TY - JOUR
T1 - The NeST (neoadjuvant systemic therapy in breast cancer) study
T2 - protocol for a prospective multi-centre cohort study to assess the current utilization and short-term outcomes of neoadjuvant systemic therapies in breast cancer
AU - Irwin, Gareth
AU - Bannon, Fiona
AU - Coles, Charlotte
AU - Copson, Ellen
AU - Cutress, Ramsey
AU - Dave, Rajiv
AU - Grayson, Margaret
AU - Holcombe, Chris
AU - Potter, Shelley
AU - McIntosh, Stuart
PY - 2019/11/11
Y1 - 2019/11/11
N2 - IntroductionNeoadjuvant systemic therapy (NST) has several potential advantages in the treatment of breast cancer. However, there is currently considerable variation in NST use across the UK. The NeST study is a national, prospective, multicentre cohort study that will investigate current patterns of care with respect to NST in the UK.Methods and AnalysisPhase 1 – a national practice questionnaire (NPQ) to survey current practicePhase 2 – a multi-centre prospective cohort study of breast cancer patients, undergoing NSTWomen undergoing NST as their MDT recommended primary breast cancer treatment between December 2017 - May 2018 will be included. The breast surgery and oncological professional associations and the trainee research collaborative networks will encourage participation by all breast cancer centres.Patient demographics, radiological, oncological, surgical and pathological data will be collected, including complications and the need for further intervention/treatment. Data will be collated to establish current practice in the UK, regarding NST usage and variability of access and provision of these therapies. Prospective data on 600 patients from ∼50 centres are anticipated.Trial registration: ISRCTN11160072Ethics and DisseminationResearch ethics approval is not required for this study, as per the online Health Research Authority decision tool. The information obtained will provide valuable insights to help patients make informed decisions about their treatment. These data should establish current practice in the UK concerning NST, inform future service delivery as well as identifying further research questions.This protocol will be disseminated through the Mammary Fold Academic Research Collaborative (MFAC), the Reconstructive Surgery Trials Network and the Association of Breast Surgery. Participating units will have access to their own data and collective results will be presented at relevant conferences and published in appropriate peer-reviewed journals, as well as being made accessible to relevant patient groups.
AB - IntroductionNeoadjuvant systemic therapy (NST) has several potential advantages in the treatment of breast cancer. However, there is currently considerable variation in NST use across the UK. The NeST study is a national, prospective, multicentre cohort study that will investigate current patterns of care with respect to NST in the UK.Methods and AnalysisPhase 1 – a national practice questionnaire (NPQ) to survey current practicePhase 2 – a multi-centre prospective cohort study of breast cancer patients, undergoing NSTWomen undergoing NST as their MDT recommended primary breast cancer treatment between December 2017 - May 2018 will be included. The breast surgery and oncological professional associations and the trainee research collaborative networks will encourage participation by all breast cancer centres.Patient demographics, radiological, oncological, surgical and pathological data will be collected, including complications and the need for further intervention/treatment. Data will be collated to establish current practice in the UK, regarding NST usage and variability of access and provision of these therapies. Prospective data on 600 patients from ∼50 centres are anticipated.Trial registration: ISRCTN11160072Ethics and DisseminationResearch ethics approval is not required for this study, as per the online Health Research Authority decision tool. The information obtained will provide valuable insights to help patients make informed decisions about their treatment. These data should establish current practice in the UK concerning NST, inform future service delivery as well as identifying further research questions.This protocol will be disseminated through the Mammary Fold Academic Research Collaborative (MFAC), the Reconstructive Surgery Trials Network and the Association of Breast Surgery. Participating units will have access to their own data and collective results will be presented at relevant conferences and published in appropriate peer-reviewed journals, as well as being made accessible to relevant patient groups.
KW - breast cancer
KW - neoadjuvant chemotherapy
KW - neoadjuvant endocrine therapy
KW - surgery
KW - pathology
KW - radiology
KW - patterns of care
KW - outcomes
U2 - 10.1016/j.isjp.2019.10.002
DO - 10.1016/j.isjp.2019.10.002
M3 - Article (Academic Journal)
C2 - 31897446
SN - 2468-3574
JO - International Journal of Surgery Protocols
JF - International Journal of Surgery Protocols
ER -