Wire-Free Targeted Axillary Dissection: A Pooled Analysis of 1300+ Cases Post-Neoadjuvant Systemic Therapy in Node-Positive Early Breast Cancer.

Recent advances in neoadjuvant systemic therapy (NST) have significantly improved pathologic complete response rates in early breast cancer, challenging the role of axillary lymph node dissection in nose-positive patients. Targeted axillary dissection (TAD) integrates marked lymph node biopsy (MLNB) and tracer-guided sentinel lymph node biopsy (SLNB). The introduction of new wire-free localisation markers (LMs) has streamlined TAD and increased its adoption. The primary endpoints include the successful localisation and retrieval rates of LMs. The secondary endpoints include the pathological complete response (pCR), SLNB, and MLNB concordance, as well as false-negative rates. Seventeen studies encompassing 1358 TAD procedures in 1355 met the inclusion criteria. The localisation and retrieval rate of LMs were 97% and 99%. A concordance rate of 67% (95% CI: 64-70) between SLNB and MLNB was demonstrated. Notably, 49 days (range: 0-272) was the average LM deployment time to surgery. pCR was observed in 46% (95% CI: 43-49) of cases, with no significant procedure-related complications. Omitting MLNB or SLNB would have under-staged the axilla in 15.2% or 5.4% (p = 0.0001) of cases, respectively. MLNB inclusion in axillary staging post-NST for initially node-positive patients is crucial. The radiation-free Savi Scout, with its minimal MRI artefacts, is the preferred technology for TAD.

How long does it take to read a mammogram? Investigating the reading time of digital breast tomosynthesis and digital mammography.

PURPOSE: To analyse digital breast tomosynthesis (DBT) reading times in the screening setting, compared to 2D full-field digital mammography (FFDM), and investigate the impact of reader experience and professional group on interpretation times. METHOD: Reading time data were recorded in the PROSPECTS Trial, a prospective randomised trial comparing DBT plus FFDM or synthetic 2D mammography (S2D) to FFDM alone, in the National Health Service (NHS) breast screening programme, from January 2019-February 2023. Time to read DBT+FFDM or DBT+S2D and FFDM alone was calculated per case and reading times were compared between modalities using dependent T-tests. Reading times were compared between readers from different professional groups (radiologists and radiographer readers) and experience levels using independent T-tests. The learning curve effect of using DBT in screening on reading time was investigated using a Kruskal-Wallis test. RESULTS: Forty-eight readers interpreted 1,242 FFDM batches (34,210 FFDM cases) and 973 DBT batches (13,983 DBT cases). DBT reading time was doubled compared to FFDM (2.09 ± 0.64 min vs. 0.98 ± 0.30 min; p < 0.001), and DBT+S2D reading was longer than DBT + FFDM (2.24 ± 0.62 min vs. 2.04 ± 0.46 min; p = 0.006). No difference was identified in reading time between radiologists and radiographers (2.06 ± 0.71 min vs. 2.14 ± 0.46 min, respectively; p = 0.71). Readers with five or more years of experience reading DBT were quicker than those with less experience (1.86 ± 0.56 min vs. 2.37 ± 0.65 min; p = 0.008), and DBT reading time decreased after less than 9 months accrued screening experience (p = 0.01). CONCLUSIONS: DBT reading times were double those of FFDM in the screening setting, but there was a short learning curve effect with readers showing significant improvements in reading times within the first nine months of DBT experience. CLINICALTRIALS: gov Identifier: NCT03733106.

Evaluating Radar Reflector Localisation in Targeted Axillary Dissection in Patients Undergoing Neoadjuvant Systemic Therapy for Node-Positive Early Breast Cancer: A Systematic Review and Pooled Analysis.

