RATIONALE:Research indicates that breast pain as the sole symptom has no association with breast cancer. However, patients with breast pain only are often referred onto urgent breast cancer diagnostic pathways, leading to unnecessary anxiety and overutilisation of secondary health care services. The novel community breast pain clinic (CBPC) service in the UK aims to improve patient care while providing system-wide improvements for patients with breast pain, patients who have 'red flag' symptoms, as well as being cost-effective. AIM AND OBJECTIVES:This study seeks to evaluate and assess the impact of the CBPC on patient care, experience, and healthcare system improvements. METHODS:Quantitative and qualitative analysis of CBPC was undertaken using data from CBPC based on a core data set designed by the programme team, secondary care follow-up data, Patient Reported Outcomes Measure (PROMs) data and family history data. RESULTS:The CBPC was well-received by patients with 98.5% recommending the service. Additionally, health economic analysis indicated a cost benefit ratio of 1.23 in year 1, indicating a positive return on investment. Breast cancer incidence within the cohort was estimated at 3.2 per 1000, in line with population estimates in the literature. For those with a breast cancer diagnosis, there is no evidence of care delays or missed diagnoses via the service. CONCLUSION:The CBPC offers significant benefits in patient experience and value for money, with no evidence of reducing patient safety. The impacts of the clinics appear to be reproducible across all five centres in the East Midlands (a population of 5.5 million). Recommendations on further assessment on optimal staff mix and clinic cost mechanisms should be considered to maximise benefits.

Rationale Literature shows that breast pain alone has no significant association with breast cancer. Currently, patients experiencing these symptoms are often referred to breast cancer diagnostic clinics (BCDCs), leading to an increase in unnecessary anxiety and overutilisation of already strained secondary care resources. The East Midlands Breast Pain Pathway (EMBPP) aims to establish a new pathway that improves patient care and eases pressure on BCDCs, as well as being cost-beneficial and providing a positive patient experience.Aim and objectives This study aims to evaluate the impact of the EMBPP on patient care, including safety, costs incurred by the health system and patient experience.Methods The EMBPP was analysed quantitatively and qualitatively using data extracted from the community breast pain clinics (CBPCs), BCDCs, patient-reported outcome measures, clinic costs, family history data and staff interviews.Results Breast cancer incidence within the cohort of patients with a full 12-month follow-up period was shown to be 3.7 per 1000 patients, below the population estimates in the literature. There was no delay to care for those who were diagnosed with breast cancer after attending a CBPC. The clinics were found to be cost-beneficial, with a cost-benefit ratio of 1.26 in year 1, 1.40 in year 2 and 1.56 in year 3. The pathway was positively received by patients, with 98.7% indicating that they would recommend the service.Conclusion Following on from previous audits and analysis of the EMBPP pathway, this national evaluation has shown that CBPCs are effective across multiple Cancer Alliances, National Health Service (NHS) Trusts and demographics. The CBPC offers a positive patient experience and is cost-beneficial and safe, with no evidence of a delay to care for the patients.

Background and ObjectivesCurrent national or regional guidelines for the pathology reporting on invasive breast cancer differ in certain aspects, resulting in divergent reporting practice and a lack of comparability of data. Here we report on a new international dataset for the pathology reporting of resection specimens with invasive cancer of the breast. The dataset was produced under the auspices of the International Collaboration on Cancer Reporting (ICCR), a global alliance of major (inter‐)national pathology and cancer organizations.Methods and ResultsThe established ICCR process for dataset development was followed. An international expert panel consisting of breast pathologists, a surgeon, and an oncologist prepared a draft set of core and noncore data items based on a critical review and discussion of current evidence. Commentary was provided for each data item to explain the rationale for selecting it as a core or noncore element, its clinical relevance, and to highlight potential areas of disagreement or lack of evidence, in which case a consensus position was formulated. Following international public consultation, the document was finalized and ratified, and the dataset, which includes a synoptic reporting guide, was published on the ICCR website.ConclusionsThis first international dataset for invasive cancer of the breast is intended to promote high‐quality, standardized pathology reporting. Its widespread adoption will improve consistency of reporting, facilitate multidisciplinary communication, and enhance comparability of data, all of which will help to improve the management of invasive breast cancer patients.

