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.

PLCG1 mutations in cutaneous T-cell lymphomas

“…1 Briefly, those patients starting with patches/ plaques and eventually developing erythroderma were considered E-MF, whereas those starting directly with erythroderma were considered SS. 33 The study, the patient information sheet, and the informed consent form were approved by the Ethics Committee of the Hospital 12 de Octubre. This study was conducted in accordance with the Declaration of Helsinki.…”

Prospective International Multicenter Phase II Trial of Intravenous Pegylated Liposomal Doxorubicin Monochemotherapy in Patients With Stage IIB, IVA, or IVB Advanced Mycosis Fungoides: Final Results From EORTC 21012

“…Disease assessment for the primary end point was conducted at baseline, once every 8 weeks during treatment, at the end of protocol treatment, and once every 12 weeks after the end of protocol treatment until disease progression. Disease assessment consisted of cutaneous disease evaluation using an internationally accepted skin scoring system 17,19 for cutaneous involvement (TBI) and the documentation of extracutaneous lesions, as suggested by the consensus response criteria published by Olsen et al 20 Secondary end points were toxicity of treatment scored according to the Common Terminology Criteria for Adverse Events version 2.0, time to progression (TTP), and duration of response (DOR).…”

Primary Cutaneous Lymphomas and Interferon Treatment

“…Guidelines propose skin-directed therapies for the management of early stages of MF (IA, IB and IIB) [10,11]. Patients with only patches and/or plaques covering <10% (stage IA) or ≥10% (stage IB) of the skin surface should be treated with skin-directed therapies and in patients developing one or a few tumours (stage IIB) additional local radiotherapy suf ices [1].…”