Patient-reported outcomes in ZUMA-7, a phase 3 study of axicabtagene ciloleucel in second-line large B-cell lymphomaIst Oncol Svizzera Italiana, Bellinzona, Switzerland..
Univ Coll London Hosp Natl Hlth Serv NHS Fdn Trus, Dept Haematol, London, England..
Icahn Sch Med Mt Sinai, New York, NY 10029 USA..
McGill Univ, Royal Victoria Hosp, Hlth Ctr, Montreal, PQ, Canada..
Med Univ Innsbruck, Univ Clin Internal Med, Dept Hematol & Oncol, Innsbruck, Austria..
Univ Maryland, Greenebaum Comprehens Canc Ctr, Transplant & Cellular Therapy Program, Med Ctr, Baltimore, MD USA..
Univ Pittsburgh, Med Ctr UPMC, Hillman Canc Ctr, Pittsburgh, PA USA..
Ohio State Univ, Comprehens Canc Ctr, Blood & Marrow Transplant Program, Columbus, OH 43210 USA..
Univ Lille, CHU Lille, Grp Rech Formes Injectables & Technol Assoc, Lille, France..
Salamanca Univ Hosp, Ctr Invest Biomed Red Canc CIBERONC, Inst Biomed Res Salamanca IBSAL, Hematol Dept, Salamanca, Spain..
Univ Calif San Diego, Moores Canc Ctr, La Jolla, CA 92093 USA..
Banner MD Anderson Canc Ctr, Gilbert, AZ USA..
Northwestern Univ, Robert H Lurie Comprehens Canc Ctr, Div Hematol & Oncol, Chicago, IL 60611 USA..
Ottawa Hosp, Ottawa, ON, Canada..
Univ Paris, DMU DHI, Hematooncol, Hop St Louis, Paris, France..
Heidelberg Univ, Dept Med, Heidelberg, Germany..
Cambridge Univ Hosp NHS Fdn Trust, Cambridge, England.;Univ Hosp Birmingham NHS Fdn Trust, Cambridge, England..
OPEN Hlth, Bethesda, MD USA..
OPEN Hlth, Bethesda, MD USA..
Kite, Santa Monica, CA USA..
Kite, Santa Monica, CA USA..
Kite, Santa Monica, CA USA..
Univ Amsterdam, Canc Ctr Amsterdam, Dept Hematol, Amsterdam UMC,Stichting Hematooncol Volwassenen N, Amsterdam, Netherlands..
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2022 (English)In: Blood, ISSN 0006-4971, E-ISSN 1528-0020, Vol. 140, no 21, p. 2248-2260Article in journal (Refereed) Published
Abstract [en]
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. Pre-specified 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.
Place, publisher, year, edition, pages
American Society of Hematology American Society of Hematology, 2022. Vol. 140, no 21, p. 2248-2260
National Category
Hematology
Identifiers
URN: urn:nbn:se:uu:diva-498943DOI: 10.1182/blood.2022015478ISI: 000928312200008PubMedID: 35839452OAI: oai:DiVA.org:uu-498943DiVA, id: diva2:1745235
Funder
AstraZenecaEli Lilly and Company2023-03-222023-03-222024-01-15Bibliographically approved