The NeST (neoadjuvant systemic therapy in breast cancer) study - Protocol for a prospective multi-centre cohort study to assess the current utilization and short-term outcomes of neoadjuvant systemic therapies in breast cancer

Irwin, GW; Bannon, Finian; Coles, C.E.; Copson, Ellen; Cutress, R.I.; Dave, RV; Grayson, Margaret; Holcombe, Chris; Irshad, Sheeba; O'Brien, Ciara S; O'Connell, RL; Palmieri, Carlo; Shaaban, AM; Sharma, Nisha; Singh, Jagdeep; Whitehead, Ian; Potter, Shelley; McIntosh, SA

doi:10.1016/j.isjp.2019.10.002

Cited by 9 publications

(14 citation statements)

References 34 publications

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“…Although NICE guidance outlines potential indications of the use of NST in breast cancer, this study indicates a clear need for both further research and the development of multidisciplinary guidance with respect to monitoring of response, pathological reporting and surgical decision-making, to ensure optimal outcomes for breast cancer patients treated with neoadjuvant therapies. We await the prospective phase of the NeST study, which will allow the corroboration of these results with the real-world use of neoadjuvant systemic therapy for breast cancer in the UK (15).…”

Section: Discussionmentioning

confidence: 98%

The NeST (Neoadjuvant Systemic Therapy in Breast Cancer Study): National Practice Questionnaire of United Kingdom Multidisciplinary Decision Making

Whitehead

Irwin

Bannon

et al. 2020

Preprint

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Background: Neoadjuvant systemic therapy (NST) is increasingly used in the treatment of breast cancer, yet it is clear that there is significant geographical variation in its use in the UK. This study aimed to examine stated practice across UK breast units, in terms of indications for use, radiological monitoring, pathological reporting of treatment response, and post-treatment surgical management. Methods: Multidisciplinary teams (MDTs) from all UK breast units were invited to participate in the NeST study. A detailed questionnaire assessing current stated practice was distributed to all participating units in December 2017 and data collated securely usingREDCap. Descriptive statistics were calculated for each questionnaire item.Results: Thirty-nine MDTs from a diverse range of hospitals responded. All MDTs routinely offered neoadjuvant chemotherapy (NACT) to a median of 10% (range 5-60%) of patients. Neoadjuvant endocrine therapy (NET) was offered to a median of 4% (range 0-25%) of patients by 66% of MDTs. The principal indication given for use of neoadjuvant therapy was for surgical downstaging. There was no consensus on methods of radiological monitoring of response, and a wide variety of pathological reporting systems were used to assess tumour response. Twenty-five percent of centres reported resecting the original tumour footprint, irrespective of clinical/radiological response. Radiologically negative axillae at diagnosis routinely had post-NACT or post-NET sentinel lymph node biopsy (SLNB) in 73.0% and 84% of centres respectively, whereas 16% performed SLNB pre-NACT. Positive axillae at diagnosis would receive axillary node clearance at 60% of centres, regardless of response to NACT. Discussion: There is wide variation in the stated use of neoadjuvant systemic therapy across the UK, with general low usage of NET. Surgical downstaging remains the most common indication of the use of NAC, although not all centres leverage the benefits of NAC for de-escalating surgery to the breast and/or axilla. There is a need for agreed multidisciplinary guidance for optimising selection and management of patients for NST. These findings will be corroborated in phase II of the NeST study which is a national collaborative prospective audit of NST utilisation and clinical outcomes.

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Section: Discussionmentioning

confidence: 98%

The NeST (Neoadjuvant Systemic Therapy in Breast Cancer Study): National Practice Questionnaire of United Kingdom Multidisciplinary Decision Making

Whitehead

Irwin

Bannon

et al. 2020

Preprint

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“…however, the prospective audit phase of NeST will seek to explore this aspect of neoadjuvant therapy usage in more detail (18). There appeared to be no substantial difference in the It remains clear that surgical downstaging is a primary indication for the use of NACT in many MDTs.…”

Section: Discussionmentioning

confidence: 99%

“…In this meta-analysis it is noted that 90% of published studies of NET include post-menopausal women, and that there is little data on the use of NET in pre-menopausal women with hormone receptor positive breast cancer. Clearly the role and bene ts of NET in such pre-menopausal women is yet to be established, and the prospective audit phase of NET will determine the age distribution and menopausal status of women in the UK being treatment with NET (18). However, this data, taken together with the MasDA ndings show that there remains a clear reluctance to utilise this approach routinely in clinical practice within the UK despite the low pCR reported with NACT in this group.…”

Section: Discussionmentioning

confidence: 99%

“…This study aimed to describe the current stated practice of multidisciplinary teams (MDTs) across the UK with respect to the use of neoadjuvant systemic therapy, including indications for use, response monitoring, pathological reporting and surgical approaches to the breast and axilla. It forms the rst stage of the Neoadjuvant Systemic Therapy in Breast Cancer (NeST) Study, a national multicentre, multidisciplinary collaborative prospective study assessing usage and real-world outcomes (18).…”

