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

Publication ,  Journal Article
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 in: Leuk Lymphoma
February 2013

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.

Duke Scholars

Published In

Leuk Lymphoma

DOI

EISSN

1029-2403

Publication Date

February 2013

Volume

54

Issue

2

Start / End Page

284 / 289

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Pruritus
  • Neoplasm Staging
  • Middle Aged
  • Male
  • Lymphoma, T-Cell, Cutaneous
  • Immunology
  • Humans
  • Female
  • Depsipeptides
 

Citation

APA
Chicago
ICMJE
MLA
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Kim, Y. H., Demierre, M.-F., Kim, E. J., Lerner, A., Rook, A. H., Duvic, M., … Whittaker, S. (2013). Clinically meaningful reduction in pruritus in patients with cutaneous T-cell lymphoma treated with romidepsin. Leuk Lymphoma, 54(2), 284–289. https://doi.org/10.3109/10428194.2012.711829
Kim, Youn H., Marie-France Demierre, Ellen J. Kim, Adam Lerner, Alain H. Rook, Madeleine Duvic, Tadeusz Robak, et al. “Clinically meaningful reduction in pruritus in patients with cutaneous T-cell lymphoma treated with romidepsin.Leuk Lymphoma 54, no. 2 (February 2013): 284–89. https://doi.org/10.3109/10428194.2012.711829.
Kim YH, Demierre M-F, Kim EJ, Lerner A, Rook AH, Duvic M, et al. Clinically meaningful reduction in pruritus in patients with cutaneous T-cell lymphoma treated with romidepsin. Leuk Lymphoma. 2013 Feb;54(2):284–9.
Kim, Youn H., et al. “Clinically meaningful reduction in pruritus in patients with cutaneous T-cell lymphoma treated with romidepsin.Leuk Lymphoma, vol. 54, no. 2, Feb. 2013, pp. 284–89. Pubmed, doi:10.3109/10428194.2012.711829.
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. Clinically meaningful reduction in pruritus in patients with cutaneous T-cell lymphoma treated with romidepsin. Leuk Lymphoma. 2013 Feb;54(2):284–289.

Published In

Leuk Lymphoma

DOI

EISSN

1029-2403

Publication Date

February 2013

Volume

54

Issue

2

Start / End Page

284 / 289

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Pruritus
  • Neoplasm Staging
  • Middle Aged
  • Male
  • Lymphoma, T-Cell, Cutaneous
  • Immunology
  • Humans
  • Female
  • Depsipeptides