Evidence map›Paper›PMID 38953781›Full record

Observational studyBlood cancer discovery2024

A Multicenter Real-life Prospective Study of Axicabtagene Ciloleucel versus Tisagenlecleucel Toxicity and Outcomes in Large B-cell Lymphomas.

Federico Stella, Annalisa Chiappella, Beatrice Casadei, Stefania Bramanti, Silva Ljevar, Patrizia Chiusolo, Alice Di Rocco, Maria C Tisi, Matteo G Carrabba, Ilaria Cutini and 20 more

Abstract readMulticenter StudyObservational StudyComparative Study
In one paragraph

Observational study in Blood cancer discovery, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 1 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.

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

20 citing papers in PubMed, 1 synthesis or guideline pooled it.

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  7. Naïve CD4Nature communications · 2026
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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

30 authors.

Federico StellaChair of Hematology, University of Milan, Milano, Italy.ORCID 0000-0003-3401-1309
Annalisa ChiappellaDivision of Hematology and Stem Cell Transplantation, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy.ORCID 0000-0002-2977-0098
Beatrice CasadeiIRCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia "Seràgnoli", Bologna, Italy.ORCID 0000-0002-4453-6064
Stefania BramantiIRCCS Humanitas Research Hospital, Transplantation Unit Department of Oncology and Haematology, Milan, Italy.ORCID 0000-0002-4117-7991
Silva LjevarUnit of Biostatistics for Clinical Research, Department of Data Science, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy.ORCID 0000-0002-1151-1477
Patrizia ChiusoloSezione di Ematologia, Dipartimento di Scienze Radiologiche ed Ematologiche, Università Cattolica del Sacro Cuore, Rome, Italy.ORCID 0000-0002-1355-1587
Alice Di RoccoHematology, Department of Translational and Precision Medicine, Sapienza University of Rome, Rome, Italy.ORCID 0000-0003-0985-9623
Maria C TisiHematology Unit, San Bortolo Hospital, Vicenza, Italy.ORCID 0000-0001-8231-6700
Matteo G CarrabbaIRCCS Ospedale San Raffaele Milano, Milano, Italy.ORCID 0000-0001-7015-4839
Ilaria CutiniSOD Terapie Cellulari e Medicina Trasfusionale, AAD Trapianto di midollo osseo, Ospedale Careggi, Firenze, Italy.ORCID 0000-0003-3721-0004
Massimo MartinoHematology and Stem Cell Transplantation and Cellular Therapies Unit (CTMO), Department of Hemato-Oncology and Radiotherapy, Grande Ospedale Metropolitano "Bianchi-Melacrino-Morelli", Reggio Calabria, Italy.ORCID 0000-0002-3987-419X
Anna DoderoDivision of Hematology and Stem Cell Transplantation, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy.ORCID 0000-0002-3172-3194
Francesca BonifaziIRCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia "Seràgnoli", Bologna, Italy.ORCID 0000-0003-1544-9911
Armando SantoroIRCCS Humanitas Research Hospital, Transplantation Unit Department of Oncology and Haematology, Milan, Italy.ORCID 0000-0003-1709-9492
Federica SoràSezione di Ematologia, Dipartimento di Scienze Radiologiche ed Ematologiche, Università Cattolica del Sacro Cuore, Rome, Italy.ORCID 0000-0002-9607-5298
Barbara BottoSC Ematologia AOU Città della Salute e della Scienza, Torino, Italy.ORCID 0009-0005-7514-6172
Anna M BarbuiAzienda Socio Sanitaria Territoriale Papa Giovanni XXIII, Bergamo, Italy.ORCID 0009-0000-1006-5930
Domenico RussoUnit of Blood Disease and Bone Marrow Transplantation, and Unit of Hematology, University of Brescia, ASST Spedali Civili di Brescia, Brescia, Italy.ORCID 0000-0003-4458-6261
Maurizio MussoUOC di Oncoematologia e TMO, Dipartimento Oncologico "La Maddalena", Palermo, Italy.ORCID 0009-0008-9407-1112
Giovanni GrilloDipartimento di Ematologia e trapianto di midollo, ASST Grande Ospedale Metropolitano Niguarda, Milano, Italy.ORCID 0000-0002-9084-9969
Mauro KramperaHematology and Bone Marrow Transplant Unit, Section of Biomedicine of Innovation, Department of Engineering for Innovative Medicine (DIMI), University of Verona, Verona, Italy.ORCID 0000-0002-7280-2040
Jacopo OlivieriClinica Ematologica, Centro Trapianti e Terapie Cellulari "Carlo Melzi", Azienda Sanitaria Universitaria Integrata di Udine, Udine, Italy.ORCID 0000-0002-2582-3500
Marco LadettoDipartimento di Medicina Traslazionale, Università del Piemonte Orientale ed SCDU Ematologia AOU SS Antonio e Biagio e Cesare Arrigo, Alessandria, Italy.ORCID 0000-0002-8283-2681
Federica CavalloDivision of Hematology, University Hospital A.O.U. "Città della Salute e della Scienza", Turin, Italy.ORCID 0000-0003-4571-1060
Massimo MassaiaDivision of Hematology-AO S. Croce e Carle, Cuneo and Laboratory of Blood Tumor Immunology, Molecular Biotechnology Center "Guido Tarone", University of Torino, Torino, Italy.ORCID 0000-0002-0021-1428
Luca ArcainiDepartment of Molecular Medicine, University of Pavia, Pavia, Italy.ORCID 0000-0002-9504-991X
Martina PennisiDivision of Hematology and Stem Cell Transplantation, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy.ORCID 0000-0003-1077-5937
Pier L ZinzaniIRCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia "Seràgnoli", Bologna, Italy.ORCID 0000-0002-2112-2651
Rosalba MiceliUnit of Biostatistics for Clinical Research, Department of Data Science, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy.ORCID 0000-0003-0954-375X
Paolo CorradiniChair of Hematology, University of Milan, Milano, Italy.ORCID 0000-0002-9186-1353

