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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


Olsen, E A; Whittaker, S J; 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; Dummer, R; Pittelkow, M; Hoppe, R; Parker, S; Geskin, L; Pinter-Brown, L; Girardi, M; Burg, G; Ranki, A; Vermeer, M H; Horwitz, S; Heald, P; Rosen, S; Cerroni, L; Dreno, B; Vonderheid, E C (2011). 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. Journal of Clinical Oncology, 29(18):2598-2607.

Abstract

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.

Abstract

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.

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Additional indexing

Item Type:Journal Article, refereed, original work
Communities & Collections:04 Faculty of Medicine > University Hospital Zurich > Dermatology Clinic
Dewey Decimal Classification:610 Medicine & health
Language:English
Date:2011
Deposited On:28 Jul 2011 11:44
Last Modified:05 Apr 2016 14:57
Publisher:American Society of Clinical Oncology
ISSN:0732-183X
Publisher DOI:https://doi.org/10.1200/JCO.2010.32.0630
PubMed ID:21576639

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