Clinical trial results indicate that romidepsin, a histone deacetylase inhibitor, is a promising treatment in relapsed/refractory T-cell lymphomas (TCL). This retrospective multicenter study was conducted in patients with relapsed/refractory TCL treated with romidepsin monotherapy through a Named Patient Program (NPP) in Italy. Principal endpoints were overall response rate (ORR), safety and overall survival (OS). The ORR in 33 evaluable patients was 24.2% with an ORR in the cutaneous TCL of 35.7%. Global OS was 39.3% at 30 months. There were not any specific differences on hematological and extrahematological adverse events. Data from patients treated with romidepsin outside a controlled clinical trial give additional information about the clinical use, efficacy, and toxicity of the drug given to relapsed or refractory TCL patients in a real life context as TCL are rare diseases and more information is needed. These findings suggest that romidepsin is effective and safe for heavily pretreated TCL patients.
Romidepsin in relapsed/refractory T-cell lymphomas : Italian experience and results of a named patient program / P.L. Zinzani, C. Pellegrini, G. Cerciello, F. Monaco, S. Volpetti, A. Peli, E. Angelucci, P. Corradini, M.C. Cox, A. Guarini, M. Musso, P. Bresciani, G. Amato, A. Billio, G. Caparrotti, A. Figuera, L. Nassi, F. Gaudio, A. Grossi, F. Onida, M. Merli, L. Rigacci, L. Argnani. - In: LEUKEMIA & LYMPHOMA. - ISSN 1042-8194. - 57:10(2016 Feb 17), pp. 2370-2374. [10.3109/10428194.2015.1137292]
Romidepsin in relapsed/refractory T-cell lymphomas : Italian experience and results of a named patient program
P. Corradini;F. Onida;
2016
Abstract
Clinical trial results indicate that romidepsin, a histone deacetylase inhibitor, is a promising treatment in relapsed/refractory T-cell lymphomas (TCL). This retrospective multicenter study was conducted in patients with relapsed/refractory TCL treated with romidepsin monotherapy through a Named Patient Program (NPP) in Italy. Principal endpoints were overall response rate (ORR), safety and overall survival (OS). The ORR in 33 evaluable patients was 24.2% with an ORR in the cutaneous TCL of 35.7%. Global OS was 39.3% at 30 months. There were not any specific differences on hematological and extrahematological adverse events. Data from patients treated with romidepsin outside a controlled clinical trial give additional information about the clinical use, efficacy, and toxicity of the drug given to relapsed or refractory TCL patients in a real life context as TCL are rare diseases and more information is needed. These findings suggest that romidepsin is effective and safe for heavily pretreated TCL patients.File | Dimensione | Formato | |
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