title: Romidepsin: a histone deacetylase inhibitor for refractory cutaneous T-cell lymphoma.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of romidepsin in refractory cutaneous T-cell lymphoma (CTCL).
  
  
  METHODS
  An English-language literature search of PubMed and MEDLINE (Nov 2011-April 2012) was performed using the terms romidepsin, CTCL, and depsipeptide (FK228). The National Comprehensive Cancer Network guidelines, American Society of Clinical Oncology abstracts, American Society of Hematology abstracts, clinical trial registry, and prescribing information from the manufacturer were reviewed for additional information.
  
  
  METHODS
  Phase 1 and 2 trials evaluating the efficacy and safety of romidepsin were reviewed with a specific focus on its use in cutaneous T-cell lymphoma. All peer-reviewed articles with clinically relevant information were evaluated for inclusion.
  
  
  RESULTS
  In advanced stage CTCL, single or combination chemotherapy regimen responses are variable and lack durability. Romidepsin is a histone deacetylase inhibitor approved for refractory cutaneous T-cell lymphoma. Romidepsin has shown an improvement in duration of response and pruritus over traditional therapy. In 2 independent Phase 2 trials, romidepsin showed an overall response rate of 34% and durable response of 13-15 months in patients with refractory CTCL. The most frequent toxicities of romidepsin include nausea, vomiting, fatigue, or myelosuppression. Clinically insignificant QT interval changes have been observed but did not correlate with a decrease in left ventricular ejection fraction, or elevated laboratory markers of myocardial damage.
  
  
  CONCLUSIONS
  Romidepsin is an effective, durable, and well-tolerated single-agent therapy in patients with refractory CTCL and should be considered for formulary addition in this population.
authors.affiliation: Department of Clinical Pharmacy, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado, Aurora, USA. miryoung.kim@ucdenver.edu
authors.forename: Miryoung
authors.initials: M
authors.lastname: Kim
authors.forename: Lisa A
authors.initials: LA
authors.lastname: Thompson
authors.forename: Sarah D
authors.initials: SD
authors.lastname: Wenger
authors.forename: Cindy L
authors.initials: CL
authors.lastname: O'Bryant
mesh_terms: D047630:Depsipeptides / Q000494:pharmacology / Q000627:therapeutic use*; D004347:Drug Interactions; D056572:Histone Deacetylase Inhibitors / Q000494:pharmacology / Q000627:therapeutic use*; D006801:Humans; D016410:Lymphoma, T-Cell, Cutaneous / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D047630:Depsipeptides; D056572:Histone Deacetylase Inhibitors; C087123:romidepsin