Background
Methods
Screening program
Case selection
Image acquisition
Image interpretation
Ground truth
Data analysis
Statistical analysis
Results
Study population
All women | BRCA mutation carriersa | Others at increased riskb | |
---|---|---|---|
Number | 2026 | 744 | 1282 |
Age | |||
Mean | 44.7 | 40.4 | 47.2 |
SD | 11.7 | 11.0 | 11.3 |
Median | 44 | 39 | 47 |
Range | 21–91 | 23–75 | 21–91 |
Number of cancers | 125 | 61 | 64 |
Number of false positive recalls | 502 | 165 | 337 |
Number of false positive biopsies | 331 | 117 | 214 |
Age < 40 years | Age 40–50 years | Age 50–60 years | Age ≥ 60 years | Overall | p valuea | |
---|---|---|---|---|---|---|
Women (N) | ||||||
BRCA | 388 | 258 | 182 | 75 | 903 | <0.001 |
Others | 329 | 504 | 482 | 273 | 1588 | 0.014 |
Overall | 717 | 762 | 664 | 348 | 2491 | <0.001 |
Exams (N) | ||||||
BRCA | 1113 | 737 | 568 | 190 | 2608 | <0.001 |
Others | 716 | 1313 | 1265 | 651 | 3945 | 0.046 |
Overall | 1829 | 2050 | 1833 | 841 | 6553 | <0.001 |
BC (N) | ||||||
Mammography | 13 | 13 | 25 | 15 | 66 | 0.253 |
Mammography only | 1 | 2 | 8 | 2 | 13 | 0.202 |
MRI | 25 | 30 | 37 | 20 | 112 | 0.697 |
MRI only | 13 | 19 | 20 | 7 | 59 | 0.254 |
Overall | 26 | 32 | 45 | 22 | 125 | 0.963 |
Invasive tumor (N) | ||||||
Mammography | 13 | 9 | 16 | 12 | 50 | 0.771 |
Mammography only | 1 | 0 | 4 | 0 | 5 | 0.822 |
MRI | 24 | 25 | 30 | 18 | 97 | 0.496 |
MRI only | 12 | 16 | 18 | 6 | 52 | 0.253 |
Overall | 25 | 25 | 34 | 18 | 102 | 0.540 |
DCIS (N) | ||||||
Mammography | 0 | 4 | 9 | 3 | 16 | 0.073 |
Mammography only | 0 | 2 | 5 | 1 | 8 | 0.281 |
MRI | 1 | 5 | 7 | 2 | 15 | 0.036 |
MRI only | 1 | 3 | 2 | 1 | 7 | 0.848 |
Overall | 1 | 7 | 11 | 4 | 23 | 0.164 |
Tumor grade of all cancers (invasive and in situ) (N) | ||||||
Grade 1 | ||||||
Mammography | 1 | 1 | 4 | 1 | 7 | 0.536 |
Mammography only | 0 | 0 | 1 | 0 | 1 | 0.655 |
MRI | 3 | 4 | 5 | 5 | 17 | 0.384 |
MRI only | 2 | 3 | 2 | 4 | 11 | 0.442 |
Grade 2 | ||||||
Mammography | 1 | 5 | 7 | 4 | 17 | 0.171 |
Mammography only | 0 | 1 | 2 | 1 | 4 | 0.317 |
MRI | 3 | 10 | 17 | 6 | 36 | 0.170 |
MRI only | 2 | 6 | 12 | 3 | 23 | 0.335 |
Grade 3 | ||||||
Mammography | 11 | 7 | 11 | 6 | 35 | 0.339 |
Mammography only | 1 | 1 | 2 | 1 | 5 | 0.822 |
MRI | 17 | 15 | 15 | 5 | 52 | 0.010 |
MRI only | 7 | 9 | 6 | 0 | 22 | 0.009 |
Missing | 2 | 1 | 3 | 4 | 10 | 0.197 |
FPR (N) | ||||||
Mammography | 63 | 75 | 55 | 22 | 215 | <0.001 |
Mammography only | 22 | 38 | 28 | 15 | 103 | 0.115 |
MRI | 159 | 143 | 72 | 25 | 399 | <0.001 |
MRI only | 118 | 106 | 45 | 18 | 287 | <0.001 |
Overall | 181 | 181 | 100 | 40 | 502 | <0.001 |
FPB (N) | ||||||
Mammography | 35 | 46 | 32 | 9 | 122 | <0.001 |
Mammography only | 6 | 15 | 11 | 3 | 35 | 0.258 |
MRI | 114 | 113 | 51 | 18 | 296 | <0.001 |
MRI only | 85 | 82 | 30 | 12 | 209 | <0.001 |
Overall | 120 | 128 | 62 | 21 | 331 | <0.001 |
Mammography-detected breast cancers
