PMID- 36737060 OWN - NLM STAT- MEDLINE DCOM- 20230224 LR - 20240218 IS - 1744-764X (Electronic) IS - 1474-0338 (Print) IS - 1474-0338 (Linking) VI - 22 IP - 1 DP - 2023 Jan TI - Safety evaluation of axicabtagene ciloleucel for relapsed or refractory large B-cell lymphoma. PG - 5-15 LID - 10.1080/14740338.2023.2177268 [doi] AB - INTRODUCTION: CD19-directed chimeric antigen receptor (CAR) T-cell therapy is a highly effective therapy for patients with relapsed/refractory large B-cell lymphoma (LBCL) and three CD19 CAR T-cell products (axicabtagene ciloleucel, tisagenlecleucel and lisocabtagene maraleucel) are currently approved for this indication. Despite the clinical benefit of CD19 directed CAR T-cell therapy, this treatment is associated with significant morbidity from treatment-emergent toxicities. AREAS COVERED: This Review discusses the safety considerations of axicabtagene ciloleucel in patients with LBCL. This includes discussion of the frequently observed immune-mediated toxicities of cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome. Additionally, we review CAR T-cell therapy related cytopenias, infection, organ dysfunction and the more recently described hemophagocytic lymphohistiocytosis. EXPERT OPINION: A thorough understanding of the toxicities associated with CD19-directed CAR T-cell therapy will facilitate the optimal selection of patients for this therapy. Furthermore, knowledge of preventative measures of CAR T-cell related complications, and early recognition and appropriate intervention will lead to the safe administration of these therapies, and ultimately improved outcomes for our patients. FAU - Nath, Karthik AU - Nath K AUID- ORCID: 0000-0002-3881-5681 AD - Cellular Therapy Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA. FAU - Wudhikarn, Kitsada AU - Wudhikarn K AUID- ORCID: 0000-0001-9528-8681 AD - Division of Hematology and Center of Excellence in Translational Hematology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand. FAU - Alarcon Tomas, Ana AU - Alarcon Tomas A AD - Division of Hematology and Hemotherapy, Hospital General Universitario Gregorio Maranon, Madrid, Spain. FAU - Perales, Miguel-Angel AU - Perales MA AD - Adult Bone Marrow Transplantation Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA. AD - Department of Medicine, Weill Cornell Medical College, New York, NY, USA. LA - eng GR - P30 CA008748/CA/NCI NIH HHS/United States PT - Journal Article PT - Review DEP - 20230217 PL - England TA - Expert Opin Drug Saf JT - Expert opinion on drug safety JID - 101163027 RN - U2I8T43Y7R (axicabtagene ciloleucel) RN - 0 (cell-associated neurotoxicity) RN - 0 (Receptors, Chimeric Antigen) RN - 0 (Antigens, CD19) SB - IM MH - Humans MH - Immunotherapy, Adoptive/adverse effects MH - *Receptors, Chimeric Antigen MH - Treatment Outcome MH - *Lymphoma, Large B-Cell, Diffuse/pathology/therapy MH - Antigens, CD19/adverse effects PMC - PMC9975047 MID - NIHMS1872022 OTO - NOTNLM OT - Axicabtagene ciloleucel OT - chimeric antigen receptor (CAR) T-cell therapy OT - cytokine release syndrome (CRS) OT - immune effector cell-associated neurotoxicity syndrome (ICANS) OT - large B-cell lymphoma (LBCL) EDAT- 2023/02/04 06:00 MHDA- 2023/02/25 06:00 PMCR- 2024/02/17 CRDT- 2023/02/03 20:32 PHST- 2023/02/04 06:00 [pubmed] PHST- 2023/02/25 06:00 [medline] PHST- 2023/02/03 20:32 [entrez] PHST- 2024/02/17 00:00 [pmc-release] AID - 10.1080/14740338.2023.2177268 [doi] PST - ppublish SO - Expert Opin Drug Saf. 2023 Jan;22(1):5-15. doi: 10.1080/14740338.2023.2177268. Epub 2023 Feb 17.