SAVI SCOUT® or radar reflector localisation (RRL) has proven accurate in localising non-palpable breast and axillary lesions, with minimal interference with MRI. Targeted axillary dissection (TAD), combining marked lymph node biopsy (MLNB) and sentinel lymph node biopsy (SLNB), is becoming a standard post-neoadjuvant systemic therapy (NST) for node-positive early breast cancer. Compared to SLNB alone, TAD reduces the false negative rate (FNR) to below 6%, enabling safer axillary surgery de-escalation. This systematic review evaluates RRL's performance during TAD, assessing localisation and retrieval rates, the concordance between MLNB and SLNB, and the pathological complete response (pCR) in clinically node-positive patients post-NST. Four studies (252 TAD procedures) met the inclusion criteria, with a 99.6% (95% confidence [CI]: 98.9-100) successful localisation rate, 100% retrieval rate, and 81% (95% CI: 76-86) concordance rate between SLNB and MLNB. The average duration from RRL deployment to surgery was 52 days (range:1-202). pCR was observed in 42% (95% CI: 36-48) of cases, with no significant migration or complications reported. Omitting MLNB or SLNB would have under-staged the axilla in 9.7% or 3.4% (p = 0.03) of cases, respectively, underscoring the importance of incorporating MLNB in axillary staging post-NST in initially node-positive patients in line with the updated National Comprehensive Cancer Network (NCCN) guidelines. These findings underscore the excellent efficacy of RRL in TAD for NST-treated patients with positive nodes, aiding in accurate axillary pCR identification and the safe omission of axillary dissection in strong responders.

Take a break: should breaks be enforced during digital breast tomosynthesis reading sessions?

OBJECTIVES: Digital breast tomosynthesis (DBT) can improve diagnostic accuracy compared to 2D mammography, but DBT reporting is time-consuming and potentially more fatiguing. Changes in diagnostic accuracy and subjective and objective fatigue were evaluated over a DBT reporting session, and the impact of taking a reporting break was assessed. MATERIALS AND METHODS: Forty-five National Health Service (NHS) mammography readers from 6 hospitals read a cancer-enriched set of 40 DBT cases whilst eye tracked in this prospective cohort study, from December 2020 to April 2022. Eye-blink metrics were assessed as objective fatigue measures. Twenty-one readers had a reporting break, 24 did not. Subjective fatigue questionnaires were completed before and after the session. Diagnostic accuracy and subjective and objective fatigue measures were compared between the cohorts using parametric and non-parametric significance testing. RESULTS: Readers had on average 10 years post-training breast screening experience and took just under 2 h (105.8 min) to report all cases. Readers without a break reported greater levels of subjective fatigue (44% vs. 33%, p = 0.04), which related to greater objective fatigue: an increased average blink duration (296 ms vs. 286 ms, p < 0.001) and a reduced eye-opening velocity (76 mm/s vs. 82 mm/s, p < 0.001). Objective fatigue increased as the trial progressed for the no break cohort only (ps < 0.001). No difference was identified in diagnostic accuracy between the groups (accuracy: 87% vs. 87%, p = 0.92). CONCLUSIONS: Implementing a break during a 2-h DBT reporting session resulted in lower levels of subjective and objective fatigue. Breaks did not impact diagnostic accuracy, which may be related to the extensive experience of the readers. CLINICAL RELEVANCE STATEMENT: DBT is being incorporated into many mammography screening programmes. Recognising that reporting breaks are required when reading large volumes of DBT studies ensures this can be factored in when setting up reading sessions. TRIAL REGISTRATION: Clinical trials registration number: NCT03733106 KEY POINTS: • Use of digital breast tomosynthesis (DBT) in breast screening programmes can cause significant reader fatigue. • The effectiveness of incorporating reading breaks into DBT reporting sessions, to reduce mammography reader fatigue, was investigated using eye tracking. • Integrating breaks into DBT reporting sessions reduced reader fatigue; however, diagnostic accuracy was unaffected.

Measuring reader fatigue in the interpretation of screening digital breast tomosynthesis (DBT).

