Safety and dosimetry of [177Lu]Lu-DOTA-TATE in adolescent patients with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours, or pheochromocytomas and paragangliomas: Primary analysis of the Phase II NETTER-P study.
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PURPOSE: NETTER-P, an open-label Phase II study, evaluated the safety and dosimetry of [177Lu]Lu-DOTA-TATE (hereafter 177Lu-DOTATATE) in adolescents with advanced, somatostatin receptor-positive, well-differentiated, Grade 1/2 gastroenteropancreatic neuroendocrine tumours (GEP-NET) or pheochromocytoma and paragangliomas (PPGL). METHODS: Patients (12-17 years old) received four cycles of 177Lu-DOTATATE (7.4 GBq every 8 ± 1 weeks; cumulative administered activity: 29.6 GBq). Primary endpoints were absorbed dose (kidneys and bone marrow) and safety after first administration. Safety during treatment and comparative assessments of dosimetry and pharmacokinetics between adolescents and historical adult patients were evaluated. RESULTS: Eleven patients (4 GEP-NET, 7 PPGL; median age 15 [range, 13-17] years) were enrolled and received ≥ 1 administration of 177Lu-DOTATATE. Median (range) cumulative administered activity was 28.2 (7.3-29.9) GBq. Lymphopenia/lymphocyte count decreased and headache were the most common adverse events (AEs) during Cycle 1 (each 4/11 [36%]). Cycle 1 Grade ≥ 3 AEs occurred in 4/11 patients (36%). During the treatment period, the most common AE was lymphopenia/lymphocyte count decreased (7/11 [64%]; Grade ≥ 3, 5/11 [45%]). No clinically meaningful impacts on safety biomarkers nor any treatment-related nephrotoxicities were observed. Projected median (range) cumulative absorbed doses (four administrations) were 21 (14-40) Gy in kidneys and 0.76 (0.55-1.0) Gy in bone marrow (using blood data). Dosimetry values were predicted to be within safety thresholds for adolescents and adults; pharmacokinetics were comparable in both populations. CONCLUSION: No new safety signals attributable to 177Lu-DOTATATE were identified in adolescents with GEP-NET or PPGL versus adults with GEP-NET. Long-term follow-up is ongoing. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04711135. Registered 15 January 2021.