[177Lu]Lu-DOTA-TATE plus long-acting octreotide versus high‑dose long-acting octreotide for the treatment of newly diagnosed, advanced grade 2–3, well-differentiated, gastroenteropancreatic neuroendocrine tumours (NETTER-2): an open-label, randomised, phase 3 study
Authors' conclusion
First-line 177Lu-Dotatate plus octreotide LAR significantly extended median progression-free survival (by 14 months) in patients with grade 2 or 3 advanced gastroenteropancreatic neuroendocrine tumours. 177Lu-Dotatate should be considered a new standard of care in first-line therapy in this population.
Study context
- Population
- Patients aged ≥15 years with newly diagnosed higher grade 2 (Ki67 ≥10% and ≤20%) and grade 3 (Ki67 >20% and ≤55%), somatostatin receptor-positive, advanced GEP-NET; 45 centres in North America, Europe and Asiarandomised 2:1
- Participants
- 226 patients
- Comparison
- 177Lu-Dotatate plus octreotide 30 mg long-acting repeatable (LAR) vs high-dose octreotide 60 mg LAR
- 177Lu-Dotataten = 151
- Controln = 75reference
- Primary endpoint
- Progression-free survival by blinded independent central radiology assessment
Methodological detailsopen-label, parallel-group, superiority, phase 3, stratified by tumour grade and origin, 45 centres, nine countries
- Open-label
- Parallel-group
- Superiority
- Phase 3
- Stratified by tumour grade and origin
- 45 centres, nine countries
Primary result
Progression-free survival
Stratified HR
0.276
95% CI 0.182–0.418
P < 0.0001
By group
177Lu-Dotatatevs Control
stratified HR 0.276 (95% CI 0.182–0.418); P < 0.0001
As reported in the abstract
Safety
Adverse events (any grade) during treatment period
- Adverse events (any grade) during treatment period — Study drug-related deaths during treatment period
- 0
- Adverse events (any grade) during treatment period: 147 and 73 treated patients, respectively
Original publication
[177Lu]Lu-DOTA-TATE plus long-acting octreotide versus high‑dose long-acting octreotide for the treatment of newly diagnosed, advanced grade 2–3, well-differentiated, gastroenteropancreatic neuroendocrine tumours (NETTER-2): an open-label, randomised, phase 3 study. Lancet. Published 5 June 2024. doi:10.
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