title: Clinically meaningful reduction in pruritus in patients with cutaneous T-cell lymphoma treated with romidepsin.
abstract: Patients with cutaneous T-cell lymphoma (CTCL) frequently experience severe pruritus that can significantly impact their quality of life. Romidepsin is approved by the US Food and Drug Administration (FDA) for the treatment of patients with CTCL who have received at least one prior systemic therapy, with a reported objective response rate of 34%. In a phase 2 study of romidepsin in patients with CTCL (GPI-04-0001), clinically meaningful reduction in pruritus (CMRP) was evaluated as an indicator of clinical benefit by using a patient-assessed visual analog scale. To determine the effect of romidepsin alone, confounding pruritus treatments including steroids and antihistamines were prohibited. At baseline, 76% of patients reported moderate-to-severe pruritus; 43% of these patients experienced CMRP, including 11 who did not achieve an objective response. Median time to CMRP was 1.8 months, and median duration of CMRP was 5.6 months. Study results suggest that the clinical benefit of romidepsin may extend beyond objective responses.
authors: Stanford Cancer Center, Stanford, CA, USA. younkim@stanford.edu
authors: Youn H
authors: YH
authors: Kim
authors: Marie-France
authors: MF
authors: Demierre
authors: Ellen J
authors: EJ
authors: Kim
authors: Adam
authors: A
authors: Lerner
authors: Alain H
authors: AH
authors: Rook
authors: Madeleine
authors: M
authors: Duvic
authors: Tadeusz
authors: T
authors: Robak
authors: Alexey
authors: A
authors: Samtsov
authors: William
authors: W
authors: McCulloch
authors: Suephy C
authors: SC
authors: Chen
authors: Joel
authors: J
authors: Waksman
authors: Jean
authors: J
authors: Nichols
authors: Sean
authors: S
authors: Whittaker
mesh_terms: D000368:Aged; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage / Q000627:therapeutic use*; D047630:Depsipeptides / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D016410:Lymphoma, T-Cell, Cutaneous / Q000150:complications* / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011537:Pruritus / Q000175:diagnosis / Q000209:etiology*; D016896:Treatment Outcome
chemical_list: D000903:Antibiotics, Antineoplastic; D047630:Depsipeptides; C087123:romidepsin