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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.

Publication ,  Journal Article
Olsen, EA; Whittaker, S; Kim, YH; Duvic, M; Prince, HM; Lessin, SR; Wood, GS; Willemze, R; Demierre, M-F; Pimpinelli, N; Bernengo, MG; Burg, G ...
Published in: J Clin Oncol
June 20, 2011

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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Published In

J Clin Oncol

DOI

EISSN

1527-7755

Publication Date

June 20, 2011

Volume

29

Issue

18

Start / End Page

2598 / 2607

Location

United States

Related Subject Headings

  • Viscera
  • Tumor Burden
  • Treatment Outcome
  • Skin Neoplasms
  • Skin
  • Sezary Syndrome
  • Severity of Illness Index
  • Research Design
  • Randomized Controlled Trials as Topic
  • Quality of Life
 

Citation

APA
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Olsen, E. A., Whittaker, S., Kim, Y. H., Duvic, M., Prince, H. M., Lessin, S. R., … Cutaneous Lymphoma Task Force of the European Organisation for Research and Treatment of Cancer, . (2011). 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. J Clin Oncol, 29(18), 2598–2607. https://doi.org/10.1200/JCO.2010.32.0630
Olsen, Elise A., Sean Whittaker, Youn H. Kim, Madeleine Duvic, H Miles Prince, Stuart R. Lessin, Gary S. Wood, et al. “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.J Clin Oncol 29, no. 18 (June 20, 2011): 2598–2607. https://doi.org/10.1200/JCO.2010.32.0630.
Olsen EA, Whittaker S, Kim YH, Duvic M, Prince HM, Lessin SR, Wood GS, Willemze R, Demierre M-F, Pimpinelli N, Bernengo MG, Ortiz-Romero PL, Bagot M, Estrach T, Guitart J, Knobler R, Sanches JA, 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, Horwitz S, Heald P, Rosen S, Cerroni L, Dreno B, Vonderheid EC, International Society for Cutaneous Lymphomas, United States Cutaneous Lymphoma Consortium, Cutaneous Lymphoma Task Force of the European Organisation for Research and Treatment of Cancer. 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. J Clin Oncol. 2011 Jun 20;29(18):2598–2607.

Published In

J Clin Oncol

DOI

EISSN

1527-7755

Publication Date

June 20, 2011

Volume

29

Issue

18

Start / End Page

2598 / 2607

Location

United States

Related Subject Headings

  • Viscera
  • Tumor Burden
  • Treatment Outcome
  • Skin Neoplasms
  • Skin
  • Sezary Syndrome
  • Severity of Illness Index
  • Research Design
  • Randomized Controlled Trials as Topic
  • Quality of Life