Michael J Michell

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.

The mammographic parenchymal patterns of women on hormonal replacement therapy

In this study 383 mammograms of women on hormone replacement therapy (HRT) for more than one year and 216 mammograms of women performed before HRT was started were examined to identify any mammographic features which are associated with a higher incidence of developing breast cancer according to Wolfes criteria. There was no significant difference in the proportion of high and low risk parenchymal patterns as the duration of HRT increased. A significantly higher proportion of low risk patterns with ageing was observed in 216 women who had never been on HRT when compared to 194 mammograms of women who had been on HRT for more than 5 years. This difference becomes more obvious in women on HRT with less than three children compared to a similar group not taking HRT. Women who had not taken HRT appeared to undergo normal involutional changes which were reflected by an increase in the proportion of low risk patterns with increasing age. We may conclude from these findings that HRT appears to inhibit involutional processes within the breast and therefore this group have higher risk parenchymal patterns for a longer period of time and subsequently may have a higher risk of developing breast cancer.

The Royal College of Radiologists Breast Group breast imaging classification

Standardisation of the classification of breast imaging reports will improve communication between the referrer and the radiologist and avoid ambiguity, which may otherwise lead to mismanagement of patients. Following wide consultation, the Royal College of Radiologists Breast Group has produced a scoring system for the classification of breast imaging. This will facilitate audit and the development of nationally agreed standards for the investigation of women with breast disease. This five-point system is as follows: 1, normal; 2, benign findings; 3, indeterminate/probably benign findings; 4, findings suspicious of malignancy; 5, findings highly suspicious of malignancy. It is recommended that this be used in the reporting of all breast imaging examinations in the UK.

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.

Acute inflammation of the breast — the role of breast ultrasound in diagnosis and management

Twenty female patients aged between 24 and 69 years were referred for breast ultrasound (US) examination between June 1989 and June 1990, with clinical suspicion of a breast abscess. Six were currently lactating. Initial US examination confirmed the presence of an abscess collection in nine out of 20 patients. Seven of these subsequently had surgical incision and drainage. Two settled on medical treatment. No abscess was detected on initial US examination in the remaining 11 patients who were treated conservatively with oral antibiotics. One patient, who had markedly dilated ducts on her initial US examination, remained symptomatic. Follow-up US demonstrated a small fluid collection, which within 7 days developed into a large multiloculated abscess requiring surgical drainage. We feel that US is very useful in accurately demonstrating the presence or absence of an abscess collection in the acutely inflamed breast.

Fibrous mastopathy in insulin dependent diabetics

The cases of two poorly controlled insulin dependent diabetic women, presenting with hard discrete breast lumps clinically suspicious of carcinoma are presented. Mammography revealed dense dysplastic parenchymal changes with no specific features of carcinoma and ultrasound showed acoustic shadowing but no discrete mass. Excision biopsy of these lumps was performed. Histologically they were benign, and were composed of fibrous tissue with a chronic inflammatory cell infiltrate. With better awareness of fibrous mastopathy which can occur in this group of diabetic patients, and with the absence of specific radiological features of malignancy, some of these women may be observed and spared excision biopsy.

Promoting early presentation of breast cancer: development of a psycho-educational intervention.

Objectives: Women who delay presenting with breast cancer have a reduced chance of survival. Older women, who are at greater risk of developing breast cancer, are more likely to delay presenting with the disease. The aim of this developmental work was to design a psycho-educational intervention to promote early help-seeking by older women with breast cancer symptoms. We also aimed to demonstrate the feasibility of implementing the intervention with women attending for their final invited mammogram in the National Health Service (NHS) Breast Screening Programme. Methods: The intervention was designed to address the factors associated with delayed presentation by women with breast cancer. These risk factors were placed in a theoretical framework to understand patient delay. The intervention incorporated behavioural change techniques that, according to previous research, have been demonstrated to be effective. Results: The intervention was developed in two formats to be delivered by diagnostic radiographers: a booklet alone and a brief interview plus the booklet. The intervention was acceptable to both older women and healthcare professionals in the NHS Breast Screening Programme. Discussion: The intervention will be tested ultimately in a multicentre randomized controlled trial to determine whether it can reduce the proportion of older women who delay their presentation and thereby save lives.

The accuracy of digital breast tomosynthesis compared with coned compression magnification mammography in the assessment of abnormalities found on mammography

AIM To compare the diagnostic accuracy of the digital breast tomosynthesis (DBT) with coned compression magnification mammography (CCMM). MATERIALS AND METHODS The study design included two reading sessions completed by seven experienced radiologists. In the first session, all readers read bilateral standard two-view mammograms and a CCMM view of the lesion before giving a combined score for assessment. In the second session, readers read bilateral standard two-view mammograms plus one-view DBT. The two reading sessions of the experiment were separated by at least 2 weeks to reduce the chance of reader memory of the images read in the previous session from influencing the performance in the subsequent session. RESULTS Three hundred and fifty-four lesions were assessed and receiver-operative characteristic (ROC) analysis was used to evaluate the difference between the two modes. For standard two-view mammography plus CCMM, the area under the curve (AUC) was 0.87 [95% confidence interval (CI): 0.83-0.91] and for standard two-view mammography plus DBT the AUC was 0.93 (95% CI: 0.91-0.95). The difference between the AUCs was 0.06 with p-value of 0.0014. CONCLUSION Two-view mammography with one-view DBT showed significantly improved accuracy compared to two-view mammography and CCMM in the assessment of mammographic abnormalities. These results show that DBT can be used effectively in the further evaluation of mammographic abnormalities found at screening and in symptomatic diagnostic practice.

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.

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.