title: 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.
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.
authors.affiliation: Duke University Medical Center, Box 3294, Durham, NC 27710, USA. olsen001@mc.duke.edu
authors.forename: Elise A
authors.initials: EA
authors.lastname: Olsen
authors.forename: Sean
authors.initials: S
authors.lastname: Whittaker
authors.forename: Youn H
authors.initials: YH
authors.lastname: Kim
authors.forename: Madeleine
authors.initials: M
authors.lastname: Duvic
authors.forename: H Miles
authors.initials: HM
authors.lastname: Prince
authors.forename: Stuart R
authors.initials: SR
authors.lastname: Lessin
authors.forename: Gary S
authors.initials: GS
authors.lastname: Wood
authors.forename: Rein
authors.initials: R
authors.lastname: Willemze
authors.forename: Marie-France
authors.initials: MF
authors.lastname: Demierre
authors.forename: Nicola
authors.initials: N
authors.lastname: Pimpinelli
authors.forename: Maria Grazia
authors.initials: MG
authors.lastname: Bernengo
authors.forename: Pablo L
authors.initials: PL
authors.lastname: Ortiz-Romero
authors.forename: Martine
authors.initials: M
authors.lastname: Bagot
authors.forename: Teresa
authors.initials: T
authors.lastname: Estrach
authors.forename: Joan
authors.initials: J
authors.lastname: Guitart
authors.forename: Robert
authors.initials: R
authors.lastname: Knobler
authors.forename: José Antonio
authors.initials: JA
authors.lastname: Sanches
authors.forename: Keiji
authors.initials: K
authors.lastname: Iwatsuki
authors.forename: Makoto
authors.initials: M
authors.lastname: Sugaya
authors.forename: Reinhard
authors.initials: R
authors.lastname: Dummer
authors.forename: Mark
authors.initials: M
authors.lastname: Pittelkow
authors.forename: Richard
authors.initials: R
authors.lastname: Hoppe
authors.forename: Sareeta
authors.initials: S
authors.lastname: Parker
authors.forename: Larisa
authors.initials: L
authors.lastname: Geskin
authors.forename: Lauren
authors.initials: L
authors.lastname: Pinter-Brown
authors.forename: Michael
authors.initials: M
authors.lastname: Girardi
authors.forename: Günter
authors.initials: G
authors.lastname: Burg
authors.forename: Annamari
authors.initials: A
authors.lastname: Ranki
authors.forename: Maartan
authors.initials: M
authors.lastname: Vermeer
authors.forename: Steven
authors.initials: S
authors.lastname: Horwitz
authors.forename: Peter
authors.initials: P
authors.lastname: Heald
authors.forename: Steve
authors.initials: S
authors.lastname: Rosen
authors.forename: Lorenzo
authors.initials: L
authors.lastname: Cerroni
authors.forename: Brigette
authors.initials: B
authors.lastname: Dreno
authors.forename: Eric C
authors.initials: EC
authors.lastname: Vonderheid
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods / Q000592:standards*; D006801:Humans; D008198:Lymph Nodes / Q000473:pathology; D009182:Mycosis Fungoides / Q000097:blood / Q000145:classification / Q000188:drug therapy* / Q000473:pathology / Q000523:psychology; D009367:Neoplasm Staging / Q000379:methods / Q000592:standards*; D017063:Outcome Assessment, Health Care / Q000592:standards*; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic / Q000379:methods / Q000592:standards; D012107:Research Design; D012720:Severity of Illness Index; D012751:Sezary Syndrome / Q000097:blood / Q000145:classification / Q000188:drug therapy* / Q000473:pathology / Q000523:psychology; D012867:Skin / Q000473:pathology; D012878:Skin Neoplasms / Q000097:blood / Q000145:classification / Q000188:drug therapy* / Q000473:pathology / Q000523:psychology; D016896:Treatment Outcome; D047368:Tumor Burden; D014781:Viscera / Q000473:pathology