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Journal ArticleDOI

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

TL;DR: The addition of DBT to 2D mammography in incident screening did not lead to a significant reduction in recall rate, and DBT may increase reader uncertainty until DBT screening experience is acquired.
About: This article is published in European Journal of Radiology.The article was published on 2017-09-01 and is currently open access. It has received 9 citations till now. The article focuses on the topics: Mammography & Breast cancer.

Summary (3 min read)

INTRODUCTION

  • In recent years digital breast tomosynthesis (DBT) has become established as a useful adjunct to, and in some centres a replacement for, conventional full-field digital mammography (FFDM).
  • Imaging the breast with DBT as a stack of contiguous thin (usually 1 mm thick) slices allows separation of overlying opacities, thus making cancers more obvious and resolving composite densities.
  • Several large trials together with in-service observational studies have demonstrated a significantly higher sensitivity of combined FFDM and DBT compared to FFDM alone together with the potential to reduce the false positive rate [1].
  • False positive rates in the UK National Health Service Breast Screening Programme are more common in women undergoing a first screen than those undergoing repeat (incident screening) (7.9% v. 3.0% [6]), as the lack of a prior mammogram for comparison can increase uncertainty about benign glandular densities.
  • These younger women are often anxious because of their increased breast cancer risk [7], and measures which potentially reduce the need for recall in this group are worthy of investigation.

Trial design

  • The primary study was a prospective parallel group study of asymptomatic women undergoing two rounds of incident screening a year apart, conducted in two large UK breast screening centres.
  • The study utilised a crossover design with 1:1 block randomisation to either conventional 2-dimensional full-field digital mammography alone (hereafter referred to as 2D mammography) or 2D mammography plus digital breast tomosynthesis (referred to as 2D+DBT), stratified by centre.
  • The crossover at the second screen was to give equitable access to DBT and to reduce disparities in the radiation dose which participants received within the study.
  • Recruitment of these women was terminated in the second year of the trial due to futility.
  • The trial was approved by the UK National Research Ethics Service (North West - Greater Manchester West committee).

Participants

  • Asymptomatic women aged 40 to 49 years previously assessed in a family history clinic (FHC) as being at moderate or high risk of breast cancer as defined by NICE (the National Institute for Health and Care Excellence) [8].
  • The authors have previously demonstrated an expected survival benefit of screening in this group [9].
  • Some previously screened women were scheduled only for mammography due to clinic capacity limitations.
  • Eligible women were identified from NBSS and sent an invitation letter and participant information leaflet with the mammogram appointment.

Randomisation

  • Randomisation was performed after written informed consent using a commercial webbased randomisation service (www.sealedenvelope.com).
  • The participant’s study number   8 was the sole identifier.
  • Randomisation was with random permuted blocks within the strata with stratification by study site.
  • The outcome of the randomisation was displayed on the web page and was manually recorded on the clinic list.
  • The date, participant’s age at entry, trial centre, screen type (prevalent or incident), whether the woman was also undergoing annual screening MRI and the assigned first examination for randomised incident women were entered.

Interventions

  • Mammography was performed on Hologic Selenia Dimensions machines.
  • Those undergoing incident screening were randomised to undergo either 2D mammography alone or 2D+DBT as the first examination.
  • All readers underwent prior training in DBT image interpretation, either through participation in the TOMMY trial [11] or through attendance at an NHSBSPapproved DBT course.
  • Where there was disagreement in the final opinion, a consensus discussion took place between the readers, with arbitration by a third reader if necessary.
  • The findings at assessment were recorded, together with whether needle biopsy was performed.

Outcomes

  • The primary outcome measure for participants undergoing incident screening at trial entry was the recall rate for further assessment with 2D mammography and 2D+DBT respectively.
  • For participants undergoing prevalent screening at trial entry, the planned primary outcome measure was the recall rate for further assessment.
  • Planned secondary outcome measures included cancer detection rates and individual reader recall rates.
  • For prevalent screens it was intended to examine the number of women whose 2D mammograms were regarded as abnormal (recorded prior to viewing the DBT images) relative to the overall decision based on viewing the 2D+DBT images together.

