Background/Objectives: The anti-GD2 monoclonal antibody dinutuximab beta has become
standard of care maintenance therapy for high-risk neuroblastoma (HR-NB) in the first-line
setting and is also approved in the relapsed/refractory setting. We present a retrospective
review of 37 children with HR-NB included in the Hungarian Childhood Cancer Registry
who received dinutuximab beta (first-line maintenance therapy, n = 31; relapsed/refractory,
n = 6). Methods: All patients received dinutuximab beta continuously over the first
10 days of each 35-day cycle, with dosing based on body surface area/weight. Five
cycles were planned, with further cycles administered at the treating physician's
discretion. Results: At data cutoff, the overall disease control rate was 54.1% (20/37)
(complete response, 51.4% (19/37); partial response, 0.0% (0/37), stable disease,
2.7% [1/37]); two patients (5.4%) had progressive disease, and 15 patients (40.5%)
had died. The 5-year overall survival (OS) and event-free survival (EFS) rates in
the overall population were 63.3% (95% confidence interval, 49.1-81.7) and 56.2% (95%
confidence interval, 42.1-75.0), respectively. Grade 3 or 4 adverse events (including
blood and lymphatic system disorders, hypoxia, hypotension, and capillary leak syndrome)
were generally consistent with dinutuximab beta's known safety profile. Conclusions:
Dinutuximab beta was an effective immunotherapy for patients with HR-NB in routine
clinical practice, with a generally manageable side effect profile.
