Fraction-dependent dose dynamics and clinical safety in high-risk neuroblastoma treated with [177Lu]Lu-DOTATATE: results from the LuDO-N trial
Abstract
Purpose: Neuroblastoma frequently overexpresses somatostatin receptors (SSTR), enabling molecular radiotherapy with [177Lu]Lu-DOTATATE (177Lu-DOTATATE). Based on prior studies suggesting that dose intensification is required to achieve objective responses, the LuDO-N trial employs a two-fraction, high-activity treatment regimen. This study aimed to evaluate fraction-dependent changes in tumour and risk-organ absorbed doses, as well as the clinical safety of the intensified 177Lu-DOTATATE treatment approach.
Methods: Fourteen patients with high-risk recurrent or refractory neuroblastoma received 177Lu-DOTATATE in a dose-intensified, dosimetry-guided regimen. Treatment was given in two fractions 2-3 weeks apart, targeting a cumulative dose of either 2.4 Gy to the whole body or 23 Gy to either kidney. The first fraction was administered at 200 MBq/kg, while the second fraction was individually adjusted to achieve the dosimetric targets.
Results: Tumour-to-kidney and tumour-to-whole-body absorbed dose ratios both decreased significantly by 44% after the second fraction, compared to the first. Tumours received a median 53% lower absorbed dose per administered activity in the second fraction, while kidney and whole-body doses per activity were reduced by 24% and 18%, respectively. Four of fourteen patients (29%) underwent peripheral blood stem cell reinfusion. No sustained renal toxicity was observed.
Conclusions: These findings support a front-loaded 177Lu-DOTATATE strategy to…
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Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence.
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