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Patient-reported outcomes in ZUMA-7, a phase 3 study of axicabtagene ciloleucel in second-line large B-cell lymphoma
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- Elsawy, Mahmoud (författare)
- 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.
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- Chavez, Julio C. (författare)
- H Lee Moffitt Canc Ctr & Res Inst, Tampa, FL USA.
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- Avivi, Irit (författare)
- Tel Aviv Univ, Tel Aviv Sourasky Med Ctr, Hematol Inst, Tel Aviv, Israel.;Tel Aviv Univ, Sacker Fac Med, Tel Aviv, Israel.
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- Larouche, Jean-Francois (författare)
- Ctr Hosp Univ CHU Quebec, Hop Enfant Jesus, Quebec City, PQ, Canada.
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- Wannesson, Luciano (författare)
- Ist Oncol Svizzera Italiana, Bellinzona, Switzerland.
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- Cwynarski, Kate (författare)
- Univ Coll London Hosp Natl Hlth Serv NHS Fdn Trus, Dept Haematol, London, England.
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- Osman, Keren (författare)
- Icahn Sch Med Mt Sinai, New York, NY 10029 USA.
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- Davison, Kelly (författare)
- McGill Univ, Royal Victoria Hosp, Hlth Ctr, Montreal, PQ, Canada.
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- Rudzki, Jakob D. (författare)
- Med Univ Innsbruck, Univ Clin Internal Med, Dept Hematol & Oncol, Innsbruck, Austria.
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- Dahiya, Saurabh (författare)
- Univ Maryland, Greenebaum Comprehens Canc Ctr, Transplant & Cellular Therapy Program, Med Ctr, Baltimore, MD USA.
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- Dorritie, Kathleen (författare)
- Univ Pittsburgh, Med Ctr UPMC, Hillman Canc Ctr, Pittsburgh, PA USA.
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- Jaglowski, Samantha (författare)
- Ohio State Univ, Comprehens Canc Ctr, Blood & Marrow Transplant Program, Columbus, OH 43210 USA.
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- Radford, John (författare)
- Christie NHS Fdn Trust, Div Canc Sci, Manchester, Lancs, England.;Univ Manchester, Manchester, Lancs, England.
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- Morschhauser, Franck (författare)
- Univ Lille, CHU Lille, Grp Rech Formes Injectables & Technol Assoc, Lille, France.
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- Cunningham, David (författare)
- Royal Marsden NHS Fdn Trust, London, England.
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- Martin Garcia-Sancho, Alejandro (författare)
- Salamanca Univ Hosp, Ctr Invest Biomed Red Canc CIBERONC, Inst Biomed Res Salamanca IBSAL, Hematol Dept, Salamanca, Spain.
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- Tzachanis, Dimitrios (författare)
- Univ Calif San Diego, Moores Canc Ctr, La Jolla, CA 92093 USA.
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- Ulrickson, Matthew L. (författare)
- Banner MD Anderson Canc Ctr, Gilbert, AZ USA.
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- Karmali, Reem (författare)
- Northwestern Univ, Robert H Lurie Comprehens Canc Ctr, Div Hematol & Oncol, Chicago, IL 60611 USA.
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- Kekre, Natasha (författare)
- Ottawa Hosp, Ottawa, ON, Canada.
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- Thieblemont, Catherine (författare)
- Univ Paris, DMU DHI, Hematooncol, Hop St Louis, Paris, France.
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- Enblad, Gunilla (författare)
- Uppsala universitet,Cancerimmunterapi
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- Dreger, Peter (författare)
- Heidelberg Univ, Dept Med, Heidelberg, Germany.
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- Malladi, Ram (författare)
- Cambridge Univ Hosp NHS Fdn Trust, Cambridge, England.;Univ Hosp Birmingham NHS Fdn Trust, Cambridge, England.
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- Joshi, Namita (författare)
- OPEN Hlth, Bethesda, MD USA.
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- Wang, Wei-Jhih (författare)
- OPEN Hlth, Bethesda, MD USA.
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- Solem, Caitlyn T. (författare)
- OPEN Hlth, Bethesda, MD USA.
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- Snider, Julia Thornton (författare)
- Kite, Santa Monica, CA USA.
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- Cheng, Paul (författare)
- Kite, Santa Monica, CA USA.
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- To, Christina (författare)
- Kite, Santa Monica, CA USA.
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- Kersten, Marie Jose (författare)
- Univ Amsterdam, Canc Ctr Amsterdam, Dept Hematol, Amsterdam UMC,Stichting Hematooncol Volwassenen N, Amsterdam, Netherlands.
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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. H Lee Moffitt Canc Ctr & Res Inst, Tampa, FL USA. (creator_code:org_t)
- American Society of Hematology, 2022
- Engelska.
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Ingår i: Blood. - : American Society of Hematology. - 0006-4971 .- 1528-0020. ; 140:21, s. 2248-2260
- Relaterad länk:
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
Ämnesord
Stäng
- 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.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Hematologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Hematology (hsv//eng)
Publikations- och innehållstyp
- ref (ämneskategori)
- art (ämneskategori)
- Av författaren/redakt...
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Elsawy, Mahmoud
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Chavez, Julio C.
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Avivi, Irit
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Larouche, Jean-F ...
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Wannesson, Lucia ...
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Cwynarski, Kate
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visa fler...
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Osman, Keren
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Davison, Kelly
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Rudzki, Jakob D.
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Dahiya, Saurabh
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Dorritie, Kathle ...
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Jaglowski, Saman ...
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Radford, John
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Morschhauser, Fr ...
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Cunningham, Davi ...
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Martin Garcia-Sa ...
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Tzachanis, Dimit ...
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Ulrickson, Matth ...
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Karmali, Reem
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Kekre, Natasha
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Thieblemont, Cat ...
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Enblad, Gunilla
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Dreger, Peter
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Malladi, Ram
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Joshi, Namita
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Wang, Wei-Jhih
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Solem, Caitlyn T ...
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Snider, Julia Th ...
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Cheng, Paul
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To, Christina
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Kersten, Marie J ...
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- Om ämnet
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- MEDICIN OCH HÄLSOVETENSKAP
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MEDICIN OCH HÄLS ...
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och Klinisk medicin
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och Hematologi
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Blood
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Uppsala universitet