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...
Autores principales: | , , , , , , |
---|---|
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 |