Introduction: The East Midlands Breast Pain Pathway (EMBPP) manages women with breast pain alone in Community Breast Pain Clinics (CBPCs), outside of the standard 2WW breast cancer diagnostic pathway. It is essential that women selected for management in CBPCs are at relatively low risk of breast cancer. We present data on clinic attendees between 06/2021 and 10/2022, all with complete 12 months follow-up (Audit: UHDBS274).

AIMS:The International Collaboration on Cancer Reporting (ICCR), a global alliance of major (inter-)national pathology and cancer organisations, is an initiative aimed at providing a unified international approach to reporting cancer. ICCR recently published new data sets for the reporting of invasive breast carcinoma, surgically removed lymph nodes for breast tumours and ductal carcinoma in situ, variants of lobular carcinoma in situ and low-grade lesions. The data set in this paper addresses the neoadjuvant setting. The aim is to promote high-quality, standardised reporting of tumour response and residual disease after neoadjuvant treatment that can be used for subsequent management decisions for each patient.METHODS:The ICCR convened expert panels of breast pathologists with a representative surgeon and oncologist to critically review and discuss current evidence. Feedback from the international public consultation was critical in the development of this data set.RESULTS:The expert panel concluded that a dedicated data set was required for reporting of breast specimens post-neoadjuvant therapy with inclusion of data elements specific to the neoadjuvant setting as core or non-core elements. This data set proposes a practical approach for handling and reporting breast resection specimens following neoadjuvant therapy. The comments for each data element clarify terminology, discuss available evidence and highlight areas with limited evidence that need further study. This data set overlaps with, and should be used in conjunction with, the data sets for the reporting of invasive breast carcinoma and surgically removed lymph nodes from patients with breast tumours, as appropriate. Key issues specific to the neoadjuvant setting are included in this paper. The entire data set is freely available on the ICCR website.CONCLUSIONS:High-quality, standardised reporting of tumour response and residual disease after neoadjuvant treatment are critical for subsequent management decisions for each patient.

IntroductionBreast pain is not typically a symptom of breast cancer, yet nationally 20% of 2-week wait (2WW) breast referrals are breast pain alone. The East Midlands Breast Pain Pathway improves patient experience and frees capacity in secondary care diagnostic breast clinics, managing women with breast pain only in a community setting. We report the results of implementation of community breast pain clinics (CBPCs) at sites in Derbyshire (catchment population ~1 million), with 12 months follow-up data.Results1036 patients were seen at CBPCs between June 2021 and February 2023. The median patient age was 49 (range 16–88) years. 993 patients (95.8%) were discharged from the clinic with breast pain management advice. 43 (4.2%) patients were referred for further assessment at a 2WW breast diagnostic clinic. Objective family history risk assessment identified 124 patients (12.3%) above population risk of breast cancer, who were offered referral to familial cancer services for ongoing management.DiscussionSeven patients were diagnosed with breast cancer at or within 12 months of CBPC attendance. Five patients were diagnosed through attending the CBPC, one patient was subsequently referred to 2WW clinic with a new symptom and had a mammographically occult tumour and one was diagnosed following a subsequent routine breast screening invitation. Two of the five patients had a personal history of breast cancer which was a stated exclusion criterion for the CBPC. Breast cancer incidence in women with breast pain only and fulfilling CBPC referral criteria was 4.8/1000, confirming that this population is at low risk of developing breast cancer.Patient service satisfaction was high with 99% (n=1022) ‘extremely likely or likely’ to recommend the service.ConclusionThe results confirm the pathway is the first to demonstrate women can be safely managed with breast pain alone in a community setting with high levels of patient satisfaction.

