NETTER-1
The trial that made radioligand therapy a standard: a radioactive drug homing to the somatostatin receptor held midgut neuroendocrine tumours in check far longer than high-dose octreotide, and it underpins Lutathera's approvals.
Overview
NETTER-1, trial NCT01578239 sponsored by Advanced Accelerator Applications and published in the New England Journal of Medicine in 2017, randomised 231 patients with inoperable, progressive, somatostatin receptor-positive midgut neuroendocrine tumours to 177Lu-Dotatate (four cycles, with octreotide) or high-dose octreotide LAR. Progression-free survival at 20 months was 65.2% with 177Lu-Dotatate against 10.8% with octreotide, and the response rate was 18% against 3%. The result supported the 2018 US and EU approvals of Lutathera and made peptide receptor radionuclide therapy the reference treatment after somatostatin analogues.
- 65.2 vs 10.8 out of 100 alive without the cancer growing at 20 months with 177Lu-Dotatate + octreotide compared with High-dose octreotide LAR; 54.4 more per 100.
- Roughly one extra person helped for every 2 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- Put another way, the treated group had about 79 percent lower chance of the event at any given time (hazard ratio 0.21, likely range 0.13 to 0.33).
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- 18 vs 3 out of 100 had their tumour shrink with 177Lu-Dotatate + octreotide compared with High-dose octreotide LAR; 15 more per 100.
- Roughly one extra person helped for every 7 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- The p-value (<0.001) says a difference this large would rarely happen by chance; it does not say how large or how useful the difference is.
- A response rate counts how many people had their tumours shrink by a set amount; shrinking is encouraging but does not by itself show that people live longer or feel better.
- These results apply to the people the trial enrolled: Inoperable, progressive midgut neuroendocrine tumours: 177Lu-Dotatate plus octreotide versus high-dose octreotide LAR. People in a different situation may not see the same effect.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
231 participants enrolled.
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