Clinically meaningful reduction in pruritus in patients with cutaneous T-cell lymphoma treated with romidepsin.

Journal Article (Journal Article)

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.

Full Text

Duke Authors

Cited Authors

  • Kim, YH; Demierre, M-F; Kim, EJ; Lerner, A; Rook, AH; Duvic, M; Robak, T; Samtsov, A; McCulloch, W; Chen, SC; Waksman, J; Nichols, J; Whittaker, S

Published Date

  • February 2013

Published In

Volume / Issue

  • 54 / 2

Start / End Page

  • 284 - 289

PubMed ID

  • 22839723

Electronic International Standard Serial Number (EISSN)

  • 1029-2403

Digital Object Identifier (DOI)

  • 10.3109/10428194.2012.711829


  • eng

Conference Location

  • United States