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Duration of response in cutaneous T-cell lymphoma patients treated with denileukin diftitox: results from 3 phase III studies.

AbstractBACKGROUND:
We aimed to determine duration of response in patients with CTCL treated using DD who experienced partial response, complete clinical response, or complete response.
PATIENTS AND METHODS:
Data from 3 phase III studies were pooled. Patients received up to 8 courses of 9 or 18 μg/kg intravenous DD daily for 5 days every 21 days, or placebo. Data on DD-treated patients were analyzed by dose and CD25 status. Kaplan-Meier product limit estimates and 95% confidence intervals were calculated for duration of response and time to response.
RESULTS:
The pooled population comprised 263 DD-treated and 44 placebo-treated patients, and 100 and 7, respectively, had at least a partial response. Median duration of response using DD was 277 days vs. 81 days using placebo. Overall response vs. placebo (n = 7; 16%) as (n = 25; 31%) for DD 9 μg/kg (P = .05), (n = 56; 47%) for DD 18 μg/kg (P = .004), (n = 8; 28%) for re-treated patients (DD 18 μg/kg; P = .21), and (n = 11; 31%) for CD25 low-expression patients (DD 18 μg/kg; P = .14). Overall response rates were similar between patients who did (n = 95; 36%) and did not (n = 105; 40%) develop capillary leak syndrome (CLS); median duration of response was longer in patients who developed CLS, but was not significant (619 vs. 267 days, respectively; P = .28). Adverse events occurred in 98% of DD-treated patients; most frequent were nausea, pyrexia, fatigue, CLS, and rigors.
CONCLUSION:
These data indicate a durable response with DD in CTCL, even in heavily pretreated patients and those with CD25 low-expression disease.
AuthorsMadeleine Duvic, Larisa Geskin, H Miles Prince
JournalClinical lymphoma, myeloma & leukemia (Clin Lymphoma Myeloma Leuk) Vol. 13 Issue 4 Pg. 377-84 (Aug 2013) ISSN: 2152-2669 [Electronic] United States
PMID23770157 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial)
CopyrightCopyright © 2013 Elsevier Inc. All rights reserved.
Chemical References
  • Antineoplastic Agents
  • Diphtheria Toxin
  • Interleukin-2
  • Recombinant Fusion Proteins
  • denileukin diftitox
Topics
  • Antineoplastic Agents (adverse effects, therapeutic use)
  • Diphtheria Toxin (adverse effects, therapeutic use)
  • Female
  • Humans
  • Interleukin-2 (adverse effects, therapeutic use)
  • Lymphoma, T-Cell, Cutaneous (drug therapy, pathology)
  • Male
  • Middle Aged
  • Recombinant Fusion Proteins (adverse effects, therapeutic use)
  • Skin Neoplasms (drug therapy, pathology)
  • Treatment Outcome

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