The number of patients with primary cutaneous lymphoma (PCL) relative to other non-Hodgkin lymphomas (NHLs) is small and the number of subtypes large. Although clinical trial guidelines have been published for mycosis fungoides/Sézary syndrome, the most common type of PCL, none exist for the other PCLs. In addition, staging of the PCLs has been evolving based on new data on potential prognostic factors, diagnosis, and assessment methods of both skin and extracutaneous disease and a desire to align the latter with the Lugano guidelines for all NHLs. The International Society for Cutaneous Lymphomas (ISCL), the United States Cutaneous LymphomaConsortium (USCLC), and the Cutaneous Lymphoma Task Force of the European Organization for the Research and Treatment of Cancer (EORTC) now propose updated staging and guidelines for the study design, assessment, endpoints, and response criteria in clinical trials for all the PCLs in alignment with that of the Lugano guidelines. These recommendations provide standardized methodology that should facilitate planning and regulatory approval of new treatments for these lymphomas worldwide, encourage cooperative investigator-initiated trials, and help to assess the comparative efficacy of therapeutic agents tested across sites and studies.

中文翻译：

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原发性皮肤淋巴瘤：ISCL、USCLC 和 EORTC 的临床试验设计和分期更新建议。

与其他非霍奇金淋巴瘤 (NHL) 相比，原发性皮肤淋巴瘤 (PCL) 患者数量较少，亚型数量较多。尽管已经针对最常见的 PCL 类型蕈样真菌病/Sézary 综合征发布了临床试验指南，但没有针对其他 PCL 的临床试验指南。此外，PCL 的分期一直在根据有关皮肤和皮肤外疾病的潜在预后因素、诊断和评估方法的新数据以及使后者与所有 NHL 的卢加诺指南保持一致的愿望不断发展。国际皮肤淋巴瘤学会 (ISCL)、美国皮肤淋巴瘤联合会 (USCLC) 和欧洲癌症研究与治疗组织 (EORTC) 的皮肤淋巴瘤工作组现在提出了研究设计的更新分期和指南，所有 PCL 的临床试验评估、终点和反应标准与卢加诺指南一致。这些建议提供了标准化的方法，应有助于在全球范围内规划和监管批准针对这些淋巴瘤的新疗法，鼓励合作研究者发起的试验，并有助于评估跨地点和研究测试的治疗药物的比较疗效。