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 / Zinzani, PIER LUIGI; Pellegrini, Cinzia; Cerciello, Giuseppe; Monaco, Federico; Volpetti, Stefano; Peli, Annalisa; Angelucci, Emanuele; Corradini, Paolo; Cox, Maria Christina; Guarini, Attilio; Musso, Maurizio; Bresciani, Paola; Amato, Gabriella; Billio, Atto; Caparrotti, Giuseppe; Figuera, Amalia; Nassi, Luca; Gaudio, Francesco; Grossi, Alberto; Onida, Francesco; Merli, Michele; Rigacci, Luigi; Argnani, Lisa. - In: LEUKEMIA & LYMPHOMA. - ISSN 1042-8194. - STAMPA. - 57:10(2016), pp. 2370-2374. [10.3109/10428194.2015.1137292]
Romidepsin in relapsed/refractory T-cell lymphomas: Italian experience and results of a named patient program
ZINZANI, PIER LUIGI;PELLEGRINI, CINZIA;CORRADINI, PAOLO;GROSSI, ALBERTO;MERLI, MICHELE;ARGNANI, LISA
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.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
