Patient Characteristics and Outcomes of Outpatient Tisagenlecleucel Recipients for B Cell Non-Hodgkin Lymphoma

Nausheen Ahmed, William Wesson, Muhammad Umair Mushtaq, David L. Porter, Sunita D. Nasta, Jamie Brower, Veronika Bachanova, Marie Hu, Loretta J. Nastoupil, Olalekan O. Oluwole, Vivek G. Patel, Caspian Oliai, Peter A. Riedell, Michael R. Bishop, Gunjan L. Shah, Miguel Angel Perales, Levanto Schachter, Richard T. Maziarz, Joseph P. McGuirk

Research output: Contribution to journalArticlepeer-review

5 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)449.e1-449.e7
JournalTransplantation and Cellular Therapy
Volume29
Issue number7
DOIs
StatePublished - Jul 2023

Bibliographical note

Publisher Copyright:
© 2023 The American Society for Transplantation and Cellular Therapy

Keywords

  • B cell malignancies
  • CD19 CAR-T
  • Outcomes
  • Outpatient
  • Tisagenlecleucel

PubMed: MeSH publication types

  • Review
  • Journal Article
  • Research Support, Non-U.S. Gov't

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