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

Abstract

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.

• Authors: H Miles Prince, Ann G Martin, Elise A Olsen, David P Fivenson, Madeleine Duvic
• Journal: Leukemia & lymphoma (Leuk Lymphoma) Vol. 54 Issue 1 Pg. 69-75 (Jan 2013) ISSN: 1029-2403 [Electronic] United States
• PMID: 22738414 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Antineoplastic Agents
• Diphtheria Toxin
• Interleukin-2
• Interleukin-2 Receptor alpha Subunit
• Recombinant Fusion Proteins
• denileukin diftitox

Topics

• Adult
• Aged
• Aged, 80 and over
• Antineoplastic Agents (administration & dosage, adverse effects, therapeutic use)
• Diphtheria Toxin (administration & dosage, adverse effects, therapeutic use)
• Female
• Humans
• Interleukin-2 (administration & dosage, adverse effects, therapeutic use)
• Interleukin-2 Receptor alpha Subunit (metabolism)
• Male
• Middle Aged
• Mycosis Fungoides (drug therapy, metabolism, mortality, pathology)
• Neoplasm Staging
• Recombinant Fusion Proteins (administration & dosage, adverse effects, therapeutic use)
• Sezary Syndrome (drug therapy, metabolism, mortality, pathology)
• Treatment Outcome