Evidence map›Paper›PMID 36854071›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2023

Anti-GD2 Antibody Dinutuximab Beta and Low-Dose Interleukin 2 After Haploidentical Stem-Cell Transplantation in Patients With Relapsed Neuroblastoma: A Multicenter, Phase I/II Trial.

Tim Flaadt, Ruth L Ladenstein, Martin Ebinger, Holger N Lode, Helga Björk Arnardóttir, Ulrike Poetschger, Wolfgang Schwinger, Roland Meisel, Friedhelm R Schuster, Michaela Döring and 17 more

Open access · hybridAbstract readClinical Trial, Phase IIClinical Trial, Phase IMulticenter Study
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 2 pooled it
9.9field-weighted citation impact, top 1% 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

33 citing papers in PubMed, 2 syntheses or guidelines pooled it, 48 citations in OpenAlex.

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  9. Immunotherapeutic Strategies Targeting GD2-Expressing Malignancies.Advances in experimental medicine and biology · 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

27 authors at 12 institutions in 3 countries.

Tim FlaadtDepartment of Hematology and Oncology, University Children's Hospital, Eberhard Karls University Tuebingen, Tuebingen, Germany.ORCID 0000-0002-2729-9941
Ruth L LadensteinSt Anna Children's Hospital and Children's Cancer Research Institute, Department of Studies and Statistics for Integrated Research and Projects, Medical University of Vienna, Vienna, Austria.ORCID 0000-0001-6548-3873
Martin EbingerDepartment of Hematology and Oncology, University Children's Hospital, Eberhard Karls University Tuebingen, Tuebingen, Germany.ORCID 0000-0002-1518-6819
Holger N LodeDepartment of Pediatric Hematology and Oncology, University Medicine Greifswald, Greifswald, Germany.ORCID 0000-0002-1201-208X
Helga Björk ArnardóttirDepartment for Studies and Statistics and Integrated Research, Children's Cancer Research Institute, Vienna, Austria.
Ulrike PoetschgerDepartment for Studies and Statistics and Integrated Research, Children's Cancer Research Institute, Vienna, Austria.ORCID 0000-0001-7024-7082
Wolfgang SchwingerDivision of Pediatric Hematology-Oncology, Department of Pediatrics and Adolescent Medicine, Medical University Graz, Graz, Austria.ORCID 0000-0002-1757-0144
Roland MeiselDivision of Pediatric Stem Cell Therapy, Department of Pediatric Oncology, Hematology and Clinical Immunology, Medical Faculty, Heinrich Heine University, Duesseldorf, Germany.ORCID 0000-0001-5230-0628
Friedhelm R SchusterDivision of Pediatric Stem Cell Therapy, Department of Pediatric Oncology, Hematology and Clinical Immunology, Medical Faculty, Heinrich Heine University, Duesseldorf, Germany.
Michaela DöringDepartment of Hematology and Oncology, University Children's Hospital, Eberhard Karls University Tuebingen, Tuebingen, Germany.
Peter F AmbrosCCRI, Children's Cancer Research Institute, Vienna, Department of Tumor Biology and Department of Pediatrics, Medical University of Vienna, Vienna, Austria.ORCID 0000-0002-5507-7211
Manon QueudevilleDepartment of Hematology and Oncology, University Children's Hospital, Eberhard Karls University Tuebingen, Tuebingen, Germany.ORCID 0000-0002-5642-1846
Jörg FuchsDepartment of Pediatric Surgery and Pediatric Urology, University Children's Hospital, Eberhard Karls University Tuebingen, Tuebingen, Germany.ORCID 0000-0001-6145-2391
Steven W WarmannDepartment of Pediatric Surgery and Pediatric Urology, University Children's Hospital, Eberhard Karls University Tuebingen, Tuebingen, Germany.
Jürgen SchäferDepartment for Diagnostic and Interventional Radiology, University Hospital, Eberhard Karls University Tuebingen, Tuebingen, Germany.ORCID 0000-0003-3279-8726
Christian SeitzDepartment of Hematology and Oncology, University Children's Hospital, Eberhard Karls University Tuebingen, Tuebingen, Germany.
Patrick SchlegelChildren's Medical Research Institute, The Cancer Centre for Children, The Children's Hospital Westmead, University of Sydney, Sydney, Australia.
Ines B BrechtDepartment of Hematology and Oncology, University Children's Hospital, Eberhard Karls University Tuebingen, Tuebingen, Germany.
Ursula HolzerDepartment of Hematology and Oncology, University Children's Hospital, Eberhard Karls University Tuebingen, Tuebingen, Germany.ORCID 0000-0002-2424-4654
Tobias FeuchtingerDepartment of Pediatric Hematology, Oncology and Stem Cell Transplantation, Dr von Hauner Children's Hospital, University Hospital, Ludwig Maximilians University Munich, Munich, Germany.ORCID 0000-0002-8517-9681
Thorsten SimonDepartment of Pediatric Oncology and Hematology, University Hospital, University of Cologne, Cologne, Germany.ORCID 0000-0002-3425-8451
Johannes H SchulteDepartment of Pediatric Oncology/Hematology, Charité-Universitaetsmedizin Berlin, Berlin, Germany.
Angelika EggertDepartment of Pediatric Oncology/Hematology, Charité-Universitaetsmedizin Berlin, Berlin, Germany.
Heiko-Manuel TeltschikDepartment of Hematology and Oncology, Children's Hospital Stuttgart-Olgahospital, Stuttgart, Germany.
Toni IllhardtDepartment of Hematology and Oncology, University Children's Hospital, Eberhard Karls University Tuebingen, Tuebingen, Germany.
Rupert HandgretingerDepartment of Hematology and Oncology, University Children's Hospital, Eberhard Karls University Tuebingen, Tuebingen, Germany.ORCID 0000-0003-1838-8990
Peter LangDepartment of Hematology and Oncology, University Children's Hospital, Eberhard Karls University Tuebingen, Tuebingen, Germany.ORCID 0000-0001-7737-2142
University Children's Hospital Tübingen · DECharité - Universitätsmedizin Berlin · DEHeinrich Heine University Düsseldorf · DEChildren's Medical Research Institute · AUComprehensive Cancer Center Vienna · ATLudwig-Maximilians-Universität München · DEMedical University of Graz · ATOlgahospital · DESt Anna Children's Hospital · ATUniversitätsmedizin Greifswald · DEUniversity of Cologne · DEUniversity of Tübingen · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposePatients with relapsed high-risk neuroblastoma (rHR-NB) have a poor prognosis. We hypothesized that graft-versus-neuroblastoma effects could be elicited by transplantation of haploidentical stem cells (haplo-SCT) exploiting cytotoxic functions of natural killer cells and their activation by the anti-GD2 antibody dinutuximab beta (DB). This phase I/II trial assessed safety, feasibility, and outcomes of immunotherapy with DB plus subcutaneous interleukin-2 (scIL2) after haplo-SCT in patients with rHR-NB.

