ArticleNeuro-oncology advances
Real-world outcomes for selumetinib in pediatric patients with neurofibromatosis type 1 and plexiform neurofibromas in Japan: A 1-year interim analysis.
Article in Neuro-oncology advances. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Not yet cited in PubMed.
What it found
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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.
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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.
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Who cites it
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No citing paper in PubMed yet.
Corrections and comments
- Erratum issued
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: This postmarketing surveillance assessed the real-world safety and effectiveness of selumetinib in pediatric patients with neurofibromatosis type 1 (NF1) and plexiform neurofibromas (PN) in Japan. Methods: The surveillance was initiated on November 16, 2022, the launch date of selumetinib in pediatric indication in Japan. All patients treated with selumetinib were eligible for enrollment. The observation period was set to 3 years from drug initiation (data cutoff for 1-year analysis: October 9, 2024). Patient characteristics and safety and effectiveness data were captured using case report forms. Results: In total, 52 patients were included in the analysis (median [range] age, 13.0 [5-20] years; age <19 years, 49 [94.2%] patients; female, 28 [53.8%] patients; dermatological, neurological, and bone manifestations [DNB] classification stage 5, 30 [57.7%] patients; median disease duration [ Conclusions: The safety profile of selumetinib was generally consistent with the findings of the phase 2 SPRINT trial and Japanese phase 1 trial. No new safety concerns were identified.
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