; Martus, Peter ; Schmitt, Michael ; Holtick, Udo ; Subklewe, Marion ; von Tresckow, Bastian
; Ayuk, Francis ; Wagner-Drouet, Eva Maria ; Wulf, Gerald G ; Marks, Reinhard ; Penack, Olaf ; Schnetzke, Ulf ; Koenecke, Christian
; von Bonin, Malte
; Stelljes, Matthias ; Glass, Bertram ; Baldus, Claudia D ; Vucinic, Vladan
; Mougiakakos, Dimitrios ; Topp, Max S ; Fante, Matthias Alexander ; Schroers, Roland ; Bayir, Lale May ; Borchmann, Peter ; Buecklein, Veit ; Hanoun, Christine ; Thomas, Simone ; Beelen, Dietrich W. ; Lengerke, Claudia ; Kroeger, Nicolaus ; Dreger, Peter ; | Item type: | Article | ||||
|---|---|---|---|---|---|
| Journal or Publication Title: | Blood | ||||
| Publisher: | AMER SOC HEMATOLOGY | ||||
| Place of Publication: | WASHINGTON | ||||
| Date: | 2022 | ||||
| Institutions: | Medicine > Lehrstuhl für Innere Medizin III (Hämatologie und Internistische Onkologie) | ||||
| Identification Number: |
| ||||
| Keywords: | AXICABTAGENE CILOLEUCEL; SALVAGE; | ||||
| Dewey Decimal Classification: | 600 Technology > 610 Medical sciences Medicine | ||||
| Status: | Published | ||||
| Refereed: | Yes, this version has been refereed | ||||
| Created at the University of Regensburg: | Yes | ||||
| Item ID: | 57704 |
Abstract
CD19-directed chimeric antigen receptor (CAR) T cells have evolved as a new standard-of-care (SOC) treatment in patients with relapsed/refractory (r/r) large B-cell lymphoma (LBCL). Here, we report the first German real-world data on SOC CAR T-cell therapies with the aim to explore risk factors associated with outcomes. Patients who received SOC axicabtagene ciloleucel (axi-cel) or ...

Abstract
CD19-directed chimeric antigen receptor (CAR) T cells have evolved as a new standard-of-care (SOC) treatment in patients with relapsed/refractory (r/r) large B-cell lymphoma (LBCL). Here, we report the first German real-world data on SOC CAR T-cell therapies with the aim to explore risk factors associated with outcomes. Patients who received SOC axicabtagene ciloleucel (axi-cel) or tisagenlecleucel (tisa-cel) for LBCL and were registered with the German Registry for Stem Cell Transplantation (DRST) were eligible. The main outcomes analyzed were toxicities, response, overall survival (OS), and progression-free survival (PFS). We report 356 patients who received axi-cel (n = 173) or tisa-cel (n = 183) between November 2018 and April 2021 at 21 German centers. Whereas the axi-cel and tisa-cel cohorts were comparable for age, sex, lactate dehydrogenase (LDH), international prognostic index (IPI), and pretreatment, the tisa-cel group comprised significantly more patients with poor performance status, ineligibility for ZUMA-1, and the need for bridging, respectively. With a median follow-up of 11 months, Kaplan-Meier estimates of OS, PFS, and nonrelapse mortality (NRM) 12 months after dosing were 52%, 30%, and 6%, respectively. While NRM was largely driven by infections subsequent to prolonged neutropenia and/or severe neurotoxicity and significantly higher with axi-cel, significant risk factors for PFS on the multivariate analysis included bridging failure, elevated LDH, age, and tisa-cel use. In conclusion, this study suggests that important outcome determinants of CD19-directed CAR T-cell treatment of LBCL in the real-world setting are bridging success, CAR-T product selection, LDH, and the absence of prolonged neutropenia and/or severe neurotoxicity. These findings may have implications for designing risk-adapted CAR T-cell therapy strategies.
Metadata last modified: 29 Feb 2024 13:02
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