Fcγ Receptor Polymorphism in Patients with Relapsed/Refractory High-Risk Neuroblastoma Correlates with Outcomes in the SIOPEN Dinutuximab Beta Long-Term Infusion Trial Article Swipe
Holger N. Lode
,
Nikolai Siebert
,
Dominique Valteau‐Couanet
,
Alberto Garaventa
,
Adela Cañete
,
John W. Anderson
,
Isaac Yaniv
,
Shifra Ash
,
Juliet C. Gray
,
Thomas Klingebiel
,
Hans Loibner
,
Roberto Luksch
,
Carla Manzitti
,
Jean Michon
,
Cormac Owens
,
Ulrike Pötschger
,
Sascha Troschke‐Meurer
,
Evgenia Glogova
,
Ruth Ladenstein
·
YOU?
·
· 2025
· Open Access
·
· DOI: https://doi.org/10.1158/1078-0432.ccr-25-0180
YOU?
·
· 2025
· Open Access
·
· DOI: https://doi.org/10.1158/1078-0432.ccr-25-0180
Purpose: To identify a tolerable dinutuximab beta long-term infusion (LTI) schedule with immunomodulatory activity for relapsed/refractory high-risk neuroblastoma (HRNBL). Patients and Methods: In 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. Results: Overall, 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. Conclusions: Dinutuximab beta LTI was well tolerated and clinically active in patients with relapsed/refractory HRNBL, with FCYR polymorphisms and NK cells identified as prognostic biomarkers.
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Concepts
Metadata
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1158/1078-0432.ccr-25-0180
- OA Status
- green
- References
- 33
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W4412157488
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W4412157488Canonical identifier for this work in OpenAlex
- DOI
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https://doi.org/10.1158/1078-0432.ccr-25-0180Digital Object Identifier
- Title
-
Fcγ Receptor Polymorphism in Patients with Relapsed/Refractory High-Risk Neuroblastoma Correlates with Outcomes in the SIOPEN Dinutuximab Beta Long-Term Infusion TrialWork title
- Type
-
articleOpenAlex work type
- Language
-
enPrimary language
- Publication year
-
2025Year of publication
- Publication date
-
2025-07-08Full publication date if available
- Authors
-
Holger N. Lode, Nikolai Siebert, Dominique Valteau‐Couanet, Alberto Garaventa, Adela Cañete, John W. Anderson, Isaac Yaniv, Shifra Ash, Juliet C. Gray, Thomas Klingebiel, Hans Loibner, Roberto Luksch, Carla Manzitti, Jean Michon, Cormac Owens, Ulrike Pötschger, Sascha Troschke‐Meurer, Evgenia Glogova, Ruth LadensteinList of authors in order
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https://doi.org/10.1158/1078-0432.ccr-25-0180Publisher landing page
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YesWhether a free full text is available
- OA status
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greenOpen access status per OpenAlex
- OA URL
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https://www.ncbi.nlm.nih.gov/pmc/articles/12402781Direct OA link when available
- Concepts
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Medicine, Oncology, Internal medicine, Refractory (planetary science), Neuroblastoma, Biology, Genetics, Cell culture, AstrobiologyTop concepts (fields/topics) attached by OpenAlex
- Cited by
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0Total citation count in OpenAlex
- References (count)
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33Number of works referenced by this work
- Related works (count)
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10Other works algorithmically related by OpenAlex
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