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Lanreotide Depot to Treat Gastroenteropancreatic Neuroendocrine Tumors in a US Community Oncology Setting: A Prospective, Observational Study

INTRODUCTION: Gastroenteropancreatic neuroendocrine tumors (GEP-NETs) can result in symptoms such as diarrhea, flushing, abdominal pain, and fatigue and are often associated with a significant disease burden and poor prognosis. This non-interventional, prospective, observational study evaluated the...

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Autores principales: Paulson, Scott, Ray, David, Aranha, Sharan, Scales, Amy, Wang, Yunfei, Liu, Eric
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Healthcare 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9681944/
https://www.ncbi.nlm.nih.gov/pubmed/36136274
http://dx.doi.org/10.1007/s40487-022-00208-1
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author Paulson, Scott
Ray, David
Aranha, Sharan
Scales, Amy
Wang, Yunfei
Liu, Eric
author_facet Paulson, Scott
Ray, David
Aranha, Sharan
Scales, Amy
Wang, Yunfei
Liu, Eric
author_sort Paulson, Scott
collection PubMed
description INTRODUCTION: Gastroenteropancreatic neuroendocrine tumors (GEP-NETs) can result in symptoms such as diarrhea, flushing, abdominal pain, and fatigue and are often associated with a significant disease burden and poor prognosis. This non-interventional, prospective, observational study evaluated the real-world safety and effectiveness of lanreotide depot, a somatostatin analog (SSA) used to treat GEP-NETs, in a community setting. METHODS: In this prospective, non-interventional study (NCT02730104), adult patients with locally advanced (inoperable), metastatic GEP-NETs treated with lanreotide depot were evaluated by their physician every 6 months from enrollment for 24 months. Clinically defined time to disease progression (TTDP) and overall survival (OS) were estimated for the total population and by primary tumor type (gastrointestinal [GI], pancreatic, unknown origin), and an exploratory analysis determined the rate of progression-free survival (PFS) at 12 and 24 months. Patient satisfaction was evaluated via the Treatment Satisfaction Questionnaire for Medication (TSQM-9), and safety information was recorded. RESULTS: Of 99 patients, the 24-month PFS rate was 73.7% (95% confidence interval [CI] 63.1–81.7) and 24-month OS rate was 84.2% (95% CI 74.0–90.7). Median TTDP was not reached because few patients experienced disease progression during the study period. The majority of responding patients expressed satisfaction with treatment on each domain of the TSQM-9. Treatment-related adverse events (AEs) occurred in 19.2% of patients, while no serious AEs (SAEs) were related to the study drug. CONCLUSIONS: Lanreotide depot is an effective and well-tolerated treatment for GEP-NETs in the real-world community setting. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT02730104. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40487-022-00208-1.
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spelling pubmed-96819442022-11-24 Lanreotide Depot to Treat Gastroenteropancreatic Neuroendocrine Tumors in a US Community Oncology Setting: A Prospective, Observational Study Paulson, Scott Ray, David Aranha, Sharan Scales, Amy Wang, Yunfei Liu, Eric Oncol Ther Original Research INTRODUCTION: Gastroenteropancreatic neuroendocrine tumors (GEP-NETs) can result in symptoms such as diarrhea, flushing, abdominal pain, and fatigue and are often associated with a significant disease burden and poor prognosis. This non-interventional, prospective, observational study evaluated the real-world safety and effectiveness of lanreotide depot, a somatostatin analog (SSA) used to treat GEP-NETs, in a community setting. METHODS: In this prospective, non-interventional study (NCT02730104), adult patients with locally advanced (inoperable), metastatic GEP-NETs treated with lanreotide depot were evaluated by their physician every 6 months from enrollment for 24 months. Clinically defined time to disease progression (TTDP) and overall survival (OS) were estimated for the total population and by primary tumor type (gastrointestinal [GI], pancreatic, unknown origin), and an exploratory analysis determined the rate of progression-free survival (PFS) at 12 and 24 months. Patient satisfaction was evaluated via the Treatment Satisfaction Questionnaire for Medication (TSQM-9), and safety information was recorded. RESULTS: Of 99 patients, the 24-month PFS rate was 73.7% (95% confidence interval [CI] 63.1–81.7) and 24-month OS rate was 84.2% (95% CI 74.0–90.7). Median TTDP was not reached because few patients experienced disease progression during the study period. The majority of responding patients expressed satisfaction with treatment on each domain of the TSQM-9. Treatment-related adverse events (AEs) occurred in 19.2% of patients, while no serious AEs (SAEs) were related to the study drug. CONCLUSIONS: Lanreotide depot is an effective and well-tolerated treatment for GEP-NETs in the real-world community setting. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT02730104. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40487-022-00208-1. Springer Healthcare 2022-09-22 /pmc/articles/PMC9681944/ /pubmed/36136274 http://dx.doi.org/10.1007/s40487-022-00208-1 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by-nc/4.0/Open AccessThis article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Original Research
Paulson, Scott
Ray, David
Aranha, Sharan
Scales, Amy
Wang, Yunfei
Liu, Eric
Lanreotide Depot to Treat Gastroenteropancreatic Neuroendocrine Tumors in a US Community Oncology Setting: A Prospective, Observational Study
title Lanreotide Depot to Treat Gastroenteropancreatic Neuroendocrine Tumors in a US Community Oncology Setting: A Prospective, Observational Study
title_full Lanreotide Depot to Treat Gastroenteropancreatic Neuroendocrine Tumors in a US Community Oncology Setting: A Prospective, Observational Study
title_fullStr Lanreotide Depot to Treat Gastroenteropancreatic Neuroendocrine Tumors in a US Community Oncology Setting: A Prospective, Observational Study
title_full_unstemmed Lanreotide Depot to Treat Gastroenteropancreatic Neuroendocrine Tumors in a US Community Oncology Setting: A Prospective, Observational Study
title_short Lanreotide Depot to Treat Gastroenteropancreatic Neuroendocrine Tumors in a US Community Oncology Setting: A Prospective, Observational Study
title_sort lanreotide depot to treat gastroenteropancreatic neuroendocrine tumors in a us community oncology setting: a prospective, observational study
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9681944/
https://www.ncbi.nlm.nih.gov/pubmed/36136274
http://dx.doi.org/10.1007/s40487-022-00208-1
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