Evidence map›Paper›PMID 36869888›Full record

ArticleJournal of neurology2023

CAR t-cell therapy in BOlogNa-NEUrotoxicity TReatment and Assessment in Lymphoma (CARBON-NEUTRAL): proposed protocol and results from an Italian study.

Umberto Pensato, Giulia Amore, Lorenzo Muccioli, Susanna Sammali, Francesca Rondelli, Rita Rinaldi, Roberto D'Angelo, Marianna Nicodemo, Susanna Mondini, Luisa Sambati and 17 more

Abstract read
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Article in Journal of neurology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing 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

11 citing papers in PubMed.

  1. Observational
  2. Review
  3. Article
  4. Review
  5. Article
  6. Review
  7. Article
  8. Article
  9. Primary vs. pre-emptive anti-seizure medication prophylaxis in anti-CD19 CAR T-cell therapy.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2024
    Article
  10. Review
  11. Article
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.

Umberto PensatoDipartimento di Scienze Biomediche e Neuromotorie, Università di Bologna, Bologna, Italia.
Giulia AmoreDipartimento di Scienze Biomediche e Neuromotorie, Università di Bologna, Bologna, Italia.
Lorenzo MuccioliDipartimento di Scienze Biomediche e Neuromotorie, Università di Bologna, Bologna, Italia.
Susanna SammaliDipartimento di Scienze Biomediche e Neuromotorie, Università di Bologna, Bologna, Italia.
Francesca RondelliIRCCS Istituto delle Scienze Neurologiche di Bologna, Italia, Sant'Orsola Hospital, Via Giuseppe Massarenti 9, Bologna, Italia.
Rita RinaldiIRCCS Istituto delle Scienze Neurologiche di Bologna, Italia, Sant'Orsola Hospital, Via Giuseppe Massarenti 9, Bologna, Italia.
Roberto D'AngeloIRCCS Istituto delle Scienze Neurologiche di Bologna, Italia, Sant'Orsola Hospital, Via Giuseppe Massarenti 9, Bologna, Italia.
Marianna NicodemoIRCCS Istituto delle Scienze Neurologiche di Bologna, Italia, Sant'Orsola Hospital, Via Giuseppe Massarenti 9, Bologna, Italia.
Susanna MondiniIRCCS Istituto delle Scienze Neurologiche di Bologna, Italia, Sant'Orsola Hospital, Via Giuseppe Massarenti 9, Bologna, Italia.
Luisa SambatiIRCCS Istituto delle Scienze Neurologiche di Bologna, Italia, Sant'Orsola Hospital, Via Giuseppe Massarenti 9, Bologna, Italia.
Gian Maria AsioliIRCCS Istituto delle Scienze Neurologiche di Bologna, Italia, Sant'Orsola Hospital, Via Giuseppe Massarenti 9, Bologna, Italia.
Simone RossiIRCCS Istituto delle Scienze Neurologiche di Bologna, Italia, Sant'Orsola Hospital, Via Giuseppe Massarenti 9, Bologna, Italia.
Rossella SantoroIRCCS Istituto delle Scienze Neurologiche di Bologna, Italia, Sant'Orsola Hospital, Via Giuseppe Massarenti 9, Bologna, Italia.
Lucia CretellaIRCCS Istituto delle Scienze Neurologiche di Bologna, Italia, Sant'Orsola Hospital, Via Giuseppe Massarenti 9, Bologna, Italia.
Susy FerrariIRCCS Istituto delle Scienze Neurologiche di Bologna, Italia, Sant'Orsola Hospital, Via Giuseppe Massarenti 9, Bologna, Italia.
Luca SpinardiDiagnostic and Interventional Neuroradiology Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.
Luca FaccioliDiagnostic and Interventional Neuroradiology Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.
Stefano FantiNuclear Medicine Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.
Andrea PaccagnellaNuclear Medicine Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.
Elisabetta PierucciIntensive Care Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.
Beatrice CasadeiIRCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia "Seràgnoli", Bologna, Italy.
Cinzia PellegriniIRCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia "Seràgnoli", Bologna, Italy.
Pier Luigi ZinzaniIRCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia "Seràgnoli", Bologna, Italy.
Massimiliano BonafèDipartimento di Scienze Mediche e Chirurgiche, Università di Bologna, Bologna, Italy.
Pietro CortelliDipartimento di Scienze Biomediche e Neuromotorie, Università di Bologna, Bologna, Italia.
Francesca Bonifazi *IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.
Maria Guarino *IRCCS Istituto delle Scienze Neurologiche di Bologna, Italia, Sant'Orsola Hospital, Via Giuseppe Massarenti 9, Bologna, Italia. maria.guarino@aosp.bo.it.ORCID http://orcid.org/0000-0002-8894-2187

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo investigate neurotoxicity clinical and instrumental features, incidence, risk factors, and early and long-term prognosis in lymphoma patients who received CAR T-cell therapy.

methodsIn this prospective study, consecutive refractory B-cell non-Hodgkin lymphoma patients who received CAR T-cell therapy were included. Patients were comprehensively evaluated (neurological examination, EEG, brain MRI, and neuropsychological test) before and after (two and twelve months) CAR T-cells. From the day of CAR T-cells infusion, patients underwent daily neurological examinations to monitor the development of neurotoxicity.

resultsForty-six patients were included in the study. The median age was 56.5 years, and 13 (28%) were females. Seventeen patients (37%) developed neurotoxicity, characterized by encephalopathy frequently associated with language disturbances (65%) and frontal lobe dysfunction (65%). EEG and brain FDG-PET findings also supported a predominant frontal lobe involvement. The median time at onset and duration were five and eight days, respectively. Baseline EEG abnormalities predicted ICANS development in the multivariable analysis (OR 4.771; CI 1.081-21.048; p = 0.039). Notably, CRS was invariably present before or concomitant with neurotoxicity, and all patients who exhibited severe CRS (grade ≥ 3) developed neurotoxicity. Serum inflammatory markers were significantly higher in patients who developed neurotoxicity. A complete neurological resolution following corticosteroids and anti-cytokines monoclonal antibodies was reached in all patients treated, except for one patient developing a fatal fulminant cerebral edema. All surviving patients completed the 1-year follow-up, and no long-term neurotoxicity was observed.

conclusionsIn the first prospective Italian real-life study, we presented novel clinical and investigative insights into ICANS diagnosis, predictive factors, and prognosis.

Indexed as

Immunotherapy, AdoptiveLymphomaNeurotoxicity SyndromesAdultAgedBiomarkersCytokine Release SyndromeFemaleHumansIncidenceItalyMaleMiddle AgedProspective StudiesBiomarkersCancer immunotherapyCytokine release syndromeCytokine storm-associated encephalopathyImmune effectors cell-associated neurotoxicity syndrome (ICANS)Neurological complications

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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.