Prophylactic corticosteroid use in patients receiving axicabtagene ciloleucel for large B-cell lymphoma

Olalekan O. Oluwole; Krimo Bouabdallah; Javier Munoz; Sophie De Guibert; Julie M. Vose; Nancy L. Bartlett; Yi Lin; Abhinav Deol; Peter A. McSweeney; Andre H. Goy; Marie Jose Kersten; Caron A. Jacobson; Umar Farooq; Monique C. Minnema; Catherine Thieblemont; John M. Timmerman; Patrick Stiff; Irit Avivi; Dimitrios Tzachanis; Jenny J. Kim; Zahid Bashir; Jeff McLeroy; Yan Zheng; John M. Rossi; Lisa Johnson; Lovely Goyal; Tom van Meerten

doi:10.1111/bjh.17527

Prophylactic corticosteroid use in patients receiving axicabtagene ciloleucel for large B-cell lymphoma

Olalekan O. Oluwole^*, Krimo Bouabdallah, Javier Munoz, Sophie De Guibert, Julie M. Vose, Nancy L. Bartlett, Yi Lin, Abhinav Deol, Peter A. McSweeney, Andre H. Goy, Marie Jose Kersten, Caron A. Jacobson, Umar Farooq, Monique C. Minnema, Catherine Thieblemont, John M. Timmerman, Patrick Stiff, Irit Avivi, Dimitrios Tzachanis, Jenny J. KimZahid Bashir, Jeff McLeroy, Yan Zheng, John M. Rossi, Lisa Johnson, Lovely Goyal, Tom van Meerten

^*Corresponding author for this work

Stem Cell Aging Leukemia and Lymphoma (SALL)

Research output: Contribution to journal › Article › Academic › peer-review

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Abstract

ZUMA-1 (NCT02348216) examined the safety and efficacy of axicabtagene ciloleucel (axi-cel), an autologous CD19-directed chimaeric antigen receptor (CAR)-T cell therapy, in refractory large B-cell lymphoma. To reduce treatment-related toxicity, several exploratory safety management cohorts were added to ZUMA-1. Specifically, cohort 6 investigated management of cytokine release syndrome (CRS) and neurologic events (NEs) with prophylactic corticosteroids and earlier corticosteroid and tocilizumab intervention. CRS and NE incidence and severity were primary end-points. Following leukapheresis, patients could receive optional bridging therapy per investigator discretion. All patients received conditioning chemotherapy (days -5 through -3), 2 x 10(6) CAR-T cells/kg (day 0) and once-daily oral dexamethasone [10 mg, day 0 (before axi-cel) through day 2]. Forty patients received axi-cel. CRS occurred in 80% of patients (all grade

Original language	English
Pages (from-to)	690-700
Number of pages	11
Journal	British Journal of Haematology
Volume	194
Issue number	4
Early online date	22-Jul-2021
DOIs	https://doi.org/10.1111/bjh.17527
Publication status	Published - Aug-2021

Keywords

large B-cell lymphoma
axi-cel
chimaeric antigen receptor-T cell
prophylaxis
corticosteroids
cytokine release syndrome
CYTOKINE RELEASE SYNDROME
PROPENSITY-SCORE
MANAGEMENT
THERAPY

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Prophylactic corticosteroid use in patients receivingaxicabtagene ciloleucel for large B-cell lymphomaFinal publisher's version, 831 KBLicence: CC BY-NC-ND

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Oluwole, O. O., Bouabdallah, K., Munoz, J., De Guibert, S., Vose, J. M., Bartlett, N. L., Lin, Y., Deol, A., McSweeney, P. A., Goy, A. H., Kersten, M. J., Jacobson, C. A., Farooq, U., Minnema, M. C., Thieblemont, C., Timmerman, J. M., Stiff, P., Avivi, I., Tzachanis, D., ... van Meerten, T. (2021). Prophylactic corticosteroid use in patients receiving axicabtagene ciloleucel for large B-cell lymphoma. British Journal of Haematology, 194(4), 690-700. https://doi.org/10.1111/bjh.17527

Oluwole, Olalekan O. ; Bouabdallah, Krimo ; Munoz, Javier ; De Guibert, Sophie ; Vose, Julie M. ; Bartlett, Nancy L. ; Lin, Yi ; Deol, Abhinav ; McSweeney, Peter A. ; Goy, Andre H. ; Kersten, Marie Jose ; Jacobson, Caron A. ; Farooq, Umar ; Minnema, Monique C. ; Thieblemont, Catherine ; Timmerman, John M. ; Stiff, Patrick ; Avivi, Irit ; Tzachanis, Dimitrios ; Kim, Jenny J. ; Bashir, Zahid ; McLeroy, Jeff ; Zheng, Yan ; Rossi, John M. ; Johnson, Lisa ; Goyal, Lovely ; van Meerten, Tom. / Prophylactic corticosteroid use in patients receiving axicabtagene ciloleucel for large B-cell lymphoma. In: British Journal of Haematology. 2021 ; Vol. 194, No. 4. pp. 690-700.

