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

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