title: Results from a pivotal, open-label, phase II study of romidepsin in relapsed or refractory peripheral T-cell lymphoma after prior systemic therapy.
abstract: OBJECTIVE
  Romidepsin is a structurally unique, potent class 1 selective histone deacetylase inhibitor. The primary objective of this international, pivotal, single-arm, phase II trial was to confirm the efficacy of romidepsin in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).
  
  
  METHODS
  Patients who were refractory to at least one prior systemic therapy or for whom at least one prior systemic therapy failed received romidepsin at 14 mg/m(2) as a 4-hour intravenous infusion on days 1, 8, and 15 every 28 days. The primary end point was the rate of complete response/unconfirmed complete response (CR/CRu) as assessed by an independent review committee.
  
  
  RESULTS
  Of the 131 patients enrolled, 130 had histologically confirmed PTCL by central review. The median number of prior systemic therapies was two (range, one to eight). The objective response rate was 25% (33 of 130), including 15% (19 of 130) with CR/CRu. Patient characteristics, prior stem-cell transplantation, number or type of prior therapies, or response to last prior therapy did not have an impact on response rate. The median duration of response was 17 months, with the longest response ongoing at 34+ months. Of the 19 patients who achieved CR/CRu, 17 (89%) had not experienced disease progression at a median follow-up of 13.4 months. The most common grade ≥ 3 adverse events were thrombocytopenia (24%), neutropenia (20%), and infections (all types, 19%).
  
  
  CONCLUSIONS
  Single-agent romidepsin induced complete and durable responses with manageable toxicity in patients with relapsed or refractory PTCL across all major PTCL subtypes, regardless of the number or type of prior therapies. Results led to US Food and Drug Administration approval of romidepsin in this indication.
authors.affiliation: Hematology, Centre Hospitalier Lyon-Sud, 69310 Pierre-Benite, France. bertrand.coiffier@chu-lyon.fr
authors.forename: Bertrand
authors.initials: B
authors.lastname: Coiffier
authors.forename: Barbara
authors.initials: B
authors.lastname: Pro
authors.forename: H Miles
authors.initials: HM
authors.lastname: Prince
authors.forename: Francine
authors.initials: F
authors.lastname: Foss
authors.forename: Lubomir
authors.initials: L
authors.lastname: Sokol
authors.forename: Matthew
authors.initials: M
authors.lastname: Greenwood
authors.forename: Dolores
authors.initials: D
authors.lastname: Caballero
authors.forename: Peter
authors.initials: P
authors.lastname: Borchmann
authors.forename: Franck
authors.initials: F
authors.lastname: Morschhauser
authors.forename: Martin
authors.initials: M
authors.lastname: Wilhelm
authors.forename: Lauren
authors.initials: L
authors.lastname: Pinter-Brown
authors.forename: Swaminathan
authors.initials: S
authors.lastname: Padmanabhan
authors.forename: Andrei
authors.initials: A
authors.lastname: Shustov
authors.forename: Jean
authors.initials: J
authors.lastname: Nichols
authors.forename: Susan
authors.initials: S
authors.lastname: Carroll
authors.forename: John
authors.initials: J
authors.lastname: Balser
authors.forename: Barbara
authors.initials: B
authors.lastname: Balser
authors.forename: Steven
authors.initials: S
authors.lastname: Horwitz
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000903:Antibiotics, Antineoplastic / Q000627:therapeutic use; D047630:Depsipeptides / Q000009:adverse effects / Q000627:therapeutic use*; D003967:Diarrhea / Q000139:chemically induced; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D053208:Kaplan-Meier Estimate; D016411:Lymphoma, T-Cell, Peripheral / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D011014:Pneumonia / Q000139:chemically induced; D016896:Treatment Outcome; D014652:Vascular Diseases / Q000139:chemically induced; D014839:Vomiting / Q000139:chemically induced; D055815:Young Adult
chemical_list: D000903:Antibiotics, Antineoplastic; D047630:Depsipeptides; C087123:romidepsin