Evidence map›Paper›PMID 36999993›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2023

Safety and Efficacy of Axicabtagene Ciloleucel versus Standard of Care in Patients 65 Years of Age or Older with Relapsed/Refractory Large B-Cell Lymphoma.

Jason R Westin, Frederick L Locke, Michael Dickinson, Armin Ghobadi, Mahmoud Elsawy, Tom van Meerten, David B Miklos, Matthew L Ulrickson, Miguel-Angel Perales, Umar Farooq and 17 more

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03391466 (A Phase 3, Randomized, Open-Label Study Evaluating the Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma), which is not on this map. Cited by 34 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03391466 phase3completednot on this map

A Phase 3, Randomized, Open-Label Study Evaluating the Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7)

TypeinterventionalSponsorKite, A Gilead CompanyRan2018 to 2024Enrolled359ConditionsRelapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)ArmsAxicabtagene Ciloleucel, Platinum-containing Salvage Chemotherapy, Cyclophosphamide, Fludarabine
3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Age as a moderator of neurocognitive performance in patients with large B-cell lymphoma treated with axicabtagene ciloleucel.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
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  13. CAR-T cell therapy for cancer: current challenges and future directions.Signal transduction and targeted therapy · 2025
    Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

27 authors.

Jason R WestinThe University of Texas MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0002-1824-2337
Frederick L LockeMoffitt Cancer Center, Tampa, Florida.ORCID 0000-0001-9063-6691
Michael DickinsonPeter MacCallum Cancer Centre, Royal Melbourne Hospital and the University of Melbourne, Melbourne, Victoria, Australia.ORCID 0000-0002-1492-5966
Armin GhobadiWashington University School of Medicine, St. Louis, Missouri.ORCID 0000-0001-8848-8474
Mahmoud ElsawyDivision of Hematology, Department of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada.ORCID 0000-0001-9872-2471
Tom van MeertenUniversity Medical Center Groningen, Groningen, The Netherlands, on behalf of HOVON/LLPC.ORCID 0000-0002-5581-6950
David B MiklosStanford University School of Medicine, Stanford, California.ORCID 0000-0003-0717-4305
Matthew L UlricksonBanner MD Anderson Cancer Center, Gilbert, Arizona.ORCID 0000-0002-1458-7813
Miguel-Angel PeralesMemorial Sloan-Kettering Cancer Center, New York, New York.ORCID 0000-0002-5910-4571
Umar FarooqUniversity of Iowa, Iowa City, Iowa.ORCID 0000-0001-7891-9891
Luciano WannessonIstituto Oncologico della Svizzera Italiana, Bellinzona, Switzerland.ORCID 0000-0002-5902-0757
Lori LeslieJohn Theurer Cancer Center, Hackensack, New Jersey.ORCID 0000-0002-7265-4076
Marie José KerstenAmsterdam UMC, University of Amsterdam, Cancer Center Amsterdam, Amsterdam, The Netherlands, on behalf of HOVON/LLPC.ORCID 0000-0002-8904-3802
Caron A JacobsonDana-Farber Cancer Institute, Boston, Massachusetts.ORCID 0000-0002-0180-0654
John M PagelSwedish Cancer Institute, Seattle, Washington.ORCID 0000-0001-5745-8125
Gerald WulfUniversity Medicine Göttingen, Göttingen, Germany.ORCID 0000-0002-7669-3785
Patrick JohnstonMayo Clinic, Rochester, Minnesota.ORCID 0000-0002-3212-3510
Aaron P RapoportUniversity of Maryland School of Medicine and Marlene and Stewart Greenebaum Comprehensive Cancer Center, Baltimore, Maryland.ORCID 0000-0003-0043-3562
Linqiu DuKite, a Gilead Company, Santa Monica, California.ORCID 0000-0002-1265-7363
Saran VardhanabhutiKite, a Gilead Company, Santa Monica, California.ORCID 0000-0003-1558-2755
Simone FilostoKite, a Gilead Company, Santa Monica, California.ORCID 0000-0002-7854-998X
Jina ShahKite, a Gilead Company, Santa Monica, California.ORCID 0000-0002-1053-2508
Julia T SniderKite, a Gilead Company, Santa Monica, California.ORCID 0000-0003-0017-4863
Paul ChengKite, a Gilead Company, Santa Monica, California.ORCID 0000-0002-9436-7764
Christina ToKite, a Gilead Company, Santa Monica, California.ORCID 0000-0001-7164-8072
Olalekan O Oluwole *Vanderbilt University Cancer Center, Nashville, Tennessee.ORCID 0000-0001-8525-9641
Anna Sureda *Hematology Department, Institut Català d'Oncologia-Hospitalet, IDIBELL, Universitat de Barcelona, Spain.ORCID 0000-0002-1238-6970

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

purposeOlder patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL) may be considered ineligible for curative-intent therapy including high-dose chemotherapy with autologous stem-cell transplantation (HDT-ASCT). Here, we report outcomes of a preplanned subgroup analysis of patients ≥65 years in ZUMA-7. PATIENTS AND

methodsPatients with LBCL refractory to or relapsed ≤12 months after first-line chemoimmunotherapy were randomized 1:1 to axicabtagene ciloleucel [axi-cel; autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy] or standard of care (SOC; 2-3 cycles of chemoimmunotherapy followed by HDT-ASCT). The primary endpoint was event-free survival (EFS). Secondary endpoints included safety and patient-reported outcomes (PROs).

resultsFifty-one and 58 patients aged ≥65 years were randomized to axi-cel and SOC, respectively. Median EFS was greater with axi-cel versus SOC (21.5 vs. 2.5 months; median follow-up: 24.3 months; HR, 0.276; descriptive P < 0.0001). Objective response rate was higher with axi-cel versus SOC (88% vs. 52%; OR, 8.81; descriptive P < 0.0001; complete response rate: 75% vs. 33%). Grade ≥3 adverse events occurred in 94% of axi-cel and 82% of SOC patients. No grade 5 cytokine release syndrome or neurologic events occurred. In the quality-of-life analysis, the mean change in PRO scores from baseline at days 100 and 150 favored axi-cel for EORTC QLQ-C30 Global Health, Physical Functioning, and EQ-5D-5L visual analog scale (descriptive P < 0.05). CAR T-cell expansion and baseline serum inflammatory profile were comparable in patients ≥65 and <65 years.

conclusionsAxi-cel is an effective second-line curative-intent therapy with a manageable safety profile and improved PROs for patients ≥65 years with R/R LBCL.

Indexed as

Biological ProductsLymphoma, Large B-Cell, DiffuseAgedAntigens, CD19HumansImmunotherapy, AdoptiveStandard of CareAntigens, CD19axicabtagene ciloleucelBiological Products

Identifiers

PMID36999993
PMCPMC10183830

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.