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Bitte verwenden Sie diesen Link, wenn Sie dieses Dokument zitieren oder verlinken wollen: https://nbn-resolving.org/urn:nbn:de:gbv:9-opus-108815

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

  • Background Short-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. Methods In 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. Results Of 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. Conclusion Long-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 registration The study is registered with ClinicalTrials.gov (NCT02743429) and EudraCT (2014-000588-42).

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Metadaten
Author: Holger N. Lode, Karoline Ehlert, Stephanie Huber, Sascha Troschke-Meurer, Nikolai Siebert, Maxi Zumpe, Hans Loibner, Ruth Ladenstein
URN:urn:nbn:de:gbv:9-opus-108815
DOI:https://doi.org/10.1038/s41416-023-02457-x
ISSN:1532-1827
Parent Title (English):British Journal of Cancer
Publisher:Nature Publishing Group
Place of publication:London
Document Type:Article
Language:English
Date of Publication (online):2023/10/10
Date of first Publication:2023/11/23
Release Date:2024/03/14
Volume:129
Issue:11
First Page:1780
Last Page:1786
Faculties:Universitätsmedizin / Klinik und Poliklinik für Kinder- und Jugendmedizin
Collections:DFG-geförderte Artikel
Licence (German):License LogoCreative Commons - Namensnennung 4.0 International