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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