Background
Methods
Study design
Eligibility criteria for enrollment of the patients
MRI technique
MRI interpretation
US imaging
Histological assessment
Statistical analyses
Results
Patient characteristics
Overestimation MRI – Histol. > 10 mm | Difference MRI – Histol. ≤10 mm | Underestimation MRI – Histol. > 10 mm | Unknown | Total | |
---|---|---|---|---|---|
Number of patients (% of total) | 11 (4.44) | 159 (64.11) | 54 (21.77) | 24 (9.68) | 248 (100.00) |
Age at initial visit [years] | |||||
Mean | 43.27 | 52.06 | 52.19 | 49.33 | 51.43 |
SD | 6.18 | 11.31 | 11.29 | 9.47 | 11.08 |
Median | 44.00 | 52.00 | 53.00 | 50.00 | 52.00 |
Min | 26.00 | 25.00 | 30.00 | 34.00 | 25.00 |
Max | 50.00 | 78.00 | 75.00 | 70.00 | 78.00 |
N.d. | 0 | 2 | 0 | 0 | 2 |
Central grade, N (%) | |||||
1 | 0 (0.00) | 4 (80.00) | 1 (20.00) | 0 (0.00) | 5 (100.00) |
2 | 5 (4.49) | 66 (65.35) | 22 (21.78) | 8 (7.92) | 101 (100.00) |
3 | 6 (4.29) | 88 (62.86) | 30 (21.43) | 16 (11.43) | 140 (100.00) |
N.d. | 0 (0.00) | 1 (50.00) | 1 (50.00) | 0 (0.00) | 2 (100.00) |
Clinical baseline characteristics, N (%) | |||||
cT | |||||
1 | 5 (4.59) | 80 (73.39) | 19 (17.43) | 5 (4.59) | 109 (100.00) |
2 | 6 (4.72) | 78 (61.42) | 29 (22.83) | 14 (11.02) | 127 (100.00) |
3 | 0 (0.00) | 1 (10.00) | 5 (50.00) | 4 (40.00) | 10 (100.00) |
4 | 0 (0.00) | 0 (0.00) | 1 (50.00) | 1 (50.00) | 2 (100.00) |
cN | |||||
0 | 6 (3.66) | 121 (73.78) | 30 (18.29) | 7 (4.27) | 164 (100.00) |
1 | 5 (6.85) | 34 (46.58) | 21 (28.77) | 13 (17.81) | 73 (100.00) |
2 | 0 (0.00) | 4 (40.00) | 3 (30.00) | 3 (30.00) | 10 (100.00) |
3 | 0 (0.00) | 0 (0.00) | 0 (0.00) | 1 (100.00) | 1 (100.00) |
Menopausal status, N (%) | |||||
Premenopausal | 11 (9.24) | 72 (60.50) | 23 (19.84) | 13 (10.92) | 119 (100.00) |
Postmenopausal | 0 (0.00) | 80 (67.23) | 28 (23.53) | 11 (9.24) | 119 (100.00) |
Unknown/unclear | 0 (0.00) | 7 (70.00) | 3 (30.00) | 0 (0.00) | 10 (100.00) |
BC subtype, N (%) | |||||
HR+/HER2+ | 5 (4.72) | 66 (62.26) | 30 (28.30) | 5 (4.72) | 106 (100.00) |
HR−/HER2− | 6 (6.52) | 62 (67.39) | 13 (14.13) | 11 (11.96) | 92 (100.00) |
HR−/HER2+ | 0 (0.00) | 31 (62.00) | 11 (22.00) | 8 (16.00) | 50 (100.00) |
Overestimation US – Histol. > 10 mm | Difference US – Histol. ≤10 mm | Underestimation US – Histol. > 10 mm | Unknown | Total | |
---|---|---|---|---|---|
Number of patients (% of total) | 60 (10.20) | 407 (69.22) | 93 (15.82) | 28 (4.76) | 588 (100.00) |
Age at initial visit [years] | |||||
Mean | 53.13 | 51.16 | 52.89 | 52.46 | 51.70 |
SD | 12.49 | 11.71 | 9.54 | 10.84 | 11.44 |
Median | 50.00 | 51.00 | 53.00 | 50.00 | 51.00 |
Min | 31.00 | 21.00 | 32.00 | 30.00 | 21.00 |
Max | 75.00 | 77.00 | 78.00 | 74.00 | 78.00 |
N.d. | 0 | 2 | 0 | 0 | 2 |
Central grade, N (%) | |||||
1 | 0 (0.00) | 8 (80.00) | 2 (20.00) | 0 (0.00) | 10 (100.00) |
2 | 32 (13.60) | 168 (71.19) | 27 (11.44) | 9 (3.81) | 236 (100.00) |
3 | 28 (8.26) | 228 (67.26) | 64 (18.88) | 19 (5.60) | 339 (100.00) |
N.d. | 0 (0.00) | 3 (100.00) | 0 (0.00) | 0 (0.00) | 3 (100.00) |
Clinical baseline characteristics, N (%) | |||||
cT | |||||
1 | 15 (6.36) | 196 (83.05) | 14 (5.93) | 11 (46.61) | 236 (100.00) |
2 | 35 (11.11) | 196 (62.22) | 68 (21.59) | 16 (5.08) | 315 (100.00) |
3 | 7 (23.33) | 12 (40.00) | 10 (33.33) | 1 (3.33) | 30 (100.00) |
