Evidence map›Paper›PMID 31754316›Full record

ArticlePatient related outcome measures2019

A Patient-Reported Outcomes Analysis Of Lanreotide In The Treatment Of NETs Patients With Carcinoid Syndrome: Evidence From The ELECT Trial.

Koenraad Blot, Luc Duchateau, Benedicte Lescrauwaet, Nilani Liyanage, David Ray, Beloo Mirakhur, Aaron I Vinik

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Patient related outcome measures, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00774930 (A Double Blind, Randomized Placebo Controlled Clinical Trial Investigating the Efficacy and Safety of Somatuline Depot), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
0.3field-weighted citation impact, top 36% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00774930 phase3completednot on this map

A Double Blind, Randomized Placebo Controlled Clinical Trial Investigating the Efficacy and Safety of Somatuline Depot (Lanreotide) Injection in the Treatment of Carcinoid Syndrome

TypeinterventionalSponsorIpsenRan2009 to 2015Enrolled115ConditionsCarcinoid SyndromeArmsLanreotide, Placebo
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it, 4 citations in OpenAlex.

  1. Pooled it
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 4 institutions in 3 countries.

Koenraad BlotAlacrita Consulting Ltd, London, UK.ORCID 0000-0001-9120-4102
Luc DuchateauDepartment of Comparative Physiology and Biometrics, Faculty of Veterinary Medicine, Ghent University, Ghent, Belgium.
Benedicte LescrauwaetXintera Bvba, Ghent, Belgium.ORCID 0000-0002-7976-0330
Nilani LiyanageIpsen Pharma France, Paris, France.ORCID 0000-0002-3596-8703
David RayIpsen Biopharmaceuticals, Basking Ridge, NJ, USA.ORCID 0000-0003-4850-0963
Beloo MirakhurIpsen Biopharmaceuticals, Basking Ridge, NJ, USA.
Aaron I VinikEastern Virginia Medical School, Norfolk, VA, USA.
Ipsen (United States) · USEastern Virginia Medical School · USGhent University · BEIpsen (France) · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe purpose of this analysis of patient-reported outcomes from the ELECT (Evaluation of Lanreotide Depot/Autogel Efficacy and Safety as a Carcinoid Syndrome Treatment) trial (NCT00774930) was to explore the effect of lanreotide on symptoms of carcinoid syndrome. Specifically, this post hoc analysis was designed to identify the most important patient-reported outcomes for patients in ELECT.

methodsThe post hoc analysis of ELECT, a placebo-controlled study of lanreotide in patients with neuroendocrine tumors, evaluated patient-reported outcomes during the double-blind phase of the trial, specifically daily diarrhea and flushing symptoms, octreotide rescue use, and the EORTC QLQ-C30 and QLQ-GINET21 questionnaires at baseline and week 12. Principal component (PC) analysis was applied on baseline data to identify independent variable clusters and clinically meaningful summary measures that highly correlated to these PCs. From those, the minimum clinical important differences were derived so to perform a responder analysis.

resultsThe three largest PCs captured 42.9% of the variation among baseline variables. The C30 summary score (C30-SS), diarrhea burden, and flushing burden were highly correlated with PC1, PC2, and PC3, respectively. Lanreotide patients were more likely to experience an improvement on the C30-SS (risk ratio [RR] 2.42;

conclusionThe higher response rates in the diarrhea burden are consistent with the previously reported effects of lanreotide on octreotide rescue medication use, while the findings of a greater efficacy of lanreotide vs placebo in the quality-of-life domains represent a novel aspect in the benefits of lanreotide.

trial registrationClinicalTrials.gov identifier: NCT00774930.

Indexed as

lanreotideNETsneuroendocrine tumorspatient-reported outcomes

Identifiers

PMID31754316
PMCPMC6825468
OpenAlexW2981984329

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.