar
• Vij A, Duvic M. Prevalence and severity of pruritus in cutaneous T cell lymphoma. Int J Dermatol 2012;51:930–934.
   PubMed Web of Science ®Google Scholar
• Olsen EA, Whittaker S, Kim YH, et al. Clinical end points and response criteria in mycosis fungoides and Sézary syndrome: a consensus statement of the International Society for Cutaneous Lymphomas, the United States Cutaneous Lymphoma Consortium, and the Cutaneous Lymphoma Task Force of the European Organisation for Research and Treatment of Cancer. J Clin Oncol 2011;29:2598–2607.
   PubMed Web of Science ®Google Scholar
• Targretin (bexarotene) [package insert]. Bridgewater, NJ: Valeant Pharmaceuticals North America LLC; 2013.
   Google Scholar
• Duvic M, Hymes K, Heald P, et al. Bexarotene is effective and safe for treatment of refractory advanced-stage cutaneous T-cell lymphoma: multinational phase II-III trial results. J Clin Oncol 2001;19:2456–2471.
   PubMed Web of Science ®Google Scholar
• Ontak (denileukin diftitox) [package insert]. Woodcliff Lake, NJ: Eisai Inc.; 2008.
   Google Scholar
• Olsen E, Duvic M, Frankel A, et al. Pivotal phase III trial of two dose levels of denileukin diftitox for the treatment of cutaneous T-cell lymphoma. J Clin Oncol 2001;19:376–388.
   PubMed Web of Science ®Google Scholar
• ISTODAX (romidepsin) [package insert]. Summit, NJ: Celgene Corporation; 2014.
   Google Scholar
• Whittaker S, Demierre M, 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
• Zolinza (vorinostat) [package insert]. Whitehouse Station, NJ: Merck & Co., Inc.; 2013.
   Google Scholar
• Duvic M, Talpur R, Ni X, et al. Phase 2 trial of oral vorinostat (suberoylanilide hydroxamic acid, SAHA) for refractory cutaneous T-cell lymphoma (CTCL). Blood 2007;109:31–39.
   PubMed Web of Science ®Google Scholar
• Tan J, Cang S, Ma Y, et al. Novel histone deacetylase inhibitors in clinical trials as anti-cancer agents. J Hematol Oncol 2010;3:5.
   PubMed Web of Science ®Google Scholar
• Bolden JE, Peart MJ, Johnstone RW. Anticancer activities of histone deacetylase inhibitors. Nat Rev Drug Discov 2006;5: 769–784.
   PubMed Web of Science ®Google Scholar
• Bradner JE, West N, Grachan ML, et al. Chemical phylogenetics of histone deacetylases. Nat Chem Biol 2010;6:238–243.
   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
• American Joint Committee on Cancer. Lymphoid neoplasms. In: Green FL Page DL, Fleming ID, et al., editors. AJCC cancer staging manual. 6th ed. New York, NY: Springer; 2002. pp 391–406.
   Google Scholar
• Bunn PA Jr, Lamberg SI. Report of the Committee on Staging and Classification of Cutaneous T-Cell Lymphomas. Cancer Treat Rep 1979;63:725–728.
   PubMedGoogle Scholar
• Stevens SR, Ke MS, Parry EJ, et al. Quantifying skin disease burden in mycosis fungoides-type cutaneous T-cell lymphomas: the severity-weighted assessment tool (SWAT). Arch Dermatol 2002;138: 42–48.
   PubMed Web of Science ®Google Scholar
• Heald P. Clinical trials and efficacy assessment in the therapy of cutaneous T cell lymphoma. Ann NY Acad Sci 2001;941:155–165.
   PubMed Web of Science ®Google Scholar
• Edelson R, Berger C, Gasparro F, et al. Treatment of cutaneous T-cell lymphoma by extracorporeal photochemotherapy. Preliminary results. N Engl J Med 1987;316:297–303.
   PubMed Web of Science ®Google Scholar
• Therasse P, Arbuck SG, Eisenhauer EA, et al. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst 2000;92:205–216.
   PubMed Web of Science ®Google Scholar
• Lundin J, Hagberg H, Repp R, et al. Phase 2 study of alemtuzumab (anti-CD52 monoclonal antibody) in patients with advanced mycosis fungoides/Sézary syndrome. Blood 2003;101:4267–4272.
   PubMed Web of Science ®Google Scholar
• Olsen EA, Kim YH, Kuzel TM, 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: 3109–3115.
   PubMed Web of Science ®Google Scholar