methodsPatients age 1-21 years underwent T-/B-cell-depleted haplo-SCT followed by DB and scIL2. The primary end point 'success of treatment' encompassed patients receiving six cycles, being alive 180 days after end of trial treatment without progressive disease, unacceptable toxicity, acute graft-versus-host-disease (GvHD) ≥grade 3, or extensive chronic GvHD.

resultsSeventy patients were screened, and 68 were eligible for immunotherapy. Median number of DB cycles was 6 (range, 1-9). Median number of scIL2 cycles was 3 (1-6). The primary end point was met by 37 patients (54.4%). Median observation time was 7.8 years. Five-year event-free survival (EFS) and overall survival from start of trial treatment were 43% (95% CI, 31 to 55) and 53% (95% CI, 41 to 65), respectively. Five-year EFS among patients in complete remission (CR; 52%; 95% CI, 31 to 69) or partial remission (44%; 95% CI, 27 to 60) before immunotherapy were significantly better compared with patients with nonresponse/mixed response/progressive disease (13%; 95% CI, 1 to 42;

conclusionDB therapy after haplo-SCT in patients with rHR-NB is feasible, with low risk of inducing GvHD, and results in long-term remissions likely attributable to increased antineuroblastoma activity by donor-derived effector cells.

Indexed as

Graft vs Host DiseaseHematopoietic Stem Cell TransplantationNeuroblastomaAdolescentAdultAntibodies, MonoclonalChildChild, PreschoolHumansInfantInterleukin-2Neoplasm Recurrence, LocalYoung AdultAntibodies, MonoclonaldinutuximabInterleukin-2

Identifiers

PMID36854071
PMCPMC10256422
OpenAlexW4322623407

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.