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Updated: Aug 13, 2026

Evaluation of Tumor-infiltrating Leukocyte Subsets in a Subcutaneous Tumor Model
Published on: April 13, 2015
CD25 expression is correlated with histological grade and response to denileukin diftitox in cutaneous T-cell
Rakhshandra Talpur1, Daniel M Jones, Alvaro J Alencar
1Department of Dermatology, The University of Texas MD Anderson Cancer Center, Houston, Texas 77030-4095, USA.
Abstract:
Denileukin diftitox (Ontak), a recombinant fusion protein of diphtheria toxin and ligand, IL-2, binds to the IL-2 receptor, is internalized, and causes cell death. Denileukin diftitox was approved for the treatment of cutaneous T-cell lymphomas (CTCLs) with CD25+ expression. We prospectively stained lesional skin biopsy specimens from 113 mycosis fungoides and Sézary Syndrome patients for activation markers CD25 and CD30 to correlate expression with clinical tumor-node metastasis (TNM) stage, histologic grade, and response to denileukin diftitox. High expression was defined as positivity of > or =20% of lesional T-cells using immunohistochemistry (IHC). CD25 and CD30 expression was more common in lesions from advanced patients (P = 0.04 and 0.002, respectively). Advanced TNM (T3 or T4) was significantly associated with intermediate-grade (P = 0.002) and large-cell transformation histology (P = 0.04). Of interest, clinical responses were observed in 78.5% of patients with high CD25 expression versus 20% with low to undetectable CD25 expression (P = 0.01) among 24 patients receiving standard 5-day infusions of denileukin diftitox at 18 microg/kg/day. These data suggest that high CD25 expression by IHC is associated with advanced CTCL and with clinical response to denileukin diftitox therapy.
Insights
High CD25 expression on T-cells in cutaneous T-cell lymphoma (CTCL) indicates advanced disease and predicts a strong response to denileukin diftitox therapy, a targeted treatment for CTCL.
Area of Science:
- Oncology
- Immunology
- Dermatology
Background:
- Denileukin diftitox (Ontak) is a fusion protein targeting the IL-2 receptor, approved for cutaneous T-cell lymphomas (CTCLs) expressing CD25.
- Understanding biomarkers for treatment response in CTCL is crucial for optimizing patient outcomes.
Purpose of the Study:
- To evaluate the correlation between CD25 and CD30 expression in lesional skin biopsies and clinical parameters in CTCL patients.
- To assess the association of CD25 expression with response to denileukin diftitox therapy.
Main Methods:
- Prospective immunohistochemistry (IHC) staining for CD25 and CD30 on skin biopsy specimens from 113 mycosis fungoides and Sézary Syndrome patients.
- Correlation of marker expression with tumor-node-metastasis (TNM) stage and histologic grade.
- Analysis of clinical response rates to denileukin diftitox based on CD25 expression levels.
Main Results:
- CD25 and CD30 expression were more frequent in advanced-stage CTCL patients (P = 0.04 and 0.002).
- Advanced TNM staging correlated with intermediate-grade and large-cell transformation histology.
- Patients with high CD25 expression (> or =20% of lesional T-cells) showed significantly higher response rates (78.5%) to denileukin diftitox compared to those with low expression (20%) (P = 0.01).
Conclusions:
- High CD25 expression, as determined by IHC, is associated with advanced CTCL.
- CD25 expression is a predictive biomarker for clinical response to denileukin diftitox therapy in CTCL patients.
