Baseline endpoints
Main endpoints
9662 women received the complete experimental procedure
66 received DM only *: 3 were recalled: 1 had cancer 1 had lesion of uncertain malignant Potential
49 had incomplete DBT imaging or registration *: 13 were recalled, 2 had cancer, and 1 had lesion of uncertain malignant potential
Interval cancers
Interval cancers negative 9433
1 or 2 years
DM at Next screening Round
1 or 2 years
DM at Next screening Round
DBT + DM arm 9777 positive 344
cancers 84( including 5 DCIS)
Potentially eligible presented for screening 33198
Eligible 30989
Randomization disclorure 19560 positive 339
cancers 44( including 5 DCIS)
DBT = digital breast tomosynthesis; DCIS = ductal carcinoma in situ; DM = digital mammography
Figure 1 Flowchart of recruitment phase and study design.
Excluded 2209( large breasts, familial risk score update recent breast cancer in relatives, augmentation prostheses, pregnancy, randomization procedure or tomosynthesis temporary not available)
Refusals 11429
DM arm 9783 negative 9444
1 or 2 years
DM at Next screening Round
1 or 2 years
DM at Next screening Round
72 8
0 80
Detected in at least one of the 2 reading rounds in 3D Detected in 2D but not in 3D Figure 2 Cancers detected with DBT only
16 %
Lesion size < 10 mm
31 % 31 %
14 %
Lesion size ≥ 10 mm to < 20 mm
5 %
DCIS
14 %
Figure 3 DBT vs digital mammography: Detection by cancer size
for DBT + DM versus DM alone, the increase was related to positive studies, suggesting it resulted from the need to review multiple images, not the interpretation itself. Variability between readers was similar in both arms. 17
“ Our data confirms the excellent results of 3D mammography, previously evidenced in other European prospective studies carried out on large-population screening programs,” said the lead investigator, Pierpaolo Pattacini, MD.“ But our results go a step further: only randomised trials can evaluate the effectiveness of a new screening technology, like whether it can save more lives.”
Conclusions The body of evidence as to the ability of DBT +
Control Arm Study Arm
Interval cancers
Interval cancers
DM to identify significantly more lesions with fewer false-positives and similar recall rates compared with DM alone continues to expand. Several large, multicentre clinical trials are currently underway that will, hopefully, answer some of the remaining questions currently preventing the greater adoption of DBT in the clinical setting.
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