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


Authors: Prince, H. M.; Duvic, M.; Martin, A.; Sterry, W.; Assaf, C.; Straus, D. J.
Article Title: Incidence of spontaneous remission in patients with CD25-positive mycosis fungoides/Sézary syndrome receiving placebo
Abstract: Spontaneous remission is recognized in mycosis fungoides (MF) and Sézary syndrome (SS). 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. 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. 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). This study had a relatively small sample size, yielding a wide 95% confidence interval. The results may serve as a useful comparator for other active-treatment studies of MF/SS that lack a placebo-control arm. Copyright © 2011 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.
Keywords: placebo; antineoplastic agents; antineoplastic agent; metabolism; interleukin 2; quality of life; skin neoplasms; tumor regression; pathology; skin tumor; hybrid protein; recombinant fusion proteins; multivariate analysis; phase 3 clinical trial; mycosis fungoides; diphtheria toxin; interleukin-2; placebos; interleukin 2 receptor alpha; interleukin-2 receptor alpha subunit; denileukin diftitox; sezary syndrome; neoplasm regression, spontaneous; intention to treat analysis; humans; human; article
Journal Title: Journal of the American Academy of Dermatology
Volume: 67
Issue: 5
ISSN: 0190-9622
Publisher: Mosby Elsevier  
Date Published: 2012-11-01
Start Page: 867
End Page: 875
Language: English
PUBMED: 22285675
PROVIDER: scopus
DOI/URL:
Notes: Cited By (since 1996):2 -- Export Date: 9 May 2014 -- Source: Scopus
Citation Impact
MSK Authors
  1. David J Straus
    356 Straus