title: Romidepsin for the treatment of relapsed/refractory peripheral T cell lymphoma: prolonged stable disease provides clinical benefits for patients in the pivotal trial.
abstract: BACKGROUND
  Achievement of durable responses in patients with relapsed/refractory peripheral T cell lymphoma (PTCL) is challenging with current therapies, and there are few data regarding the potential benefits of continuing treatment in patients with the best response of stable disease (SD). Histone deacetylase inhibitors are a novel class of drugs with activity in T cell malignancies. Romidepsin was approved by the US Food and Drug Administration for the treatment of relapsed/refractory PTCL based on a pivotal trial demonstrating an objective response rate of 25% (33/130), including 15% with confirmed/unconfirmed complete response and a median duration of response of 28 months. Our objective was to further study the clinical benefits of romidepsin in patients that had the best response of SD.
  
  
  METHODS
  Patients with PTCL relapsed/refractory to ≥1 prior therapy were treated with the approved dose of 14 mg/m(2) romidepsin on days 1, 8, and 15 of six 28-day cycles; patients with SD or response after cycle 6 were allowed to continue on study until progression. By protocol amendment, patients treated for ≥12 cycles could receive maintenance dosing twice per cycle; after cycle 24, dosing could be further reduced to once per cycle in those who had received maintenance dosing for ≥6 months.
  
  
  RESULTS
  Of the 32 patients (25%) with the best response of SD, 22 had SD for ≥90 days (SD90; cycle 4 response assessment). The longest SD was >3 years in a patient who received maintenance dosing of 14 mg/m(2) on days 1 and 15 beginning in cycle 13. Patients with the best response of SD90 or partial response achieved similar overall and progression-free survival. Prolonged dosing of romidepsin was well tolerated.
  
  
  CONCLUSIONS
  We concluded that patients who achieve SD may consider continuing treatment because the clinical benefits of romidepsin may extend beyond objective responses.
  
  
  BACKGROUND
  NCT00426764.
authors.affiliation: Yale Cancer Center, PO Box 208028, 333 Cedar St, TMP 3, New Haven, CT, 06520-8028, USA. francine.foss@yale.edu.
authors.forename: Francine
authors.initials: F
authors.lastname: Foss
authors.affiliation: Memorial Sloan-Kettering Cancer Center, New York, NY, USA.
authors.forename: Steven
authors.initials: S
authors.lastname: Horwitz
authors.affiliation: Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, PA, USA.
authors.forename: Barbara
authors.initials: B
authors.lastname: Pro
authors.affiliation: Peter MacCallum Cancer Centre, University of Melbourne, Melbourne, Australia.
authors.forename: H Miles
authors.initials: HM
authors.lastname: Prince
authors.affiliation: Moffitt Cancer Center, Tampa, FL, USA.
authors.forename: Lubomir
authors.initials: L
authors.lastname: Sokol
authors.affiliation: Veristat, LLC, Southborough, MA, USA.
authors.forename: Barbara
authors.initials: B
authors.lastname: Balser
authors.affiliation: Veristat, LLC, Southborough, MA, USA.
authors.forename: Julie
authors.initials: J
authors.lastname: Wolfson
authors.affiliation: Hospices Civils de Lyon, Lyon, France.
authors.forename: Bertrand
authors.initials: B
authors.lastname: Coiffier
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000903:Antibiotics, Antineoplastic / Q000009:adverse effects / Q000627:therapeutic use; D047630:Depsipeptides / Q000009:adverse effects / Q000627:therapeutic use*; D018450:Disease Progression; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D019008:Drug Resistance, Neoplasm / Q000187:drug effects*; D005221:Fatigue / Q000139:chemically induced; D005260:Female; D056572:Histone Deacetylase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D016411:Lymphoma, T-Cell, Peripheral / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D009364:Neoplasm Recurrence, Local; D009503:Neutropenia / Q000139:chemically induced; D012074:Remission Induction; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000903:Antibiotics, Antineoplastic; D047630:Depsipeptides; D056572:Histone Deacetylase Inhibitors; C087123:romidepsin
keywords: Peripheral T cell lymphoma; Romidepsin; Stable disease