Number | Risk category | Ipsi/ contrab | Age | Tumor type | Tumor sizea | Tumor grade | ER-status | PR- status | H2N-status | Nodal status | 1st round versus FU |
---|---|---|---|---|---|---|---|---|---|---|---|
1 |
BRCA1
| N/A | 50 | DCIS | 6 | 2 | – | – | – | 0 | FU |
2 | Family | N/A | 43 | DCIS | 7 | 2 | – | – | – | 0 | FU |
3 | Family | N/A | 48 | DCIS | – | 3 | – | – | – | 0 | FU |
4 | Personal | Ipsi | 55 | DCIS | 23 | – | – | – | – | 0 | FU |
5 | Personal | Contra | 58 | DCIS | – | – | – | – | – | 0 | FU |
6 | Personal | Contra | 69 | DCIS | 6 | 2 | – | – | – | 0 | FU |
7 | Other | N/A | 61 | DCIS | 21 | 3 | – | – | – | – | FU |
8 | Personal | Contra | 55 | DCIS | – | 3 | – | – | – | 0 | FU |
9 |
BRCA2
| N/A | 57 | DCIS1 | 6 | – | Positive | Positive | Negative | 0 | FU |
10 |
BRCA1
| N/A | 56 | IDC | 8 | 3 | Positive | Positive | Negative | 0 | FU |
11 | Family | N/A | 35 | IDC | 4 | 3 | Positive | Positive | – | 0 | FU |
12 | Family | N/A | 53 | Tubular | 3 | 1 | Positive | Positive | Negative | 0 | FU |
13 | Other | N/A | 54 | ILC | 23 | 2 | Positive | Positive | Negative | 1mi | FU |
Age group (years) | Number of breast cancers | Number of screens | Breast cancers detected by mammography only | NSN for mammography to detect breast cancer missed by MRI | |
---|---|---|---|---|---|
Overall | < 40 years | 26 | 1829 | 1 | 1829 |
40–50 years | 32 | 2050 | 2 | 1025 | |
50–60 years | 45 | 1833 | 8 | 229 | |
≥ 60 years | 22 | 841 | 2 | 421 | |
BRCA
| < 40 years | 17 | 1113 | 0 | N/A |
40–50 years | 14 | 737 | 0 | N/A | |
50–60 years | 26 | 568 | 3 | 189 | |
≥ 60 years | 4 | 190 | 0 | N/A | |
No BRCA | < 40 years | 9 | 716 | 1 | 716 |
40–50 years | 18 | 1313 | 2 | 657 | |
50–60 years | 19 | 1265 | 5 | 253 | |
≥ 60 years | 18 | 651 | 2 | 326 | |
Follow up | < 40 years | 17 | 1112 | 1 | 1112 |
40–50 years | 20 | 1447 | 2 | 724 | |
50–60 years | 28 | 1342 | 8 | 168 | |
≥ 60 years | 11 | 626 | 2 | 313 | |
BRCA
| < 40 years | 12 | 725 | 0 | N/A |
40–50 years | 9 | 554 | 0 | N/A | |
50–60 years | 18 | 433 | 3 | 144 | |
≥ 60 years | 0 | 152 | 0 | N/A | |
No BRCA | < 40 years | 5 | 387 | 1 | 387 |
40–50 years | 11 | 893 | 2 | 447 | |
50–60 years | 10 | 909 | 5 | 182 | |
≥ 60 years | 11 | 474 | 2 | 237 |
Cancer yield
Age category | Risk category | Cancer yielda (95% CI) | FPRa (95% CI) | FPBa (95% CI) |
---|---|---|---|---|
A. Mammography | ||||
< 40 years | Overall | 6.54 (3.73–11.46) | 36.06 (27.57–47.03) | 19.48 (13.73–27.58) |
BRCA
| 7.17 (3.61–14.18) | 26.96 (18.07–40.03) | 15.52 (9.03–26.57) | |
No BRCA | 5.61 (2.10–14.89) | 49.62 (34.62–70.64) | 24.94 (15.94–38.83) | |
40–50 years | Overall | 6.35 (3.71–10.83) | 40.44 (31.53–51.72) | 24.23 (17.66–33.16) |
BRCA
| 6.78 (2.85–16.02) | 18.90 (11.26–31.56) | 12.21 (6.37–23.30) | |
No BRCA | 6.11 (3.08–12.06) | 52.66 (39.80–69.38) | 30.56 (21.36–43.55) | |
50–60 years | Overall | 13.57 (9.21–19.94) | 33.28 (24.94–44.29) | 18.38 (12.60–26.75) |
BRCA
| 26.10 (15.93–42.47) | 10.56 (4.75–23.31) | 8.85 (3.67–21.15) | |
