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A Phase II trial of Belinostat ( PXD 101) in patients with relapsed or refractory peripheral or cutaneous T‐cell lymphoma

2014; Wiley; Volume: 168; Issue: 6 Linguagem: Inglês

10.1111/bjh.13222

1365-2141

Francine M. Foss, Ranjana H. Advani, Madeleine Duvic, Kenneth B. Hymes, Tanin Intragumtornchai, Arnuparp Lekhakula, Ofer Shpilberg, Adam Lerner, Robert J. Belt, Eric D. Jacobsen, Guy Laurent, Dina Ben‐Yehuda, M. Beylot‐Barry, Uwe Hillen, Poul Knoblauch, Gajanan Bhat, Shanta Chawla, Lee F. Allen, Brad Pohlman,

Viral-associated cancers and disorders

Summary 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 ORR s 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 NCT 00274651.