Artículos de revistas
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
Date
2011Registration in:
JOURNAL OF CLINICAL ONCOLOGY, v.29, n.18, p.2598-2607, 2011
0732-183X
10.1200/JCO.2010.32.0630
Author
OLSEN, Elise A.
WHITTAKER, Sean
KIM, Youn H.
DUVIC, Madeleine
PRINCE, H. Miles
LESSIN, Stuart R.
WOOD, Gary S.
WILLEMZE, Rein
DEMIERRE, Marie-France
PIMPINELLI, Nicola
BERNENGO, Maria Grazia
ORTIZ-ROMERO, Pablo L.
BAGOT, Martine
ESTRACH, Teresa
GUITART, Joan
KNOBLER, Robert
SANCHES, Jose Antonio
IWATSUKI, Keiji
SUGAYA, Makoto
DUMMER, Reinhard
PITTELKOW, Mark
HOPPE, Richard
PARKER, Sareeta
GESKIN, Larisa
PINTER-BROWN, Lauren
GIRARDI, Michael
BURG, Guenter
RANKI, Annamari
VERMEER, Maartan
HORWITZ, Steven
HEALD, Peter
ROSEN, Steve
CERRONI, Lorenzo
DRENO, Brigette
VONDERHEID, Eric C.
Institutions
Abstract
Mycosis fungoides (MF) and Sezary 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. J Clin Oncol 29:2598-2607. (C) 2011 by American Society of Clinical Oncology