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Leuk Lymphoma. 2016 Oct;57(10):2370-4. doi: 10.3109/10428194.2015.1137292. Epub 2016 Feb 17.

Romidepsin in relapsed/refractory T-cell lymphomas: Italian experience and results of a named patient program.

Author information

1
a Institute of Hematology "L. E A. Seràgnoli", University of Bologna , Bologna , Italy ;
2
b AOU Policlinico Federico II , Napoli , Italy ;
3
c A.O. SS Antonio E Biagio E Cesare Arrigo , Alessandria , Italy ;
4
d Centro Trapianti E Terapie Cellulari Azienda Ospedaliero-Universitaria , Udine , Italy ;
5
e Department of Hematology, Spedali Civili , Brescia , Italy ;
6
f UO Ematologia E Centro Trapianti, Ospedale Oncologico Di Riferimento Regionale "Armando Businco", Azienda Ospedaliera "Brotzu" , Cagliari , Italy ;
7
g Istituto Nazionale Dei Tumori, Università Di Milano , Milano , Italy ;
8
h Hematology Unit, Sant'andrea Hospital , Roma , Italy ;
9
i Natl Cancer Center "Istituto Tumori Giovanni Paolo II IRCCS" , Bari , Italy ;
10
j Oncohematology and Bone Marrow Unit, Oncology Department , La Maddalena , Palermo , Italy ;
11
k Department of Medical and Surgical Sciences , UNIMORE, AOU Policlinico , Modena , Italy ;
12
l Oncology and Hematology Department , IOM Istituto Oncologico Del Mediterraneo , Viagrande , Catania , Italy ;
13
m Hematology and BMT , Central Hospital , Bolzano , Italy ;
14
n Division of Hematology , San Giuseppe Moscati Hospital , Aversa, Caserta , Italy ;
15
o Division of Hematology , AOU Policlinico-Vittorio Emanuele , Catania , Italy ;
16
p Division of Hematology , Department of Translational Medicine Amedeo Avogadro University of Eastern Piedmont and Maggiore Hospital , Novara , Italy ;
17
q Department of Emergency and Organ Transplantation (D.E.T.O.), Hematology Section , University of Bari , Bari , Italy ;
18
r Istituto Fiorentino Di Cura E Assistenza , Firenze , Italy ;
19
s Onco-Hematology, BMT Center Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico University of Milan , Milano , Italy ;
20
t Ospedale Di Circolo, Fondazione Macchi , University Hospital , Varese , Italy ;
21
u Hematology Department AOU Careggi , Firenze , Italy.

Abstract

Clinical trial results indicate that romidepsin, a histone deacetylase inhibitor, is a promising treatment in relapsed/refractory T-cell lymphomas (TCLs). 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 TCLs are rare diseases and more information is needed. These findings suggest that romidepsin is effective and safe for heavily pretreated TCL patients.

KEYWORDS:

Real life; T-cell lymphoma; refractory; relapsed; romidepsin

PMID:
26732313
DOI:
10.3109/10428194.2015.1137292
[Indexed for MEDLINE]

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