title: Clinically significant responses achieved with romidepsin across disease compartments in patients with cutaneous T-cell lymphoma.
abstract: Cutaneous T-cell lymphoma (CTCL) is a rare heterogeneous group of non-Hodgkin lymphomas that arises in the skin but can progress to systemic disease (lymph nodes, blood, viscera). Historically, in clinical trials of CTCL there has been little consistency in how responses were defined in each disease "compartment"; some studies only assessed responses in the skin. The histone deacetylase inhibitor romidepsin is approved by the US Food and Drug Administration for the treatment of CTCL in patients who have received at least one prior systemic therapy. Phase II studies that led to approval used rigorous composite end points that incorporated disease assessments in all compartments. The objective of this analysis was to thoroughly examine the activity of romidepsin within each disease compartment in patients with CTCL. Romidepsin was shown to have clinical activity across disease compartments and is suitable for use in patients with CTCL having skin involvement only, erythroderma, lymphadenopathy and/or blood involvement.
authors: a University of Pennsylvania , PA , USA.
authors: Ellen J
authors: EJ
authors: Kim
authors: b Stanford Cancer Center , Stanford , CA , USA.
authors: Youn H
authors: YH
authors: Kim
authors: a University of Pennsylvania , PA , USA.
authors: Alain H
authors: AH
authors: Rook
authors: c Boston Medical Center , Boston , MA , USA.
authors: Adam
authors: A
authors: Lerner
authors: d The University of Texas M. D. Anderson Cancer Center , Houston , TX , USA.
authors: Madeleine
authors: M
authors: Duvic
authors: b Stanford Cancer Center , Stanford , CA , USA.
authors: Sunil
authors: S
authors: Reddy
authors: e Medical University of Lodz , Lodz , Poland.
authors: Tadeusz
authors: T
authors: Robak
authors: f Medical University of Graz , Graz , Austria.
authors: Jürgen C
authors: JC
authors: Becker
authors: g State Educational Institution for Higher Professional Education Military Medical Academy , Saint Petersburg , Russia.
authors: Alexey
authors: A
authors: Samtsov
authors: h Alba BioPharm Advisors Inc ., Raleigh , NC , USA.
authors: William
authors: W
authors: McCulloch
authors: i Brightech International LLC , Somerset , NJ , USA.
authors: Joel
authors: J
authors: Waksman
authors: j Guy's and St Thomas' Hospitals , London , UK.
authors: Sean
authors: S
authors: Whittaker
mesh_terms: D000903:Antibiotics, Antineoplastic / Q000494:pharmacology / Q000627:therapeutic use*; D047630:Depsipeptides / Q000494:pharmacology / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D016410:Lymphoma, T-Cell, Cutaneous / Q000188:drug therapy* / Q000473:pathology*; D008297:Male; D060787:Neoplasm Grading; D009367:Neoplasm Staging; D019233:Retreatment; D016896:Treatment Outcome; D047368:Tumor Burden
chemical_list: D000903:Antibiotics, Antineoplastic; D047630:Depsipeptides; C087123:romidepsin
keywords: Lymphoma and Hodgkin disease; pharmacotherapeutics; prognostication