TY - JOUR
T1 - Expert consensus guidelines on management and best practices for tumor-infiltrating lymphocyte cell therapy
AU - Betof Warner, Allison
AU - Hamid, Omid
AU - Komanduri, Krishna
AU - Amaria, Rodabe
AU - Butler, Marcus O.
AU - Haanen, John
AU - Nikiforow, Sarah
AU - Puzanov, Igor
AU - Sarnaik, Amod
AU - Bishop, Michael R.
AU - Schoenfeld, Adam J.
N1 - Publisher Copyright:
© 2024 BMJ Publishing Group. All rights reserved.
PY - 2024/2/29
Y1 - 2024/2/29
N2 - Adoptive cell therapy with autologous, ex vivo-expanded, tumor-infiltrating lymphocytes (TILs) is being investigated for treatment of solid tumors and has shown robust responses in clinical trials. Based on the encouraging efficacy, tolerable safety profile, and advancements in a central manufacturing process, lifileucel is now the first US Food and Drug Administration (FDA)-approved TIL cell therapy product. To this end, treatment management and delivery practice guidance is needed to ensure successful integration of this modality into clinical care. This review includes clinical and toxicity management guidelines pertaining to the TIL cell therapy regimen prepared by the TIL Working Group, composed of internationally recognized hematologists and oncologists with expertize in TIL cell therapy, and relates to patient care and operational aspects. Expert consensus recommendations for patient management, including patient eligibility, screening tests, and clinical and toxicity management with TIL cell therapy, including tumor tissue procurement surgery, non-myeloablative lymphodepletion, TIL infusion, and IL-2 administration, are discussed in the context of potential standard of care TIL use. These recommendations provide practical guidelines for optimal clinical management during administration of the TIL cell therapy regimen, and recognition of subsequent management of toxicities. These guidelines are focused on multidisciplinary teams of physicians, nurses, and stakeholders involved in the care of these patients.
AB - Adoptive cell therapy with autologous, ex vivo-expanded, tumor-infiltrating lymphocytes (TILs) is being investigated for treatment of solid tumors and has shown robust responses in clinical trials. Based on the encouraging efficacy, tolerable safety profile, and advancements in a central manufacturing process, lifileucel is now the first US Food and Drug Administration (FDA)-approved TIL cell therapy product. To this end, treatment management and delivery practice guidance is needed to ensure successful integration of this modality into clinical care. This review includes clinical and toxicity management guidelines pertaining to the TIL cell therapy regimen prepared by the TIL Working Group, composed of internationally recognized hematologists and oncologists with expertize in TIL cell therapy, and relates to patient care and operational aspects. Expert consensus recommendations for patient management, including patient eligibility, screening tests, and clinical and toxicity management with TIL cell therapy, including tumor tissue procurement surgery, non-myeloablative lymphodepletion, TIL infusion, and IL-2 administration, are discussed in the context of potential standard of care TIL use. These recommendations provide practical guidelines for optimal clinical management during administration of the TIL cell therapy regimen, and recognition of subsequent management of toxicities. These guidelines are focused on multidisciplinary teams of physicians, nurses, and stakeholders involved in the care of these patients.
KW - Adoptive cell therapy - ACT
KW - Infusion
KW - Skin Cancer
KW - T cell
KW - Tumor infiltrating lymphocyte - TIL
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U2 - 10.1136/jitc-2023-008735
DO - 10.1136/jitc-2023-008735
M3 - Article
C2 - 38423748
AN - SCOPUS:85186364798
SN - 2051-1426
VL - 12
JO - Journal for immunotherapy of cancer
JF - Journal for immunotherapy of cancer
IS - 2
M1 - e008735
ER -