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1. 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

Author

Olsen, Ea, Whittaker, S, Kim, Yh, Duvic, M, Prince, Hm, Lessin, Sr, Wood, Gs, Willemze, R, Demierre, Mf, Pimpinelli, Nicola, 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

Published
2011

2. 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

Author

Olsen, Ea, Whittaker, S, Kim, Yh, Duvic, M, Prince, Hm, Lessin, Sr, Wood, Gs, Willemze, R, Demierre, Mf, Pimpinelli, N, Bernengo, Maria Grazia, 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, Treatment of Cancer, and University of Zurich

Subjects
Cancer Research, medicine.medical_specialty, Skin Neoplasms, Refractory Mycosis Fungoides, 610 Medicine & health, Disease, Severity of Illness Index, Cutaneous lymphoma, Special Article, 030207 dermatology & venereal diseases, 03 medical and health sciences, 0302 clinical medicine, Response criteria, Outcome Assessment, Health Care, Severity of illness, medicine, Humans, Sezary Syndrome, 1306 Cancer Research, Neoplasm Staging, Randomized Controlled Trials as Topic, Skin, Clinical Trials as Topic, Mycosis fungoides, business.industry, mycosis fungoides, HEMORRAGIA (ETIOLOGIA), Cancer, 10177 Dermatology Clinic, t-cell lymphoma of-life measure peripheral-blood expression disease classification diagnosis phase trial identification, medicine.disease, Dermatology, Sézary syndrome, Clinical end points, Tumor Burden, 3. Good health, Surgery, Lymphoma, Clinical trial, Viscera, Treatment Outcome, Oncology, Research Design, 030220 oncology & carcinogenesis, Quality of Life, 2730 Oncology, Lymph Nodes, business
Abstract

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

Published
2011

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