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

Elise A. Olsen, Sean Whittaker, Youn H. Kim, Madeleine Duvic, H. Miles Prince, Stuart R. Lessin, Gary S. Wood, Rein Willemze, Marie France Demierre, Nicola Pimpinelli, Maria Grazia Bernengo, Pablo L. Ortiz-Romero, Martine Bagot, Teresa Estrach, Joan Guitart, Robert Knobler, José Antonio Sanches, Keiji Iwatsuki, Makoto Sugaya, Reinhard DummerMark Pittelkow, Richard Hoppe, Sareeta Parker, Larisa Geskin, Lauren Pinter-Brown, Michael Girardi, Günter Burg, Annamari Ranki, Maartan Vermeer, Steven Horwitz, Peter Heald, Steve Rosen, Lorenzo Cerroni, Brigette Dreno, Eric C. Vonderheid

Research output: Contribution to journalReview article

291 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)2598-2607
Number of pages10
JournalJournal of Clinical Oncology
Volume29
Issue number18
DOIs
Publication statusPublished - Jun 20 2011

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ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Olsen, E. A., Whittaker, S., Kim, Y. H., Duvic, M., Prince, H. M., Lessin, S. R., Wood, G. S., Willemze, R., Demierre, M. F., Pimpinelli, N., Bernengo, M. G., Ortiz-Romero, P. L., Bagot, M., Estrach, T., Guitart, J., Knobler, R., Sanches, J. A., Iwatsuki, K., Sugaya, M., ... Vonderheid, E. C. (2011). 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. Journal of Clinical Oncology, 29(18), 2598-2607. https://doi.org/10.1200/JCO.2010.32.0630