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Incidence of spontaneous remission in patients with CD25-positive mycosis fungoides/Sézary syndrome receiving placebo.

AbstractBACKGROUND:
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).
LIMITATIONS:
This study had a relatively small sample size, yielding a wide 95% confidence interval.
CONCLUSION:
The results may serve as a useful comparator for other active-treatment studies of MF/SS that lack a placebo-control arm.
AuthorsH Miles Prince, Madeleine Duvic, Ann Martin, Wolfram Sterry, Chalid Assaf, David J Straus
JournalJournal of the American Academy of Dermatology (J Am Acad Dermatol) Vol. 67 Issue 5 Pg. 867-75 (Nov 2012) ISSN: 1097-6787 [Electronic] United States
PMID22285675 (Publication Type: Clinical Trial, Phase III, Journal Article, Research Support, Non-U.S. Gov't)
CopyrightCopyright © 2011 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.
Chemical References
  • Antineoplastic Agents
  • Diphtheria Toxin
  • Interleukin-2
  • Interleukin-2 Receptor alpha Subunit
  • Placebos
  • Recombinant Fusion Proteins
  • denileukin diftitox
Topics
  • Antineoplastic Agents (therapeutic use)
  • Diphtheria Toxin (therapeutic use)
  • Humans
  • Intention to Treat Analysis
  • Interleukin-2 (therapeutic use)
  • Interleukin-2 Receptor alpha Subunit (metabolism)
  • Multivariate Analysis
  • Mycosis Fungoides (metabolism, pathology, therapy)
  • Neoplasm Regression, Spontaneous
  • Placebos
  • Quality of Life
  • Recombinant Fusion Proteins (therapeutic use)
  • Sezary Syndrome (metabolism, pathology, therapy)
  • Skin Neoplasms

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