title: Romidepsin is effective and well tolerated in older patients with peripheral T-cell lymphoma: analysis of two phase II trials.
abstract: Peripheral T-cell lymphomas (PTCLs) are a rare group of lymphoid neoplasms with high relapse rates after initial therapy and poor prognosis. Most patients are aged ≥60 years and are often not candidates for aggressive salvage therapies. Romidepsin, a potent class I histone deacetylase inhibitor, has shown significant single-agent activity in relapsed/refractory PTCL. We evaluated the efficacy and tolerability of romidepsin in elderly patients in this setting. Ninety-five patients aged ≥60 years were identified from 2 prospective phase 2 registration trials of romidepsin, and comparative analyses were performed with younger patients from these trials. Response rates, progression-free survival, and overall survival were not statistically different for younger vs older patients. The toxicity profile in older and younger patients was similar in both trials. Romidepsin demonstrated similar efficacy and tolerability in younger and older patients and presents an attractive treatment option for relapsed/refractory PTCL regardless of age.
  
  
  BACKGROUND
  Clinicaltrials.gov identifiers: NCT00426764, NCT00007345.
authors.affiliation: a Department of Hematology , University of Washington Medical Center , Seattle , WA , USA.
authors.forename: Andrei
authors.initials: A
authors.lastname: Shustov
authors.affiliation: b Department of Hematology , Hospices Civils de Lyon , Lyon , France.
authors.forename: Bertrand
authors.initials: B
authors.lastname: Coiffier
authors.affiliation: c Department of Oncology , Memorial Sloan Kettering Cancer Center , New York , NY , USA.
authors.forename: Steven
authors.initials: S
authors.lastname: Horwitz
authors.affiliation: d Department of Hematology , Moffitt Cancer Center , Tampa , FL , USA.
authors.forename: Lubomir
authors.initials: L
authors.lastname: Sokol
authors.affiliation: e Department of Hematology/Oncology , Kimmel Cancer Center, Thomas Jefferson University , Philadelphia , PA , USA.
authors.forename: Barbara
authors.initials: B
authors.lastname: Pro
authors.affiliation: f Veristat, LLC , Southborough , MA , USA.
authors.forename: Julie
authors.initials: J
authors.lastname: Wolfson
authors.affiliation: f Veristat, LLC , Southborough , MA , USA.
authors.forename: Barbara
authors.initials: B
authors.lastname: Balser
authors.affiliation: g Department of Investigational Therapeutics , National Cancer Institute , Bethesda , MD , USA.
authors.forename: Robin
authors.initials: R
authors.lastname: Eisch
authors.affiliation: h Department of Hematology/Oncology , City of Hope Medical Center-Oncology , Duarte , CA , USA.
authors.forename: Leslie
authors.initials: L
authors.lastname: Popplewell
authors.affiliation: i Department of Hematology , Peter MacCallum Cancer Centre and University of Melbourne , Melbourne , Australia.
authors.forename: H Miles
authors.initials: HM
authors.lastname: Prince
authors.affiliation: j Department of Hematology , Hofstra North Shore-LIJ School of Medicine and Monter Cancer Center , Lake Success , NY , USA.
authors.forename: Steven L
authors.initials: SL
authors.lastname: Allen
authors.affiliation: g Department of Investigational Therapeutics , National Cancer Institute , Bethesda , MD , USA.
authors.forename: Richard
authors.initials: R
authors.lastname: Piekarz
authors.affiliation: k Department of Hematology/Oncology , Columbia University Medical Center , New York , NY , USA.
authors.forename: Susan
authors.initials: S
authors.lastname: Bates
mesh_terms: D000368:Aged; D000903:Antibiotics, Antineoplastic / Q000009:adverse effects / Q000627:therapeutic use; D047630:Depsipeptides / Q000009:adverse effects / Q000627:therapeutic use; D056572:Histone Deacetylase Inhibitors / Q000627:therapeutic use; D006801:Humans; D016411:Lymphoma, T-Cell, Peripheral / Q000188:drug therapy; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D011446:Prospective Studies
chemical_list: D000903:Antibiotics, Antineoplastic; D047630:Depsipeptides; D056572:Histone Deacetylase Inhibitors; C087123:romidepsin
keywords: Peripheral T-cell lymphoma; clinical trial; elderly; histone deacetylase inhibitor; romidepsin