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

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Fältnamn	Indikatorer	Metadata
000		06574naa a2200637 4500
001		oai:DiVA.org:uu-498943
003		SwePub
008		230322s2022 \| \|\|\|\|\|\|\|\|\|\|\|000 \|\|eng\|
024	7	a https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-4989432 URI
024	7	a https://doi.org/10.1182/blood.20220154782 DOI
040		a (SwePub)uu
041		a engb eng
042		9 SwePub
072	7	a ref2 swepub-contenttype
072	7	a art2 swepub-publicationtype
100	1	a Elsawy, Mahmoudu Dalhousie Univ, Queen Elizabeth II Hlth Sci Ctr, Halifax, NS, Canada.;Dalhousie Univ, Div Hematol, Dept Med, QEII Bethune Bldg,Suite 430 Bethune Bldg, Halifax, NS B3H 2Y9, Canada.4 aut
245	1 0	a Patient-reported outcomes in ZUMA-7, a phase 3 study of axicabtagene ciloleucel in second-line large B-cell lymphoma
264	1	b American Society of Hematology,c 2022
338		a print2 rdacarrier
520		a 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.
650	7	a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicinx Hematologi0 (SwePub)302022 hsv//swe
650	7	a MEDICAL AND HEALTH SCIENCESx Clinical Medicinex Hematology0 (SwePub)302022 hsv//eng
700	1	a Chavez, Julio C.u H Lee Moffitt Canc Ctr & Res Inst, Tampa, FL USA.4 aut
700	1	a Avivi, Iritu Tel Aviv Univ, Tel Aviv Sourasky Med Ctr, Hematol Inst, Tel Aviv, Israel.;Tel Aviv Univ, Sacker Fac Med, Tel Aviv, Israel.4 aut
700	1	a Larouche, Jean-Francoisu Ctr Hosp Univ CHU Quebec, Hop Enfant Jesus, Quebec City, PQ, Canada.4 aut
700	1	a Wannesson, Lucianou Ist Oncol Svizzera Italiana, Bellinzona, Switzerland.4 aut
700	1	a Cwynarski, Kateu Univ Coll London Hosp Natl Hlth Serv NHS Fdn Trus, Dept Haematol, London, England.4 aut
700	1	a Osman, Kerenu Icahn Sch Med Mt Sinai, New York, NY 10029 USA.4 aut
700	1	a Davison, Kellyu McGill Univ, Royal Victoria Hosp, Hlth Ctr, Montreal, PQ, Canada.4 aut
700	1	a Rudzki, Jakob D.u Med Univ Innsbruck, Univ Clin Internal Med, Dept Hematol & Oncol, Innsbruck, Austria.4 aut
700	1	a Dahiya, Saurabhu Univ Maryland, Greenebaum Comprehens Canc Ctr, Transplant & Cellular Therapy Program, Med Ctr, Baltimore, MD USA.4 aut
700	1	a Dorritie, Kathleenu Univ Pittsburgh, Med Ctr UPMC, Hillman Canc Ctr, Pittsburgh, PA USA.4 aut
700	1	a Jaglowski, Samanthau Ohio State Univ, Comprehens Canc Ctr, Blood & Marrow Transplant Program, Columbus, OH 43210 USA.4 aut
700	1	a Radford, Johnu Christie NHS Fdn Trust, Div Canc Sci, Manchester, Lancs, England.;Univ Manchester, Manchester, Lancs, England.4 aut
700	1	a Morschhauser, Francku Univ Lille, CHU Lille, Grp Rech Formes Injectables & Technol Assoc, Lille, France.4 aut
700	1	a Cunningham, Davidu Royal Marsden NHS Fdn Trust, London, England.4 aut
700	1	a Martin Garcia-Sancho, Alejandrou Salamanca Univ Hosp, Ctr Invest Biomed Red Canc CIBERONC, Inst Biomed Res Salamanca IBSAL, Hematol Dept, Salamanca, Spain.4 aut
700	1	a Tzachanis, Dimitriosu Univ Calif San Diego, Moores Canc Ctr, La Jolla, CA 92093 USA.4 aut
700	1	a Ulrickson, Matthew L.u Banner MD Anderson Canc Ctr, Gilbert, AZ USA.4 aut
700	1	a Karmali, Reemu Northwestern Univ, Robert H Lurie Comprehens Canc Ctr, Div Hematol & Oncol, Chicago, IL 60611 USA.4 aut
700	1	a Kekre, Natashau Ottawa Hosp, Ottawa, ON, Canada.4 aut
700	1	a Thieblemont, Catherineu Univ Paris, DMU DHI, Hematooncol, Hop St Louis, Paris, France.4 aut
700	1	a Enblad, Gunillau Uppsala universitet,Cancerimmunterapi4 aut0 (Swepub:uu)gunienbl
700	1	a Dreger, Peteru Heidelberg Univ, Dept Med, Heidelberg, Germany.4 aut
700	1	a Malladi, Ramu Cambridge Univ Hosp NHS Fdn Trust, Cambridge, England.;Univ Hosp Birmingham NHS Fdn Trust, Cambridge, England.4 aut
700	1	a Joshi, Namitau OPEN Hlth, Bethesda, MD USA.4 aut
700	1	a Wang, Wei-Jhihu OPEN Hlth, Bethesda, MD USA.4 aut
700	1	a Solem, Caitlyn T.u OPEN Hlth, Bethesda, MD USA.4 aut
700	1	a Snider, Julia Thorntonu Kite, Santa Monica, CA USA.4 aut
700	1	a Cheng, Paulu Kite, Santa Monica, CA USA.4 aut
700	1	a To, Christinau Kite, Santa Monica, CA USA.4 aut
700	1	a Kersten, Marie Joseu Univ Amsterdam, Canc Ctr Amsterdam, Dept Hematol, Amsterdam UMC,Stichting Hematooncol Volwassenen N, Amsterdam, Netherlands.4 aut
710	2	a Dalhousie Univ, Queen Elizabeth II Hlth Sci Ctr, Halifax, NS, Canada.;Dalhousie Univ, Div Hematol, Dept Med, QEII Bethune Bldg,Suite 430 Bethune Bldg, Halifax, NS B3H 2Y9, Canada.b H Lee Moffitt Canc Ctr & Res Inst, Tampa, FL USA.4 org
773	0	t Bloodd : American Society of Hematologyg 140:21, s. 2248-2260q 140:21<2248-2260x 0006-4971x 1528-0020
856	4 8	u https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-498943
856	4 8	u https://doi.org/10.1182/blood.2022015478

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