OBJECTIVES: The interpretation of digital breast tomosynthesis (DBT) screening examinations is a complex task for an already overstretched workforce which has the potential to increase pressure on readers leading to fatigue and patient safety issues. Studies in non-medical and medical settings have suggested that changes in blink characteristics can reflect fatigue. The purpose of this study is to investigate the use of blink characteristics as an objective marker of fatigue in readers interpreting DBT breast screening examinations. METHODS: Twenty-six DBT readers involved in the UK PROSPECTS trial interpreted a test set of 40 DBT cases while being observed by an eye tracking device from November 2019 to February 2021. Raw data from the eye tracker were collected and automated processing software was used to produce eye blinking characteristics data which were analysed using multiple linear regression statistical models. RESULTS: Of the 26 DBT readers recruited, eye tracking data from 23 participants were analysed due to missing data rendering 3 participants' data uninterpretable. The mean reading time per DBT case was 2.81 min. There was a statistically significant increase in blinking duration of 0.38 ms/case as the reading session progressed (p < 0.0001). This was the result of a significant decrease in the number of ultra-short blinks lasting ≤50 ms (p = 0.0005) and a significant increase in longer blinks lasting 51-100 ms (p = 0.008). CONCLUSION: Changes in blinking characteristics could serve as objective measures of reader fatigue and may prove useful in the development of DBT reading protocols. ADVANCES IN KNOWLEDGE: Blink characteristics can be used as an objective measure of fatigue; however there is limited evidence of their use in radiological settings. Our study suggests that changes in blink duration and frequency could be used to monitor fatigue in DBT reading sessions.

Accurate Screening for Early-Stage Breast Cancer by Detection and Profiling of Circulating Tumor Cells.

BACKGROUND: The early detection of breast cancer (BrC) is associated with improved survival. We describe a blood-based breast cancer detection test based on functional enrichment of breast-adenocarcinoma-associated circulating tumor cells (BrAD-CTCs) and their identification via multiplexed fluorescence immunocytochemistry (ICC) profiling for GCDFP15, GATA3, EpCAM, PanCK, and CD45 status. METHODS: The ability of the test to differentiate BrC cases (N = 548) from healthy women (N = 9632) was evaluated in a case-control clinical study. The ability of the test to differentiate BrC cases from those with benign breast conditions was evaluated in a prospective clinical study of women (N = 141) suspected of BrC. RESULTS: The test accurately detects BrAD-CTCs in breast cancers, irrespective of age, ethnicity, disease stage, grade, or hormone receptor status. Analytical validation established the high accuracy and reliability of the test under intended use conditions. The test detects and differentiates BrC cases from healthy women with 100% specificity and 92.07% overall sensitivity in a case-control study. In a prospective clinical study, the test shows 93.1% specificity and 94.64% overall sensitivity in differentiating breast cancer cases (N = 112) from benign breast conditions (N = 29). CONCLUSION: The findings reported in this manuscript support the clinical potential of this test for blood-based BrC detection.

Reflector-Guided Localisation of Non-Palpable Breast Lesions: A Prospective Evaluation of the SAVI SCOUT® System.

Wire-guided localisation (WGL) has been the mainstay for localising non-palpable breast lesions before excision. Due to its limitations, various wireless alternatives have been developed. In this prospective study, we evaluate the role of radiation-free wireless localisation using the SAVI SCOUT® system at the London Breast Institute. A total of 72 reflectors were deployed in 67 consecutive patients undergoing breast conserving surgery for non-palpable breast lesions. The mean interval between deployment and surgery for the therapeutic cases was 18.8 days (range: 0-210). The median deployment duration was 5 min (range: 1-15 min). The mean distance from the lesion was 1.1 mm (median distance: 0; range: 0-20 mm). The rate of surgical localisation and retrieval of the reflector was 98.6% and 100%, respectively. The median operating time was 28 min (range: 15-55 min) for the therapeutic excision of malignancy and 17 min (range: 15-24) for diagnostic excision. The incidence of reflector migration was 0%. Radial margin positivity in malignant cases was 7%. The median weight for malignant lesions was 19.6 g (range: 3.5-70 g). Radiologists and surgeons rated the system higher than WGL (93.7% and 98.6%, respectively; 60/64 and 70/71). The patient mean satisfaction score was 9.7/10 (n = 47, median = 10; range: 7-10). One instance of signal failure was reported. In patients who had breast MRI after the deployment of the reflector, the MRI void signal was <5 mm (n = 6). There was no specific technique-related surgical complication. Our study demonstrates that wire-free localisation using SAVI SCOUT® is an effective and time-efficient alternative to WGL with excellent physician and patient acceptance.

