The CAR-HEMATOTOX score identifies patients at high risk for hematological toxicity, infectious complications, and poor treatment outcomes following brexucabtagene autoleucel for relapsed or refractory MCL
© 2023 The Authors. American Journal of Hematology published by Wiley Periodicals LLC..
CD19-directed CAR T-cell therapy with brexucabtagene autoleucel (brexu-cel) has substantially improved treatment outcomes for patients with relapsed/refractory mantle cell lymphoma (r/r MCL). Prolonged cytopenias and infections represent common and clinically relevant side effects. In this multicenter observational study, we describe cytopenias and infections in 103 r/r MCL patients receiving brexu-cel. Furthermore, we report associations between the baseline CAR-HEMATOTOX (HT) score and toxicity events, non-relapse mortality (NRM), and progression-free/overall survival (PFS/OS). At lymphodepletion, 56 patients were HTlow (score 0-1) while 47 patients were HThigh (score ≥2). The HThigh cohort exhibited prolonged neutropenia (median 14 vs. 6 days, p < .001) and an increased rate of severe infections (30% vs. 5%, p = .001). Overall, 1-year NRM was 10.4%, primarily attributed to infections, and differed by baseline HT score (high vs. low: 17% vs. 4.6%, p = .04). HThigh patients experienced inferior 90-day complete response rate (68% vs. 93%, p = .002), PFS (median 9 months vs. not-reached, p < .0001), and OS (median 26 months vs. not-reached, p < .0001). Multivariable analyses showed that high HT scores were independently associated with severe hematotoxicity, infections, and poor PFS/OS. In conclusion, infections and hematotoxicity are common after brexu-cel and contribute to NRM. The baseline HT score identified patients at increased risk of poor treatment outcomes.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:98 |
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| Enthalten in: |
American journal of hematology - 98(2023), 11 vom: 29. Nov., Seite 1699-1710 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Rejeski, Kai [VerfasserIn] |
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| Links: |
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| Themen: |
4MD2J2T8SJ |
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| Anmerkungen: |
Date Completed 15.11.2023 Date Revised 22.11.2023 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1002/ajh.27056 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM360837271 |
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| 100 | 1 | |a Rejeski, Kai |e verfasserin |4 aut | |
| 245 | 1 | 4 | |a The CAR-HEMATOTOX score identifies patients at high risk for hematological toxicity, infectious complications, and poor treatment outcomes following brexucabtagene autoleucel for relapsed or refractory MCL |
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| 500 | |a Date Revised 22.11.2023 | ||
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| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2023 The Authors. American Journal of Hematology published by Wiley Periodicals LLC. | ||
| 520 | |a CD19-directed CAR T-cell therapy with brexucabtagene autoleucel (brexu-cel) has substantially improved treatment outcomes for patients with relapsed/refractory mantle cell lymphoma (r/r MCL). Prolonged cytopenias and infections represent common and clinically relevant side effects. In this multicenter observational study, we describe cytopenias and infections in 103 r/r MCL patients receiving brexu-cel. Furthermore, we report associations between the baseline CAR-HEMATOTOX (HT) score and toxicity events, non-relapse mortality (NRM), and progression-free/overall survival (PFS/OS). At lymphodepletion, 56 patients were HTlow (score 0-1) while 47 patients were HThigh (score ≥2). The HThigh cohort exhibited prolonged neutropenia (median 14 vs. 6 days, p < .001) and an increased rate of severe infections (30% vs. 5%, p = .001). Overall, 1-year NRM was 10.4%, primarily attributed to infections, and differed by baseline HT score (high vs. low: 17% vs. 4.6%, p = .04). HThigh patients experienced inferior 90-day complete response rate (68% vs. 93%, p = .002), PFS (median 9 months vs. not-reached, p < .0001), and OS (median 26 months vs. not-reached, p < .0001). Multivariable analyses showed that high HT scores were independently associated with severe hematotoxicity, infections, and poor PFS/OS. In conclusion, infections and hematotoxicity are common after brexu-cel and contribute to NRM. The baseline HT score identified patients at increased risk of poor treatment outcomes | ||
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Observational Study | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, N.I.H., Extramural | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 7 | |a brexucabtagene autoleucel |2 NLM | |
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| 700 | 1 | |a Wang, Yucai |e verfasserin |4 aut | |
| 700 | 1 | |a Albanyan, Omar |e verfasserin |4 aut | |
| 700 | 1 | |a Munoz, Javier |e verfasserin |4 aut | |
| 700 | 1 | |a Sesques, Pierre |e verfasserin |4 aut | |
| 700 | 1 | |a Iacoboni, Gloria |e verfasserin |4 aut | |
| 700 | 1 | |a Lopez-Corral, Lucia |e verfasserin |4 aut | |
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| 700 | 1 | |a Bücklein, Veit L |e verfasserin |4 aut | |
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| 700 | 1 | |a Baluch, Aliyah |e verfasserin |4 aut | |
| 700 | 1 | |a Shah, Bijal |e verfasserin |4 aut | |
| 700 | 1 | |a Locke, Frederick L |e verfasserin |4 aut | |
| 700 | 1 | |a Hess, Georg |e verfasserin |4 aut | |
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| 700 | 1 | |a Subklewe, Marion |e verfasserin |4 aut | |
| 700 | 1 | |a Jain, Michael D |e verfasserin |4 aut | |
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