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Establishing the Quantitative Relationship Between Lanreotide Autogel®, Chromogranin A, and Progression-Free Survival in Patients with Nonfunctioning Gastroenteropancreatic Neuroendocrine Tumors
Plain-language guide to PMID 26908127 (2016): double-blind randomized controlled trial study of Somatostatin and Lanreotide in 204 patients.
Key Facts
- PMID
- 26908127
- Journal
- The AAPS journal
- Year
- 2016
- Study type
- Randomized Controlled Trial
- Authors
- Buil-Bruna N et al. (5 authors)
- DOI
- 10.1208/s12248-016-9884-3
What This Study Did, in Plain Language
What Was Tested
Researchers studied Somatostatin and Lanreotide in this randomized controlled trial publication.
Data for 810 LAN and 1298 CgA serum samples (n = 632 placebo and n = 666 LAN) were used to develop a parametric time-to-event model to relate CgA levels and PFS (76 patients experienced disease progression: n = 49 placebo and n = 27 LAN).
LAN serum profiles were described by a one-compartment disposition model.
Who Took Part
According to the abstract, 204 patients were involved.
The age groups tagged for this paper are adults, middle-aged adults, older adults and people over 80, both men and women.
How the Study Was Run
In design terms this was a randomized, double-blind, placebo-controlled and parallel-group study.
Because people in this Somatostatin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
As a double-blind Somatostatin study, the assignments were hidden from both participants and investigators until the end.
The comparison arm used a placebo, so changes seen with Somatostatin could be set against what happens without it.
Groups ran in parallel: each of the patients stayed in one arm throughout.
The methods mention a period of 96 weeks.
What Was Measured
Data for 810 LAN and 1298 CgA serum samples (n = 632 placebo and n = 666 LAN) were used to develop a parametric time-to-event model to relate CgA levels and PFS (76 patients experienced disease progression: n = 49 placebo and n = 27 LAN).
The subject headings attached to it are Antineoplastic Agents, Chromogranin A, Disease-Free Survival, Gels, Intestinal Neoplasms, Neuroendocrine Tumors and Pancreatic Neoplasms.
The authors tagged it with the keywords lanreotide, population PK/PD and time-to-event analysis.
What This Means in Plain Language
The paper is a randomized, double-blind and placebo-controlled study of Somatostatin and Lanreotide in 204 patients over 96 weeks.
The publication is from 2016 (The AAPS journal), a journal based in United States.
More context: the Somatostatin compound page and the Lanreotide compound page, all human trials.
Our Notes on the Compounds
Somatostatin: A 14-amino-acid hormone that switches off the release of several other hormones, including growth hormone and insulin.
Lanreotide: A long-acting 8-amino-acid somatostatin analog (Somatuline Depot) in the same class as octreotide.
Related Pages
Source: PubMed record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.