Patterns of use, outcomes, and resource utilization among recipients of commercial axicabtagene ciloleucel and tisagenlecleucel for relapsed/refractory aggressive B cell lymphomas Journal Article
| Authors: | Riedell, P. A.; Hwang, W. T.; Nastoupil, L. J.; Pennisi, M.; McGuirk, J. P.; Maziarz, R. T.; Bachanova, V.; Oluwole, O. O.; Brower, J.; Flores, O. A.; Ahmed, N.; Schachter, L.; Bharucha, K.; Dholaria, B. R.; Schuster, S. J.; Perales, M. A.; Bishop, M. R.; Porter, D. L. |
| Article Title: | Patterns of use, outcomes, and resource utilization among recipients of commercial axicabtagene ciloleucel and tisagenlecleucel for relapsed/refractory aggressive B cell lymphomas |
| Abstract: | Axicabtagene ciloleucel (axi-cel) and tisagenlecleucel (tisa-cel) are CD19-directed chimeric antigen receptor (CAR) T cell therapies approved for the treatment of relapsed/refractory aggressive B cell lymphomas. We present a multicenter retrospective study among centers that prescribe either commercial product to evaluate usage patterns, safety and efficacy outcomes, and resource utilization. Data collection included all patients from 8 US centers who underwent apheresis between May 1, 2018, and July 31, 2019. Patient selection, toxicity management, and disease assessment followed institutional practices. Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) were graded according to American Society for Transplantation and Cellular Therapy consensus criteria, and tumor responses were assessed according to the Lugano 2014 classification scheme. A total of 260 patients underwent apheresis, including 168 (65%) for axi-cel and 92 (35%) for tisa-cel. Among the infused patients, the median age was 59 years for axi-cel recipients and 67 years for tisa-cel recipients (P < .001). The median time from apheresis to infusion was 28 days for axi-cel recipients and 45 days for tisa-cel recipients (P < .001). Sixty-one percent of the axi-cel recipients and 43% of the tisa-cel recipients would have been ineligible for the ZUMA-1 and JULIET trials, respectively. Grade ≥3 CRS occurred in 9% of axi-cel recipients and in 1% of tisa-cel recipients (P = .017), and grade ≥3 ICANS was seen in 38% of axi-cel recipients and 1% of tisa-cel recipients (P < .001). Inpatient cell therapy infusion was common (92% in axi-cel recipients, 37% in tisa-cel recipients). The day 90 overall response rate was 52% in the axi-cel group and 41% in the tisa-cel group (P =. 113), with complete response in 44% and 35%, respectively (P =. 319). Twelve-month progression-free survival (42% versus 32%; P =. 206) and overall survival (62% versus 59%; P =. 909) rates were comparable in the axi-cel and tisa-cel groups. Baseline characteristics differed between the 2 groups, although response rates and survival outcomes were comparable, albeit lower than those in the pivotal trials. Safety and resource utilization appear to be key differentiators between axi-cel and tisa-cel. © 2022 The American Society for Transplantation and Cellular Therapy |
| Keywords: | adult; cancer chemotherapy; cancer survival; controlled study; treatment outcome; aged; middle aged; retrospective studies; major clinical study; overall survival; fludarabine; clinical trial; cancer recurrence; drug efficacy; drug safety; united states; cancer staging; drug megadose; neurotoxicity; outcome assessment; follow up; consensus; progression free survival; infection; bendamustine; cyclophosphamide; dexamethasone; retrospective study; histology; hypoxia; health care utilization; prescription; hypotension; intensive care unit; length of stay; hospitalization; b cell lymphoma; receptors, antigen, t-cell; multicenter study; lactate dehydrogenase; methylprednisolone; lymphoma, large b-cell, diffuse; kaplan meier method; drug therapy; disease exacerbation; lactate dehydrogenase blood level; outpatient care; cd19 antigen; lymphocyte antigen receptor; antigens, cd19; autologous hematopoietic stem cell transplantation; biological product; biological products; ferritin; artificial ventilation; turnaround time; infectious complication; ferritin blood level; cumulative incidence; international prognostic index; institutional care; apheresis; cytokine release syndrome; overall response rate; diffuse large b cell lymphoma; tocilizumab; resource utilization; charlson comorbidity index; intention to treat analysis; humans; human; male; female; article; transformed follicular lymphoma; disease assessment; primary mediastinal b cell lymphoma; ecog performance status; tisagenlecleucel t; chimeric antigen receptor t-cell immunotherapy; axicabtagene ciloleucel; chimeric antigen receptor t cell therapy; high grade b cell lymphoma; immune effector cell associated neurotoxicity syndrome; receptors, chimeric antigen; aggressive large b cell lymphoma; car t cell therapy outcomes; car t cell toxicity; noninvasive positive pressure ventilation |
| Journal Title: | Transplantation and Cellular Therapy |
| Volume: | 28 |
| Issue: | 10 |
| ISSN: | 2666-6375 |
| Publisher: | Elsevier Inc. |
| Date Published: | 2022-10-01 |
| Start Page: | 669 |
| End Page: | 676 |
| Language: | English |
| DOI: | 10.1016/j.jtct.2022.07.011 |
| PUBMED: | 35850429 |
| PROVIDER: | scopus |
| PMCID: | PMC9547952 |
| DOI/URL: | |
| Notes: | Article -- Export Date: 1 November 2022 -- Source: Scopus |
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