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Patient-reported outcomes in ZUMA-7, a phase 3 study of axicabtagene ciloleucel in second-line large B-cell lymphoma

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 cilo...

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Hauptverfasser: Elsawy, Mahmoud (VerfasserIn) , Chavez, Julio C. (VerfasserIn) , Avivi, Irit (VerfasserIn) , Larouche, Jean-François (VerfasserIn) , Wannesson, Luciano (VerfasserIn) , Cwynarski, Kate (VerfasserIn) , Osman, Keren (VerfasserIn) , Davison, Kelly (VerfasserIn) , Rudzki, Jakob D. (VerfasserIn) , Dahiya, Saurabh (VerfasserIn) , Dorritie, Kathleen (VerfasserIn) , Jaglowski, Samantha (VerfasserIn) , Radford, John (VerfasserIn) , Morschhauser, Franck (VerfasserIn) , Cunningham, David (VerfasserIn) , Martin Garcia-Sancho, Alejandro (VerfasserIn) , Tzachanis, Dimitrios (VerfasserIn) , Ulrickson, Matthew L. (VerfasserIn) , Karmali, Reem (VerfasserIn) , Kekre, Natasha (VerfasserIn) , Thieblemont, Catherine (VerfasserIn) , Enblad, Gunilla (VerfasserIn) , Dreger, Peter (VerfasserIn) , Malladi, Ram (VerfasserIn) , Joshi, Namita (VerfasserIn) , Wang, Wei-Jhih (VerfasserIn) , Solem, Caitlyn T. (VerfasserIn) , Snider, Julia Thornton (VerfasserIn) , Cheng, Paul (VerfasserIn) , To, Christina (VerfasserIn) , Kersten, Marie José (VerfasserIn)
Dokumenttyp: Article (Journal)
Sprache:Englisch
Veröffentlicht: 24 November 2022
In: Blood
Year: 2022, Jahrgang: 140, Heft: 21, Pages: 2248-2260
ISSN:1528-0020
DOI:10.1182/blood.2022015478
Online-Zugang:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1182/blood.2022015478
Volltext
Verfasserangaben: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
Beschreibung
Zusammenfassung: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.
Beschreibung:Online verfügbar 19 July 2022, Version des Artikels 24 November 2022
Gesehen am 26.04.2023
Beschreibung:Online Resource
ISSN:1528-0020
DOI:10.1182/blood.2022015478

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