Patient characteristics and outcomes of outpatient tisagenlecleucel recipients for B cell non-Hodgkin lymphoma Review
| Authors: | Ahmed, N.; Wesson, W.; Mushtaq, M. U.; Porter, D. L.; Nasta, S. D.; Brower, J.; Bachanova, V.; Hu, M.; Nastoupil, L. J.; Oluwole, O. O.; Patel, V. G.; Oliai, C.; Riedell, P. A.; Bishop, M. R.; Shah, G. L.; Perales, M. A.; Schachter, L.; Maziarz, R. T.; McGuirk, J. P. |
| Review Title: | Patient characteristics and outcomes of outpatient tisagenlecleucel recipients for B cell non-Hodgkin lymphoma |
| Abstract: | 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. © 2023 The American Society for Transplantation and Cellular Therapy |
| Keywords: | adolescent; adult; cancer survival; controlled study; treatment outcome; aged; retrospective studies; human cell; major clinical study; overall survival; fludarabine; clinical feature; cancer combination chemotherapy; drug efficacy; patient selection; cancer patient; neurotoxicity; outcome assessment; cancer incidence; c reactive protein; progression free survival; neoplasm recurrence, local; cohort analysis; bendamustine; cyclophosphamide; hemoglobin blood level; retrospective study; health care utilization; intensive care unit; length of stay; b cell lymphoma; nonhodgkin lymphoma; drug combination; lymphoma, non-hodgkin; tumor recurrence; comorbidity; carcinoma; hospital patient; chimeric antigen receptor; outpatient; hospital admission; lactate dehydrogenase; drug therapy; endothelium; university hospital; outcomes; cd19 antigen; drug induced disease; ferritin; platelet count; ferritin blood level; clinical outcome; outpatients; cytokine release syndrome; diffuse large b cell lymphoma; tocilizumab; physiological stress; charlson comorbidity index; humans; human; male; female; article; absolute neutrophil count; ecog performance status; tisagenlecleucel t; chimeric antigen receptor t-cell immunotherapy; tisagenlecleucel; receptors, chimeric antigen; cd19 car-t; b cell malignancies; cell-associated neurotoxicity; immune effector cell associated neurotoxicity |
| Journal Title: | Transplantation and Cellular Therapy |
| Volume: | 29 |
| Issue: | 7 |
| ISSN: | 2666-6375 |
| Publisher: | Elsevier Inc. |
| Date Published: | 2023-07-01 |
| Start Page: | 449.e1 |
| End Page: | 449.e7 |
| Language: | English |
| DOI: | 10.1016/j.jtct.2023.04.019 |
| PUBMED: | 37120134 |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | Article -- Source: Scopus |
Altmetric
Citation Impact
BMJ Impact Analytics
Related MSK Work