Evidence map›Paper›PMID 38955420›Full record

ArticleJournal for immunotherapy of cancer2024

Bendamustine is a safe and effective lymphodepletion agent for axicabtagene ciloleucel in patients with refractory or relapsed large B-cell lymphoma.

Sushma Bharadwaj, Eric Lau, Mark P Hamilton, Anmol Goyal, Hrishi Srinagesh, Alexandria Jensen, Dasom Lee, Jayasindhu Mallampet, Sarah Elkordy, Shriya Syal and 21 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal for immunotherapy of cancer, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
–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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed.

  1. Article
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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

31 authors.

Sushma Bharadwaj *Stanford University School of Medicine, Stanford, California, USA.
Eric Lau *Stanford University School of Medicine, Stanford, California, USA.
Mark P HamiltonStanford University School of Medicine, Stanford, California, USA.
Anmol GoyalStanford University School of Medicine, Stanford, California, USA.
Hrishi SrinageshStanford University School of Medicine, Stanford, California, USA.
Alexandria JensenStanford University School of Medicine, Stanford, California, USA.
Dasom LeeStanford University School of Medicine, Stanford, California, USA.
Jayasindhu MallampetDepartment of Biomedical Data Science, Stanford University School of Medicine, Stanford, California, USA.
Sarah ElkordyDepartment of Biomedical Data Science, Stanford University School of Medicine, Stanford, California, USA.
Shriya SyalDepartment of Biomedical Data Science, Stanford University School of Medicine, Stanford, California, USA.
Sunita PatilDepartment of Biomedical Data Science, Stanford University School of Medicine, Stanford, California, USA.
Theresa LatchfordStanford University School of Medicine, Stanford, California, USA.
Bita SahafCancer Institute, Stanford University School of Medicine, Palo Alto, California, USA.
Sally AraiStanford University School of Medicine, Stanford, California, USA.
Laura J JohnstonStanford University School of Medicine, Stanford, California, USA.
Robert LowskyStanford University School of Medicine, Stanford, California, USA.
Robert NegrinStanford University, Stanford, California, USA.
Andrew R RezvaniStanford University School of Medicine, Stanford, California, USA.
Judith ShizuruStanford Medicine, Palo Alto, California, USA.
Everett H MeyerStanford University School of Medicine, Stanford, California, USA.
Parveen ShirazStanford University School of Medicine, Stanford, California, USA.
Lekha MikkilineniStanford University School of Medicine, Stanford, California, USA.
Wen-Kai WengStanford University School of Medicine, Stanford, California, USA.
Melody SmithStanford University School of Medicine, Stanford, California, USA.
Surbhi SidanaStanford University School of Medicine, Stanford, California, USA.
Lori MufflyStanford University, Palo Alto, California, USA.
Holden T MaeckerStanford University, Stanford, California, USA.
Matthew J FrankStanford University School of Medicine, Stanford, California, USA.
Crystal MackallStanford University, Stanford, California, USA.
David Miklos *Stanford University, Stanford, California, USA.
Saurabh Dahiya *Stanford University School of Medicine, Stanford, California, USA sdahiya@stanford.edu.ORCID http://orcid.org/0000-0001-8291-1796

Funding

Translational Oncology Research Program (Project-005)P30CA124435 · NCI · STANFORD UNIVERSITY · PI Vittorio Sebastiano · 2007 to 2026
$71.4M
NCI NIH HHS P30 CA124435
6 · The paper itself

Abstract

backgroundFludarabine in combination with cyclophosphamide (FC) is the standard lymphodepletion regimen for CAR T-cell therapy (CAR T). A national fludarabine shortage in 2022 necessitated the exploration of alternative regimens with many centers employing single-agent bendamustine as lymphodepletion despite a lack of clinical safety and efficacy data. To fill this gap in the literature, we evaluated the safety, efficacy, and expansion kinetics of bendamustine as lymphodepletion prior to axicabtagene ciloleucel (axi-cel) therapy.

methods84 consecutive patients with relapsed or refractory large B-cell lymphoma treated with axi-cel and managed with a uniform toxicity management plan at Stanford University were studied. 27 patients received alternative lymphodepletion with bendamustine while 57 received FC.

resultsBest complete response rates were similar (73.7% for FC and 74% for bendamustine, p=0.28) and there was no significant difference in 12-month progression-free survival or overall survival estimates (p=0.17 and p=0.62, respectively). The frequency of high-grade cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome was similar in both the cohorts. Bendamustine cohort experienced lower proportions of hematological toxicities and antibiotic use for neutropenic fever. Immune reconstitution, as measured by quantitative assessment of cellular immunity, was better in bendamustine cohort as compared with FC cohort. CAR T expansion as measured by peak expansion and area under the curve for expansion was comparable between cohorts.

conclusionsBendamustine is a safe and effective alternative lymphodepletion conditioning for axi-cel with lower early hematological toxicity and favorable immune reconstitution.

Indexed as

Bendamustine HydrochlorideBiological ProductsLymphoma, Large B-Cell, DiffuseAdultAgedAntigens, CD19FemaleHumansImmunotherapy, AdoptiveMaleMiddle AgedAntigens, CD19axicabtagene ciloleucelBendamustine HydrochlorideBiological ProductsChemotherapyChimeric antigen receptor - CARLymphoma

Identifiers

PMID38955420
PMCPMC11218002

What OpenQuestion holds

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Registered trials

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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.