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

J Clin Oncol. 2011 Jun 20;29(18):2598-607. doi: 10.1200/JCO.2010.32.0630. Epub 2011 May 16.


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 types

  • Consensus Development Conference
  • Practice Guideline

MeSH terms

  • Clinical Trials as Topic / methods
  • Clinical Trials as Topic / standards*
  • Humans
  • Lymph Nodes / pathology
  • Mycosis Fungoides / blood
  • Mycosis Fungoides / classification
  • Mycosis Fungoides / drug therapy*
  • Mycosis Fungoides / pathology
  • Mycosis Fungoides / psychology
  • Neoplasm Staging / methods
  • Neoplasm Staging / standards*
  • Outcome Assessment, Health Care / standards*
  • Quality of Life
  • Randomized Controlled Trials as Topic / methods
  • Randomized Controlled Trials as Topic / standards
  • Research Design
  • Severity of Illness Index
  • Sezary Syndrome / blood
  • Sezary Syndrome / classification
  • Sezary Syndrome / drug therapy*
  • Sezary Syndrome / pathology
  • Sezary Syndrome / psychology
  • Skin / pathology
  • Skin Neoplasms / blood
  • Skin Neoplasms / classification
  • Skin Neoplasms / drug therapy*
  • Skin Neoplasms / pathology
  • Skin Neoplasms / psychology
  • Treatment Outcome
  • Tumor Burden
  • Viscera / pathology