Romidepsin is effective and well tolerated in older patients with peripheral T-cell lymphoma: analysis of two phase II trials

References

• Horwitz SM. Management of peripheral T-cell non-Hodgkin's lymphoma. Curr Opin Oncol. 2007;19:438–443.
   PubMed Web of Science ®Google Scholar
• Vose J, Armitage J, Weisenburger D, et al. International peripheral T-cell and natural killer/T-cell lymphoma study: pathology findings and clinical outcomes. J Clin Oncol. 2008;26:4124–4130.
   PubMed Web of Science ®Google Scholar
• American Cancer Society. Cancer facts & figures; 2015. Available from: http://www.cancer.org/acs/groups/content/@editorial/documents/document/acspc-044552.pdf
   Google Scholar
• Adams SV, Newcomb PA, Shustov AR. Racial patterns of peripheral T-cell lymphoma incidence and survival in the United States. J Clin Oncol. 2016;34:963–971.
   PubMed Web of Science ®Google Scholar
• A predictive model for aggressive non-Hodgkin's lymphoma. The International non-Hodgkin's Lymphoma Prognostic Factors Project. N Engl J Med. 1993;329:987–994.
   PubMed Web of Science ®Google Scholar
• Mak V, Hamm J, Chhanabhai M, et al. Survival of patients with peripheral T-cell lymphoma after first relapse or progression: spectrum of disease and rare long-term survivors. J Clin Oncol. 2013;31:1970–1976.
   PubMed Web of Science ®Google Scholar
• Sorror ML, Storb RF, Sandmaier BM, et al. Comorbidity-age index: a clinical measure of biologic age before allogeneic hematopoietic cell transplantation. J Clin Oncol. 2014;32:3249–3256.
   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
• 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
• 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
• Coiffier B, Pro B, Prince HM, et al. Romidepsin for the treatment of relapsed/refractory peripheral T-cell lymphoma: pivotal study update demonstrates durable responses. J Hematol Oncol. 2014;7:11.
   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;117:5827–5834.
   PubMed Web of Science ®Google Scholar
• Pro B, Horwitz SM, Prince HM, et al. Romidepsin induces durable responses in patients with relapsed or refractory angioimmunoblastic T-cell lymphoma (AITL). Hematol Oncol. [cited 2016 Jul 12]. DOI:10.1002/hon.2320
   Google Scholar
• ISTODAX (romidepsin) [package insert]; 2014. Summit, NJ: Celgene Corporation; 2014.
   Google Scholar
• Moskowitz AJ, Horwitz SM. Targeting histone deacetylases in T-cell lymphoma. Leuk Lymphoma. [cited 2016 Nov]:[14 p.]. DOI:10.1080/10428194.2016.1247956
   Web of Science ®Google Scholar
• Cheson BD, Horning SJ, Coiffier B, et al. Report of an international workshop to standardize response criteria for non-Hodgkin's lymphomas. NCI Sponsored International Working Group. J Clin Oncol. 1999;17:1244–1253.
   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
• 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
• Stein WD, Wilkerson J, Kim ST, et al. Analyzing the pivotal trial that compared sunitinib and IFN-alpha in renal cell carcinoma, using a method that assesses tumor regression and growth. Clin Cancer Res. 2012;18:2374–2381.
   PubMed Web of Science ®Google Scholar
• Stein WD, Gulley JL, Schlom J, et al. Tumor regression and growth rates determined in five intramural NCI prostate cancer trials: the growth rate constant as an indicator of therapeutic efficacy. Clin Cancer Res. 2011;17:907–917.
   PubMed Web of Science ®Google Scholar
• Burotto M, Wilkerson J, Stein W, et al. Continuing a cancer treatment despite tumor growth may be valuable: sunitinib in renal cell carcinoma as example. PLoS One. 2014;9:e96316.
   PubMed Web of Science ®Google Scholar
• Piekarz RL, Frye AR, Wright JJ, et al. Cardiac studies in patients treated with depsipeptide, FK228, in a phase II trial for T-cell lymphoma. Clin Cancer Res. 2006;12:3762–3773.
   PubMed Web of Science ®Google Scholar
• Sager PT, Balser B, Wolfson J, et al. Electrocardiographic effects of class 1 selective histone deacetylase inhibitor romidepsin. Cancer Med. 2015;4:1178–1185.
   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
• Shah MH, Binkley P, Chan K, et al. Cardiotoxicity of histone deacetylase inhibitor depsipeptide in patients with metastatic neuroendocrine tumors. Clin Cancer Res. 2006;12:3997–4003.
   PubMed Web of Science ®Google Scholar
• Cabell C, Bates S, Piekarz R, et al. Systematic assessment of potential cardiac effects of the novel histone deacetylase (HDAC) inhibitor romidepsin. Blood. 2009;114:3709.
   Web of Science ®Google Scholar
• Bishton MJ, Harrison SJ, Martin BP, et al. Deciphering the molecular and biologic processes that mediate histone deacetylase inhibitor-induced thrombocytopenia. Blood. 2011;117:3658–3668.
   PubMed Web of Science ®Google Scholar