title: Phase 2 trial of romidepsin in patients with peripheral T-cell lymphoma.
abstract: Romidepsin (depsipeptide or FK228) is a histone deacetylase inhibitor, one of a new class of agents active in T-cell lymphoma. A phase 2 trial was conducted in cutaneous (CTCL) and peripheral (PTCL) T-cell lymphoma. Major and durable responses in CTCL supported the approval of romidepsin for CTCL. Forty-seven patients with PTCL of various subtypes including PTCL NOS, angioimmunoblastic, ALK-negative anaplastic large cell lymphoma, and enteropathy-associated T-cell lymphoma were enrolled. All patients had received prior therapy with a median of 3 previous treatments (range 1-11); 18 (38%) had undergone stem-cell transplant. All patients were evaluated for toxicity; 2 patients discovered to be ineligible were excluded from response assessment. Common toxicities were nausea, fatigue, and transient thrombocytopenia and granulocytopenia. Complete responses were observed in 8 and partial responses in 9 of 45 patients, for an overall response rate of 38% (95% confidence interval 24%-53%). The median duration of overall response was 8.9 months (range 2-74). Responses were observed in various subtypes, with 6 responses among the 18 patients with prior stem-cell transplant. The histone deacetylase inhibitor romidepsin has single agent clinical activity associated with durable responses in patients with relapsed PTCL.
authors.affiliation: Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, National Institutes of Health/DHHS, 6130 Executive Blvd., Rockville, MD 20852, USA. rpiekarz@nih.gov
authors.forename: Richard L
authors.initials: RL
authors.lastname: Piekarz
authors.forename: Robin
authors.initials: R
authors.lastname: Frye
authors.forename: H Miles
authors.initials: HM
authors.lastname: Prince
authors.forename: Mark H
authors.initials: MH
authors.lastname: Kirschbaum
authors.forename: Jasmine
authors.initials: J
authors.lastname: Zain
authors.forename: Steven L
authors.initials: SL
authors.lastname: Allen
authors.forename: Elaine S
authors.initials: ES
authors.lastname: Jaffe
authors.forename: Alexander
authors.initials: A
authors.lastname: Ling
authors.forename: Maria
authors.initials: M
authors.lastname: Turner
authors.forename: Cody J
authors.initials: CJ
authors.lastname: Peer
authors.forename: William D
authors.initials: WD
authors.lastname: Figg
authors.forename: Seth M
authors.initials: SM
authors.lastname: Steinberg
authors.forename: Sonali
authors.initials: S
authors.lastname: Smith
authors.forename: David
authors.initials: D
authors.lastname: Joske
authors.forename: Ian
authors.initials: I
authors.lastname: Lewis
authors.forename: Laura
authors.initials: L
authors.lastname: Hutchins
authors.forename: Michael
authors.initials: M
authors.lastname: Craig
authors.forename: A Tito
authors.initials: AT
authors.lastname: Fojo
authors.forename: John J
authors.initials: JJ
authors.lastname: Wright
authors.forename: Susan E
authors.initials: SE
authors.lastname: Bates
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000903:Antibiotics, Antineoplastic / Q000493:pharmacokinetics / Q000627:therapeutic use*; D047630:Depsipeptides / Q000493:pharmacokinetics / Q000627:therapeutic use*; D018450:Disease Progression; D005260:Female; D006801:Humans; D017728:Lymphoma, Large-Cell, Anaplastic / Q000188:drug therapy*; D016410:Lymphoma, T-Cell, Cutaneous / Q000188:drug therapy*; D016411:Lymphoma, T-Cell, Peripheral / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D012074:Remission Induction; D012878:Skin Neoplasms / Q000188:drug therapy; D015996:Survival Rate; D014018:Tissue Distribution; D016896:Treatment Outcome
chemical_list: D000903:Antibiotics, Antineoplastic; D047630:Depsipeptides; C087123:romidepsin