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首页> 美国卫生研究院文献>Journal of Clinical Oncology >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
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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

机译：真菌病和塞氏病综合症的临床终点和反应标准：国际皮肤性淋巴瘤学会美国皮肤性淋巴瘤协会和欧洲癌症研究与治疗组织的皮肤性淋巴瘤工作队的共识声明

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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.
机译：皮肤真菌T细胞淋巴瘤的主要形式有蕈样真菌病（MF）和塞萨里综合症（SS），具有使其与其他类型的非霍奇金淋巴瘤区分开的独特特征。 MF / SS的临床试验在评估，分期，评估，终点和反应标准方面缺乏标准化。最近定义的早期MF诊断标准，初始评估指南以及修订的MF和SS分期和分类标准现在为参与MF / SS临床试验的患者提供了统一分期​​的潜力。本文提出了针对MF / SS患者临床试验的一般性建议，以及对皮肤，淋巴结，血液和内脏器官中潜在疾病表现进行标准化评估的方法，以及终点和反应标准的定义。这些指南应有助于研究者之间的合作，以及由发起人或研究者发起的涉及MF或SS患者的临床试验数据的整理。

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