Funding

Alleanza Contro il Cancro (ACC)Associazione Italiana Contro le Leucemie - Linfomi e Mieloma (AIL)Italian Ministry of Health RF-2019 12370243
6 · The paper itself

Abstract

This real-world prospective observational study across 21 Italian centers (CART-SIE) compares axicabtagene ciloleucel (axi-cel) and tisagenlecleucel (tisa-cel) outcomes in 485 patients with relapsed/refractory large B-cell lymphoma with baseline characteristics matched by stabilized inverse propensity score weighting. Axi-cel versus tisa-cel had higher all-grade cytokine release syndrome (78.6% vs. 89.3%, P = 0.0017) and neurotoxicity (9.9% vs. 32.2%, P < 0.0001) but also superior progression-free survival (PFS) at 1 year (46.5% vs. 34.1%, P = 0.0009). Even among patients who failed bridging therapy, axi-cel PFS was superior to tisa-cel (37.5% vs. 22.7%, P = 0.0059). Differences in overall survival and high-grade immune toxicities were not significant. The CAR-HEMATOTOX score not only predicted hematologic toxicity but also 1-year survival outcomes (51.5% in CAR-HEMATOTOX high vs. 77.2% in CAR-HEMATOTOX low, P < 0.0001). Twenty patients developed second primary malignancies, including two cases of T-cell neoplasms. These findings enable more informed selection of anti-CD19 CAR T-cell therapy, balancing bridging, safety, and efficacy considerations for individual patients. Significance: The findings of this study on 485 patients with relapsed/refractory large B-cell lymphoma treated with commercial axi-cel and tisa-cel indicate axi-cel's superior PFS after propensity score weighting. The predictive utility of CAR-HEMATOTOX in assessing not only toxicity but also outcomes across both CAR T-cell products may guide future risk-stratified management strategies.

Indexed as

Biological ProductsLymphoma, Large B-Cell, DiffuseAdultAgedAged, 80 and overAntigens, CD19FemaleHumansImmunotherapy, AdoptiveMaleMiddle AgedProspective StudiesReceptors, Antigen, T-CellTreatment OutcomeAntigens, CD19axicabtagene ciloleucelBiological ProductsReceptors, Antigen, T-Celltisagenlecleucel

Identifiers

PMID38953781
PMCPMC11369587

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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.