The Evolving Role of Marked Lymph Node Biopsy (MLNB) and Targeted Axillary Dissection (TAD) after Neoadjuvant Chemotherapy (NACT) for Node-Positive Breast Cancer: Systematic Review and Pooled Analysis.

Targeted axillary dissection (TAD) is a new axillary staging technique that consists of the surgical removal of biopsy-proven positive axillary nodes, which are marked (marked lymph node biopsy (MLNB)) prior to neoadjuvant chemotherapy (NACT) in addition to the sentinel lymph node biopsy (SLNB). In a meta-analysis of more than 3000 patients, we previously reported a false-negative rate (FNR) of 13% using the SLNB alone in this setting. The aim of this systematic review and pooled analysis is to determine the FNR of MLNB alone and TAD (MLNB plus SLNB) compared with the gold standard of complete axillary lymph node dissection (cALND). The PubMed, Cochrane and Google Scholar databases were searched using MeSH-relevant terms and free words. A total of 9 studies of 366 patients that met the inclusion criteria evaluating the FNR of MLNB alone were included in the pooled analysis, yielding a pooled FNR of 6.28% (95% CI: 3.98-9.43). In 13 studies spanning 521 patients, the addition of SLNB to MLNB (TAD) was associated with a FNR of 5.18% (95% CI: 3.41-7.54), which was not significantly different from that of MLNB alone (p = 0.48). Data regarding the oncological safety of this approach were lacking. In a separate analysis of all published studies reporting successful identification and surgical retrieval of the MLN, we calculated a pooled success rate of 90.0% (95% CI: 85.1-95.1). The present pooled analysis demonstrates that the FNR associated with MLNB alone or combined with SLNB is acceptably low and both approaches are highly accurate in staging the axilla in patients with node-positive breast cancer after NACT. The SLNB adds minimal new information and therefore can be safely omitted from TAD. Further research to confirm the oncological safety of this de-escalation approach of axillary surgery is required. MLNB alone and TAD are associated with acceptably low FNRs and represent valid alternatives to cALND in patients with node-positive breast cancer after excellent response to NACT.

Reflector-guided Localization of Non-palpable Breast Lesions: The First Reported European Evaluation of the SAVI SCOUT® System.

BACKGROUND: Wire-guided localization (WGL) has been the mainstay for localizing non-palpable breast lesions before excision. Due to its limitations, various wireless alternatives have been developed. In this prospective study, we evaluate the role of radiation-free wireless localization using the SAVI SCOUT® localization at a European centre. PATIENTS AND METHODS: This technique was evaluated in a prospective cohort of 20 patients. The evaluation focused on clinical and pathological parameters in addition to patient and physician acceptance. RESULTS: SAVI SCOUT reflectors (n=23) were deployed to localize 22 occult breast lesions and one axillary lymph node in 20 patients. The mean deployment duration was 5.6 min, with a mean distance from the lesion of 0.6 mm. The migration rate was 0% and the mean identification and retrieval time was 25.1 min. In patients undergoing therapeutic excision for malignancy (n=17), only one (5.9%) required reoperation for positive surgical margins. Radiologists and surgeons rated the technique as better than WGL and patient satisfaction was high. CONCLUSION: Our study demonstrates that wireless localization using SAVI SCOUT® is an effective and time-efficient alternative to WGL with excellent physician and patient acceptance.

The Use of Magnetic Seeds and Radiofrequency Identifier Tags in Breast Surgery for Non-palpable Lesions.

