title: Incidence of spontaneous remission in patients with CD25-positive mycosis fungoides/Sézary syndrome receiving placebo.
abstract: BACKGROUND
  Spontaneous remission is recognized in mycosis fungoides (MF) and Sézary syndrome (SS).
  
  
  OBJECTIVE
  We analyzed the outcome of 44 patients with previously treated CD25-positive (CD25+), recurrent/persistent MF/SS randomly assigned to receive placebo as part of a phase III trial.
  
  
  METHODS
  This trial investigated the efficacy and safety of two doses of denileukin diftitox in patients with MF/SS who had received up to 3 prior therapies. The primary end point was overall response rate. Multivariate regression analyses were used to assess the relationship between baseline covariates and clinical outcomes.
  
  
  RESULTS
  The overall response rate was 15.9% for placebo recipients (complete response: 2.3%; partial response: 13.6%), reflecting the baseline rate of disease remission that can be expected in a clinical trial. The median progression-free survival (PFS) in the placebo arm was moderately short at 4.4 months compared with the active-agent arm but important to consider in the context of recent single-arm phase II studies of other therapies for MF/SS that report PFS of approximately 6 months. Multivariate analyses identified no significant effects of any baseline factors on either overall response rate or PFS, although there was a trend toward poorer PFS with advanced age. Because sepsis occurred significantly more often in the placebo arm versus the active-treatment arm, the role of antibiotics in causing remission cannot be discounted (6.8% vs 0%; P < .05).
  
  
  CONCLUSIONS
  This study had a relatively small sample size, yielding a wide 95% confidence interval.
  
  
  CONCLUSIONS
  The results may serve as a useful comparator for other active-treatment studies of MF/SS that lack a placebo-control arm.
authors.affiliation: Haematology Service, Peter MacCallum Cancer Center and University of Melbourne, Melbourne, Australia. miles.prince@petermac.org
authors.forename: H Miles
authors.initials: HM
authors.lastname: Prince
authors.forename: Madeleine
authors.initials: M
authors.lastname: Duvic
authors.forename: Ann
authors.initials: A
authors.lastname: Martin
authors.forename: Wolfram
authors.initials: W
authors.lastname: Sterry
authors.forename: Chalid
authors.initials: C
authors.lastname: Assaf
authors.forename: David J
authors.initials: DJ
authors.lastname: Straus
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use; D004167:Diphtheria Toxin / Q000627:therapeutic use; D006801:Humans; D057194:Intention to Treat Analysis; D007376:Interleukin-2 / Q000627:therapeutic use; D053645:Interleukin-2 Receptor alpha Subunit / Q000378:metabolism*; D015999:Multivariate Analysis; D009182:Mycosis Fungoides / Q000378:metabolism / Q000473:pathology* / Q000628:therapy; D009365:Neoplasm Regression, Spontaneous; D010919:Placebos; D011788:Quality of Life; D011993:Recombinant Fusion Proteins / Q000627:therapeutic use; D012751:Sezary Syndrome / Q000378:metabolism / Q000473:pathology* / Q000628:therapy; D012878:Skin Neoplasms
chemical_list: D000970:Antineoplastic Agents; D004167:Diphtheria Toxin; D007376:Interleukin-2; D053645:Interleukin-2 Receptor alpha Subunit; D010919:Placebos; D011993:Recombinant Fusion Proteins; C078456:denileukin diftitox