Cargando…

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

PURPOSE: The 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...

Descripción completa

Detalles Bibliográficos
Autores principales: Blot, Koenraad, Duchateau, Luc, Lescrauwaet, Benedicte, Liyanage, Nilani, Ray, David, Mirakhur, Beloo, Vinik, Aaron I
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Dove 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6825468/
https://www.ncbi.nlm.nih.gov/pubmed/31754316
http://dx.doi.org/10.2147/PROM.S219982
_version_ 1783464906935238656
author Blot, Koenraad
Duchateau, Luc
Lescrauwaet, Benedicte
Liyanage, Nilani
Ray, David
Mirakhur, Beloo
Vinik, Aaron I
author_facet Blot, Koenraad
Duchateau, Luc
Lescrauwaet, Benedicte
Liyanage, Nilani
Ray, David
Mirakhur, Beloo
Vinik, Aaron I
author_sort Blot, Koenraad
collection PubMed
description PURPOSE: The 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. METHODS: The 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. RESULTS: The 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; P=0.023), diarrhea burden (RR 2.85; P=0.005), and flushing burden (RR 1.39; P=0.31) compared to placebo patients. Lanreotide-treated patients have a higher probability of being a responder on at least one of the three domains of C30-SS, diarrhea burden, or flushing burden compared to placebo patients (RR 1.48; P=0.06). CONCLUSION: The 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 REGISTRATION: ClinicalTrials.gov identifier: NCT00774930.
format Online
Article
Text
id pubmed-6825468
institution National Center for Biotechnology Information
language English
publishDate 2019
publisher Dove
record_format MEDLINE/PubMed
spelling pubmed-68254682019-11-21 A Patient-Reported Outcomes Analysis Of Lanreotide In The Treatment Of NETs Patients With Carcinoid Syndrome: Evidence From The ELECT Trial Blot, Koenraad Duchateau, Luc Lescrauwaet, Benedicte Liyanage, Nilani Ray, David Mirakhur, Beloo Vinik, Aaron I Patient Relat Outcome Meas Original Research PURPOSE: The 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. METHODS: The 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. RESULTS: The 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; P=0.023), diarrhea burden (RR 2.85; P=0.005), and flushing burden (RR 1.39; P=0.31) compared to placebo patients. Lanreotide-treated patients have a higher probability of being a responder on at least one of the three domains of C30-SS, diarrhea burden, or flushing burden compared to placebo patients (RR 1.48; P=0.06). CONCLUSION: The 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 REGISTRATION: ClinicalTrials.gov identifier: NCT00774930. Dove 2019-10-29 /pmc/articles/PMC6825468/ /pubmed/31754316 http://dx.doi.org/10.2147/PROM.S219982 Text en © 2019 Blot et al. http://creativecommons.org/licenses/by-nc/3.0/ This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms (https://www.dovepress.com/terms.php).
spellingShingle Original Research
Blot, Koenraad
Duchateau, Luc
Lescrauwaet, Benedicte
Liyanage, Nilani
Ray, David
Mirakhur, Beloo
Vinik, Aaron I
A Patient-Reported Outcomes Analysis Of Lanreotide In The Treatment Of NETs Patients With Carcinoid Syndrome: Evidence From The ELECT Trial
title A Patient-Reported Outcomes Analysis Of Lanreotide In The Treatment Of NETs Patients With Carcinoid Syndrome: Evidence From The ELECT Trial
title_full A Patient-Reported Outcomes Analysis Of Lanreotide In The Treatment Of NETs Patients With Carcinoid Syndrome: Evidence From The ELECT Trial
title_fullStr A Patient-Reported Outcomes Analysis Of Lanreotide In The Treatment Of NETs Patients With Carcinoid Syndrome: Evidence From The ELECT Trial
title_full_unstemmed A Patient-Reported Outcomes Analysis Of Lanreotide In The Treatment Of NETs Patients With Carcinoid Syndrome: Evidence From The ELECT Trial
title_short A Patient-Reported Outcomes Analysis Of Lanreotide In The Treatment Of NETs Patients With Carcinoid Syndrome: Evidence From The ELECT Trial
title_sort patient-reported outcomes analysis of lanreotide in the treatment of nets patients with carcinoid syndrome: evidence from the elect trial
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6825468/
https://www.ncbi.nlm.nih.gov/pubmed/31754316
http://dx.doi.org/10.2147/PROM.S219982
work_keys_str_mv AT blotkoenraad apatientreportedoutcomesanalysisoflanreotideinthetreatmentofnetspatientswithcarcinoidsyndromeevidencefromtheelecttrial
AT duchateauluc apatientreportedoutcomesanalysisoflanreotideinthetreatmentofnetspatientswithcarcinoidsyndromeevidencefromtheelecttrial
AT lescrauwaetbenedicte apatientreportedoutcomesanalysisoflanreotideinthetreatmentofnetspatientswithcarcinoidsyndromeevidencefromtheelecttrial
AT liyanagenilani apatientreportedoutcomesanalysisoflanreotideinthetreatmentofnetspatientswithcarcinoidsyndromeevidencefromtheelecttrial
AT raydavid apatientreportedoutcomesanalysisoflanreotideinthetreatmentofnetspatientswithcarcinoidsyndromeevidencefromtheelecttrial
AT mirakhurbeloo apatientreportedoutcomesanalysisoflanreotideinthetreatmentofnetspatientswithcarcinoidsyndromeevidencefromtheelecttrial
AT vinikaaroni apatientreportedoutcomesanalysisoflanreotideinthetreatmentofnetspatientswithcarcinoidsyndromeevidencefromtheelecttrial
AT blotkoenraad patientreportedoutcomesanalysisoflanreotideinthetreatmentofnetspatientswithcarcinoidsyndromeevidencefromtheelecttrial
AT duchateauluc patientreportedoutcomesanalysisoflanreotideinthetreatmentofnetspatientswithcarcinoidsyndromeevidencefromtheelecttrial
AT lescrauwaetbenedicte patientreportedoutcomesanalysisoflanreotideinthetreatmentofnetspatientswithcarcinoidsyndromeevidencefromtheelecttrial
AT liyanagenilani patientreportedoutcomesanalysisoflanreotideinthetreatmentofnetspatientswithcarcinoidsyndromeevidencefromtheelecttrial
AT raydavid patientreportedoutcomesanalysisoflanreotideinthetreatmentofnetspatientswithcarcinoidsyndromeevidencefromtheelecttrial
AT mirakhurbeloo patientreportedoutcomesanalysisoflanreotideinthetreatmentofnetspatientswithcarcinoidsyndromeevidencefromtheelecttrial
AT vinikaaroni patientreportedoutcomesanalysisoflanreotideinthetreatmentofnetspatientswithcarcinoidsyndromeevidencefromtheelecttrial