A phase IIa trial of molecular radiotherapy with 177-lutetium DOTATATE in children with primary refractory or relapsed high-risk neuroblastoma.

European Journal of Nuclear Medicine and Molecular Imaging
Jennifer E GainsMark N Gaze

Abstract

The objective of this phase IIa, open-label, single-centre, single-arm, two-stage clinical trial was to evaluate the safety and activity of 177-lutetium DOTATATE (LuDO) molecular radiotherapy in neuroblastoma. Children with relapsed or refractory metastatic high-risk neuroblastoma were treated with up to four courses of LuDO. The administered activity was 75 to 100 MBq kg-1 per course, spaced at 8- to 12-week intervals. Outcomes were assessed by the International Neuroblastoma Response Criteria (primary outcome), progression-free survival (PFS), and overall survival (OS). The trial recruited 21 patients; eight received the planned four courses. There was dose-limiting haematologic toxicity in one case, but no other significant haematologic or renal toxicities. None of 14 evaluable patients had an objective response at 1 month after completion of treatment (Wilson 90% CI 0.0, 0.16; and 95% CI is 0.0, 0.22). The trial did not therefore proceed to the second stage. The median PFS was 2.96 months (95% CI 1.71, 7.66), and the median OS was 13.0 months (95% CI 2.99, 21.52). In the absence of any objective responses, the use of LuDO as a single agent at the dose schedule used in this study is not recommended for the treatment of neuro...Continue Reading

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Citations

Oct 22, 2020·Journal of Personalized Medicine·LauraMay DavisMark N Gaze
Nov 29, 2020·Clinical Oncology : a Journal of the Royal College of Radiologists·M D AldridgeM N Gaze
Apr 13, 2021·Pediatric Blood & Cancer·Jennifer H FosterRajkumar Venkatramani
May 1, 2021·Journal of Personalized Medicine·Atia SamimBart de Keizer
Jun 1, 2021·PET Clinics·Margarida Simao RafaelDaniel A Morgenstern
Aug 27, 2021·BMC Cancer·Arman RomianiEva Forssell-Aronsson

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