TY - JOUR
T1 - Clinical end points and response criteria in mycosis fungoides and Sézary syndrome
T2 - 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
AU - Olsen, Elise A.
AU - Whittaker, Sean
AU - Kim, Youn H.
AU - Duvic, Madeleine
AU - Prince, H. Miles
AU - Lessin, Stuart R.
AU - Wood, Gary S.
AU - Willemze, Rein
AU - Demierre, Marie France
AU - Pimpinelli, Nicola
AU - Bernengo, Maria Grazia
AU - Ortiz-Romero, Pablo L.
AU - Bagot, Martine
AU - Estrach, Teresa
AU - Guitart, Joan
AU - Knobler, Robert
AU - Sanches, José Antonio
AU - Iwatsuki, Keiji
AU - Sugaya, Makoto
AU - Dummer, Reinhard
AU - Pittelkow, Mark
AU - Hoppe, Richard
AU - Parker, Sareeta
AU - Geskin, Larisa
AU - Pinter-Brown, Lauren
AU - Girardi, Michael
AU - Burg, Günter
AU - Ranki, Annamari
AU - Vermeer, Maartan
AU - Horwitz, Steven
AU - Heald, Peter
AU - Rosen, Steve
AU - Cerroni, Lorenzo
AU - Dreno, Brigette
AU - Vonderheid, Eric C.
PY - 2011/6/20
Y1 - 2011/6/20
N2 - 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.
AB - 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.
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U2 - 10.1200/JCO.2010.32.0630
DO - 10.1200/JCO.2010.32.0630
M3 - Review article
C2 - 21576639
AN - SCOPUS:79959290992
SN - 0732-183X
VL - 29
SP - 2598
EP - 2607
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 18
ER -