ASTCT Consensus Grading for Cytokine Release Syndrome and Neurologic Toxicity Associated with Immune Effector Cells

Biology of Blood and Marrow Transplantation - Tập 25 Số 4 - Trang 625-638 - 2019
Daniel W. Lee1, Bianca Santomasso2, Frederick L. Locke3, Armin Ghobadi4, Cameron J. Turtle5, Jennifer N. Brudno6, Marcela V. Maus7, Jae H. Park8, Elena Mead9, Steven Z. Pavletic6, William Y. Go10, Lamis Eldjerou11, Rebecca Gardner12, Noelle V. Frey13, Kevin J. Curran14, Karl S. Peggs15, Marcelo C. Pasquini16, John F. DiPersio4, Marcel R.M. van den Brink8, Krishna V. Komanduri17, Stephan A. Grupp18, Sattva S. Neelapu19
1Division of Pediatric Hematology/Oncology, University of Virginia School of Medicine, Charlottesville, VA
2Department of Neurology, Memorial Sloan Kettering Cancer Center, New York, NY
3Department of Blood & Marrow Transplantation, Moffitt Cancer Center, Tampa, FL
4Division of Oncology, Washington University School of Medicine, St. Louis, MO
5Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA
6Experimental Transplantation and Immunology Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD
7Cellular Immunotherapy Program, Massachusetts General Hospital, Boston, MA
8Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY
9Department of Anesthesiology and Critical Care Medicine, Memorial Sloan Kettering Cancer Center, New York, NY
10Kite, A Gilead Company, Foster City, CA
11Novartis Pharmaceuticals, East Hanover, NJ
12Ben Towne Center for Childhood Cancer Research, Seattle Children's Hospital, Seattle, WA
13Division of Hematology-Oncology, Abramson Cancer Center and Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA
14Department of Pediatrics, Memorial Sloan Kettering Cancer Center, New York, NY
15Department of Haematology, University College of London, London, United Kingdom
16Center for International Blood and Marrow Transplant Research, Department of Medicine, Medical College of Wisconsin, Milwaukee, WI
17Department of Medicine, Sylvester Comprehensive Cancer Center, University of Miami, Miami, FL
18Section of Cellular Therapy and Transplant, Children's Hospital of Philadelphia and Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA
19Department of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center, Houston, TX

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Tài liệu tham khảo

Maude, 2018, Tisagenlecleucel in children and young adults with B-cell lymphoblastic leukemia, N Engl J Med, 378, 439, 10.1056/NEJMoa1709866

Neelapu, 2017, Axicabtagene ciloleucel CAR T-cell therapy in refractory large B-cell lymphoma, N Engl J Med, 377, 2531, 10.1056/NEJMoa1707447

Locke, 2019, Long-term safety and activity of axicabtagene ciloleucel in refractory large B-cell lymphoma (ZUMA-1): a single-arm, multicentre, phase 1-2 trial, Lancet Oncol, 20, 31, 10.1016/S1470-2045(18)30864-7

Schuster, 2019, Tisagenlecleucel in adult relapsed or refractory diffuse large B-cell lymphoma, N Engl J Med, 380, 45, 10.1056/NEJMoa1804980

Fry, 2018, CD22-targeted CAR T cells induce remission in B-ALL that is naive or resistant to CD19-targeted CAR immunotherapy, Nat Med, 24, 20, 10.1038/nm.4441

Ali, 2016, T cells expressing an anti-B-cell maturation antigen chimeric antigen receptor cause remissions of multiple myeloma, Blood, 128, 1688, 10.1182/blood-2016-04-711903

Suntharalingam, 2006, Cytokine storm in a phase 1 trial of the anti-CD28 monoclonal antibody TGN1412, N Engl J Med, 355, 1018, 10.1056/NEJMoa063842

Grupp, 2013, Chimeric antigen receptor-modified T cells for acute lymphoid leukemia, N Engl J Med, 368, 1509, 10.1056/NEJMoa1215134

Rosenbaum, 2017, Tragedy, perseverance, and chance—the story of CAR-T therapy, N Engl J Med, 377, 1313, 10.1056/NEJMp1711886

National Cancer Institute. Common terminology criteria for adverse events v3.0 (CTCAE). Available at: https://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/ctcaev3.pdf. Accessed July 20, 2018.

National Cancer Institute. Common terminology criteria for adverse events (CTCAE). Version 4.0. Available at: https://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03/CTCAE_4.03_2010-06-14_QuickReference_8.5x11.pdf. Accessed July 20, 2018.

Neelapu, 2018, Chimeric antigen receptor T-cell therapy – assessment and management of toxicities, Nat Rev Clin Oncol, 15, 47, 10.1038/nrclinonc.2017.148

National Cancer Institute. Common terminology criteria for adverse events (CTCAE). Version 5.0. Available at: https://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/CTCAE_v5_Quick_Reference_8.5x11.pdf. Accessed July 20, 2018.

