RESUMO
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.
Assuntos
Ensaios Clínicos como Assunto/normas , Micose Fungoide/tratamento farmacológico , Estadiamento de Neoplasias/normas , Avaliação de Resultados em Cuidados de Saúde/normas , Síndrome de Sézary/tratamento farmacológico , Neoplasias Cutâneas/tratamento farmacológico , Ensaios Clínicos como Assunto/métodos , Humanos , Linfonodos/patologia , Micose Fungoide/sangue , Micose Fungoide/classificação , Micose Fungoide/patologia , Micose Fungoide/psicologia , Estadiamento de Neoplasias/métodos , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Projetos de Pesquisa , Índice de Gravidade de Doença , Síndrome de Sézary/sangue , Síndrome de Sézary/classificação , Síndrome de Sézary/patologia , Síndrome de Sézary/psicologia , Pele/patologia , Neoplasias Cutâneas/sangue , Neoplasias Cutâneas/classificação , Neoplasias Cutâneas/patologia , Neoplasias Cutâneas/psicologia , Resultado do Tratamento , Carga Tumoral , Vísceras/patologiaAssuntos
Aminoquinolinas/administração & dosagem , Antineoplásicos/administração & dosagem , Antígeno Ki-1/imunologia , Linfoma Anaplásico Cutâneo Primário de Células Grandes/tratamento farmacológico , Linfoma Anaplásico Cutâneo Primário de Células Grandes/imunologia , Idoso , Emolientes , Humanos , Imiquimode , MasculinoRESUMO
The exact role of CD4+CD25(high) regulatory T cells (Treg) in adoptive immunotherapy of melanoma is still to be determined, and an association between an expansion of Treg cells and the expansion of therapeutic tumor-infiltrating lymphocytes (TIL) remains unelucidated. In this context, the aim of our study was to determine whether functional Treg cells were detectable and amplified among in vitro-expanded TIL from 10 metastatic melanoma lymph nodes (LNs). In this study, we investigated the expression of forkhead/winged helix transcription factor 3 (Foxp3) in melanoma-invaded LNs and determined proportion and functionality of Treg cells among TIL extracted from these 10 metastatic melanoma LNs at different steps of their in vitro expansion. We found that metastatic melanoma LNs expressed very heterogeneous levels of Foxp3 and that CD4+CD25(high) Treg cells extracted from these LNs were detectable at each step of the in vitro culture of TIL but decreasing during the culture. In addition, functional assays demonstrated that these CD4+CD25(high) T cells were capable of suppressing autologous CD8+ and CD4+CD25- T cell proliferation. These cells were indeed Treg cells as they expressed Foxp3. In conclusion, our work suggests that CD4+CD25(high) Foxp3 expressing T cells are not expanded during in vitro amplification of TIL obtained from melanoma-invaded LNs.
