Evidence map›Paper›PMID 35454826›Full record

ArticleCancers2022

Clinical Phenotype and Management of Severe Neurotoxicity Observed in Patients with Neuroblastoma Treated with Dinutuximab Beta in Clinical Trials.

Aleksandra Wieczorek, Carla Manzitti, Alberto Garaventa, Juliet Gray, Vassilios Papadakis, Dominique Valteau-Couanet, Katarzyna Zachwieja, Ulrike Poetschger, Ingrid Pribill, Stefan Fiedler and 2 more

Open access · goldAbstract read
In one paragraph

Article in Cancers, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
2.4field-weighted citation impact, top 10% of its field
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

12 citing papers in PubMed, 21 citations in OpenAlex.

  1. Trial
  2. Review
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  4. Strategies to manage the adverse effects of immunotherapy with dinutuximab beta in neuroblastoma: an Italian experience and literature review.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 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

12 authors at 8 institutions in 8 countries.

Aleksandra WieczorekPediatric Hematology Oncology, Jagiellonian University Medical College, 30-663 Krakow, Poland.
Carla ManzittiOncology Unit, IRCCS Istituto Giannina Gaslini, 16147 Genova, Italy.
Alberto GaraventaOncology Unit, IRCCS Istituto Giannina Gaslini, 16147 Genova, Italy.
Juliet GrayCentre for Cancer Immunology, University of Southampton, Southampton SO16 6YD, UK.
Vassilios PapadakisDepartment of Pediatric Hematology-Oncology, Agia Sofia Children's Hospital, 11527 Athens, Greece.
Dominique Valteau-CouanetChildren and Adolescent Oncology Department, Gustave Roussy, 94805 Villejuif, France.
Katarzyna ZachwiejaDepartment of Pediatric Nephrology and Hypertension, Jagiellonian University Medical College, 30-663 Krakow, Poland.
Ulrike PoetschgerDepartment for Studies and Statistics and Integrated Research, Children's Cancer Research Institute, 1090 Vienna, Austria.
Ingrid PribillDepartment for Studies and Statistics and Integrated Research, Children's Cancer Research Institute, 1090 Vienna, Austria.
Stefan FiedlerDepartment for Studies and Statistics and Integrated Research at the Children's Cancer Research Institute of the St. Anna Children's Hospital and Department of Paediatrics, Medical University, 1090 Vienna, Austria.ORCID 0000-0003-0581-8509
Ruth LadensteinDepartment for Studies and Statistics and Integrated Research at the Children's Cancer Research Institute of the St. Anna Children's Hospital and Department of Paediatrics, Medical University, 1090 Vienna, Austria.
Holger N LodePediatric Hematology and Oncology, University Medicine Greifswald, 17475 Greifswald, Germany.ORCID 0000-0002-1201-208X
Cancer Research Institute of the Slovak Academy of Sciences · SKIstituto Giannina Gaslini · ITJagiellonian University · PLSt Anna Children's Hospital · ATIaso Children’s Hospital · GRInstitut Gustave Roussy · FRUniversitätsmedizin Greifswald · DEUniversity of Southampton · GB

Funding

Editorial support was funded by EUSA Pharma Not applicableSt. Anna Kinderkrebsforschung e.V QLRI-CT-2002-01768
6 · The paper itself

Abstract

Neurotoxicity is an off-tumour, on-target side effect of GD2-directed immunotherapy with monoclonal antibodies. Here, we report the frequency, management and outcome of patients enrolled in two prospective clinical trials who experienced severe neurotoxicity during immunotherapy with the anti-GD2 antibody dinutuximab beta (DB) administered as short-term infusion (HR-NBL1/SIOPEN study, randomisation R2, EudraCT 2006-001489-17) or as long-term infusion (HR-NBL1/SIOPEN study, randomisation R4, EudraCT 2006-001489-17 and LTI/SIOPEN study, EudraCT 2009-018077-31), either alone or with subcutaneous interleukin-2 (scIL-2). The total number of patients included in this analysis was 1102. Overall, 44/1102 patients (4.0%) experienced Grade 3/4 neurotoxicities (HR-NBL1 R2, 21/406; HR-NBL1 R4, 8/408; LTI study, 15/288), including 27 patients with severe neurotoxicities (2.5%). Events occurred predominantly in patients receiving combined treatment with DB and scIL-2. Neurotoxicity was treated using dexamethasone, prednisolone, intravenous immunoglobulins and, in two patients, plasmapheresis, which was highly effective. While neurological recovery was observed in 16 of 21 patients with severe neurotoxicities, 5/1102 (0.45%) patients experienced persistent and severe neurological deficits. In conclusion, severe neurotoxicity is most commonly observed in patients receiving DB with scIL-2. Considering the lack of clinical benefit for IL-2 in clinical trials so far, the administration of IL-2 alongside DB is not recommended.

Indexed as

anti-GD2 antibodydinutuximab betaneuroblastomaneurotoxicity

Identifiers

PMID35454826
PMCPMC9026788
OpenAlexW4223602652

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.