title: Romidepsin in relapsed/refractory T-cell lymphomas: Italian experience and results of a named patient program.
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.
authors.affiliation: a Institute of Hematology "L. E A. Seràgnoli", University of Bologna , Bologna , Italy ;
authors.forename: Pier Luigi
authors.initials: PL
authors.lastname: Zinzani
authors.affiliation: a Institute of Hematology "L. E A. Seràgnoli", University of Bologna , Bologna , Italy ;
authors.forename: Cinzia
authors.initials: C
authors.lastname: Pellegrini
authors.affiliation: b AOU Policlinico Federico II , Napoli , Italy ;
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Cerciello
authors.affiliation: c A.O. SS Antonio E Biagio E Cesare Arrigo , Alessandria , Italy ;
authors.forename: Federico
authors.initials: F
authors.lastname: Monaco
authors.affiliation: d Centro Trapianti E Terapie Cellulari Azienda Ospedaliero-Universitaria , Udine , Italy ;
authors.forename: Stefano
authors.initials: S
authors.lastname: Volpetti
authors.affiliation: e Department of Hematology, Spedali Civili , Brescia , Italy ;
authors.forename: Annalisa
authors.initials: A
authors.lastname: Peli
authors.affiliation: f UO Ematologia E Centro Trapianti, Ospedale Oncologico Di Riferimento Regionale "Armando Businco", Azienda Ospedaliera "Brotzu" , Cagliari , Italy ;
authors.forename: Emanuele
authors.initials: E
authors.lastname: Angelucci
authors.affiliation: g Istituto Nazionale Dei Tumori, Università Di Milano , Milano , Italy ;
authors.forename: Paolo
authors.initials: P
authors.lastname: Corradini
authors.affiliation: h Hematology Unit, Sant'andrea Hospital , Roma , Italy ;
authors.forename: Maria Christina
authors.initials: MC
authors.lastname: Cox
authors.affiliation: i Natl Cancer Center "Istituto Tumori Giovanni Paolo II IRCCS" , Bari , Italy ;
authors.forename: Attilio
authors.initials: A
authors.lastname: Guarini
authors.affiliation: j Oncohematology and Bone Marrow Unit, Oncology Department , La Maddalena , Palermo , Italy ;
authors.forename: Maurizio
authors.initials: M
authors.lastname: Musso
authors.affiliation: k Department of Medical and Surgical Sciences , UNIMORE, AOU Policlinico , Modena , Italy ;
authors.forename: Paola
authors.initials: P
authors.lastname: Bresciani
authors.affiliation: l Oncology and Hematology Department , IOM Istituto Oncologico Del Mediterraneo , Viagrande , Catania , Italy ;
authors.forename: Gabriella
authors.initials: G
authors.lastname: Amato
authors.affiliation: m Hematology and BMT , Central Hospital , Bolzano , Italy ;
authors.forename: Atto
authors.initials: A
authors.lastname: Billio
authors.affiliation: n Division of Hematology , San Giuseppe Moscati Hospital , Aversa, Caserta , Italy ;
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Caparrotti
authors.affiliation: o Division of Hematology , AOU Policlinico-Vittorio Emanuele , Catania , Italy ;
authors.forename: Amalia
authors.initials: A
authors.lastname: Figuera
authors.affiliation: p Division of Hematology , Department of Translational Medicine Amedeo Avogadro University of Eastern Piedmont and Maggiore Hospital , Novara , Italy ;
authors.forename: Luca
authors.initials: L
authors.lastname: Nassi
authors.affiliation: q Department of Emergency and Organ Transplantation (D.E.T.O.), Hematology Section , University of Bari , Bari , Italy ;
authors.forename: Francesco
authors.initials: F
authors.lastname: Gaudio
authors.affiliation: r Istituto Fiorentino Di Cura E Assistenza , Firenze , Italy ;
authors.forename: Alberto
authors.initials: A
authors.lastname: Grossi
authors.affiliation: s Onco-Hematology, BMT Center Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico University of Milan , Milano , Italy ;
authors.forename: Francesco
authors.initials: F
authors.lastname: Onida
authors.affiliation: t Ospedale Di Circolo, Fondazione Macchi , University Hospital , Varese , Italy ;
authors.forename: Michele
authors.initials: M
authors.lastname: Merli
authors.affiliation: u Hematology Department AOU Careggi , Firenze , Italy.
authors.forename: Luigi
authors.initials: L
authors.lastname: Rigacci
authors.affiliation: a Institute of Hematology "L. E A. Seràgnoli", University of Bologna , Bologna , Italy ;
authors.forename: Lisa
authors.initials: L
authors.lastname: Argnani
mesh_terms: D000328:Adult; D000368:Aged; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D047630:Depsipeptides / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D019008:Drug Resistance, Neoplasm; D005260:Female; D006801:Humans; D016399:Lymphoma, T-Cell / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D012008:Recurrence; D019233:Retreatment; D012189:Retrospective Studies; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D000903:Antibiotics, Antineoplastic; D047630:Depsipeptides; C087123:romidepsin
keywords: Real life; T-cell lymphoma; refractory; relapsed; romidepsin