Bethge, Wolfgang A. and Martus, Peter and Schmitt, Michael and Holtick, Udo and Subklewe, Marion and von Tresckow, Bastian and Ayuk, Francis and Wagner-Drouet, Eva Marie and Wulf, Gerald G. and Marks, Reinhard and Penack, Olaf and Schnetzke, Ulf and Koenecke, Christian and von Bonin, Malte and Stelljes, Matthias and Glass, Bertram and Baldus, Claudia D. and Vucinic, Vladan and Mougiakakos, Dimitrios and Topp, Max and Fante, Matthias A. and Schroers, Roland and Bayir, Lale and Borchmann, Peter and Buecklein, Veit and Hasenkamp, Justin and Hanoun, Christine and Thomas, Simone and Beelen, Dietrich W. and Lengerke, Claudia and Kroeger, Nicolaus and Dreger, Peter (2022) GLA/DRST real-world outcome analysis of CAR T-cell therapies for large B-cell lymphoma in Germany. BLOOD, 140 (4). pp. 349-358. ISSN 0006-4971, 1528-0020
Full text not available from this repository. (Request a copy)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.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | AXICABTAGENE CILOLEUCEL; SALVAGE; |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Innere Medizin III (Hämatologie und Internistische Onkologie) |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 29 Jan 2024 14:44 |
| Last Modified: | 29 Jan 2024 14:44 |
| URI: | https://pred.uni-regensburg.de/id/eprint/58633 |
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