BACKGROUND: Wire-guided localisation (WGL) remains the most widely used technique to guide surgical excision of non-palpable breast lesions worldwide. However, recent technological advances have led to the advent of less invasive radiation-free localisation methods to overcome the limitations of WGL. PATIENTS AND METHODS: This study prospectively evaluated the role of two radiation-free non-wire localisation methods. Magnetic seeds (n=16) and radiofrequency tags (n=6) were deployed under imaging guidance to guide the surgical excision in 19 consecutive patients. RESULTS: The identification/retrieval and migration rates were 100% and 4.5%, respectively. Twenty-one out of 22 (95.5%) cases had clear surgical margins and no complications were observed. All radiologists and the surgeon rated these methods as being much better than wire localisation. Patient satisfaction data were recorded using a linear visual analogue scale (n=10/19). The mean score was 9.7/10 (range=8-10). CONCLUSION: Our study provides further evidence that radiation-free wireless breast localisation is an effective alternative to WGL.

Wireless Breast Localization Using Radio-frequency Identification Tags: The First Reported European Experience in Breast Cancer.

BACKGROUND/AIM: Wire-guided localisation (WGL) has been the mainstay for localisation of clinically occult breast lesions before excision. However, it has restrictive scheduling requirements, and causes patient discomfort. This has prompted the development of various wireless alternatives. In this prospective study we shall evaluate the role of radiation-free wireless localisation using a radiofrequency identification (RFID) tag and a hand-held reader (LOCalizer™) in the management of occult breast lesions. PATIENTS AND METHODS: This technique was evaluated in a prospective cohort of 10 patients. The evaluation focused on: i) successful deployment, ii) identification and retrieval, iii) the status of surgical margins and need for re-operation, iv) resected specimen weight, v) marker migration rates (>5mm), and vi) acceptance by patients, radiologists and surgeons. RESULTS: RFID tags (n=11) were deployed under ultrasound guidance pre-operatively to localise occult breast lesions in 10 patients. The mean time for deployment of the RFID tag was 5.4 min (range=2-20). The mean distance from the lesion was 0.45 mm (range=0-3). The mean duration for retrieval was 10.2 min (range=6-20). Mean specimen weight was 19.6 g for malignant lesions (range=4.5-42). All tags were identified, and none had migrated. There were no positive margins, re-operations, nor complications. Patient feedback was highly positive. Both radiologists and surgeons rated the LOCalizer™ technique as better than WGL. CONCLUSION: Our study demonstrates that wireless localisation using RFID is an effective and time-efficient alternative to WGL, with low margin positivity and re-operation rates, and high patient, radiologist and surgeon acceptance.

Mammographic density and breast cancer risk in breast screening assessment cases and women with a family history of breast cancer.

BACKGROUND: Mammographic density has been shown to be a strong independent predictor of breast cancer and a causative factor in reducing the sensitivity of mammography. There remain questions as to the use of mammographic density information in the context of screening and risk management, and of the association with cancer in populations known to be at increased risk of breast cancer. AIM: To assess the association of breast density with presence of cancer by measuring mammographic density visually as a percentage, and with two automated volumetric methods, Quantra™ and VolparaDensity™. METHODS: The TOMosynthesis with digital MammographY (TOMMY) study of digital breast tomosynthesis in the Breast Screening Programme of the National Health Service (NHS) of the United Kingdom (UK) included 6020 breast screening assessment cases (of whom 1158 had breast cancer) and 1040 screened women with a family history of breast cancer (of whom two had breast cancer). We assessed the association of each measure with breast cancer risk in these populations at enhanced risk, using logistic regression adjusted for age and total breast volume as a surrogate for body mass index (BMI). RESULTS: All density measures showed a positive association with presence of cancer and all declined with age. The strongest effect was seen with Volpara absolute density, with a significant 3% (95% CI 1-5%) increase in risk per 10 cm3 of dense tissue. The effect of Volpara volumetric density on risk was stronger for large and grade 3 tumours. CONCLUSIONS: Automated absolute breast density is a predictor of breast cancer risk in populations at enhanced risk due to either positive mammographic findings or family history. In the screening context, density could be a trigger for more intensive imaging.

A randomised trial of screening with digital breast tomosynthesis plus conventional digital 2D mammography versus 2D mammography alone in younger higher risk women.

