Patient-reported outcomes in ZUMA-7, a phase 3 study of axicabtagene ciloleucel in second-line large B-cell lymphoma
2022; Elsevier BV; Volume: 140; Issue: 21 Linguagem: Inglês
10.1182/blood.2022015478
ISSN1528-0020
AutoresMahmoud Elsawy, Julio C. Chávez, Irit Avivi, Jean-François Larouche, Luciano Wannesson, Kate Cwynarski, Keren Osman, Kelly Davison, Jakob Rudzki, Saurabh Dahiya, Kathleen A. Dorritie, Samantha Jaglowski, John Radford, Franck Morschhauser, David Cunningham, Alejandro Martı́n, Dimitrios Tzachanis, Matthew L. Ulrickson, Reem Karmali, Natasha Kekre, Catherine Thiéblemont, Gunilla Enblad, Peter Dreger, Ram Malladi, Namita Joshi, Wei‐Jhih Wang, Caitlyn T. Solem, Julia Thornton Snider, Paul Cheng, Christina To, Marie José Kersten,
Tópico(s)Integrated Circuits and Semiconductor Failure Analysis
ResumoHere, 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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