TY - JOUR
T1 - Primary cutaneous lymphoma
T2 - recommendations for clinical trial design and staging update from the ISCL, USCLC, and EORTC
AU - Olsen, Elise A.
AU - Whittaker, Sean
AU - Willemze, Rein
AU - Pinter-Brown, Lauren
AU - Foss, Francine
AU - Geskin, Larisa
AU - Schwartz, Lawrence
AU - Horwitz, Steven
AU - Guitart, Joan
AU - Zic, John
AU - Kim, Youn H.
AU - Wood, Gary S.
AU - Duvic, Madeleine
AU - Ai, Wei
AU - Girardi, Michael
AU - Gru, Alejandro
AU - Guenova, Emmanuella
AU - Hodak, Emmilia
AU - Hoppe, Richard
AU - Kempf, Werner
AU - Kim, Ellen
AU - Lechowicz, Mary Jo
AU - Ortiz-Romero, Pablo
AU - Papadavid, Evangelia
AU - Quaglino, Pietro
AU - Pittelkow, Mark
AU - Prince, H. Miles
AU - Sanches, Jose Antonio
AU - Sugaya, Makoto
AU - Vermeer, Maarten
AU - Zain, Jasmine
AU - Knobler, Robert
AU - Stadler, Rudolf
AU - Bagot, Martine
AU - Scarisbrick, Julia
N1 - Publisher Copyright:
© 2022 American Society of Hematology
PY - 2022/8/4
Y1 - 2022/8/4
N2 - 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.
AB - 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.
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U2 - 10.1182/blood.2021012057
DO - 10.1182/blood.2021012057
M3 - Article
C2 - 34758074
AN - SCOPUS:85135597884
SN - 0006-4971
VL - 140
SP - 419
EP - 437
JO - Blood
JF - Blood
IS - 5
ER -