Background: Surgical specimen volume is an important factor to consider in breast reconstruction and is also used to classify oncoplastic breast surgery (i.e. level 2 when >20% breast volume excised). However, surgical specimen volume is not routinely measured in breast surgery, and specimen weight is used as a surrogate measure, either as it is (assumed density 1g/ml) or adjusted for a breast density coefficient of 0.958g/ml, based on the assumption that breast tissue is equally composed of fibro-glandular and fatty tissue.

Introduction: At UHDB we run a community breast pain clinic for patients presenting with breast pain only in which 11% of patients are found to be at above population risk of breast cancer and a further 20% have ≥1 family member affected but are at near population risk. We aimed to audit family history (FH) risk assessment in patients presenting to 2WW breast clinics with symptoms other than breast pain only.

Purpose The introduction of breast screening in the UK led to an increase in the detection of non-invasive breast neoplasia, predominantly ductal carcinoma in situ (DCIS), a non-obligatory precursor of invasive breast cancer. The Sloane Project, a UK prospective cohort study of screen-detected non-invasive breast neoplasia, commenced in 2003 to evaluate the radiological assessment, surgical management, pathology, adjuvant therapy and outcomes for non-invasive breast neoplasia. Long-term follow-up and accurate data collection are essential to examine the clinical impact. Here, we describe the establishment, development and analytical processes for this large UK cohort study.Participants Women diagnosed with non-invasive breast neoplasia via the UK National Health Service Breast Screening Programme (NHSBSP) from 01 April 2003 are eligible, with a minimum age of 46 years. Diagnostic, therapeutic and follow-up data collected via proformas, complement date and cause of death from national data sources. Accrual for patients with DCIS ceased in 2012 but is ongoing for patients with epithelial atypia/in situ neoplasia, while follow-up for all continues long term.Findings to date To date, patients within the Sloane cohort comprise one-third of those diagnosed with DCIS within the NHSBSP and are representative of UK practice. DCIS has a variable outcome and confirms the need for longer-term follow-up for screen-detected DCIS. However, the radiology and pathology features of DCIS can be used to inform patient management. We demonstrate validation of follow-up information collected from national datasets against traditional, manual methods.Future plans Conclusions derived from the Sloane Project are generalisable to women in the UK with screen-detected DCIS. The follow-up methodology may be extended to other UK cohort studies and routine clinical follow-up. Data from English patients entered into the Sloane Project are available on request to researchers under data sharing agreement. Annual follow-up data collection will continue for a minimum of 20 years.

Breast pain has no association with breast cancer yet is a frequent reason for referral from Primary to Secondary Care, often on an urgent (2-week wait) referral. The referral often causes significant patient anxiety, further heightened by screening mammograms and/or ultrasound scans in the absence of an associated red flag symptom or finding by the patient or general practitioner. This paper reports the pilot implementation of a specialist Primary Care Breast Pain Clinic in Mid-Nottinghamshire where patients were seen, examined without any imaging and assessed for their risk of familial breast cancer: numerous studies have reported 15%–>30% of patients with breast pain only have a family history of breast cancer. 177 patients with breast pain only were seen in this clinic between March, 2020 and April, 2021 with a 6-month interim suspension due to COVID-19. The mean age of patients was 48.4 years (range: 16–86). 172/177 (97.2%) patients required no imaging although there were three (1.7%) inappropriate referrals and two additional abnormalities (1.1%—hamartoma, thickening/tethering) that were referred onward. There were no cancers. 21 (12.4%) patients were identified to have an increased familial risk of breast cancer and were referred to the specialist familial cancer service. 170/177 patients completed an anonymous questionnaire on leaving the clinic. 167/169 (99%) were reassured regarding their breast pain, 155/156 (99%) were reassured of the Familial Risk Assessment, 162/168 (96%) were reassured regarding their personal risk assessment while 169/170 (99%) were ‘extremely likely/likely to recommend the service’. This specialist Primary Care Breast Pain Clinic provides service improvement across all levels of care (Primary, Secondary and Tertiary). Patients were successfully managed in the community with high levels of patient satisfaction and together this obviated referral to secondary care. The familial breast cancer risk assessment also helped identify unmet need in the community.