Section: Introductionmentioning

confidence: 99%

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The NeST (Neoadjuvant Systemic Therapy in Breast Cancer) Study: National Practice Questionnaire of United Kingdom Multi-Disciplinary Decision Making

Whitehead

Irwin

Bannon

et al. 2020

Preprint

View full text Add to dashboard Cite

Background: Neoadjuvant systemic therapy (NST) is increasingly used in the treatment of breast cancer, yet it is clear that there is significant geographical variation in its use in the UK. This study aimed to examine stated practice across UK breast units, in terms of indications for use, radiological monitoring, pathological reporting of treatment response, and post-treatment surgical management. Methods: Multidisciplinary teams (MDTs) from all UK breast units were invited to participate in the NeST study. A detailed questionnaire assessing current stated practice was distributed to all participating units in December 2017 and data collated securely usingREDCap. Descriptive statistics were calculated for each questionnaire item.Results: Thirty-nine MDTs from a diverse range of hospitals responded. All MDTs routinely offered neoadjuvant chemotherapy (NACT) to a median of 10% (range 5-60%) of patients. Neoadjuvant endocrine therapy (NET) was offered to a median of 4% (range 0-25%) of patients by 66% of MDTs. The principal indication given for use of neoadjuvant therapy was for surgical downstaging. There was no consensus on methods of radiological monitoring of response, and a wide variety of pathological reporting systems were used to assess tumour response. Twenty-five percent of centres reported resecting the original tumour footprint, irrespective of clinical/radiological response. Radiologically negative axillae at diagnosis routinely had post-NACT or post-NET sentinel lymph node biopsy (SLNB) in 73.0% and 84% of centres respectively, whereas 16% performed SLNB pre-NACT. Positive axillae at diagnosis would receive axillary node clearance at 60% of centres, regardless of response to NACT.Discussion: There is wide variation in the stated use of neoadjuvant systemic therapy across the UK, with general low usage of NET. Surgical downstaging remains the most common indication of the use of NAC, although not all centres leverage the benefits of NAC for de-escalating surgery to the breast and/or axilla. There is a need for agreed multidisciplinary guidance for optimising selection and management of patients for NST. These findings will be corroborated in phase II of the NeST study which is a national collaborative prospective audit of NST utilisation and clinical outcomes.

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“…Collaborative study design is a well-tested method of delivery of high-quality cohort studies in the UK [14] , [19] , [20] with the capacity to generate meaningful large scale data with the potential to inform or change clinical practice. There have been several successful trainee collaborative studies related to breast surgery [21] , [22] , [23] , [24] .…”

Section: Methods and Analysismentioning

confidence: 99%

The B-MaP-C study: Breast cancer management pathways during the COVID-19 pandemic. Study protocol

Courtney

O’Connell

Rattay

et al. 2020

International Journal of Surgery Protocols

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Introduction Approximately 55,000 women in the United Kingdom are diagnosed with new breast cancer annually. Since emerging in December 2019, SARS-CoV-2 (coronavirus disease 2019, COVID-19) has become a global pandemic, affecting healthcare delivery worldwide. In response to the pandemic, multiple guidelines were issued to assist with rationalising breast cancer care. The primary aim of the B-MaP-C study is to audit and describe breast cancer management of patients newly diagnosed with breast cancer during the COVID-19 pandemic against pre-COVID-19 management practice in the UK. The implications of changes to management will be determined and the impact of a COVID-19 diagnosis on the patient’s breast cancer management will be determined. Methods and analysis This is a multi-centre collaborative audit of consecutive breast cancer patients undergoing treatment decisions during the acute and recovery phases of the COVID-19 pandemic. All patients with newly diagnosed primary breast cancer, whose treatment was decided in a multidisciplinary meeting from the 16th March 2020, are eligible for inclusion. Ethics and dissemination As this is an audit ethical approval is not required. Each participating centre is required to register the study locally and obtain local governance approvals prior to commencement of data collection. Local audit data will be available to individual participating units for governance purposes. The results of the data analysis will be submitted for publication, as well as disseminated via the ABS newsletter and a webinar. All data will be presented at national and international conferences, circumstances permitting. Registration details Each participating centre received local governance audit registration.

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The NeST (neoadjuvant systemic therapy in breast cancer) study - Protocol for a prospective multi-centre cohort study to assess the current utilization and short-term outcomes of neoadjuvant systemic therapies in breast cancer

Cited by 9 publications

References 34 publications

The NeST (Neoadjuvant Systemic Therapy in Breast Cancer Study): National Practice Questionnaire of United Kingdom Multidisciplinary Decision Making

The NeST (Neoadjuvant Systemic Therapy in Breast Cancer Study): National Practice Questionnaire of United Kingdom Multidisciplinary Decision Making

The NeST (Neoadjuvant Systemic Therapy in Breast Cancer) Study: National Practice Questionnaire of United Kingdom Multi-Disciplinary Decision Making

The B-MaP-C study: Breast cancer management pathways during the COVID-19 pandemic. Study protocol

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