Article: Biologic correlates of response and survival in patients with cutaneous T-cell lymphoma treated with denileukin diftitox.
2006 Volume 7, Issue 3, Page(s) 199–204
Abstract: Background: Denileukin diftitox, a fusion protein consisting of peptide sequences for the enzymatically active and membrane translocation domains of diphtheria toxin and human interleukin, resulted in a response rate of 30% in the phase III registration ...
| Abstract | Background: Denileukin diftitox, a fusion protein consisting of peptide sequences for the enzymatically active and membrane translocation domains of diphtheria toxin and human interleukin, resulted in a response rate of 30% in the phase III registration trial in patients with recurrent or persistent cutaneous T-cell lymphoma (CTCL). Little is known with regard to the biologic correlates of response or the impact of denileukin diftitox on disease progression and survival. Patients and methods: In our single-center series of 37 patients with early- and advanced-stage disease with CTCL treated with denileukin diftitox at a dose of 9 microg/kg or 18 microg/kg per day, we observed an overall response rate of 51%. Results: In 8 patients with early-stage (< IIA) CTCL, there were 5 responses (62.5%), and the median survival has not been reached, with 70% of patients still alive at 46 months. In 29 patients with advanced-stage (>/= IIB) disease, there were 14 responses (49.3%), and the median survival was 31 months. Changes in the number of CD4+ CD25+ T-cell populations were observed in 7 of 19 responders, with no overall changes in the absolute lymphocyte counts during the course of therapy. Decrease in lactate dehydrogenase was strongly correlated with clinical response (P < 0.05). Conclusion: Denilekin diftitox was a well-tolerated treatment in early- and advanced-stage CTCL and was not associated with detrimental immunologic efects on lymphocyte populations. |
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| MeSH term(s) | Adult ; Aged ; Aged, 80 and over ; Antineoplastic Agents/therapeutic use ; CD4-Positive T-Lymphocytes/metabolism ; Clinical Trials as Topic ; Diphtheria Toxin/therapeutic use ; Female ; Humans ; Interleukin-2/therapeutic use ; Interleukin-2 Receptor alpha Subunit/biosynthesis ; Lymphoma, T-Cell, Cutaneous/drug therapy ; Lymphoma, T-Cell, Cutaneous/mortality ; Male ; Middle Aged ; Mycosis Fungoides/etiology ; Mycosis Fungoides/pathology ; Receptors, Interleukin-2/metabolism ; Recombinant Fusion Proteins/therapeutic use ; Skin Neoplasms/drug therapy ; Skin Neoplasms/mortality ; Treatment Outcome |
| Chemical Substances | Antineoplastic Agents ; Diphtheria Toxin ; Interleukin-2 ; Interleukin-2 Receptor alpha Subunit ; Receptors, Interleukin-2 ; Recombinant Fusion Proteins ; denileukin diftitox (25E79B5CTM) |
| Language | English |
| Publishing date | 2006-11 |
| Publishing country | United States |
| Document type | Clinical Trial ; Journal Article |
| ZDB-ID | 2228154-X |
| ISSN | 1557-9190 |
| ISSN | 1557-9190 |
| DOI | 10.3816/CLM.2006.n.059 |
| Database | MEDical Literature Analysis and Retrieval System OnLINE |
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