| |  Online-Ressource |
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| Verfasst von: | Elsawy, Mahmoud [VerfasserIn]  |
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| | Chavez, Julio C. [VerfasserIn] |
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| | Avivi, Irit [VerfasserIn] |
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| | Larouche, Jean-François [VerfasserIn] |
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| | Wannesson, Luciano [VerfasserIn] |
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| | Cwynarski, Kate [VerfasserIn] |
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| | Osman, Keren [VerfasserIn] |
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| | Davison, Kelly [VerfasserIn] |
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| | Rudzki, Jakob D. [VerfasserIn] |
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| | Dahiya, Saurabh [VerfasserIn] |
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| | Dorritie, Kathleen [VerfasserIn] |
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| | Jaglowski, Samantha [VerfasserIn] |
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| | Radford, John [VerfasserIn] |
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| | Morschhauser, Franck [VerfasserIn] |
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| | Cunningham, David [VerfasserIn] |
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| | Martin Garcia-Sancho, Alejandro [VerfasserIn] |
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| | Tzachanis, Dimitrios [VerfasserIn] |
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| | Ulrickson, Matthew L. [VerfasserIn] |
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| | Karmali, Reem [VerfasserIn] |
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| | Kekre, Natasha [VerfasserIn] |
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| | Thieblemont, Catherine [VerfasserIn] |
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| | Enblad, Gunilla [VerfasserIn] |
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| | Dreger, Peter [VerfasserIn] |
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| | Malladi, Ram [VerfasserIn] |
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| | Joshi, Namita [VerfasserIn] |
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| | Wang, Wei-Jhih [VerfasserIn] |
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| | Solem, Caitlyn T. [VerfasserIn] |
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| | Snider, Julia Thornton [VerfasserIn] |
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| | Cheng, Paul [VerfasserIn] |
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| | To, Christina [VerfasserIn] |
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| | Kersten, Marie José [VerfasserIn] |
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| Titel: | Patient-reported outcomes in ZUMA-7, a phase 3 study of axicabtagene ciloleucel in second-line large B-cell lymphoma |
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| Verf.angabe: | Mahmoud Elsawy, Julio C. Chavez, Irit Avivi, Jean-François Larouche, Luciano Wannesson, Kate Cwynarski, Keren Osman, Kelly Davison, Jakob D. Rudzki, Saurabh Dahiya, Kathleen Dorritie, Samantha Jaglowski, John Radford, Franck Morschhauser, David Cunningham, Alejandro Martin Garcia-Sancho, Dimitrios Tzachanis, Matthew L. Ulrickson, Reem Karmali, Natasha Kekre, Catherine Thieblemont, Gunilla Enblad, Peter Dreger, Ram Malladi, Namita Joshi, Wei-Jhih Wang, Caitlyn T. Solem, Julia Thornton Snider, Paul Cheng, Christina To, and Marie José Kersten |
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| E-Jahr: | 2022 |
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| Jahr: | 24 November 2022 |
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| Umfang: | 13 S. |
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| Fussnoten: | Online verfügbar 19 July 2022, Version des Artikels 24 November 2022 ; Gesehen am 26.04.2023 |
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| Titel Quelle: | Enthalten in: Blood |
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| Ort Quelle: | Washington, DC : American Society of Hematology, 1946 |
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| Jahr Quelle: | 2022 |
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| Band/Heft Quelle: | 140(2022), 21 vom: Nov., Seite 2248-2260 |
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| ISSN Quelle: | 1528-0020 |
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| Abstract: | Here, we report the first comparative analysis of patient-reported outcomes (PROs) with chimeric antigen receptor T-cell therapy vs standard-of-care (SOC) therapy in second-line relapsed/refractory large B-cell lymphoma (R/R LBCL) from the pivotal randomized phase 3 ZUMA-7 study of axicabtagene ciloleucel (axi-cel) vs SOC. PRO instruments were administered at baseline, day 50, day 100, day 150, month 9, and every 3 months from randomization until 24 months or an event-free survival event. The quality of life (QoL) analysis set comprised patients with a baseline and ≥1 follow-up PRO completion. Prespecified hypotheses for Quality of Life Questionnaire-Core 30 (QLQ-C30) physical functioning, global health status/QoL, and EQ-5D-5L visual analog scale (VAS) were tested using mixed-effects models with repeated measures. Clinically meaningful changes were defined as 10 points for QLQ-C30 and 7 for EQ-5D-5L VAS. Among 359 patients, 296 (165 axi-cel, 131 SOC) met inclusion criteria for QoL analysis. At day 100, statistically significant and clinically meaningful differences in mean change of scores from baseline were observed favoring axi-cel over SOC for QLQ-C30 global health status/QoL (estimated difference 18.1 [95% confidence interval (CI), 12.3-23.9]), physical functioning (13.1 [95% CI, 8.0-18.2]), and EQ-5D-5L VAS (13.7 [95% CI, 8.5-18.8]; P < .0001 for all). At day 150, scores significantly favored axi-cel vs SOC for global health status/QoL (9.8 [95% CI, 2.6-17.0]; P = .0124) and EQ-5D-5L VAS (11.3 [95% CI, 5.4-17.1]; P = .0004). Axi-cel showed clinically meaningful improvements in QoL over SOC. Superior clinical outcomes and favorable patient experience with axi-cel should help inform treatment choices in second-line R/R LBCL. This trial was registered at www.clinicaltrials.gov as #NCT03391466. |
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| DOI: | doi:10.1182/blood.2022015478 |
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| URL: | Bitte beachten Sie: Dies ist ein Bibliographieeintrag. Ein Volltextzugriff für Mitglieder der Universität besteht hier nur, falls für die entsprechende Zeitschrift/den entsprechenden Sammelband ein Abonnement besteht oder es sich um einen OpenAccess-Titel handelt.
Volltext: https://doi.org/10.1182/blood.2022015478 |
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| | DOI: https://doi.org/10.1182/blood.2022015478 |
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| Datenträger: | Online-Ressource |
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| Sprache: | eng |
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| K10plus-PPN: | 1843591235 |
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| Verknüpfungen: | → Zeitschrift |
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Patient-reported outcomes in ZUMA-7, a phase 3 study of axicabtagene ciloleucel in second-line large B-cell lymphoma / Elsawy, Mahmoud [VerfasserIn]; 24 November 2022 (Online-Ressource)