INTRODUCTION: Digital breast tomosynthesis (DBT) has been shown to increase invasive cancer detection rates at screening compared to full field digital (2D) mammography alone, and some studies have reported a reduction in the screening recall rate. No prospective randomised studies of DBT have previously been published. This study compares recall rates with 2D mammography with and without concurrent DBT in women in their forties with a family history of breast cancer undergoing incident screening. MATERIALS AND METHODS: Asymptomatic women aged 40-49 who had previously undergone mammography for an increased risk of breast cancer were recruited in two screening centres. Participants were randomised to screening with 2D mammography only at the first study screen followed a year later by screening with 2D plus DBT, or vice versa. Recall rates were compared using an intention to treat analysis. Reading performance was analysed for the larger centre. RESULTS: 1227 women were recruited. 1221 first screens (604 2D, 617 2D+DBT) and 1124second screens (558 2D+DBT, 566 2D) were analysed. Eleven women had screen-detected cancers: 5 after 2D, 6 after 2D+DBT. The false positive recall rates were 2.4% for 2D and 2.2% for 2D+DBT (p=0.89). There was a significantly greater reduction between rounds in the number of women with abnormal reads who were not recalled after consensus/arbitration with 2D+DBT than 2D (p=0.023). CONCLUSION: The addition of DBT to 2D mammography in incident screening did not lead to a significant reduction in recall rate. DBT may increase reader uncertainty until DBT screening experience is acquired.

Accuracy of Digital Breast Tomosynthesis for Depicting Breast Cancer Subgroups in a UK Retrospective Reading Study (TOMMY Trial).

PURPOSE: To compare the diagnostic performance of two-dimensional (2D) mammography, 2D mammography plus digital breast tomosynthesis (DBT), and synthetic 2D mammography plus DBT in depicting malignant radiographic features. MATERIALS AND METHODS: In this multicenter, multireader, retrospective reading study (the TOMMY trial), after written informed consent was obtained, 8869 women (age range, 29-85 years; mean, 56 years) were recruited from July 2011 to March 2013 in an ethically approved study. From these women, a reading dataset of 7060 cases was randomly allocated for independent blinded review of (a) 2D mammography images, (b) 2D mammography plus DBT images, and (c) synthetic 2D mammography plus DBT images. Reviewers had no access to results of previous examinations. Overall sensitivities and specificities were calculated for younger women and those with dense breasts. RESULTS: Overall sensitivity was 87% for 2D mammography, 89% for 2D mammography plus DBT, and 88% for synthetic 2D mammography plus DBT. The addition of DBT was associated with a 34% increase in the odds of depicting cancer (odds ratio [OR] = 1.34, P = .06); however, this level did not achieve significance. For patients aged 50-59 years old, sensitivity was significantly higher (P = .01) for 2D mammography plus DBT than it was for 2D mammography. For those with breast density of 50% or more, sensitivity was 86% for 2D mammography compared with 93% for 2D mammography plus DBT (P = .03). Specificity was 57% for 2D mammography, 70% for 2D mammography plus DBT, and 72% for synthetic 2D mammography plusmDBT. Specificity was significantly higher than 2D mammography (P < .001in both cases) and was observed for all subgroups (P < .001 for all cases). CONCLUSION: The addition of DBT increased the sensitivity of 2D mammography in patients with dense breasts and the specificity of 2D mammography for all subgroups. The use of synthetic 2D DBT demonstrated performance similar to that of standard 2D mammography with DBT. DBT is of potential benefit to screening programs, particularly in younger women with dense breasts. (©) RSNA, 2015.

The TOMMY trial: a comparison of TOMosynthesis with digital MammographY in the UK NHS Breast Screening Programme--a multicentre retrospective reading study comparing the diagnostic performance of digital breast tomosynthesis and digital mammography with digital mammography alone.

