(177)Lu-Dotatate plus long-acting octreotide versus high‑dose long-acting octreotide in patients with midgut neuroendocrine tumours (NETTER-1): final overall survival and long-term safety results from an open-label, randomised, controlled, phase 3 trial

What Was Tested

This randomized controlled trial paper looks at Octreotide.

Here, the researchers report the prespecified final analysis of overall survival and long-term safety results.

Who Took Part

The abstract describes 3 patients taking part.

PubMed indexes the participants as older adults, both men and women.

This open-label, randomised, phase 3 trial enrolled patients from 41 sites in eight countries across Europe and the USA.

How the Study Was Run

In design terms this was a randomized and open-label study.

Random assignment meant chance, not the researchers, decided who got Octreotide and who got the comparison, which limits bias.

Everyone knew when Octreotide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

The primary endpoint of progression-free survival has been previously reported; here, the researchers report the key secondary endpoint of overall survival in the intention-to-treat population.

During long-term follow-up, adverse events of special interest were reported in the 177Lu-Dotatate group only.

This trial is registered with ClinicalTrials.gov, NCT01578239.

What Was Measured

PubMed files the paper under topics including Antineoplastic Agents, Hormonal, Chemoradiotherapy, Digestive System Neoplasms, Neuroendocrine Tumors, Octreotide, Organometallic Compounds and Prognosis.

What This Means in Plain Language

The paper is a randomized and open-label study of Octreotide in 3 patients.

With fewer than 40 people, it is a small study, so it is better read as an early signal for further research than as a settled answer.

The abstract goes on to report its results in about 9 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2021 (The Lancet. Oncology), a journal based in England.

More context: the Octreotide compound page, all human trials.