Primary cutaneous lymphoma: recommendations for clinical trial design and staging update from the ISCL, USCLC, and EORTC

• DOI: 10.1182/blood.2021012057
• Publication Date: 2021-11-11T00:50:56Z
• Authors: Elise A. Olsen; Sean Whittaker; Rein Willemze; Lauren Pinter-Brown; Francine Foss; Larisa Geskin; Lawrence Schwartz; Steven Horwitz; Joan Guitart; John Zic; Youn H. Kim; Gary S. Wood; Madeleine Duvic; Wei Ai; Michael Girardi; Alejandro Gru; Emmanuella Guenova; Emmilia Hodak; Richard Hoppe; Werner Kempf; Ellen Kim; Mary Jo Lechowicz; Pablo Ortiz-Romero; Evangelia Papadavid; Pietro Quaglino; Mark Pittelkow; H. Miles Prince; Jose Antonio Sanches; Makoto Sugaya; Maarten Vermeer; Jasmine Zain; Robert Knobler; Rudolf Stadler; Martine Bagot; Julia Scarisbrick
• Keywords: Clinical Trials as Topic; 03 medical and health sciences; Mycosis Fungoides; Skin Neoplasms; 0302 clinical medicine; Humans; Sezary Syndrome; United States; Lymphoma, T-Cell, Cutaneous; Neoplasm Staging; 3. Good health

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/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.