Effect of integrating 3D-mammography (digital breast tomosynthesis) with 2D-mammography on radiologists’ true-positive and false-positive detection in a population breast screening trial

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Abstract

Objective

We investigated the effect of integrating three-dimensional (3D)-mammography with 2D-mammography on radiologists’ detection measures in the ‘screening with tomosynthesis or standard mammography’ (STORM) trial.

Methods

STORM, a prospective population-based trial (Trento and Verona breast screening services) compared sequential screen-reading: 2D-mammography alone and integrated 2D/3D-mammography. Radiologist-specific detection measures were calculated for each screen-reading phase for eight radiologists: number of detected cancers, proportion of true-positive (TP) detection, and number and rate of false-positive (FP) recalls (FPR). We estimated the incremental cancer detection rate (CDR).

Results

There were 59 cancers and 395 false recalls amongst 7292 screening participants. At 2D-mammography screening, radiologist-specific TP detection ranged between 38% and 83% (median 63%; mean 60% and sd 15.4%); at integrated 2D/3D-mammography, TP detection ranged between 78% and 93% (median 87%; mean 87% and sd 5.2%). For all but one radiologist, 2D/3D-mammography improved breast cancer detection (relative to 2D-mammography) ranging between 0% and 54% (median 29%; mean 27% and sd 16.2%) increase in the proportion of detected cancers. Incremental CDR attributable to integrating 3D-mammography in screening varied between 0/1000 and 5.3/1000 screens (median 1.8/1000; mean 2.3/1000 and sd 1.6/1000). Radiologist-specific FPR for 2D-mammography ranged between 1.5% and 4.2% (median 3.1%; mean 2.9% and sd 0.87%), and FPR based on the integrated 2D/3D-mammography read ranged between 1.0% and 3.3% (median 2.4%; mean 2.2% and sd 0.72%). Integrated 2D/3D-mammography screening, relative to 2D-mammography, had the effect of reducing FP and increasing TP detection for most radiologists.

Conclusion

There was broad variability in radiologist-specific TP detection at 2D-mammography and hence in the additional TP detection and incremental CDR attributable to integrated 2D/3D-mammography; more consistent (less variable) TP-detection estimates were observed for the integrated screen-read. Integrating 3D-mammography with 2D-mammography improves radiologists’ screen-reading through improved cancer detection and/or reduced FPR, with most readers achieving both using integrated 2D/3D mammography.

Introduction

Reviews of the evidence from the breast screening randomised trials conclude that mammography screening reduces breast cancer mortality [1], [2]. Digital breast tomosynthesis (DBT), a three-dimensional (3D) form of mammographic technology [3], [4], [5], [6] has been investigated in various clinical studies [6], [7], [8], [9], [10], which have been reviewed by Houssami and Skaane [6] highlighting the need for evidence from prospective screening trials. Recently, two large screening trials, the Oslo trial [11] and the ‘screening with tomosynthesis or standard mammography’ (STORM) trial [12], have provided remarkably consistent findings on 3D-mammography: both have shown that interpreting mammography using standard (2D) images in combination with the 3D images increases breast cancer detection and can also reduce false-positive (FP) detection. Both of these contemporary screening trials were based on double-reading involving several participating radiologists who had interpreted subsets of the screens in the respective trials [11], [12]. The implications of the emerging evidence on 3D-mammography (DBT) for breast screening necessitates investigation of its effect on radiologist-specific detection measures – little evidence is available on this aspect of integrated 2D/3D mammography in the context of population breast screening.

We report an evaluation of the effect of integrating 3D-mammography with 2D-mammography for breast screening on individual radiologists’ true-positive (TP) and FP detection, based on radiologists who participated in the STORM trial.

Section snippets

Methods

We investigated reader-specific detection for radiologists who participated in screen-reading in the STORM trial [12], a prospective population-based study comparing sequential mammography screen-reading implemented in two phases: 2D-mammography alone and integrated 2D/3D mammography. The STORM study methods and population have been described in a recent publication from Ciatto et al. [12], and will be outlined only briefly in this paper. The STORM trial recruited asymptomatic women aged 48 

Results

Across all radiologists’ reads, 59 breast cancers were detected at screening in 57 subjects from 7292 screening participants (median age 58 years; range 48–71 years). The mammographic findings for these 59 screen-detected cancers are shown in Table 1 by detection method. The distributions of histology type and stage for the 59 cancers have been described in our primary report of STORM [12] – there were 52 invasive cancers and seven ductal carcinoma in situ (DCIS). The primary outcomes of the

Discussion

We report the effect of screen-reading using 3D-mammography with conventional 2D-mammography on detection measures for radiologists who participated in the STORM trial [12]. The primary outcomes from our trial were based on double-reading, and showed a significant increase in breast cancer detection for integrated 2D/3D mammography screening relative to that using 2D-mammography alone. The present evaluation describes radiologist-specific detection measures, to inform of the potential effect of

Role of funding source

The funding sources did not have any role in the design of the study, in the collection, analysis or interpretation of the data, in the writing of the report, or in the decision to submit the paper.

Conflict of interest statement and acknowledegment of funding

Centres and investigators in Italy participating in this trial declare that they received assistance from Hologic (USA) and Technologic (Italy) in the form of tomosynthesis technology and technical support for the duration of the study, and travel support to attend collaborators’ meetings. We thank Mr. Enrico Tedesco for technical support.

Assoc/Prof Houssami receives research support via a National Breast Cancer Foundation (NBCF Australia) Practitioner Fellowship. Professor Macaskill receives

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