Bethge, Wolfgang A., Martus, Peter, Schmitt, Michael, Holtick, Udo, Subklewe, Marion, von Tresckow, Bastian ORCID: 0000-0003-1410-4487, Ayuk, Francis, Wagner-Drouet, Eva Marie, Wulf, Gerald G., Marks, Reinhard, Penack, Olaf, Schnetzke, Ulf, Koenecke, Christian, von Bonin, Malte ORCID: 0000-0002-2995-3230, Stelljes, Matthias, Glass, Bertram, Baldus, Claudia D., Vucinic, Vladan ORCID: 0000-0002-8398-285X, Mougiakakos, Dimitrios, Topp, Max, Fante, Matthias A., Schroers, Roland, Bayir, Lale, Borchmann, Peter, Buecklein, Veit, Hasenkamp, Justin, Hanoun, Christine, Thomas, Simone, Beelen, Dietrich W., Lengerke, Claudia, 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). S. 349 - 359. WASHINGTON: AMER SOC HEMATOLOGY. ISSN 1528-0020

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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: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Bethge, Wolfgang A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Martus, PeterUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schmitt, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Holtick, UdoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Subklewe, MarionUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
von Tresckow, BastianUNSPECIFIEDorcid.org/0000-0003-1410-4487UNSPECIFIED
Ayuk, FrancisUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wagner-Drouet, Eva MarieUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wulf, Gerald G.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Marks, ReinhardUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Penack, OlafUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schnetzke, UlfUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Koenecke, ChristianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
von Bonin, MalteUNSPECIFIEDorcid.org/0000-0002-2995-3230UNSPECIFIED
Stelljes, MatthiasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Glass, BertramUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Baldus, Claudia D.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Vucinic, VladanUNSPECIFIEDorcid.org/0000-0002-8398-285XUNSPECIFIED
Mougiakakos, DimitriosUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Topp, MaxUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fante, Matthias A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schroers, RolandUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bayir, LaleUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Borchmann, PeterUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Buecklein, VeitUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hasenkamp, JustinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hanoun, ChristineUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Thomas, SimoneUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Beelen, Dietrich W.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lengerke, ClaudiaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kroeger, NicolausUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Dreger, PeterUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-696993
DOI: 10.1182/blood.2021015209
Journal or Publication Title: Blood
Volume: 140
Number: 4
Page Range: S. 349 - 359
Date: 2022
Publisher: AMER SOC HEMATOLOGY
Place of Publication: WASHINGTON
ISSN: 1528-0020
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
AXICABTAGENE CILOLEUCEL; SALVAGEMultiple languages
HematologyMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/69699

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