Sample size

  • These were based on historic data from Centre A. Incident screening: A 7% recall rate was anticipated for incident screening with FFDM alone, reducing to 4.9% with the addition of DBT.
  • For 90% power to detect a difference of this magnitude as significant using McNemar or conditional logistic regression estimates (5% level, two-sided testing) would require 1305 women and 2610 screens.
  • An 11.5% recall rate was anticipated for prevalent screening with FFDM alone, reducing to 8% with the addition of DBT.
  • These numbers were insufficient for a comparative trial with adequate power, hence a single arm study of combined 2D+DBT was performed.
  • A study size of 528 would give approximately 80% power for a one-sample test of these recall rates with an expected confidence interval of less than 2.3% in either direction.

Statistical methods

  • A generalised estimating equation regression model with an exchangeable correlation structure was used to compare recall and biopsy rates between 2D only and 2D+DBT examination strategies.
  • This analysis accounted appropriately for the crossover design of the study, namely, each woman was examined using either 2D only or 2D+DBT at the first of two incident screening rounds and by the alternative examination strategy at the second incident screening round.
  • Differences between sites (Centres A and B) and the effect of the order of the examination strategy were also assessed.
  • Analysis was by intention to treat (i.e. by randomised examination strategy allocation).

Incident screening

  • Two women were randomised to 2D+DBT but incorrectly underwent 2D mammography only as the first study examination (both had 2D+DBT at the second screen).
  • Table 1 shows the number of women screened, the number of cancers detected and the number of false positive recalls in each arm.
  • The corresponding numbers for Centre B are 1 after 2D and 2 after 2D+DBT.

Prevalent screening

  • Table 4 shows the number of women recalled for further assessment.
  • None of these women were diagnosed with breast cancer.
  • No further analysis has been performed due to the low numbers.

DISCUSSION

  • There is now a substantial body of published literature which demonstrates that digital breast tomosynthesis has a higher sensitivity for cancer detection than conventional full field digital mammography alone [13] [14] [15] [16] [17] [18].
  • Many of the studies that have shown a reduced recall rate with DBT had a higher recall rate with 2D mammography than ours [16] [23] [24] [26] [27] [28] and thus had a larger proportion of women who could potentially benefit.
  • This was despite the fact that all readers were trained in DBT and almost all had experience of using it routinely in screening assessment prior to the start of the study.
  • This ‘learning curve’ effect did not have a significant impact upon the false positive recall rate in their study due to the routine use of consensus discussion of   17 cases where the readers disagreed, together with arbitration by a third reader when necessary.
  • The potential remains for DBT to reduce the recall rate at prevalent screening, but this question has yet to be answered.

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Citations
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Journal ArticleDOI
TL;DR: In this article, the authors evaluated screening outcomes with digital breast tomosynthesis (DBT) in a real-world cohort and to characterize the population health impact of DBT as it is widely adopted.
Abstract: BACKGROUND Digital breast tomosynthesis (DBT) may have a higher cancer detection rate and lower recall compared with 2-dimensional (2 D) mammography for breast cancer screening. The goal of this study was to evaluate screening outcomes with DBT in a real-world cohort and to characterize the population health impact of DBT as it is widely adopted. METHODS This observational study evaluated breast cancer screening outcomes among women screened with 2 D mammography vs DBT. We used deidentified administrative data from a large private health insurer and included women aged 40-64 years screened between January 2015 and December 2017. Outcomes included recall, biopsy, and incident cancers detected. We used 2 complementary techniques: a patient-level analysis using multivariable logistic regression and an area-level analysis evaluating the relationship between population-level adoption of DBT use and outcomes. All statistical tests were 2-sided. RESULTS Our sample included 7 602 869 mammograms in 4 580 698 women, 27.5% of whom received DBT. DBT was associated with modestly lower recall compared with 2 D mammography (113.6 recalls per 1000 screens, 99% confidence interval [CI] = 113.0 to 114.2 vs 115.4, 99% CI = 115.0 to 115.8, P < .001), although younger women aged 40-44 years had a larger reduction in recall (153 recalls per 1000 screens, 99% CI = 151 to 155 vs 164 recalls per 1000 screens, 99% CI = 163 to 166, P < .001). DBT was associated with higher biopsy rates than 2 D mammography (19.6 biopsies per 1000 screens, 99% CI = 19.3 to 19.8 vs 15.2, 99% CI = 15.1 to 15.4, P < .001) and a higher cancer detection rate (4.9 incident cancers per 1000 screens, 99% CI = 4.7 to 5.0 vs 3.8, 99% CI = 3.7 to 3.9, P < .001). Point estimates from the area-level analysis generally supported these findings. CONCLUSIONS In a large population of privately insured women, DBT was associated with a slightly lower recall rate than 2 D mammography and a higher cancer detection rate. Whether this increased cancer detection improves clinical outcomes remains unknown.