4 | 3 (42.86) | 3 (42.86) | 1 (14.29) | 0 (0.00) | 7 (100.00) |
cN | |||||
0 | 33 (7.97) | 304 (73.43) | 58 (14.01) | 19 (4.59) | 414 (100.00) |
1 | 25 (16.23) | 93 (60.39) | 30 (19.48) | 6 (3.90) | 154 (100.00) |
2 | 2 (10.53) | 9 (47.37) | 5 (26.32) | 3 (15.79) | 19 (100.00) |
3 | 0 (0.00) | 1 (100.00) | 0 (0.00) | 0 (0.00) | 1 (100.00) |
Menopausal status, N (%) | |||||
Premenopausal | 31 (10.99) | 199 (70.57) | 38 (13.48) | 14 (4.96) | 282 (100.00) |
Postmenopausal | 28 (10.07) | 189 (67.99) | 49 (17.63) | 12 (4.32) | 278 (100.00) |
Unknown/unclear | 1 (3.57) | 19 (67.86) | 6 (21.43) | 2 (7.14) | 28 (100.00) |
BC subtype, N (%) | |||||
HR+/HER2+ | 28 (10.98) | 187 (73.33) | 31 (12.16) | 9 (3.53) | 255 (100.00) |
HR−/HER2− | 26 (10.44) | 166 (66.67) | 45 (18.07) | 12 (4.82) | 249 (100.00) |
HR−/HER2+ | 6 (7.14) | 54 (64.29) | 17 (20.24) | 7 (8.33) | 84 (100.00) |
Prediction of pCR and presence of residual tumor
Group | pCR, N | CR, N | TN, N | FP, N | TP, N | FN, N | Specificity (CL) | Sensitivity (CL) | NPV (CL) | PPV (CL) | |
Overall | MRI (N = 244) | 89 | 84 | 61 | 28 | 132 | 23 | 0.69 (0.58–0.78) | 0.85 (0.79–0.90) | 0.73 (0.62–0.82) | 0.83 (0.76–0.88) |
US (N = 578) | 218 | 149 | 101 | 117 | 312 | 48 | 0.46 (0.40–0.53) | 0.87 (0.83–0.90) | 0.68 (0.60–0.75) | 0.73 (0.68–0.77) | |
HR+/HER2+ | MRI (N = 103) | 34 | 25 | 19 | 15 | 63 | 6 | 0.56 (0.38–0.73) | 0.91 (0.82–0.97) | 0.76 (0.55–0.91) | 0.81 (0.70–0.89) |
US (N = 252) | 83 | 62 | 39 | 44 | 146 | 23 | 0.47 (0.36–0.58) | 0.86 (0.80–0.91) | 0.63 (0.50–0.75) | 0.77 (0.70–0.83) | |
HR−/HER2− | MRI (N = 91) | 31 | 38 | 22 | 9 | 44 | 15 | 0.71 (0.52–0.86) | 0.73 (0.60–0.84) | 0.58 (0.41–0.74) | 0.83 (0.70–0.92) |
US (N = 242) | 93 | 65 | 48 | 45 | 132 | 17 | 0.52 (0.41–0.62) | 0.89 (0.82–0.93) | 0.74 (0.62–0.84) | 0.75 (0.68–0.81) | |
HR−/HER2+ | MRI (N = 50) | 24 | 21 | 20 | 4 | 25 | 1 | 0.83 (0.63–0.95) | 0.96 (0.80–1) | 0.95 (0.76–1) | 0.86 (0.68–0.96) |
US (N = 84) | 42 | 22 | 14 | 28 | 34 | 8 | 0.33 (0.20–0.50) | 0.81 (0.66–0.91) | 0.64 (0.41–0.83) | 0.55 (0.42–0.68) | |
Group | ≤10 mm at histology, N | ≤10 mm at imaging, N | TN, N | FP, N | TP, N | FN, N | Specificity (CL) | Sensitivity (CL) | NPV (CL) | PPV (CL) | |
Overall | MRI (N = 224) | 151 | 100 | 92 | 59 | 65 | 8 | 0.61 (0.53–0.69) | 0.89 (0.80–0.95) | 0.92 (0.85–0.96) | 0.52 (0.43–0.62) |
US (N = 560) | 353 | 306 | 253 | 100 | 154 | 53 | 0.72 (0.67–0.76) | 0.74 (0.68–0.80) | 0.83 (0.78–0.87) | 0.61 (0.54–0.67) | |
HR+/HER2+ | MRI (N = 101) | 61 | 30 | 27 | 34 | 37 | 3 | 0.44 (0.32–0.58) | 0.93 (0.80–0.98) | 0.90 (0.74–0.98) | 0.52 (0.40–0.64) |
US (N = 246) | 142 | 138 | 106 | 36 | 72 | 32 | 0.75 (0.67–0.82) | 0.69 (0.59–0.78) | 0.77 (0.69–0.84) | 0.67 (0.57–0.75) | |
HR−/HER2− | MRI (N = 81) | 55 | 45 | 40 | 15 | 21 | 5 | 0.73 (0.59–0.84) | 0.81 (0.61–0.93) | 0.89 (0.76–0.96) | 0.58 (0.41–0.74) |
US (N = 237) | 156 | 124 | 107 | 49 | 64 | 17 | 0.69 (0.61–0.76) | 0.79 (0.69–0.87) | 0.86 (0.79–0.92) | 0.57 (0.47–0.66) | |
HR−/HER2+ | MRI (N = 42) | 35 | 25 | 25 | 10 | 7 | 0 | 0.71 (0.54–0.85) | 1 (0.59–1) | 1 (0.86–1) | 0.41 (0.18–0.67) |
US (N = 77) | 55 | 44 | 40 | 15 | 18 | 4 | 0.73 (0.59–0.84) | 0.82 (0.60–0.95) | 0.91 (0.78–0.98) | 0.55 (0.36–0.72) |