The STORM trial of screening mammography: screening with Tomosynthesis or standard mammography

Purpose: To examine the incremental effect of adding 3D-mammography with
tomosynthesis to standard 2D digital mammography in population breast screening.
Methods and Materials: STORM is a prospective comparative study of integrated
2D/3D and 2D-only mammography that investigated screening in two phases [2D
relative to 2D/3D obtained with Combo®], yielding paired data for each screening
examination. Women aged ³49 years who attended population-based screening
services in Trento and Verona (Italy), from September 2011 to March 2012, were
included. Screens were interpreted sequentially using standard double-reading,
with recall of a positive screen at either reading phases. Paired proportions were
compared using McNemar's Chi-square test.
Results: Based on 5000 screens, 33 breast cancers were detected: 23 cancers
were detected at both 2D and 2D/3D reading, 10 cancers were detected only with
integrated 2D/3D screening, and no cancers were detected only at 2D reading
(p=0.002); incremental detection attributable to 2D/3D screening was 2.0/1000
screens (95% CI 0.8-3.2/1000) or an incremental 30.3% (95% CI 15.6-48.7%) of
cancers. There were 299 false positive (FP) recalls: 141 were FP at both reading
phases, 106 were FP at 2D-only, and 52 were FP at 2D/3D reading (p < 0.001).
Had recall been conditional to 2D/3D screen-positivity, FP recalls would have been
reduced by 18.1% (95% CI 13.9-22.9%) without missing any of the breast cancers
identified to date in the study population.
Conclusion: Integrated 2D/3D mammography has the potential to enhance
breast screening outcomes by improving cancer detection as well as by reducing
FP recalls. Randomised trials of 2D/3D screening versus standard 2D screening
are needed.
Author Disclosures:
N. Houssami: Grant Recipient; Receives research support via National Health
and Medical Research Council program grant 633003 to the Screening & Test
Evaluation Program. Other; Travel support was provided by Hologic (USA/Italy)
for attendance at collaborators/research meetings. D. Bernardi: Equipment
Support Recipient; Technologic support for trial from Hologic USA/Italy.
Other; Travel support from Hologic to attend collaborators/research meetings.
F. Caumo: Equipment Support Recipient; Technologic support for the trial
received through Hologic. Other; Travel support to collaborators meetings was
received through Hologic. P. Macaskill: Grant Recipient; Receives research
support through National Health and Medical Research Council program grant
633003 to STEP.
10:30 - 12:00 Room G