Expert consensus guidelines on management and best practices for tumor-infiltrating lymphocyte cell therapy

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 manufacturi...

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Main Authors: Sarah Nikiforow, John Haanen, Omid Hamid, Igor Puzanov, Rodabe Amaria, Amod Sarnaik, Marcus O Butler, Michael R Bishop, Allison Betof Warner, Adam J Schoenfeld, Krishna Komanduri
Format: Article
Language:English
Published: BMJ Publishing Group 2024-02-01
Series:Journal for ImmunoTherapy of Cancer
Online Access:https://jitc.bmj.com/content/12/2/e008735.full
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author Sarah Nikiforow
John Haanen
Omid Hamid
Igor Puzanov
Rodabe Amaria
Amod Sarnaik
Marcus O Butler
Michael R Bishop
Allison Betof Warner
Adam J Schoenfeld
Krishna Komanduri
author_facet Sarah Nikiforow
John Haanen
Omid Hamid
Igor Puzanov
Rodabe Amaria
Amod Sarnaik
Marcus O Butler
Michael R Bishop
Allison Betof Warner
Adam J Schoenfeld
Krishna Komanduri
author_sort Sarah Nikiforow
collection DOAJ
description 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.
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spelling doaj-art-4e07c2e8bb504c78877c9560e59a0a722025-02-09T22:05:13ZengBMJ Publishing GroupJournal for ImmunoTherapy of Cancer2051-14262024-02-0112210.1136/jitc-2023-008735Expert consensus guidelines on management and best practices for tumor-infiltrating lymphocyte cell therapySarah Nikiforow0John Haanen1Omid Hamid2Igor Puzanov3Rodabe Amaria4Amod Sarnaik5Marcus O Butler6Michael R Bishop7Allison Betof Warner8Adam J Schoenfeld9Krishna Komanduri107 Dana-Farber Cancer Institute, Boston, Massachusetts, USA6 Medical Oncology, Antoni van Leeuwenhoek Nederlands Kanker Instituut, Amsterdam, Netherlands4The Angeles Clinic and Research Institute, a Cedars Sinai Affiliate, Los Angeles, CA, USA3Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA4 The University of Texas MD Anderson Cancer Center, Houston, Texas, USA10 H Lee Moffitt Canc Ctr, Tampa, Florida, USA2University Health Network, Toronto, ON, Canada11 The David and Etta Jonas Center for Cellular Therapy, Chicago, Illinois, USAStanford University School of Medicine, Stanford, California, USA1Memorial Sloan Kettering Cancer Center, New York, NY, USA3 UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, USAAdoptive 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.https://jitc.bmj.com/content/12/2/e008735.full
spellingShingle Sarah Nikiforow
John Haanen
Omid Hamid
Igor Puzanov
Rodabe Amaria
Amod Sarnaik
Marcus O Butler
Michael R Bishop
Allison Betof Warner
Adam J Schoenfeld
Krishna Komanduri
Expert consensus guidelines on management and best practices for tumor-infiltrating lymphocyte cell therapy
Journal for ImmunoTherapy of Cancer
title Expert consensus guidelines on management and best practices for tumor-infiltrating lymphocyte cell therapy
title_full Expert consensus guidelines on management and best practices for tumor-infiltrating lymphocyte cell therapy
title_fullStr Expert consensus guidelines on management and best practices for tumor-infiltrating lymphocyte cell therapy
title_full_unstemmed Expert consensus guidelines on management and best practices for tumor-infiltrating lymphocyte cell therapy
title_short Expert consensus guidelines on management and best practices for tumor-infiltrating lymphocyte cell therapy
title_sort expert consensus guidelines on management and best practices for tumor infiltrating lymphocyte cell therapy
url https://jitc.bmj.com/content/12/2/e008735.full
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