Lee, 2014, Current concepts in the diagnosis and management of cytokine release syndrome, Blood, 124, 188, 10.1182/blood-2014-05-552729

Davila, 2014, Efficacy and toxicity management of 19-28z CAR T cell therapy in B cell acute lymphoblastic leukemia, Sci Transl Med, 6, 10.1126/scitranslmed.3008226

Park, 2018, Long-term follow-up of CD19 CAR therapy in acute lymphoblastic leukemia, N Engl J Med, 378, 449, 10.1056/NEJMoa1709919

Porter, 2018, Grading of cytokine release syndrome associated with the CAR T cell therapy tisagenlecleucel, J Hematol Oncol, 11, 35, 10.1186/s13045-018-0571-y

Norelli, 2018, Monocyte-derived IL-1 and IL-6 are differentially required for cytokine-release syndrome and neurotoxicity due to CAR T cells, Nat Med, 24, 739, 10.1038/s41591-018-0036-4

Giavridis, 2018, CAR T cell-induced cytokine release syndrome is mediated by macrophages and abated by IL-1 blockade, Nat Med, 24, 731, 10.1038/s41591-018-0041-7

Maude, 2014, Chimeric antigen receptor T cells for sustained remissions in leukemia, N Engl J Med, 371, 1507, 10.1056/NEJMoa1407222

Teachey, 2018, Toxicity management after chimeric antigen receptor T cell therapy: one size does not fit “ALL.”, Nat Rev Clin Oncol, 15, 218, 10.1038/nrclinonc.2018.19

Teachey, 2016, Identification of predictive biomarkers for cytokine release syndrome after chimeric antigen receptor T-cell therapy for acute lymphoblastic leukemia, Cancer Discov, 6, 664, 10.1158/2159-8290.CD-16-0040

von Stackelberg, 2016, Phase I/Phase II study of blinatumomab in pediatric patients with relapsed/refractory acute lymphoblastic leukemia, J Clin Oncol, 34, 4381, 10.1200/JCO.2016.67.3301

Martinelli, 2017, Complete hematologic and molecular response in adult patients with relapsed/refractory Philadelphia chromosome-positive B-precursor acute lymphoblastic leukemia following treatment with blinatumomab: results from a phase II, single-arm, multicenter study, J Clin Oncol, 35, 1795, 10.1200/JCO.2016.69.3531

Liu, 2018, Cord blood NK cells engineered to express IL-15 and a CD19-targeted CAR show long-term persistence and potent antitumor activity, Leukemia, 32, 520, 10.1038/leu.2017.226

Nellan, 2018, Improved CNS exposure to tocilizumab after cerebrospinal fluid compared to intravenous administration in rhesus macaques, Blood, 132, 662, 10.1182/blood-2018-05-846428

Porter, 2015, Chimeric antigen receptor T cells persist and induce sustained remissions in relapsed refractory chronic lymphocytic leukemia, Sci Transl Med, 7, 10.1126/scitranslmed.aac5415

Teachey, 2013, Cytokine release syndrome after blinatumomab treatment related to abnormal macrophage activation and ameliorated with cytokine-directed therapy, Blood, 121, 5154, 10.1182/blood-2013-02-485623

Santomasso, 2018, Clinical and biological correlates of neurotoxicity associated with CAR T-cell therapy in patients with B-cell acute lymphoblastic leukemia, Cancer Discov, 8, 958, 10.1158/2159-8290.CD-17-1319

Gust, 2017, Endothelial activation and blood-brain barrier disruption in neurotoxicity after adoptive immunotherapy with CD19 CAR-T cells, Cancer Discov, 7, 1404, 10.1158/2159-8290.CD-17-0698

Lee, 2015, T cells expressing CD19 chimeric antigen receptors for acute lymphoblastic leukaemia in children and young adults: a phase 1 dose-escalation trial, Lancet, 385, 517, 10.1016/S0140-6736(14)61403-3

Turtle, 2016, CD19 CAR-T cells of defined CD4+:CD8+ composition in adult B cell ALL patients, J Clin Invest, 126, 2123, 10.1172/JCI85309

Turtle, 2016, Immunotherapy of non-Hodgkin's lymphoma with a defined ratio of CD8+ and CD4+ CD19-specific chimeric antigen receptor-modified T cells, Sci Transl Med, 8, 355ra116, 10.1126/scitranslmed.aaf8621

Avery, 2010, Reference range for cerebrospinal fluid opening pressure in children, N Engl J Med, 363, 891, 10.1056/NEJMc1004957

Frisén, 1982, Swelling of the optic nerve head: a staging scheme, J Neurol Neurosurg Psychiatry, 45, 13, 10.1136/jnnp.45.1.13

Traube, 2014, Cornell Assessment of Pediatric Delirium: a valid, rapid, observational tool for screening delirium in the PICU, Crit Care Med, 42, 656, 10.1097/CCM.0b013e3182a66b76

Silver, 2015, Delirium screening anchored in child development: the Cornell Assessment for Pediatric Delirium, Palliat Support Care, 13, 1005, 10.1017/S1478951514000947

Mahadeo, 2019, Management guidelines for paediatric patients receiving chimeric antigen receptor T cell therapy, Nat Rev Clin Oncol, 16, 45, 10.1038/s41571-018-0075-2

Center for International Blood and Marrow Transplant Research. Form 4100 R3.0: Cellular Therapy Essential Data Follow-Up Form. Available at: https://www.cibmtr.org/DataManagement/DataCollectionForms/Documents/4100/Rev3.0/4100R3.0.pdf. Accessed November 08, 2018.

European Medicines Agency. Report on CAR T-cell therapy registries workshop February 9, 2018: Patient Registries Initiative. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Report/2018/05/WC500249247.pdf. Accessed November 08, 2018.

European Medicines Agency. Chimeric antigen receptor (CAR) T-cell therapy registries workshop February 9, 2018. Available at: https://www.ema.europa.eu/en/events/chimeric-antigen-receptor-car-t-cell-therapy-registries-workshop. Accessed January 10, 2018.

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Biology of Blood and Marrow Transplantation

Tập 25 Số 4

625-638

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