title: Duration of response in cutaneous T-cell lymphoma patients treated with denileukin diftitox: results from 3 phase III studies.
abstract: BACKGROUND
  We aimed to determine duration of response in patients with CTCL treated using DD who experienced partial response, complete clinical response, or complete response.
  
  
  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.
  
  
  CONCLUSIONS
  These data indicate a durable response with DD in CTCL, even in heavily pretreated patients and those with CD25 low-expression disease.
authors.affiliation: Department of Dermatology, University of Texas MD Anderson Cancer Center, Houston, TX, USA. mduvic@mdanderson.org
authors.forename: Madeleine
authors.initials: M
authors.lastname: Duvic
authors.forename: Larisa
authors.initials: L
authors.lastname: Geskin
authors.forename: H Miles
authors.initials: HM
authors.lastname: Prince
mesh_terms: D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004167:Diphtheria Toxin / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007376:Interleukin-2 / Q000009:adverse effects / Q000627:therapeutic use*; D016410:Lymphoma, T-Cell, Cutaneous / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D011993:Recombinant Fusion Proteins / Q000009:adverse effects / Q000627:therapeutic use; D012878:Skin Neoplasms / Q000188:drug therapy* / Q000473:pathology; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D004167:Diphtheria Toxin; D007376:Interleukin-2; D011993:Recombinant Fusion Proteins; C078456:denileukin diftitox
keywords: Fusion protein; Mycosis fungoides; Sézary syndrome