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Real-world evidence from a University Hospital system regarding the uptake of adjuvant pertuzumab and/or neratinib before and after their FDA approval

PURPOSE: Adjuvant pertuzumab and neratinib are independently FDA-approved for treatment of early-stage HER2-positive breast cancer in combination with or following trastuzumab for one year, respectively. Both agents reduce the risk of recurrence; however, the absolute benefit is modest for many pati...

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Autores principales: Stoen, Ericson, Kagihara, Jodi, Shagisultanova, Elena, Fisher, Christine M., Nicklawsky, Andrew, Kabos, Peter, Borges, Virginia F., Diamond, Jennifer R.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer US 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8197701/
https://www.ncbi.nlm.nih.gov/pubmed/33625615
http://dx.doi.org/10.1007/s10549-021-06132-8
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author Stoen, Ericson
Kagihara, Jodi
Shagisultanova, Elena
Fisher, Christine M.
Nicklawsky, Andrew
Kabos, Peter
Borges, Virginia F.
Diamond, Jennifer R.
author_facet Stoen, Ericson
Kagihara, Jodi
Shagisultanova, Elena
Fisher, Christine M.
Nicklawsky, Andrew
Kabos, Peter
Borges, Virginia F.
Diamond, Jennifer R.
author_sort Stoen, Ericson
collection PubMed
description PURPOSE: Adjuvant pertuzumab and neratinib are independently FDA-approved for treatment of early-stage HER2-positive breast cancer in combination with or following trastuzumab for one year, respectively. Both agents reduce the risk of recurrence; however, the absolute benefit is modest for many patients with added risk of adverse effects. The purpose of this study was to evaluate the clinical use of adjuvant pertuzumab and neratinib in patients with early-stage HER2-positive breast cancer. METHODS: Patients diagnosed with stage I–III HER2-positive breast cancer treated with trastuzumab at four University of Colorado Health hospitals between July 2016 and April 2019 were identified. Patient demographics, cancer stage, treatment, and administration of pertuzumab and/or neratinib were obtained. RESULTS: We identified a total of 350 patients who received adjuvant trastuzumab for stage I–III HER2-positive breast cancer; 253 (73.1%) had tumors that were ≥ T2 or node-positive disease. The rate of adjuvant pertuzumab use increased following FDA approval; pertuzumab was administered to the majority of patients with node-positive HER2-positive breast cancer. The use of adjuvant pertuzumab was associated with younger age, premenopausal status, and node-positive disease. Rates of administration of adjuvant neratinib were lower, with only 15.2% of patients receiving this therapy within 3 months of completing adjuvant trastuzumab. CONCLUSION: In our cohort of patients treated within a diverse healthcare network, the majority of patients with node-positive HER2-positive breast cancer received adjuvant pertuzumab following FDA approval. The use of adjuvant neratinib was less common, potentially as a result of adverse effects, prolongation of therapy, previous administration of adjuvant pertuzumab, and modest benefit.
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spelling pubmed-81977012021-06-28 Real-world evidence from a University Hospital system regarding the uptake of adjuvant pertuzumab and/or neratinib before and after their FDA approval Stoen, Ericson Kagihara, Jodi Shagisultanova, Elena Fisher, Christine M. Nicklawsky, Andrew Kabos, Peter Borges, Virginia F. Diamond, Jennifer R. Breast Cancer Res Treat Epidemiology PURPOSE: Adjuvant pertuzumab and neratinib are independently FDA-approved for treatment of early-stage HER2-positive breast cancer in combination with or following trastuzumab for one year, respectively. Both agents reduce the risk of recurrence; however, the absolute benefit is modest for many patients with added risk of adverse effects. The purpose of this study was to evaluate the clinical use of adjuvant pertuzumab and neratinib in patients with early-stage HER2-positive breast cancer. METHODS: Patients diagnosed with stage I–III HER2-positive breast cancer treated with trastuzumab at four University of Colorado Health hospitals between July 2016 and April 2019 were identified. Patient demographics, cancer stage, treatment, and administration of pertuzumab and/or neratinib were obtained. RESULTS: We identified a total of 350 patients who received adjuvant trastuzumab for stage I–III HER2-positive breast cancer; 253 (73.1%) had tumors that were ≥ T2 or node-positive disease. The rate of adjuvant pertuzumab use increased following FDA approval; pertuzumab was administered to the majority of patients with node-positive HER2-positive breast cancer. The use of adjuvant pertuzumab was associated with younger age, premenopausal status, and node-positive disease. Rates of administration of adjuvant neratinib were lower, with only 15.2% of patients receiving this therapy within 3 months of completing adjuvant trastuzumab. CONCLUSION: In our cohort of patients treated within a diverse healthcare network, the majority of patients with node-positive HER2-positive breast cancer received adjuvant pertuzumab following FDA approval. The use of adjuvant neratinib was less common, potentially as a result of adverse effects, prolongation of therapy, previous administration of adjuvant pertuzumab, and modest benefit. Springer US 2021-02-24 2021 /pmc/articles/PMC8197701/ /pubmed/33625615 http://dx.doi.org/10.1007/s10549-021-06132-8 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits 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/4.0/ (https://creativecommons.org/licenses/by/4.0/) .
spellingShingle Epidemiology
Stoen, Ericson
Kagihara, Jodi
Shagisultanova, Elena
Fisher, Christine M.
Nicklawsky, Andrew
Kabos, Peter
Borges, Virginia F.
Diamond, Jennifer R.
Real-world evidence from a University Hospital system regarding the uptake of adjuvant pertuzumab and/or neratinib before and after their FDA approval
title Real-world evidence from a University Hospital system regarding the uptake of adjuvant pertuzumab and/or neratinib before and after their FDA approval
title_full Real-world evidence from a University Hospital system regarding the uptake of adjuvant pertuzumab and/or neratinib before and after their FDA approval
title_fullStr Real-world evidence from a University Hospital system regarding the uptake of adjuvant pertuzumab and/or neratinib before and after their FDA approval
title_full_unstemmed Real-world evidence from a University Hospital system regarding the uptake of adjuvant pertuzumab and/or neratinib before and after their FDA approval
title_short Real-world evidence from a University Hospital system regarding the uptake of adjuvant pertuzumab and/or neratinib before and after their FDA approval
title_sort real-world evidence from a university hospital system regarding the uptake of adjuvant pertuzumab and/or neratinib before and after their fda approval
topic Epidemiology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8197701/
https://www.ncbi.nlm.nih.gov/pubmed/33625615
http://dx.doi.org/10.1007/s10549-021-06132-8
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