A Phase II trial of Belinostat (PXD101) in patients with relapsed or refractory peripheral or cutaneous T-cell lymphoma

作者：Foss Francine^*; Advani Ranjana; Duvic Madeleine; Hymes Kenneth B; Intragumtornchai Tanin; Lekhakula Arnuparp; Shpilberg Ofer; Lerner Adam; Belt Robert J; Jacobsen Eric D; Laurent Guy; Ben Yehuda Dina; Beylot Barry Marie; Hillen Uwe; Knoblauch Poul; Bhat Gajanan; Chawla Shanta; Allen Lee F; Pohlman Brad

来源：British Journal of Haematology, 2015, 168(6): 811-819.

DOI：10.1111/bjh.13222

• belinostat
• histone deacetylase inhibitors
• T cell lymphoma
• mycosis fungoides
• peripheral T cell Lymphoma

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 (1000mg/m(2) intravenously x5d 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 as NCT00274651.

• 出版日期2015-3
• 单位河南工业大学