Denileukin diftitox for the treatment of CD25 low-expression mycosis fungoides and Sézary syndrome.

Journal Article (Clinical Trial;Journal Article;Multicenter Study)

In a placebo-controlled study, denileukin diftitox (DD) was effective against cutaneous T-cell lymphoma (CTCL) expressing CD25. An open-label companion study examined the efficacy and safety of DD in 36 patients with skin biopsies containing < 20% CD25 cells by immunohistochemistry staining (CD25 low expression). Patients received DD 18 μg/kg/day for 5 consecutive days every 3 weeks for up to eight courses. The primary endpoint, overall response rate, was 30.6% (95% confidence interval: 16.3, 48.1), 33.3% for stage IIA or lower disease, and 26.7% for stage IIB or greater disease. Median progression-free survival (PFS) was > 487 days, and median time to treatment failure was 68.5 days. No difference in PFS by disease stage was observed. The safety profile of DD in CD25 low-expression disease was similar to that in CD25+ disease. These findings suggest that CD25 low expression does not preclude a meaningful clinical response to DD in patients with CTCL.

Full Text

Duke Authors

Cited Authors

  • Prince, HM; Martin, AG; Olsen, EA; Fivenson, DP; Duvic, M

Published Date

  • January 2013

Published In

Volume / Issue

  • 54 / 1

Start / End Page

  • 69 - 75

PubMed ID

  • 22738414

Pubmed Central ID

  • PMC3523809

Electronic International Standard Serial Number (EISSN)

  • 1029-2403

Digital Object Identifier (DOI)

  • 10.3109/10428194.2012.706286


  • eng

Conference Location

  • United States