Purpose Changes occur in the expression of oestrogen-regulated and proliferation-associated genes in oestrogen receptor (ER)-positive breast tumours during the menstrual cycle. We investigated if Oncotype® DX recurrence score (RS), Prosigna® (ROR) and EndoPredict® (EP/EPclin) prognostic tests, which include some of these genes, vary according to the time in the menstrual cycle when they are measured. Methods Pairs of test scores were derived from 30 ER-positive/human epidermal growth factor receptor-2-negative tumours sampled at two different points of the menstrual cycle. Menstrual cycle windows were prospectively defined as either W1 (days 1–6 and 27–35; low oestrogen and low progesterone) or W2 (days 7–26; high oestrogen and high or low progesterone). Results The invasion module score of RS was lower (− 10.9%; p = 0.098), whereas the ER (+ 16.6%; p = 0.046) and proliferation (+ 7.3%; p = 0.13) module scores were higher in W2. PGR expression was significantly increased in W2 (+ 81.4%; p = 0.0029). Despite this, mean scores were not significantly different between W1 and W2 for any of the tests and the two measurements showed high correlation ( r = 0.72–0.93). However, variability between the two measurements led to tumours being assigned to different risk categories in the following proportion of cases: RS 22.7%, ROR 27.3%, EP 13.6% and EPclin 13.6%. Conclusion There are significant changes during the menstrual cycle in the expression of some of the genes and gene module scores comprising the RS, ROR and EP/EPclin scores. These did not affect any of the prognostic scores in a systematic fashion, but there was substantial variability in paired measurements.

Background: Burnout among physicians has gained significant attention recently because of its rising prevalence, and detrimental impact on quality of care and professional satisfaction. Little is known about burnout among breast surgeons in the United Kingdom (UK). We sought to identify factors that influence overall burnout and professional fulfilment in UK surgeons.

BackgroundPreoperative and perioperative aromatase inhibitor (POAI) therapy has the potential to improve outcomes in women with operable oestrogen receptor-positive primary breast cancer. It has also been suggested that tumour Ki67 values after 2 weeks (Ki672W) of POAI predicts individual patient outcome better than baseline Ki67 (Ki67B). The POETIC trial aimed to test these two hypotheses.MethodsPOETIC was an open-label, multicentre, parallel-group, randomised, phase 3 trial (done in 130 UK hospitals) in which postmenopausal women aged at least 50 years with WHO performance status 0–1 and hormone receptor-positive, operable breast cancer were randomly assigned (2:1) to POAI (letrozole 2·5 mg per day orally or anastrozole 1 mg per day orally) for 14 days before and following surgery or no POAI (control). Adjuvant treatment was given as per UK standard local practice. Randomisation was done centrally by computer-generated permuted block method (variable block size of six or nine) and was stratified by hospital. Treatment allocation was not masked. The primary endpoint was time to recurrence. A key second objective explored association between Ki67 (dichotomised at 10%) and disease outcomes. The primary analysis for clinical endpoints was by modified intention to treat (excluding patients who withdrew consent). For Ki67 biomarker association and endpoint analysis, the evaluable population included all randomly assigned patients who had paired Ki67 values available. This study is registered with ClinicalTrials.gov, NCT02338310; the European Clinical Trials database, EudraCT2007-003877-21; and the ISRCTN registry, ISRCTN63882543. Recruitment is complete and long-term follow-up is ongoing.FindingsBetween Oct 13, 2008, and April 16, 2014, 4480 women were recruited and randomly assigned to POAI (n=2976) or control (n=1504). On Feb 6, 2018, median follow-up was 62·9 months (IQR 58·1–74·1). 434 (10%) of 4480 women had a breast cancer recurrence (280 [9%] POAI; 154 [10%] control), hazard ratio 0·92 (95% CI 0·75–1·12); p=0·40 with the proportion free from breast cancer recurrence at 5 years of 91·0% (95% CI 89·9–92·0) for patients in the POAI group and 90·4% (88·7–91·9) in the control group. Within the POAI-treated HER2-negative subpopulation, 5-year recurrence risk in women with low Ki67B and Ki672W (low–low) was 4·3% (95% CI 2·9–6·3), 8·4% (6·8–10·5) with high Ki67B and low Ki672W (high–low) and 21·5% (17·1–27·0) with high Ki67B and Ki672W (high–high). Within the POAI-treated HER2-positive subpopulation, 5-year recurrence risk in the low–low group was 10·1% (95% CI 3·2–31·3), 7·7% (3·4–17·5) in the high–low group, and 15·7% (10·1–24·4) in the high–high group. The most commonly reported grade 3 adverse events were hot flushes (20 [1%] of 2801 patients in the POAI group vs six [<1%] of 1400 in the control group) and musculoskeletal pain (29 [1%] vs 13 [1%]). No treatment-related deaths were reported.InterpretationPOAI has not been shown to improve treatment outcome, but can be used without detriment to help select appropriate adjuvant therapy based on tumour Ki67. Most patients with low Ki67B or low POAI-induced Ki672W do well with adjuvant standard endocrine therapy (giving consideration to clinical–pathological factors), whereas those whose POAI-induced Ki672W remains high might benefit from further adjuvant treatment or trials of new therapies.FundingCancer Research UK.

