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Correspondence: Elise A. Olsen, MD, Duke University Medical Center, Box 3294, Durham, NC 27710; e-mail: olsen001@mc.duke.edu

AUTHOR CONTRIBUTIONS Conception and design: Elise A. Olsen, Sean Whittaker, Youn H. Kim, Madeleine Duvic, Gary S. Wood, Rein Willemze, Nicola Pimpinelli, Reinhard Dummer, Mark Pittelkow, Günter Burg, Peter Heald, Eric C. Vonderheid

Administrative support: Elise A. Olsen

Provision of study materials or patients: Elise A. Olsen

Collection and assembly of data: Elise A. Olsen, Sean Whittaker, Eric Vonderheid

Data analysis and interpretation: All authors

Manuscript writing: All authors

Final approval of manuscript: All authors

Acknowledgment: This article is dedicated to the memory of our esteemed colleague and co-author, Marie-France Demierre, MD, in honor of and appreciation for her generous and loving spirit and her dedication to the advancement of care of patients with cutaneous T-cell lymphoma.

See publication for a full list of disclosures from all authors.

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Keywords:

  • Science & Technology
  • Life Sciences & Biomedicine
  • Oncology
  • T-CELL LYMPHOMA
  • OF-LIFE MEASURE
  • PERIPHERAL-BLOOD
  • EXPRESSION
  • DISEASE
  • CLASSIFICATION
  • DIAGNOSIS
  • PHASE
  • TRIAL
  • IDENTIFICATION

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

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Journal Title:

Journal of Clinical Oncology

Volume:

Volume 29, Number 18

Publisher:

, Pages 2598-2607

Type of Work:

Article | Final Publisher PDF

Abstract:

Mycosis fungoides (MF) and Sé zary 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. © 2011 by American Society of Clinical Oncology.

Copyright information:

Copyright © 2011 by American Society of Clinical Oncology

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