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

被引：515

作者：

Olsen, Elise A. ^{[1
]}

Whittaker, Sean ^{[2
]}

Kim, Youn H. ^{[3
]}

Duvic, Madeleine ^{[6
]}

Prince, H. Miles ^{[7
,8
]}

Lessin, Stuart R. ^{[9
]}

Wood, Gary S. ^{[11
,12
]}

Willemze, Rein ^{[13
]}

Demierre, Marie-France ^{[14
]}

Pimpinelli, Nicola ^{[15
]}

Bernengo, Maria Grazia ^{[16
]}

Ortiz-Romero, Pablo L. ^{[17
]}

Bagot, Martine ^{[19
]}

Estrach, Teresa ^{[18
]}

Guitart, Joan

Knobler, Robert ^{[22
]}

Sanches, Jose Antonio ^{[24
]}

Iwatsuki, Keiji ^{[25
]}

Sugaya, Makoto ^{[26
]}

Dummer, Reinhard ^{[27
]}

Pittelkow, Mark ^{[28
]}

Hoppe, Richard ^{[4
]}

Parker, Sareeta ^{[29
]}

Geskin, Larisa ^{[10
]}

Pinter-Brown, Lauren ^{[5
]}

Girardi, Michael ^{[30
]}

Burg, Guenter ^{[27
]}

Ranki, Annamari ^{[31
,32
]}

Vermeer, Maartan ^{[13
]}

Horwitz, Steven ^{[33
]}

Heald, Peter ^{[30
]}

Rosen, Steve ^{[21
]}

Cerroni, Lorenzo ^{[23
]}

Dreno, Brigette ^{[20
]}

Vonderheid, Eric C. ^{[34
]}

机构：

[1] Duke Univ, Med Ctr, Durham, NC 27710 USA

[2] Kings Coll London, Guys & St Thomas Natl Hlth Serv Fdn Trust, St Johns Inst Dermatol, London, England

[3] Stanford Canc Ctr, Stanford, CA USA

[4] Stanford Univ, Stanford, CA 94305 USA

[5] Univ Calif Los Angeles, Los Angeles, CA USA

[6] Univ Texas MD Anderson Canc Ctr, Houston, TX 77030 USA

[7] Peter MacCallum Canc Ctr, Melbourne, Vic, Australia

[8] Univ Melbourne, Melbourne, Vic, Australia

[9] Fox Chase Canc Ctr, Philadelphia, PA 19111 USA

[10] Univ Pittsburgh, Sch Med, Pittsburgh, PA USA

[11] Univ Wisconsin, Madison, WI USA

[12] VA Med Ctr, Madison, WI USA

[13] Leiden Univ, Med Ctr, Leiden, Netherlands

[14] Boston Univ, Boston, MA 02215 USA

[15] Univ Florence, Sch Med, I-50121 Florence, Italy

[16] Univ Turin, Turin, Italy

[17] Univ Complutense, E-28040 Madrid, Spain

[18] Univ Barcelona, IDIBAPS, Hosp Clin, Barcelona, Spain

[19] Hop St Louis, Paris, France

[20] Univ Hosp, U892, Nantes, France

[21] Northwestern Univ, Robert H Lurie Comprehens Canc Ctr, Chicago, IL 60611 USA

[22] Med Univ Vienna, Vienna, Austria

[23] Med Univ Graz, Graz, Austria

[24] Univ Sao Paulo, Sch Med, Sao Paulo, Brazil

[25] Okayama Univ, Okayama, Japan

[26] Univ Tokyo, Tokyo, Japan

[27] Univ Zurich, Zurich, Switzerland

[28] Mayo Clin, Coll Med, Rochester, MN USA

[29] Emory Univ, Sch Med, Atlanta, GA USA

[30] Yale Univ, Sch Med, New Haven, CT USA

[31] Univ Helsinki, Skin & Allergy Hosp, Helsinki, Finland

[32] Univ Helsinki, Cent Hosp, Helsinki, Finland

[33] Mem Sloan Kettering Canc Ctr, New York, NY 10021 USA

[34] Johns Hopkins Med Inst, Baltimore, MD 21205 USA

来源：

JOURNAL OF CLINICAL ONCOLOGY | 2011年 / 29卷 / 18期

关键词：

T-CELL LYMPHOMA; OF-LIFE MEASURE; PERIPHERAL-BLOOD; EXPRESSION; DISEASE; CLASSIFICATION; DIAGNOSIS; PHASE; TRIAL; IDENTIFICATION;

D O I：

10.1200/JCO.2010.32.0630

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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

引用

页码：2598 / 2607

页数：10

共 41 条

[1] The relevance of the CD4+CD26-subset in the identification of circulating Sezary cells [J].