4 citations

Journal ArticleDOI
TL;DR: Differences in screening recommendations for average risk and high-risk women as well as the frequently suggested modalities for screening these populations are discussed.

3 citations

Journal ArticleDOI
TL;DR: The purpose of this review article is to provide relevant information to physicians and other health care providers to aid in identifying patients that are classified as "high risk" for developing breast or a gynecologic cancer, outlining what interventions exist for adequate screening and risk reduction strategies, and to provide an update on current screening guidelines for individuals at average and high risk.

2 citations

Journal ArticleDOI
TL;DR: A substantial proportion of women are analyzed for additional ipsilateral breast lesions following recall, which are more frequently biopsied than recalled lesions, but have a comparable probability of being malignant.
References
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Journal ArticleDOI
TL;DR: The use of mammography plus tomosynthesis in a screening environment resulted in a significantly higher cancer detection rate and enabled the detection of more invasive cancers.
Abstract: We found a significant increase in cancer detection rates, particularly for invasive cancers, and a simultaneous decrease in false-positive rates with use of mammography plus tomosynthesis compared with mammography alone.

890 citations

Journal ArticleDOI
TL;DR: Integrated 2D and 3D mammography improves breast-cancer detection and has the potential to reduce false positive recalls.
Abstract: Summary Background Digital breast tomosynthesis with 3D images might overcome some of the limitations of conventional 2D mammography for detection of breast cancer. We investigated the effect of integrated 2D and 3D mammography in population breast-cancer screening. Methods Screening with Tomosynthesis OR standard Mammography (STORM) was a prospective comparative study. We recruited asymptomatic women aged 48 years or older who attended population-based breast-cancer screening through the Trento and Verona screening services (Italy) from August, 2011, to June, 2012. We did screen-reading in two sequential phases—2D only and integrated 2D and 3D mammography—yielding paired data for each screen. Standard double-reading by breast radiologists determined whether to recall the participant based on positive mammography at either screen read. Outcomes were measured from final assessment or excision histology. Primary outcome measures were the number of detected cancers, the number of detected cancers per 1000 screens, the number and proportion of false positive recalls, and incremental cancer detection attributable to integrated 2D and 3D mammography. We compared paired binary data with McNemar's test. Findings 7292 women were screened (median age 58 years [IQR 54–63]). We detected 59 breast cancers (including 52 invasive cancers) in 57 women. Both 2D and integrated 2D and 3D screening detected 39 cancers. We detected 20 cancers with integrated 2D and 3D only versus none with 2D screening only (p Interpretation Integrated 2D and 3D mammography improves breast-cancer detection and has the potential to reduce false positive recalls. Randomised controlled trials are needed to compare integrated 2D and 3D mammography with 2D mammography for breast cancer screening. Funding National Breast Cancer Foundation, Australia; National Health and Medical Research Council, Australia; Hologic, USA; Technologic, Italy.

