Clinical End Points and Response Criteria in Mycosis Fungoides and Sezary 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

• Type of Material: Article
• Authors: Elise A Olsen, Duke University; Sean Whittaker, Kings College London; Youn H. Kim, Stanford Cancer Center; Madeleine Duvic, University of Texas MD Anderson Cancer Center; Sareeta Parker, Emory University
• Language: English
• Date: 2011-06-20
• Publisher: American Society of Clinical Oncology
• Publication Version: Final Published Version
• Copyright Statement: Copyright © 2011 by American Society of Clinical Oncology
• Final Published Version (URL): http://dx.doi.org/10.1200/JCO.2010.32.0630
• Title of Journal or Parent Work: Journal of Clinical Oncology
• Volume: 29
• Issue: 18
• Start Page: 2598
• End Page: 2607
• Grant/Funding Information: See publication for a full list of funding agencies.
• Keywords: Life Sciences & Biomedicine; TRIAL; OF-LIFE MEASURE; EXPRESSION; PERIPHERAL-BLOOD; Science & Technology; T-CELL LYMPHOMA; CLASSIFICATION; PHASE; DIAGNOSIS; IDENTIFICATION; DISEASE; Oncology
• Research Categories: Health Sciences, Oncology

Abstract

Mycosis fungoides (MF) and Sé zary 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. © 2011 by American Society of Clinical Oncology.