TY - JOUR
T1 - Patient Characteristics and Outcomes of Outpatient Tisagenlecleucel Recipients for B Cell Non-Hodgkin Lymphoma
AU - Ahmed, Nausheen
AU - Wesson, William
AU - Mushtaq, Muhammad Umair
AU - Porter, David L.
AU - Nasta, Sunita D.
AU - Brower, Jamie
AU - Bachanova, Veronika
AU - Hu, Marie
AU - Nastoupil, Loretta J.
AU - Oluwole, Olalekan O.
AU - Patel, Vivek G.
AU - Oliai, Caspian
AU - Riedell, Peter A.
AU - Bishop, Michael R.
AU - Shah, Gunjan L.
AU - Perales, Miguel Angel
AU - Schachter, Levanto
AU - Maziarz, Richard T.
AU - McGuirk, Joseph P.
N1 - Publisher Copyright:
© 2023 The American Society for Transplantation and Cellular Therapy
PY - 2023/7
Y1 - 2023/7
N2 - Tisagenlecleucel (tisa-cel) is an approved CD19-directed chimeric antigen receptor T cell (CAR-T) therapy for relapsed/refractory B cell malignancies. Given potentially life-threatening toxicities, including cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome, inpatient tisa-cel infusion and toxicity monitoring are often considered; however, the toxicity profile of tisa-cel may be conducive to outpatient administration. Here we review the characteristics and outcomes of tisa-cel recipients treated in the outpatient setting. Patients age ≥18 years with B cell non-Hodgkin lymphoma who received tisa-cel between June 25, 2018, and January 22, 2021, at 9 US academic medical centers were included in a retrospective analysis. Six of the 9 representative centers (75%) had an outpatient program in place. A total of 157 patients were evaluable, including 93 (57%) in the outpatient treatment group and 64 (43%) in the inpatient treatment group. Baseline characteristics, toxicity and efficacy, and resource utilization were summarized. The most common lymphodepletion (LD) regimen was bendamustine in the outpatient group (65%) and fludarabine/cyclophosphamide (91%) in the inpatient group. The outpatient group had more patients with a Charlson Comorbidity Index of 0 (51% versus 15%; P <.001), fewer patients with an elevated lactate dehydrogenase (LDH) level above the normal range at the time of LD (32% versus 57%, P =.003) compared to the inpatient group, and a lower Endothelial Activation and Stress Index score (.57 versus 1.4; P <.001). Any-grade CRS and ICANS were lower in the outpatient group (29% versus 56% [P <.001] and 10% versus 16% [P =.051], respectively). Forty-two outpatient tisa-cel recipients (45%) required an unplanned admission, with a median length of stay of 5 days (range, 1 to 27 days), compared to 13 days (range, 4 to 38 days) in the inpatient group. The median number of tocilizumab doses administered was similar in the 2 groups as were the rate of intensive care unit (ICU) transfer (5% versus 8%; P =.5) and median length of ICU stay (6 days versus 5 days; P =.7). There were no toxicity-related deaths in the 30 days post-CAR-T infusion in either group. Progression-free survival and overall survival were similar in the 2 groups. With careful patient selection, outpatient tisa-cel administration is feasible and associated with similar efficacy outcomes as inpatient treatment. Outpatient toxicity monitoring and management may help optimize healthcare resource utilization.
AB - Tisagenlecleucel (tisa-cel) is an approved CD19-directed chimeric antigen receptor T cell (CAR-T) therapy for relapsed/refractory B cell malignancies. Given potentially life-threatening toxicities, including cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome, inpatient tisa-cel infusion and toxicity monitoring are often considered; however, the toxicity profile of tisa-cel may be conducive to outpatient administration. Here we review the characteristics and outcomes of tisa-cel recipients treated in the outpatient setting. Patients age ≥18 years with B cell non-Hodgkin lymphoma who received tisa-cel between June 25, 2018, and January 22, 2021, at 9 US academic medical centers were included in a retrospective analysis. Six of the 9 representative centers (75%) had an outpatient program in place. A total of 157 patients were evaluable, including 93 (57%) in the outpatient treatment group and 64 (43%) in the inpatient treatment group. Baseline characteristics, toxicity and efficacy, and resource utilization were summarized. The most common lymphodepletion (LD) regimen was bendamustine in the outpatient group (65%) and fludarabine/cyclophosphamide (91%) in the inpatient group. The outpatient group had more patients with a Charlson Comorbidity Index of 0 (51% versus 15%; P <.001), fewer patients with an elevated lactate dehydrogenase (LDH) level above the normal range at the time of LD (32% versus 57%, P =.003) compared to the inpatient group, and a lower Endothelial Activation and Stress Index score (.57 versus 1.4; P <.001). Any-grade CRS and ICANS were lower in the outpatient group (29% versus 56% [P <.001] and 10% versus 16% [P =.051], respectively). Forty-two outpatient tisa-cel recipients (45%) required an unplanned admission, with a median length of stay of 5 days (range, 1 to 27 days), compared to 13 days (range, 4 to 38 days) in the inpatient group. The median number of tocilizumab doses administered was similar in the 2 groups as were the rate of intensive care unit (ICU) transfer (5% versus 8%; P =.5) and median length of ICU stay (6 days versus 5 days; P =.7). There were no toxicity-related deaths in the 30 days post-CAR-T infusion in either group. Progression-free survival and overall survival were similar in the 2 groups. With careful patient selection, outpatient tisa-cel administration is feasible and associated with similar efficacy outcomes as inpatient treatment. Outpatient toxicity monitoring and management may help optimize healthcare resource utilization.
KW - B cell malignancies
KW - CD19 CAR-T
KW - Outcomes
KW - Outpatient
KW - Tisagenlecleucel
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UR - http://www.scopus.com/inward/citedby.url?scp=85160054285&partnerID=8YFLogxK
U2 - 10.1016/j.jtct.2023.04.019
DO - 10.1016/j.jtct.2023.04.019
M3 - Article
C2 - 37120134
AN - SCOPUS:85160054285
SN - 2666-6367
VL - 29
SP - 449.e1-449.e7
JO - Transplantation and Cellular Therapy
JF - Transplantation and Cellular Therapy
IS - 7
ER -