dc.contributor.author | Elsawy, M | |
dc.contributor.author | Chavez, JC | |
dc.contributor.author | Avivi, I | |
dc.contributor.author | Larouche, J-F | |
dc.contributor.author | Wannesson, L | |
dc.contributor.author | Cwynarski, K | |
dc.contributor.author | Osman, K | |
dc.contributor.author | Davison, K | |
dc.contributor.author | Rudzki, JD | |
dc.contributor.author | Dahiya, S | |
dc.contributor.author | Dorritie, KA | |
dc.contributor.author | Jaglowski, SM | |
dc.contributor.author | Radford, J | |
dc.contributor.author | Morschhauser, F | |
dc.contributor.author | Cunningham, D | |
dc.contributor.author | Martin Garcia-Sancho, A | |
dc.contributor.author | Tzachanis, D | |
dc.contributor.author | Ulrickson, ML | |
dc.contributor.author | Karmali, R | |
dc.contributor.author | Kekre, N | |
dc.contributor.author | Thieblemont, C | |
dc.contributor.author | Enblad, G | |
dc.contributor.author | Dreger, P | |
dc.contributor.author | Malladi, R | |
dc.contributor.author | Joshi, N | |
dc.contributor.author | Wang, W-J | |
dc.contributor.author | Solem, CT | |
dc.contributor.author | Snider, JT | |
dc.contributor.author | Cheng, P | |
dc.contributor.author | To, C | |
dc.contributor.author | Kersten, MJ | |
dc.coverage.spatial | United States | |
dc.date.accessioned | 2022-09-27T11:09:21Z | |
dc.date.available | 2022-09-27T11:09:21Z | |
dc.date.issued | 2022-07-15 | |
dc.identifier | 485937 | |
dc.identifier.citation | Blood, 2022, pp. blood.2022015478 - | en_US |
dc.identifier.issn | 0006-4971 | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/5505 | |
dc.identifier.eissn | 1528-0020 | |
dc.identifier.eissn | 1528-0020 | |
dc.identifier.doi | 10.1182/blood.2022015478 | |
dc.description.abstract | Here we report the first comparative analysis of patient-reported outcomes (PROs) with chimeric antigen receptor T-cell therapy versus 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 (NCT03391466) study of axicabtagene ciloleucel (axi-cel) versus 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 QLQ-C30 Physical Functioning, Global Health Status/QoL, and EQ-5D-5L visual analogue scale (VAS) were tested using mixed-effect 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% 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 versus 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. | |
dc.format | Print-Electronic | |
dc.format.extent | blood.2022015478 - | |
dc.language | eng | |
dc.language.iso | eng | en_US |
dc.publisher | American Society of Hematology | en_US |
dc.relation.ispartof | Blood | |
dc.rights.uri | https://creativecommons.org/licenses/by-nc-nd/4.0/ | en_US |
dc.title | Patient-reported outcomes in ZUMA-7, a phase 3 study of axicabtagene ciloleucel in second-line large B-cell lymphoma. | en_US |
dc.type | Journal Article | |
dcterms.dateAccepted | 2022-06-23 | |
dc.date.updated | 2022-09-27T11:08:46Z | |
rioxxterms.version | AM | en_US |
rioxxterms.versionofrecord | 10.1182/blood.2022015478 | en_US |
rioxxterms.licenseref.startdate | 2022-07-15 | |
rioxxterms.type | Journal Article/Review | en_US |
pubs.author-url | https://www.ncbi.nlm.nih.gov/pubmed/35839452 | |
pubs.organisational-group | /ICR | |
pubs.organisational-group | /ICR/Primary Group | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies/Medicine (RMH Smith Cunningham) | |
pubs.organisational-group | /ICR/Primary Group/Royal Marsden Clinical Units | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies/Medicine (RMH Smith Cunningham)/Medicine (RMH Smith Cunningham) (hon.) | |
pubs.publication-status | Published online | |
pubs.publisher-url | http://dx.doi.org/10.1182/blood.2022015478 | |
icr.researchteam | Medicine (RMH) | en_US |
dc.contributor.icrauthor | Cunningham, David | |
icr.provenance | Deposited by Mr Arek Surman (impersonating Prof Chris Lord) on 2022-09-27. Deposit type is initial. No. of files: 1. Files: blood.2022015478.pdf | |