The major changes in hormone levels that occur through the menstrual cycle have been postulated to affect the expression of hormone-regulated and proliferation-associated genes (PAGs) in premenopausal ER+ breast cancer. Whilst previous studies have demonstrated differences in gene expression, here, we investigated if there are within patient changes in the expression of oestrogen- and progesterone-regulated genes (ERGs and PRGs) and PAGs in ER+ breast cancer during the menstrual cycle. Samples from 96 patients in two independent prospective studies of the effect of menstrual cycle on ER+ breast cancer were used. Plasma hormone measurements were used to assign tumours to one of three pre-defined menstrual cycle windows: W1 (days 27-35 and 1-6; low oestradiol and low progesterone), W2 (days 7-16; high oestradiol and low progesterone) and W3 (days 17-26; intermediate oestradiol and high progesterone). RNA expression of 50 genes, including 27 ERGs, 11 putative PRGs and seven PAGs was measured. The AvERG (geomean of PGR, GREB1, TFF1 and PDZK1) was used as a composite measure of ERG expression and showed significant changes between the three windows of the menstrual cycle increasing over 2.2-fold between W1 and W2 and decreasing between W2 and W3 and between W3 and W1. Proliferation gene expression also varied significantly, following the same pattern of changes as ERG expression, but the changes were of lower magnitude (1.4-fold increase between W1 and W2). Significant changes in the expression of eight individual ERGs, including GREB1, PGR and TFF1, and two PAGs were observed between W1 and either W2 or W3 with all genes showing higher levels in W2 or W3 (1.3-2.4-fold; FDR 0.016-0.05). The AvProg, a composite measure of PRG expression, increased significantly (1.5-fold) in W3 compared to W1 or W2 but no significant changes were observed for individual PRGs. In conclusion, we observed significant changes in ERG, PRG and PAG expression in ER+ breast tumours during the menstrual cycle that may affect the assessment and interpretation of prominent biomarkers (e.g. PgR) and commonly used multigene prognostic signatures in premenopausal ER+ breast cancer.

Breast cancer is the most common cancer in the UK predominately affecting women. The majority of breast cancer patients present with symptoms, but approximately 40% are diagnosed in asymptomatic women through the NHS Breast Screening Programme. Most breast cancers are now diagnosed non-operatively by triple assessment (the combination of clinical, radiological and pathological assessment) in specialist breast clinics. Breast cancer management is provided by a multidisciplinary team of breast specialists, including surgeons, radiologists, pathologists, breast care nurses and clinical/medical oncologists. Breast cancer patients now receive individualized treatment plans that may include surgery to both the breast and axilla (including breast reconstruction when appropriate), radiotherapy, endocrine treatment, chemotherapy and targeted treatments such as trastuzumab.