title: A phase II study on the role of gemcitabine plus romidepsin (GEMRO regimen) in the treatment of relapsed/refractory peripheral T-cell lymphoma patients.
abstract: BACKGROUND
  There is no consensus regarding optimal treatment for peripheral T-cell lymphomas (PTCL), especially in relapsed or refractory cases, which have very poor prognosis and a dismal outcome, with 5-year overall survival of 30 %.
  
  
  METHODS
  A multicenter prospective phase II trial was conducted to investigate the role of the combination of gemcitabine plus romidepsin (GEMRO regimen) in relapsed/refractory PTCL, looking for a potential synergistic effect of the two drugs. GEMRO regimen contemplates an induction with romidepsin plus gemcitabine for six 28-day cycles followed by maintenance with romidepsin for patients in at least partial remission. The primary endpoint was the overall response rate (ORR); secondary endpoints were survival, duration of response, and safety of the regimen.
  
  
  RESULTS
  The ORR was 30 % (6/20) with 15 % (3) complete response (CR) rate. Two-year overall survival was 50 % and progression-free survival 11.2 %. Grade ≥3 adverse events were represented by thrombocytopenia (60 %), neutropenia (50 %), and anemia (20 %). Two patients are still in CR with median response duration of 18 months. The majority of non-hematological toxicities were mild and transient. No treatment-related death occurred and no toxicity led to treatment interruption.
  
  
  CONCLUSIONS
  GEMRO combination regimen shows efficacy data similar to those of single-agent romidepsin with additional hematologic toxicities. Synergy observed in preclinical phase did not turn into ability to improve clinical outcomes.
  
  
  BACKGROUND
  The trial was registered under EudraCT 2012-001404-38; ClinicalTrials.gov number, NCT01822886 .
authors.affiliation: Institute of Hematology "L. e A. Seràgnoli", University of Bologna, Via Massarenti, 9-40138, Bologna, Italy.
authors.forename: Cinzia
authors.initials: C
authors.lastname: Pellegrini
authors.affiliation: Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
authors.forename: Anna
authors.initials: A
authors.lastname: Dodero
authors.affiliation: Azienda Ospedaliera-Universitaria Città della Salute e della Scienza di Torino, Turin, Italy.
authors.forename: Annalisa
authors.initials: A
authors.lastname: Chiappella
authors.affiliation: A.O. SS Antonio e Biagio e Cesare Arrigo, Alessandria, Italy.
authors.forename: Federico
authors.initials: F
authors.lastname: Monaco
authors.affiliation: Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
authors.forename: Debora
authors.initials: D
authors.lastname: Degl'Innocenti
authors.affiliation: A.O. SS Antonio e Biagio e Cesare Arrigo, Alessandria, Italy.
authors.forename: Flavia
authors.initials: F
authors.lastname: Salvi
authors.affiliation: Azienda Ospedaliera-Universitaria Città della Salute e della Scienza di Torino, Turin, Italy.
authors.forename: Umberto
authors.initials: U
authors.lastname: Vitolo
authors.affiliation: Institute of Hematology "L. e A. Seràgnoli", University of Bologna, Via Massarenti, 9-40138, Bologna, Italy.
authors.forename: Lisa
authors.initials: L
authors.lastname: Argnani
authors.affiliation: Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Corradini
authors.affiliation: Institute of Hematology "L. e A. Seràgnoli", University of Bologna, Via Massarenti, 9-40138, Bologna, Italy. pierluigi.zinzani@unibo.it.
authors.forename: Pier Luigi
authors.initials: PL
authors.lastname: Zinzani
mesh_terms: D000328:Adult; D000368:Aged; D000740:Anemia / Q000139:chemically induced; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D047630:Depsipeptides / Q000008:administration & dosage / Q000009:adverse effects; D004334:Drug Administration Schedule; D019008:Drug Resistance, Neoplasm; D005260:Female; D006801:Humans; D016411:Lymphoma, T-Cell, Peripheral / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D009503:Neutropenia / Q000139:chemically induced; D011446:Prospective Studies; D012074:Remission Induction; D016019:Survival Analysis; D013921:Thrombocytopenia / Q000139:chemically induced; D016896:Treatment Outcome; D055815:Young Adult; D000093542:Gemcitabine
chemical_list: D047630:Depsipeptides; D003841:Deoxycytidine; C087123:romidepsin; D000093542:Gemcitabine
keywords: Gemcitabine; Peripheral T-cell lymphoma; Refractory; Relapsed; Romidepsin