Primary cutaneous lymphoma: recommendations for clinical trial design and staging update from the ISCL, USCLC, and EORTC
Details
Publication Year 2022-08-04,Volume 140,Issue #5,Page 419-437
Journal Title
Blood
Publication Type
Review
Abstract
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/Sezary 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.
Keywords
Clinical Trials as Topic; Humans; *Lymphoma, T-Cell, Cutaneous/diagnosis/pathology/therapy; *Mycosis Fungoides/diagnosis/pathology/therapy; Neoplasm Staging; *Sezary Syndrome/diagnosis/pathology/therapy; *Skin Neoplasms/diagnosis/pathology/therapy; United States
Department(s)
Haematology
PubMed ID
34758074
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