BACKGROUND: Digital breast tomosynthesis (DBT) is a three-dimensional mammography technique with the potential to improve accuracy by improving differentiation between malignant and non-malignant lesions. OBJECTIVES: The objectives of the study were to compare the diagnostic accuracy of DBT in conjunction with two-dimensional (2D) mammography or synthetic 2D mammography, against standard 2D mammography and to determine if DBT improves the accuracy of detection of different types of lesions. STUDY POPULATION: Women (aged 47-73 years) recalled for further assessment after routine breast screening and women (aged 40-49 years) with moderate/high of risk of developing breast cancer attending annual mammography screening were recruited after giving written informed consent. INTERVENTION: All participants underwent a two-view 2D mammography of both breasts and two-view DBT imaging. Image-processing software generated a synthetic 2D mammogram from the DBT data sets. RETROSPECTIVE READING STUDY: In an independent blinded retrospective study, readers reviewed (1) 2D or (2) 2D + DBT or (3) synthetic 2D + DBT images for each case without access to original screening mammograms or prior examinations. Sensitivities and specificities were calculated for each reading arm and by subgroup analyses. RESULTS: Data were available for 7060 subjects comprising 6020 (1158 cancers) assessment cases and 1040 (two cancers) family history screening cases. Overall sensitivity was 87% [95% confidence interval (CI) 85% to 89%] for 2D only, 89% (95% CI 87% to 91%) for 2D + DBT and 88% (95% CI 86% to 90%) for synthetic 2D + DBT. The difference in sensitivity between 2D and 2D + DBT was of borderline significance (p = 0.07) and for synthetic 2D + DBT there was no significant difference (p = 0.6). Specificity was 58% (95% CI 56% to 60%) for 2D, 69% (95% CI 67% to 71%) for 2D + DBT and 71% (95% CI 69% to 73%) for synthetic 2D + DBT. Specificity was significantly higher in both DBT reading arms for all subgroups of age, density and dominant radiological feature (p < 0.001 all cases). In all reading arms, specificity tended to be lower for microcalcifications and higher for distortion/asymmetry. Comparing 2D + DBT to 2D alone, sensitivity was significantly higher: 93% versus 86% (p < 0.001) for invasive tumours of size 11-20 mm. Similarly, for breast density 50% or more, sensitivities were 93% versus 86% (p = 0.03); for grade 2 invasive tumours, sensitivities were 91% versus 87% (p = 0.01); where the dominant radiological feature was a mass, sensitivities were 92% and 89% (p = 0.04) For synthetic 2D + DBT, there was significantly (p = 0.006) higher sensitivity than 2D alone in invasive cancers of size 11-20 mm, with a sensitivity of 91%. CONCLUSIONS: The specificity of DBT and 2D was better than 2D alone but there was only marginal improvement in sensitivity. The performance of synthetic 2D appeared to be comparable to standard 2D. If these results were observed with screening cases, DBT and 2D mammography could benefit to the screening programme by reducing the number of women recalled unnecessarily, especially if a synthetic 2D mammogram were used to minimise radiation exposure. Further research is required into the feasibility of implementing DBT in a screening setting, prognostic modelling on outcomes and mortality, and comparison of 2D and synthetic 2D for different lesion types. STUDY REGISTRATION: Current Controlled Trials ISRCTN73467396. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 19, No. 4. See the HTA programme website for further project information.

Percutaneous tattoo pigment simulating calcific deposits in axillary lymph nodes.

The isolated finding of calcific deposits within axillary lymph nodes on mammography suggests a broad range of differential diagnoses, from benign causes such as granulomatous reaction secondary to previous histoplasmosis infection to malignancies such as breast cancer and metastatic disease from extramammary primary malignancies. Therefore, the isolated finding of intranodal calcium may warrant biopsy for a definitive diagnosis when a benign etiology is not apparent. We present a patient with isolated axillary lymph node densities on mammography and chest computed tomography, which were subsequently proven to represent deposition of tattoo pigment.

Extending the age range for breast screening in England: pilot study to assess the feasibility and acceptability of randomization.

