title: A Phase II trial of Belinostat (PXD101) in patients with relapsed or refractory peripheral or cutaneous T-cell lymphoma.
abstract: Belinostat is a pan-histone deacetylase inhibitor with antitumour and anti-angiogenic properties. An open label, multicentre study was conducted in patients with peripheral T-cell lymphoma (PTCL) or cutaneous T-cell lymphoma (CTCL) who failed ≥1 prior systemic therapy and were treated with belinostat (1000 mg/m(2) intravenously ×5 d of a 21-d cycle). The primary endpoint was objective response rate (ORR). Patients with PTCL (n = 24) had received a median of three prior systemic therapies (range 1-9) and 40% had stage IV disease. Patients with CTCL (n = 29) had received a median of one prior skin-directed therapy (range 0-4) and four prior systemic therapies (range 1-9); 55% had stage IV disease. The ORRs were 25% (PTCL) and 14% (CTCL). Treatment-related adverse events occurred in 77% of patients; nausea (43%), vomiting (21%), infusion site pain (13%) and dizziness (11%) had the highest incidence. Treatment-related serious adverse events were Grade 5 ventricular fibrillation; Grade 4 thrombocytopenia; Grade 3 peripheral oedema, apraxia, paralytic ileus and pneumonitis; and Grade 2 jugular vein thrombosis. Belinostat monotherapy was well tolerated and efficacious in patients with recurrent/refractory PTCL and CTCL. This trial was registered at www.clinicaltrials.gov as NCT00274651.
authors.affiliation: Yale Cancer Center, New Haven, CT, USA.
authors.forename: Francine
authors.initials: F
authors.lastname: Foss
authors.forename: Ranjana
authors.initials: R
authors.lastname: Advani
authors.forename: Madeleine
authors.initials: M
authors.lastname: Duvic
authors.forename: Kenneth B
authors.initials: KB
authors.lastname: Hymes
authors.forename: Tanin
authors.initials: T
authors.lastname: Intragumtornchai
authors.forename: Arnuparp
authors.initials: A
authors.lastname: Lekhakula
authors.forename: Ofer
authors.initials: O
authors.lastname: Shpilberg
authors.forename: Adam
authors.initials: A
authors.lastname: Lerner
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Belt
authors.forename: Eric D
authors.initials: ED
authors.lastname: Jacobsen
authors.forename: Guy
authors.initials: G
authors.lastname: Laurent
authors.forename: Dina
authors.initials: D
authors.lastname: Ben-Yehuda
authors.forename: Marie
authors.initials: M
authors.lastname: Beylot-Barry
authors.forename: Uwe
authors.initials: U
authors.lastname: Hillen
authors.forename: Poul
authors.initials: P
authors.lastname: Knoblauch
authors.forename: Gajanan
authors.initials: G
authors.lastname: Bhat
authors.forename: Shanta
authors.initials: S
authors.lastname: Chawla
authors.forename: Lee F
authors.initials: LF
authors.lastname: Allen
authors.forename: Brad
authors.initials: B
authors.lastname: Pohlman
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D005260:Female; D056572:Histone Deacetylase Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D006877:Hydroxamic Acids / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D007262:Infusions, Intravenous; D016410:Lymphoma, T-Cell, Cutaneous / Q000188:drug therapy* / Q000473:pathology; D016411:Lymphoma, T-Cell, Peripheral / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D012008:Recurrence; D013449:Sulfonamides / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D056572:Histone Deacetylase Inhibitors; D006877:Hydroxamic Acids; D013449:Sulfonamides; C487081:belinostat
keywords: T cell lymphoma; belinostat; histone deacetylase inhibitors; mycosis fungoides; peripheral T cell Lymphoma