title: Clinical Efficacy of Romidepsin in Tumor Stage and Folliculotropic Mycosis Fungoides.
abstract: Tumor stage and folliculotropic mycosis fungoides are uncommon subtypes of cutaneous T-cell lymphoma (CTCL) with an aggressive disease course. Romidepsin is a histone deacetylase inhibitor approved by the US Food and Drug Administration for patients with CTCL who have received ≥ 1 previous systemic therapy. In the present study, we examined the efficacy and safety of romidepsin in patients from the pivotal, single-arm, open-label, phase II study of relapsed or refractory CTCL with cutaneous tumors and/or folliculotropic disease involvement.
  
  
  
  Patients with CTCL who had received ≥ 1 previous systemic therapy received romidepsin at 14 mg/m2on days 1, 8, and 15 of 28-day cycles. Responses were determined by a composite endpoint (assessments of the skin, blood, and lymph nodes). Patients with cutaneous tumors and/or folliculotropic disease involvement were identified by review of diagnosis and histology reports.
  
  
  
  The objective response rate to romidepsin was 45% in patients with cutaneous tumors (n = 20) and 60% in patients with folliculotropic disease involvement (n = 10).
  
  
  
  Romidepsin is active in subtypes of CTCL with less favorable outcomes, such as tumor stage and folliculotropic mycosis fungoides.
authors.affiliation: Yale Cancer Center, New Haven, CT. Electronic address: francine.foss@yale.edu.
authors.forename: Francine
authors.initials: F
authors.lastname: Foss
authors.affiliation: Department of Dermatology, The University of Texas MD Anderson Cancer Center, Houston, TX.
authors.forename: Madeleine
authors.initials: M
authors.lastname: Duvic
authors.affiliation: Boston Medical Center, Boston, MA.
authors.forename: Adam
authors.initials: A
authors.lastname: Lerner
authors.affiliation: Brightech International, Somerset, NJ.
authors.forename: Joel
authors.initials: J
authors.lastname: Waksman
authors.affiliation: Kings College London, St John's Institute of Dermatology, London, United Kingdom.
authors.forename: Sean
authors.initials: S
authors.lastname: Whittaker
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D047630:Depsipeptides / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D018450:Disease Progression; D019008:Drug Resistance, Neoplasm; D005260:Female; D056572:Histone Deacetylase Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D053208:Kaplan-Meier Estimate; D016410:Lymphoma, T-Cell, Cutaneous / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology*; D008297:Male; D008875:Middle Aged; D009182:Mycosis Fungoides / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology*; D012008:Recurrence; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000903:Antibiotics, Antineoplastic; D047630:Depsipeptides; D056572:Histone Deacetylase Inhibitors; C087123:romidepsin
keywords: CTCL; Cutaneous T-cell lymphoma; Cutaneous tumors; Histone deacetylase inhibitor; Pruritus