No BRCA | 7.89 (4.26–14.58) | 43.06 (31.68–58.27) | 22.16 (14.61–33.47) | |
≥ 60 years | Overall | 17.72 (10.81–28.93) | 25.82 (16.76–39.58) | 10.88 (5.64–20.90) |
BRCA
| 21.48 (7.99–56.49) | 10.69 (2.64–42.22) | 0.00 (N/A) | |
No BRCA | 16.90 (9.54–29.77) | 30.38 (19.27–47.57) | 14.14 (7.31–27.15) | |
Overall | Overall | 9.95 (7.80–12.69) | 36.42 (31.42–42.19) | 20.05 (16.49–24.37) |
BRCA
| 12.44 (8.75–17.65) | 20.65 (15.32–27.77) | 12.56 (8.50–18.51) | |
No BRCA | 8.33 (5.95–11.65) | 47.08 (39.74–55.71) | 24.95 (19.91–31.24) | |
B. MRI | ||||
< 40 years | Overall | 13.09 (8.80–19.44) | 87.25 (74.68–101.71) | 62.30 (51.89–74.63) |
BRCA
| 14.31 (8.81–23.16) | 75.49 (60.59–93.70) | 56.72 (44.03–72.79) | |
No BRCA | 11.22 (5.61–22.31) | 104.96 (84.38–129.84) | 70.70 (54.44–91.35) | |
40–50 years | Overall | 14.06 (9.83–20.07) | 70.45 (59.44–83.31) | 55.95 (46.39–67.33) |
BRCA
| 18.86 (11.26–31.42) | 47.03 (34.06–64.61) | 34.73 (23.93–50.15) | |
No BRCA | 11.37 (6.91–18.66) | 82.49 (67.63–100.27) | 67.55 (54.44–83.53) | |
50–60 years | Overall | 19.56 (14.16–26.96) | 41.64 (32.53–53.16) | 29.88 (22.29–39.94) |
BRCA
| 40.37 (27.00–59.96) | 44.36 (29.42–66.36) | 30.66 (18.27–51.02) | |
No BRCA | 10.25 (5.97–17.55) | 40.08 (29.42–54.38) | 29.41 (20.59–41.84) | |
≥ 60 years | Overall | 23.56 (15.39–35.93) | 29.04 (19.45–43.15) | 20.49 (12.72–32.85) |
BRCA
| 21.48 (7.99–56.49) | 10.85 (2.66–43.12) | 10.85 (2.66–43.12) | |
No BRCA | 24.40 (15.23–38.87) | 34.37 (22.63–51.89) | 23.31 (14.04–38.45) | |
Overall | Overall | 16.64 (13.81–20.04) | 62.52 (56.37–69.29) | 46.27 (41.11–52.06) |
BRCA
| 22.08 (17.03–28.60) | 56.98 (48.07–67.42) | 41.81 (34.35–50.80) | |
No BRCA | 13.10 (10.02–17.10) | 66.13 (58.03–75.27) | 49.21 (42.42–57.03) | |
C. Combination | ||||
< 40 years | Overall | 13.56 (9.24–20.10) | 99.78 (86.35–115.04) | 65.68 (54.96–78.31) |
BRCA
| 14.31 (8.81–23.16) | 85.01 (69.45–103.66) | 60.34 (47.29–76.70) | |
No BRCA | 12.65 (6.58–24.21) | 121.64 (99.00–148.59) | 73.85 (56.96–95.26) | |
40–50 years | Overall | 15.02 (10.64–21.17) | 89.74 (77.29–103.98) | 63.26 (53.13–75.18) |
BRCA
| 18.86 (11.26–31.42) | 57.42 (42.61–76.97) | 42.39 (29.86–59.85) | |
No BRCA | 12.89 (8.10–20.48) | 107.19 (90.27–126.84) | 74.68 (61.11–90.97) | |
50–60 years | Overall | 23.82 (17.82–31.76) | 60.11 (48.79–73.85) | 36.58 (28.05–47.59) |
BRCA
| 45.29 (31.14–65.43) | 47.62 (32.20–69.90) | 33.91 (20.91–54.54) | |
No BRCA | 14.16 (8.97–22.29) | 65.53 (51.26–83.42) | 37.51 (27.28–51.37) | |
≥ 60 years | Overall | 26.49 (17.31–40.36) | 46.86 (34.05–64.17) | 24.16 (15.57–37.33) |
BRCA
| 21.48 (7.99–56.49) | 22.05 (8.12–58.46) | 10.85 (2.66–43.12) | |
No BRCA | 27.87 (17.39–44.38) | 54.21 (38.71–75.43) | 28.06 (17.67–44.30) | |
Overall | Overall | 18.68 (15.65–22.27) | 79.65 (72.70–87.21) | 51.73 (46.28–57.78) |
BRCA
| 23.17 (18.00–29.79) | 65.59 (56.09–76.55) | 46.14 (38.31–55.47) | |
No BRCA | 15.74 (12.28–20.15) | 89.14 (79.65–99.64) | 55.39 (48.20–63.57) |