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Use and outcomes of targeted therapies in early and metastatic HER2-positive breast cancer in Australia: protocol detailing observations in a whole of population cohort

BACKGROUND: The management of human epidermal growth factor receptor 2 (HER2)-positive breast cancer (BC) has changed dramatically with the introduction and widespread use of HER2-targeted therapies. However, there is relatively limited real-world information on patterns of use, effectiveness and sa...

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Autores principales: Daniels, Benjamin, Lord, Sarah J, Kiely, Belinda E, Houssami, Nehmat, Haywood, Philip, Lu, Christine Y, Ward, Robyn L, Pearson, Sallie-Anne
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5278255/
https://www.ncbi.nlm.nih.gov/pubmed/28119394
http://dx.doi.org/10.1136/bmjopen-2016-014439
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author Daniels, Benjamin
Lord, Sarah J
Kiely, Belinda E
Houssami, Nehmat
Haywood, Philip
Lu, Christine Y
Ward, Robyn L
Pearson, Sallie-Anne
author_facet Daniels, Benjamin
Lord, Sarah J
Kiely, Belinda E
Houssami, Nehmat
Haywood, Philip
Lu, Christine Y
Ward, Robyn L
Pearson, Sallie-Anne
author_sort Daniels, Benjamin
collection PubMed
description BACKGROUND: The management of human epidermal growth factor receptor 2 (HER2)-positive breast cancer (BC) has changed dramatically with the introduction and widespread use of HER2-targeted therapies. However, there is relatively limited real-world information on patterns of use, effectiveness and safety in whole of population cohorts. The research programme detailed in this protocol will generate evidence on the prescribing patterns, safety monitoring and outcomes of patients with BC treated with HER2-targeted therapies in Australia. METHODS/DESIGN: Our ongoing research programme will involve a series of retrospective cohort studies that include every patient accessing Commonwealth-funded HER2-targeted therapies for the treatment of early BC and advanced BC in Australia. At the time of writing, our cohorts consist of 11 406 patients with early BC and 5631 with advanced BC who accessed trastuzumab and lapatinib between 2001 and 2014. Pertuzumab and trastuzumab emtansine were publicly funded for metastatic BC in 2015, and future data updates will include patients accessing these medicines. We will use dispensing claims for cancer and other medicines, medical service claims and demographics data for each patient accessing HER2-targeted therapies to undertake this research. ETHICS AND DISSEMINATION: Ethics approval has been granted by the Population Health Service Research Ethics Committee and data access approval has been granted by the Australian Department of Human Services (DHS) External Review Evaluation Committee. Our findings will be reported in peer-reviewed publications, conference presentations and policy forums. By providing detailed information on the use and outcomes associated with HER2-targeted therapies in a national cohort treated in routine clinical care, our research programme will better inform clinicians and patients about the real-world use of these treatments and will assist third-party payers to better understand the use and economic costs of these treatments.
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spelling pubmed-52782552017-02-07 Use and outcomes of targeted therapies in early and metastatic HER2-positive breast cancer in Australia: protocol detailing observations in a whole of population cohort Daniels, Benjamin Lord, Sarah J Kiely, Belinda E Houssami, Nehmat Haywood, Philip Lu, Christine Y Ward, Robyn L Pearson, Sallie-Anne BMJ Open Oncology BACKGROUND: The management of human epidermal growth factor receptor 2 (HER2)-positive breast cancer (BC) has changed dramatically with the introduction and widespread use of HER2-targeted therapies. However, there is relatively limited real-world information on patterns of use, effectiveness and safety in whole of population cohorts. The research programme detailed in this protocol will generate evidence on the prescribing patterns, safety monitoring and outcomes of patients with BC treated with HER2-targeted therapies in Australia. METHODS/DESIGN: Our ongoing research programme will involve a series of retrospective cohort studies that include every patient accessing Commonwealth-funded HER2-targeted therapies for the treatment of early BC and advanced BC in Australia. At the time of writing, our cohorts consist of 11 406 patients with early BC and 5631 with advanced BC who accessed trastuzumab and lapatinib between 2001 and 2014. Pertuzumab and trastuzumab emtansine were publicly funded for metastatic BC in 2015, and future data updates will include patients accessing these medicines. We will use dispensing claims for cancer and other medicines, medical service claims and demographics data for each patient accessing HER2-targeted therapies to undertake this research. ETHICS AND DISSEMINATION: Ethics approval has been granted by the Population Health Service Research Ethics Committee and data access approval has been granted by the Australian Department of Human Services (DHS) External Review Evaluation Committee. Our findings will be reported in peer-reviewed publications, conference presentations and policy forums. By providing detailed information on the use and outcomes associated with HER2-targeted therapies in a national cohort treated in routine clinical care, our research programme will better inform clinicians and patients about the real-world use of these treatments and will assist third-party payers to better understand the use and economic costs of these treatments. BMJ Publishing Group 2017-01-24 /pmc/articles/PMC5278255/ /pubmed/28119394 http://dx.doi.org/10.1136/bmjopen-2016-014439 Text en Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/ This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
spellingShingle Oncology
Daniels, Benjamin
Lord, Sarah J
Kiely, Belinda E
Houssami, Nehmat
Haywood, Philip
Lu, Christine Y
Ward, Robyn L
Pearson, Sallie-Anne
Use and outcomes of targeted therapies in early and metastatic HER2-positive breast cancer in Australia: protocol detailing observations in a whole of population cohort
title Use and outcomes of targeted therapies in early and metastatic HER2-positive breast cancer in Australia: protocol detailing observations in a whole of population cohort
title_full Use and outcomes of targeted therapies in early and metastatic HER2-positive breast cancer in Australia: protocol detailing observations in a whole of population cohort
title_fullStr Use and outcomes of targeted therapies in early and metastatic HER2-positive breast cancer in Australia: protocol detailing observations in a whole of population cohort
title_full_unstemmed Use and outcomes of targeted therapies in early and metastatic HER2-positive breast cancer in Australia: protocol detailing observations in a whole of population cohort
title_short Use and outcomes of targeted therapies in early and metastatic HER2-positive breast cancer in Australia: protocol detailing observations in a whole of population cohort
title_sort use and outcomes of targeted therapies in early and metastatic her2-positive breast cancer in australia: protocol detailing observations in a whole of population cohort
topic Oncology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5278255/
https://www.ncbi.nlm.nih.gov/pubmed/28119394
http://dx.doi.org/10.1136/bmjopen-2016-014439
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