ReviewCancer reports (Hoboken, N.J.)2023
Outpatient administration of naxitamab in combination with granulocyte-macrophage colony-stimulating factor in patients with refractory and/or relapsed high-risk neuroblastoma: Management of adverse events.
Review in Cancer reports (Hoboken, N.J.), 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03363373 (A Pivotal Phase 2 Trial of Antibody Naxitamab), which is not on this map. Cited by 16 papers.
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.
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.
A Pivotal Phase 2 Trial of Antibody Naxitamab (hu3F8) and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in High-Risk Neuroblastoma Patients With Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone Marrow
Who cites it
16 citing papers in PubMed, 24 citations in OpenAlex.
- Naxitamab plus stepped-up dosing of granulocyte-macrophage colony-stimulating factor for primary refractory high-risk neuroblastoma: results of a phase I/II trial.Journal of hematology & oncology · 2025Trial
- The anti-GD2 monoclonal antibody naxitamab plus GM-CSF for relapsed or refractory high-risk neuroblastoma: a phase 2 clinical trial.Nature communications · 2025Trial
- Concurrent naxitamab and lorlatinib in a patient with refractory high-risk neuroblastoma: a case report.Frontiers in oncology · 2026Article
- Rapid COJEC without myeloablative therapy for high-risk neuroblastoma.International journal of cancer · 2025Article
- Adverse Reaction Reporting for Naxitamab in Chinese Expanded Access Treatment for Relapsed/Refractory High-Risk Neuroblastoma at the Children's Hospital of Fudan University.Drugs - real world outcomes · 2025Article
- Characterizing Relationships between T-cell Inflammation and Outcomes in Patients with High-Risk Neuroblastoma According to Mesenchymal and Adrenergic Signatures.Cancer research communications · 2024Article
- GM-CSF, G-CSF or no cytokine therapy with anti-GD2 immunotherapy for high-risk neuroblastoma.International journal of cancer · 2024Review
- Guidelines for outpatient administration of naxitamab: Experience from Atrium Health Levine Children's Hospital.Cancer medicine · 2024Article
- GD2-targeting therapy: a comparative analysis of approaches and promising directions.Frontiers in immunology · 2024Review
- Desensitizing the autonomic nervous system to mitigate anti-GD2 monoclonal antibody side effects.Frontiers in oncology · 2024Article
- Case Report: Successful treatment of metastatic retinoblastoma with CNS involvement with anti-GD2 immunotherapy, intrathecal topotecan and reduced systemic chemotherapy.Frontiers in pediatrics · 2024Article
- Article
- Review
- Acute myocarditis with transient myocardial thickening in two oncologic patients treated with anti-GD2 immunotherapy.ESC heart failure · 2023Article
- Novel infusion strategy reduces severe adverse events caused by the anti-GD2 monoclonal antibody naxitamab.Frontiers in oncology · 2023Article
- Outpatient administration of naxitamab in combination with granulocyte-macrophage colony-stimulating factor in patients with refractory and/or relapsed high-risk neuroblastoma: Management of adverse events.Cancer reports (Hoboken, N.J.) · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 7 institutions in 6 countries.
Funding
Abstract
backgroundNaxitamab is a humanized GD2-binding monoclonal antibody that received accelerated approval from the U.S. Food and Drug Administration for refractory or relapsed high-risk neuroblastoma limited to bone or bone marrow. Trial 201 (NCT03363373) is an ongoing global clinical trial to evaluate the efficacy and safety of naxitamab in combination with granulocyte-macrophage colony-stimulating factor in this population.
aimsHere, we review the safety profile and adverse event (AE) management associated with naxitamab administration in a pediatric population, based on Trial 201 protocol guidelines and clinical trial experience. METHODS AND
resultsAt least 50% of patients experienced pain, hypotension, bronchospasm, cough, vomiting, diarrhea, nausea, and tachycardia, with the following reported at grade ≥3 AEs for at least 10% of patients: pain, hypotension, urticaria, and bronchospasm. These AEs were generally manageable in the outpatient setting using premedications, supportive therapies, and appropriate monitoring post-infusion. Algorithms were established for infusion-related AEs, including hypotension and bronchospasm, to provide guidance to investigators for early recognition and timely intervention, including medication and infusion rate modification or interruption, or treatment discontinuation, based on AE severity. Educating patients and caregivers on what to expect regarding premedication at home, experience during the infusion cycle, and post-infusion monitoring helps optimize naxitamab treatment and supportive therapies and may reduce treatment burden.
conclusionThis article highlights the protocol-based recommendations for the management of acute AEs associated with outpatient naxitamab treatment in Trial 201. The authors recommend close monitoring and timely implementation of measures to ensure that patients can remain on treatment and obtain maximum clinical benefit from naxitamab therapy.
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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.