Phase II Study of Everolimus and Octreotide LAR in Patients with Nonfunctioning Gastrointestinal Neuroendocrine Tumors: The GETNE1003_EVERLAR Study

What Was Tested

The paper reports a study of Octreotide, published as a clinical trial, phase ii.

The primary endpoint was progression-free survival (PFS) at 12 months; secondary endpoints included early biochemical response, objective response rate (ORR) by RECIST v1.0, overall survival (OS), AEs, activation of mTOR pathway (insulin-like growth factor 1 receptor [IGF1R] and phosphoS6 [pS6] expression).

Why It Was Studied

Antitumor activity of the combination of somatostatin analogues (SSAs) and the mammalian target of rapamycin (mTOR) inhibitor everolimus in patients with neuroendocrine tumors (NETs) has been reported but not confirmed in prospective trials.

Who Took Part

The study group was 28 patients.

By PubMed's age tags, the people studied were older adults, both men and women.

Prior treatment with SSAs and any systemic or locoregional therapy was allowed except for mTOR inhibitors.

Patients continued treatment until disease progression or unacceptable adverse events (AEs).

How the Study Was Run

The researchers set it up as a multicenter study.

More than one site took part, so the patients came from several places.

What Was Measured

Topics PubMed links to this paper include Everolimus, Intestinal Neoplasms, Neuroendocrine Tumors, Octreotide, Pancreatic Neoplasms and Stomach Neoplasms.

Author keywords: Nonfunctioning.

What This Means in Plain Language

The paper is a multicenter study of Octreotide in 28 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 10 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2019 (The oncologist), a journal based in England.

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