PRINCE, H.M.; DUVIC, M.; MARTIN, A.; STERRY, W.; ASSAF, C.; STRAUS, D.J.<\/p>\n
<\/p>\n
Abstract<\/p>\n
BACKGROUND<\/strong>: Spontaneous remission is recognized in mycosis fungoides (MF) and S\u00e9zary syndrome (SS).<\/p>\n OBJECTIVE<\/strong>: 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.<\/p>\n METHODS<\/strong>: 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.<\/p>\n RESULTS<\/strong>: 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.<\/p>\n CONCLUSION<\/strong>: The results may serve as a useful comparator for other active-treatment studies of MF\/SS that lack a placebo-control arm<\/p>\n","protected":false},"excerpt":{"rendered":" PRINCE, H.M.; DUVIC, M.; MARTIN, A.; STERRY, W.; ASSAF, C.; STRAUS, D.J.<\/p>\n","protected":false},"author":16,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[8,1],"tags":[],"class_list":["post-31690","post","type-post","status-publish","format-standard","","category-articulos-cientificos","category-generales"],"_links":{"self":[{"href":"https:\/\/piel-l.org\/blog\/wp-json\/wp\/v2\/posts\/31690","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/piel-l.org\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/piel-l.org\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/piel-l.org\/blog\/wp-json\/wp\/v2\/users\/16"}],"replies":[{"embeddable":true,"href":"https:\/\/piel-l.org\/blog\/wp-json\/wp\/v2\/comments?post=31690"}],"version-history":[{"count":0,"href":"https:\/\/piel-l.org\/blog\/wp-json\/wp\/v2\/posts\/31690\/revisions"}],"wp:attachment":[{"href":"https:\/\/piel-l.org\/blog\/wp-json\/wp\/v2\/media?parent=31690"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/piel-l.org\/blog\/wp-json\/wp\/v2\/categories?post=31690"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/piel-l.org\/blog\/wp-json\/wp\/v2\/tags?post=31690"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}