OBJECTIVE: To assess the feasibility and acceptability of randomizing the phased introduction of the extension of the invited age range in the National Health Service (NHS) Breast Screening Programme in England from 50-70 to 47-73 years. SETTING: Six volunteer breast screening units (BSUs) in England. METHODS: Cluster-randomized trial of invitation versus no invitation for breast screening. STUDY PARTICIPANTS: women aged 47-49 and 71-73 years in screening batches randomized between 1 June 2009 and 31 May 2010. OUTCOMES: workload, screening uptake among women invited, self-referrals among women not invited, and screening outcomes among women invited. RESULTS: A total of 312 screening batches (clusters) were randomized including 60,708 women. Screening uptake was 63% in women aged 47-49 and 62% in women aged 71-73. Those who attended screening in the younger age group were more likely to be recalled for assessment than older attendees (7.5% vs. 3.0%) but less likely to be diagnosed with breast cancer (0.5% vs. 1.1%). Among women not invited, 0.2% of those aged 47-49 and 6.8% of those aged 71-73 self-referred for screening. Despite the extra workload BSUs largely coped although there was some slippage in round lengths and other targets. CONCLUSION: No major problems of feasibility or acceptability of randomization were found. This pilot study has informed the randomized phasing-in of the age extension across the whole of England.

Oral and enteral resuscitation of burn shock the historical record and implications for mass casualty care.

In the aftermath of a mass disaster, standard care methods for treatment of burn injury will often not be available for all victims. A method of fluid resuscitation for burns that has largely been forgotten by contemporary burn experts is enteral resuscitation. We identified 12 studies with over 700 patients treated with enteral resuscitation, defined as drinking or gastric infusion of salt solutions, from the literature. These studies suggest that enteral resuscitation can be an effective treatment for burn shock under conditions in which the standard IV therapy is unavailable or delayed, such as in mass disasters and combat casualties. Enteral resuscitation of burn shock was effective in patients with moderate (10-40% TBSA) and in some patients with more severe injuries. The data suggests that some hypovolemic burn and trauma patients can be treated exclusively with enteral resuscitation, and others might benefit from enteral resuscitation as an initial alternative and a supplement to IV therapy. A complication of enteral resuscitation was vomiting, which occurred less in children and much less when therapy was initiated within the first postburn hour. Enteral resuscitation is contra-indicated when the patient is in "peripheral circulatory collapse". The optimal enteral solution and regimen has not yet been defined, nor has its efficacy been tested against modern IV resuscitation. The oldest studies used glucose-free solutions of buffered isotonic and hypotonic saline. Studies that are more recent show benefit of adding glucose to electrolyte solutions similar to those used in the treatment of cholera. If IV therapy for mass casualty care is delayed due to logistical constraints, enteral resuscitation should be considered.

Promoting early presentation of breast cancer by older women: a preliminary evaluation of a one-to-one health professional-delivered intervention.

OBJECTIVE: To test the early effects of a novel one-to-one health professional-delivered intervention designed to increase awareness and thereby promote early presentation of breast cancer among older women. METHODS: Women attending their final routine appointment in the English NHS Breast Screening Programme received a booklet or a booklet supplemented by a brief interview, in addition to usual care. This was a within-group before-and-after evaluation of the two versions of the intervention. The primary outcome was change in the knowledge of breast cancer symptoms from baseline to 1 month postintervention. Secondary outcomes were knowledge of risk of developing breast cancer, confidence to detect a breast change, and likelihood of disclosure to someone close. Levels of cancer worry and any adverse effects caused by the intervention were also monitored. RESULTS: One hundred seventy-six women received the booklet and 116 received the booklet-plus-interview. At 1-month postintervention, the mean number of breast cancer symptoms identified (out of 11) increased from 5.3 by 1 symptom (P<.001) in the booklet group and by 1.9 (P<.001) in the booklet-plus-interview group. Improvements were sustained at 6 months. Positive improvements were made in the knowledge of risk of developing breast cancer and the confidence to detect a breast change in both groups; however, neither version of the intervention had an impact on encouraging women to disclose to someone close immediately on discovery of a breast symptom. No adverse effects were reported, and there was no significant increase in the level of cancer worry. DISCUSSION: Both versions of the intervention are worthy of testing in randomized trials to assess the impact on breast cancer awareness and ultimately on delayed presentation of breast cancer and mortality.