Clinical end points and response criteria in mycosis fungoides and Sézary syndrome: A consensus statement of the International Society for Cutaneous Lymphomas, the United States Cutaneous Lymphoma Consortium, and the Cutaneous Lymphoma Task Force of the European Organisation for Research and Treatment of Cancer Conference Paper uri icon


MeSH Major

  • Clinical Trials as Topic
  • Mycosis Fungoides
  • Neoplasm Staging
  • Outcome Assessment (Health Care)
  • Sezary Syndrome
  • Skin Neoplasms


  • Mycosis fungoides (MF) and Sézary syndrome (SS), the major forms of cutaneous T-cell lymphoma, have unique characteristics that distinguish them from other types of non-Hodgkin's lymphomas. Clinical trials in MF/SS have suffered from a lack of standardization in evaluation, staging, assessment, end points, and response criteria. Recently defined criteria for the diagnosis of early MF, guidelines for initial evaluation, and revised staging and classification criteria for MF and SS now offer the potential for uniform staging of patients enrolled in clinical trials for MF/SS. This article presents consensus recommendations for the general conduct of clinical trials of patients with MF/SS as well as methods for standardized assessment of potential disease manifestations in skin, lymph nodes, blood, and visceral organs, and definition of end points and response criteria. These guidelines should facilitate collaboration among investigators and collation of data from sponsor-generated or investigator-initiated clinical trials involving patients with MF or SS.


publication date

  • June 20, 2011



  • Conference Paper



  • eng

PubMed Central ID

  • PMC3422534

Digital Object Identifier (DOI)

  • 10.1200/JCO.2010.32.0630

PubMed ID

  • 21576639

Additional Document Info

start page

  • 2598

end page

  • 607


  • 29


  • 18