713 citations

Journal ArticleDOI
25 Jun 2014-JAMA
TL;DR: Addition of tomosynthesis to digital mammography was associated with a decrease in recall rate and an increase in cancer detection rate, and further studies are needed to assess the relationship to clinical outcomes.
Abstract: mammography + tomosynthesis; difference, 1.3 (95% CI, 0.4-2.1; P = .004); for cancer detection, 4.2 (95% CI, 3.8-4.7) with digital mammography vs 5.4 (95% CI, 4.9-6.0) with digital mammography + tomosynthesis; difference, 1.2 (95% CI, 0.8-1.6; P < .001); and for invasive cancer detection, 2.9 (95% CI, 2.5-3.2) with digital mammography vs 4.1 (95% CI, 3.7-4.5) with digital mammography + tomosynthesis; difference, 1.2 (95% CI, 0.8-1.6; P < .001). The in situ cancer detection rate was 1.4 (95% CI, 1.2-1.6) per 1000 screens with both methods. Adding tomosynthesis was associated with an increase in the positive predictive value for recall from 4.3% to 6.4% (difference, 2.1%; 95% CI, 1.7%-2.5%; P < .001) and for biopsy from 24.2% to 29.2% (difference, 5.0%; 95% CI, 3.0%-7.0%; P < .001). CONCLUSIONS AND RELEVANCE Addition of tomosynthesis to digital mammography was associated with a decrease in recall rate and an increase in cancer detection rate. Further studies are needed to assess the relationship to clinical outcomes.

699 citations


"A randomised trial of screening wit..." refers methods in this paper

  • ...Published studies of screening DBT have utilised various reading methods, including double reading by two radiologists [24], single reading with computedaided detection (CAD) [16,26] and, in a multicentre study of over 450,000 women, presumably either single reading or a mixture of methods [27]....

    [...]

01 Jan 2006
TL;DR: User experience surveys (UESs) are regarded as an important part of the overall performance framework for social care and, providing councils with information about how they might improve services locally, and are required to submit their results to government bodies so that the relative performance of the CSSRs can be judged.
Abstract: For some time now councils with social services responsibilities (CSSRs) have been required to conduct surveys of user’s experience of social services. These have taken place nationally in three-yearly cycles. In 2002/03 the survey was for older people, in 2003/04 it was for younger adults with physical and sensory impairments, and in 2004/05 it was for children. 2005/06 marked the beginning of the second wave of the cycle. The mandate for conducting surveys of user’s experiences and satisfaction with services was first given in the white paper Modern Local Government: in Touch with the People (Department for the Environment, Trade and the Regions, 1998). In 2002 the Office of National Statistics (ONS) and SPRU developed a set of questionnaires for this purpose (Qureshi and Rowlands, 2004). Subsequent national surveys have drawn on this work to identify a set of compulsory questions for each round. User experience surveys (UESs) are regarded as an important part of the overall performance framework for social care and, providing councils with information about how they might improve services locally. Local authorities are required to submit their results to government bodies so that the relative performance of the CSSRs can be judged. This report is composed of five sections. The aims and objectives of the report are outlined in the second section and the method used to gather the data is outlined in section 3. In section 4 we report on the findings from the fieldwork and draw some conclusions and recommendations for the national survey in section 5. The topic guides for the focus groups and interviews are included in the appendices along with a brief discussion of the findings from the focus groups and a copy of the final extended questionnaire.

628 citations

Journal ArticleDOI
TL;DR: Patients undergoing tomosynthesis plus digital mammography had significantly lower screening recall rates, and the greatest reductions were for those younger than 50 years and those with dense breasts.
Abstract: Although all breast density and age subgroups benefitted from the addition of tomosynthesis to conventional digital mammography, the patients receiving the greatest benefit were women with dense breasts and those younger than 50 years.

364 citations

Related Papers (5)
Frequently Asked Questions (1)
Q1. What are the contributions mentioned in the paper "A randomised trial of screening with digital breast tomosynthesis plus conventional digital 2d mammography versus 2d mammography alone in younger higher risk women" ?

Maxwell et al. this paper compared the performance of digital breast tomosynthesis ( DBT ) and conventional full-field digital mammography ( FFDM ) for women aged 40-49.