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title = "Prophylactic corticosteroid use in patients receiving axicabtagene ciloleucel for large B-cell lymphoma",

abstract = "ZUMA-1 (NCT02348216) examined the safety and efficacy of axicabtagene ciloleucel (axi-cel), an autologous CD19-directed chimaeric antigen receptor (CAR)-T cell therapy, in refractory large B-cell lymphoma. To reduce treatment-related toxicity, several exploratory safety management cohorts were added to ZUMA-1. Specifically, cohort 6 investigated management of cytokine release syndrome (CRS) and neurologic events (NEs) with prophylactic corticosteroids and earlier corticosteroid and tocilizumab intervention. CRS and NE incidence and severity were primary end-points. Following leukapheresis, patients could receive optional bridging therapy per investigator discretion. All patients received conditioning chemotherapy (days -5 through -3), 2 x 10(6) CAR-T cells/kg (day 0) and once-daily oral dexamethasone [10 mg, day 0 (before axi-cel) through day 2]. Forty patients received axi-cel. CRS occurred in 80% of patients (all grade",

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author = "Oluwole, {Olalekan O.} and Krimo Bouabdallah and Javier Munoz and {De Guibert}, Sophie and Vose, {Julie M.} and Bartlett, {Nancy L.} and Yi Lin and Abhinav Deol and McSweeney, {Peter A.} and Goy, {Andre H.} and Kersten, {Marie Jose} and Jacobson, {Caron A.} and Umar Farooq and Minnema, {Monique C.} and Catherine Thieblemont and Timmerman, {John M.} and Patrick Stiff and Irit Avivi and Dimitrios Tzachanis and Kim, {Jenny J.} and Zahid Bashir and Jeff McLeroy and Yan Zheng and Rossi, {John M.} and Lisa Johnson and Lovely Goyal and {van Meerten}, Tom",

year = "2021",

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language = "English",

volume = "194",

pages = "690--700",

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Oluwole, OO, Bouabdallah, K, Munoz, J, De Guibert, S, Vose, JM, Bartlett, NL, Lin, Y, Deol, A, McSweeney, PA, Goy, AH, Kersten, MJ, Jacobson, CA, Farooq, U, Minnema, MC, Thieblemont, C, Timmerman, JM, Stiff, P, Avivi, I, Tzachanis, D, Kim, JJ, Bashir, Z, McLeroy, J, Zheng, Y, Rossi, JM, Johnson, L, Goyal, L & van Meerten, T 2021, 'Prophylactic corticosteroid use in patients receiving axicabtagene ciloleucel for large B-cell lymphoma', British Journal of Haematology, vol. 194, no. 4, pp. 690-700. https://doi.org/10.1111/bjh.17527

Prophylactic corticosteroid use in patients receiving axicabtagene ciloleucel for large B-cell lymphoma. / Oluwole, Olalekan O.; Bouabdallah, Krimo; Munoz, Javier; De Guibert, Sophie; Vose, Julie M.; Bartlett, Nancy L.; Lin, Yi; Deol, Abhinav; McSweeney, Peter A.; Goy, Andre H.; Kersten, Marie Jose; Jacobson, Caron A.; Farooq, Umar; Minnema, Monique C.; Thieblemont, Catherine; Timmerman, John M.; Stiff, Patrick; Avivi, Irit; Tzachanis, Dimitrios; Kim, Jenny J.; Bashir, Zahid; McLeroy, Jeff; Zheng, Yan; Rossi, John M.; Johnson, Lisa; Goyal, Lovely; van Meerten, Tom.

In: British Journal of Haematology, Vol. 194, No. 4, 08.2021, p. 690-700.

Research output: Contribution to journal › Article › Academic › peer-review

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AU - De Guibert, Sophie

AU - Vose, Julie M.

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AU - McSweeney, Peter A.

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AU - Stiff, Patrick

AU - Avivi, Irit

AU - Tzachanis, Dimitrios

AU - Kim, Jenny J.

AU - Bashir, Zahid

AU - McLeroy, Jeff

AU - Zheng, Yan

AU - Rossi, John M.

AU - Johnson, Lisa

AU - Goyal, Lovely

AU - van Meerten, Tom

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KW - chimaeric antigen receptor-T cell

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KW - CYTOKINE RELEASE SYNDROME

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