Evidence map›Paper›PMID 37813959›Full record

Trial reportBritish journal of cancer2023

Long-term, continuous infusion of single-agent dinutuximab beta for relapsed/refractory neuroblastoma: an open-label, single-arm, Phase 2 study.

Holger N Lode, Karoline Ehlert, Stephanie Huber, Sascha Troschke-Meurer, Nikolai Siebert, Maxi Zumpe, Hans Loibner, Ruth Ladenstein

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase II
In one paragraph

Trial report in British journal of cancer, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02743429 (Phase II Study of Monoclonal Antibody ch14.18/CHO Continuous Infusion in Patients With Primary Refractory or Relapsed Neuroblastoma), which is not on this map. Cited by 15 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 2 pooled it
4.3field-weighted citation impact, top 5% 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.

NCT02743429 phase2unknown statusnot on this map

Phase II Study of Monoclonal Antibody ch14.18/CHO Continuous Infusion in Patients With Primary Refractory or Relapsed Neuroblastoma

TypeinterventionalSponsorUniversity Medicine GreifswaldRan2015 to 2024Enrolled40ConditionsNeuroblastomaArmsdinutuximab beta
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 2 syntheses or guidelines pooled it, 21 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. A Phase II Trial of Naxitamab plus Stepped-up Dosing of GM-CSF for Patients with High-Risk Neuroblastoma in First Complete Remission.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025
    Trial
  5. Trial
  6. Review
  7. Article
  8. Article
  9. Article
  10. Article
  11. Recommendations for the use of nuclear medicine imaging in patients with neuroblastoma.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2025
    Review
  12. GD2-targeted theranostics of neuroblastoma with [European journal of nuclear medicine and molecular imaging · 2025
    Article
  13. Observational
  14. Article
  15. Review
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

8 authors at 2 institutions in 3 countries.

Holger N LodeDepartment of Pediatric Hematology and Oncology, University Medicine Greifswald, Greifswald, Germany. Holger.Lode@med.uni-greifswald.de.ORCID 0000-0002-1201-208X
Karoline EhlertDepartment of Pediatric Hematology and Oncology, University Medicine Greifswald, Greifswald, Germany.
Stephanie HuberDepartment of Pediatric Hematology and Oncology, University Medicine Greifswald, Greifswald, Germany.
Sascha Troschke-MeurerDepartment of Pediatric Hematology and Oncology, University Medicine Greifswald, Greifswald, Germany.
Nikolai SiebertDepartment of Pediatric Hematology and Oncology, University Medicine Greifswald, Greifswald, Germany.
Maxi ZumpeDepartment of Pediatric Hematology and Oncology, University Medicine Greifswald, Greifswald, Germany.
Hans LoibnerAnyxis Immuno Oncology, Vienna, Austria.
Ruth LadensteinDepartment of Studies and Statistics for Integrated Research and Projects, Children's Cancer Research Institute, Vienna, Austria.ORCID 0000-0001-6548-3873
Universitätsmedizin Greifswald · DECancer Research Institute of the Slovak Academy of Sciences · SK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundShort-term infusions of dinutuximab beta plus isotretinoin and cytokines administered in previous immunotherapy studies in neuroblastoma were associated with severe pain. Here, long-term, continuous infusion of single-agent dinutuximab beta was evaluated in patients with relapsed/refractory neuroblastoma.

methodsIn this open-label, single-arm, Phase 2 study, patients with either refractory or relapsed high-risk neuroblastoma received dinutuximab beta by continuous infusion over 10 days of each cycle, for up to five cycles. The primary endpoint was objective response rate 24 weeks after the end of cycle 5. Secondary endpoints included adverse events, intravenous morphine use, best response, duration of response, and three-year progression-free and overall survival.

resultsOf the 40 patients included, 38 had evaluable response. Objective response rate was 26% and best response rate 37%. Median duration of response was 238 days (IQR 108-290). Three-year progression-free and overall survival rates were 31% (95% CI 17-47) and 66% (95% CI 47-79), respectively. Prophylactic intravenous morphine use and duration of use decreased with increasing cycles. The most common grade 3 treatment-related adverse events were pain, diarrhea, and hypokalemia.

conclusionLong-term continuous infusion of single-agent dinutuximab beta is tolerable and associated with clinically meaningful responses in patients with relapsed/refractory high-risk neuroblastoma. CLINICAL

trial registrationThe study is registered with ClinicalTrials.gov (NCT02743429) and EudraCT (2014-000588-42).

Indexed as

NeuroblastomaAntibodies, MonoclonalHumansMorphine DerivativesNeoplasm Recurrence, LocalPainAntibodies, MonoclonaldinutuximabMorphine Derivatives

Identifiers

PMID37813959
PMCPMC10667538
OpenAlexW4387472932

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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.