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J Clin Oncol ; 29(18): 2598-607, 2011 Jun 20.
Article in English | MEDLINE | ID: mdl-21576639

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.


Subject(s)
Clinical Trials as Topic/standards , Mycosis Fungoides/drug therapy , Neoplasm Staging/standards , Outcome Assessment, Health Care/standards , Sezary Syndrome/drug therapy , Skin Neoplasms/drug therapy , Clinical Trials as Topic/methods , Humans , Lymph Nodes/pathology , Mycosis Fungoides/blood , Mycosis Fungoides/classification , Mycosis Fungoides/pathology , Mycosis Fungoides/psychology , Neoplasm Staging/methods , Quality of Life , Randomized Controlled Trials as Topic/methods , Randomized Controlled Trials as Topic/standards , Research Design , Severity of Illness Index , Sezary Syndrome/blood , Sezary Syndrome/classification , Sezary Syndrome/pathology , Sezary Syndrome/psychology , Skin/pathology , Skin Neoplasms/blood , Skin Neoplasms/classification , Skin Neoplasms/pathology , Skin Neoplasms/psychology , Treatment Outcome , Tumor Burden , Viscera/pathology
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