Evidence map›Paper›PMID 40627545›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2025

Fcγ Receptor Polymorphism in Patients with Relapsed/Refractory High-Risk Neuroblastoma Correlates with Outcomes in the SIOPEN Dinutuximab Beta Long-Term Infusion Trial.

Holger N Lode, Nikolai Siebert, Dominique Valteau-Couanet, Alberto Garaventa, Adela Canete, John Anderson, Isaac Yaniv, Shifra Ash, Juliet Gray, Thomas Klingebiel and 10 more

Abstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Review
  2. Article
  3. 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

20 authors.

Holger N LodeUniversity Medicine Greifswald, Greifswald, Germany.ORCID 0000-0002-1201-208X
Nikolai SiebertUniversity Medicine Greifswald, Greifswald, Germany.ORCID 0000-0001-6254-1302
Dominique Valteau-CouanetChildren and Adolescent Oncology Department, Villejuif, France.ORCID 0009-0001-9880-2241
Alberto GaraventaUnit of Pediatric Oncology, IRCCS Istituto Giannina Gaslini, Genova, Italy.ORCID 0000-0002-5368-6363
Adela CaneteHospital Universitario y Politecnico La Fe, University of Valencia, Valencia, Spain.ORCID 0000-0002-5669-5097
John AndersonUCL Great Ormond Street Institute of Child Health, London, United Kingdom.ORCID 0000-0001-7509-3203
Isaac YanivSchneider Children's Medical Center of Israel, Sackler Faculty of Medicine Tel Aviv University, Tel Aviv, Israel.ORCID 0009-0005-1063-5872
Shifra AshDepartment of Pediatric Hematology-Oncology, Ruth Rappaport Children's Hospital, Rambam Health Care Campus, Technion - Israel Institute of Technology, Rappaport Faculty of Medicine, Haifa, Israel.ORCID 0000-0003-4278-1645
Juliet GrayCentre for Cancer Immunology, University of Southampton, Southampton, United Kingdom.ORCID 0000-0002-5652-4722
Thomas KlingebielUniversity Children's Hospital, Goethe University Frankfurt, Frankfurt, Germany.ORCID 0000-0001-5726-9092
Hans LoibnerAnYxis Immuno-Oncology GmbH, Vienna, Austria.ORCID 0000-0001-8159-9083
Roberto LukschFondazione IRCCS Istituto Nazionale dei Tumori Milano, Italy.ORCID 0000-0002-7203-4176
Carla ManzittiUnit of Pediatric Oncology, IRCCS Istituto Giannina Gaslini, Genova, Italy.ORCID 0000-0002-1501-5518
Jean Marie MichonInstitut Curie Paris, France.ORCID 0000-0002-2935-2750
Cormac OwensPaediatric Haematology/Oncology, Our Lady's Children's Hospital, Dublin, Ireland.ORCID 0000-0001-6559-3239
Ulrike PötschgerChildren's Cancer Research Institute (CCRI), St. Anna Kinderkrebsforschung Vienna, Austria.ORCID 0000-0001-7024-7082
Sascha Troschke-MeurerUniversity Medicine Greifswald, Greifswald, Germany.ORCID 0000-0002-6185-462X
Evgenia GlogovaChildren's Cancer Research Institute (CCRI), St. Anna Kinderkrebsforschung Vienna, Austria.ORCID 0009-0007-9165-2731
Ruth LadensteinPaediatric Department, St. Anna Children's Hospital and Children's Cancer Research Institute (CCRI), and Medical University of Vienna, Vienna, Austria.ORCID 0000-0001-6548-3873
SIOP Europe Neuroblastoma Group (SIOPEN)

Funding

Cancer Research UK (CRUK) C8574/A14042Deutsche Kinderkrebsstiftung (German Childhood Cancer Foundation) Grant DKS 2014.05 A/BUniversity Medicine Greifswald Grant M57
6 · The paper itself

Abstract

purposeTo identify a tolerable dinutuximab beta long-term infusion (LTI) schedule with immunomodulatory activity for relapsed/refractory high-risk neuroblastoma (HRNBL). PATIENTS AND

methodsIn this phase I/II trial, dinutuximab beta LTI (five 35-day cycles) with subcutaneous interleukin-2 (IL-2) was evaluated in HRNBL cohorts (1× exploratory and 2× confirmatory). The composite primary endpoint was >80% patients free of intravenous morphine by day 5/cycle 1 plus ≥100 natural killer (NK) cells/μL and ≥1 μg/mL dinutuximab beta concentration by day 15/cycle 1. Secondary endpoints included objective response rate, event-free survival (EFS), overall survival (OS), Fcγ receptor (FCYR) polymorphisms, and NK cells.

resultsOverall, 122 patients were treated. At 10 mg/m2/day dinutuximab beta LTI, 95% patients (22/24 exploratory cohort and 20/20 confirmatory cohort 1) achieved the composite primary endpoint, with ≥80% patients intravenous morphine-free by day 5/cycle 1. The end-of-treatment objective response rate was 45% in 78 evaluable patients. Two-year EFS and OS were 56% (±4%) and 73% (±4%) overall and 45% (±5%) and 65% (±5%) in relapsed/refractory disease, respectively. Two-year survival rates were greater in patients with high-affinity FCYR polymorphisms and high-level NK cells versus patients with low-affinity FCYR polymorphisms and low-level NK cells [EFS, 79% (±9%) vs. 35% (±11%), P = 0.009; OS, 84% (±8%) vs. 70% (±10%); P = 0.083]. Multivariate analysis identified age >5 years, low-affinity FCYR polymorphisms, and relapse/refractory disease as independent risk factors.

conclusionsDinutuximab beta LTI was well tolerated and clinically active in patients with relapsed/refractory HRNBL, with FCYR polymorphisms and NK cells identified as prognostic biomarkers.

Indexed as

Antibodies, MonoclonalNeoplasm Recurrence, LocalNeuroblastomaPolymorphism, GeneticReceptors, IgGAdolescentAdultChildChild, PreschoolDrug Resistance, NeoplasmFemaleHumansInfantInterleukin-2Killer Cells, NaturalMaleAntibodies, MonoclonaldinutuximabInterleukin-2Receptors, IgG

Identifiers

PMID40627545
PMCPMC12402781

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.