Characteristics | Training cohort (n = 242) | p-value | Internal validation cohort (n = 197) | p-value | External test cohort1 (n = 212) | p-value | External test cohort2 (n = 150) | p-value | ||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
pCR (n = 71) | NpCR (n = 171) | pCR (n = 57) | NpCR (n = 140) | pCR (n = 77) | NpCR (n = 135) | pCR (n = 38) | NpCR (n = 112) | |||||
Age | Â | Â | 0.4 | Â | Â | 0.4 | Â | Â | 0.4 | Â | Â | 0.7 |
  < 40 | 19 (27%) | 35 (20%) |  | 9 (16%) | 25 (18%) |  | 10 (13%) | 26 (19%) |  | 5 (13%) | 18 (16%) |  |
  40–50 | 30 (42%) | 69 (40%) |  | 27 (47%) | 65 (46%) |  | 34 (44%) | 50 (37%) |  | 10 (26%) | 35 (31%) |  |
  > 50 | 22 (31%) | 67 (39%) |  | 21 (37%) | 50 (36%) |  | 33 (43%) | 59 (44%) |  | 23 (61%) | 59 (53%) |  |
Menstruation | Â | Â | 0.3 | Â | Â | 0.6 | Â | Â | 0.6 | Â | Â | 0.069 |
  No | 55 (77%) | 122 (71%) |  | 40 (70%) | 101 (72%) |  | 41 (53%) | 67 (50%) |  | 17 (45%) | 69 (62%) |  |
  Yes | 16 (23%) | 49 (29%) |  | 17 (30%) | 39 (28%) |  | 36 (47%) | 68 (50%) |  | 21 (55%) | 43 (38%) |  |
Ki-67 | Â | Â | 0.4 | Â | Â | 0.2 | Â | Â | 0.2 | Â | Â | 0.058 |
  Negative | 16 (23%) | 48 (28%) |  | 10 (18%) | 43 (31%) |  | 16 (21%) | 38 (28%) |  | 2 (5.3%) | 20 (18%) |  |
  Positive | 55 (77%) | 123 (72%) |  | 47 (82%) | 97 (69%) |  | 61 (79%) | 97 (72%) |  | 36 (95%) | 92 (82%) |  |
ER |  |  | 0.2 |  |  |  < 0.001 |  |  |  < 0.001 |  |  | 0.003 |
  Negative | 26 (37%) | 48 (28%) |  | 21 (37%) | 35 (25%) |  | 51 (66%) | 38 (28%) |  | 21 (55%) | 32 (29%) |  |
  Positive | 45 (63%) | 123 (72%) |  | 36 (63%) | 105 (75%) |  | 26 (34%) | 97 (72%) |  | 17 (45%) | 80 (71%) |  |
PR |  |  | 0.4 |  |  |  < 0.001 |  |  |  < 0.001 |  |  |  < 0.001 |
  Negative | 22 (31%) | 44 (26%) |  | 17 (30%) | 33 (24%) |  | 58 (75%) | 57 (42%) |  | 31 (82%) | 55 (49%) |  |
  Positive | 49 (69%) | 127 (74%) |  | 40 (70%) | 107 (76%) |  | 19 (25%) | 78 (58%) |  | 7 (18%) | 57 (51%) |  |
Her2 |  |  | 0.043 |  |  |  < 0.001 |  |  |  < 0.001 |  |  | 0.5 |
  Negative | 34 (48%) | 106 (62%) |  | 31 (54%) | 100 (71%) |  | 23 (30%) | 80 (59%) |  | 21 (55%) | 69 (62%) |  |
  Positive | 37 (52%) | 65 (38%) |  | 26 (46%) | 40 (29%) |  | 54 (70%) | 55 (41%) |  | 17 (45%) | 43 (38%) |  |
NAC protocols | Â | Â | 0.3 | Â | Â | 0.068 | Â | Â | 0.068 | Â | Â | 0.15 |
  Anthracycline-based | 47 (66%) | 110 (64%) |  | 43 (75%) | 92 (66%) |  | 29 (38%) | 55 (41%) |  | 4 (11%) | 28 (25%) |  |
  Taxane-based | 10 (14%) | 36 (21%) |  | 9 (16%) | 27 (19%) |  | 42 (55%) | 56 (41%) |  | 7 (18%) | 14 (12%) |  |
  Anthracycline and Taxane-based | 14 (20%) | 25 (15%) |  | 5 (8.8%) | 21 (15%) |  | 6 (7.8%) | 24 (18%) |  | 27 (71%) | 70 (62%) |  |
Subtype |  |  | 0.10 |  |  |  < 0.001 |  |  |  < 0.001 |  |  | 0.004 |
  HER2(+) | 37 (52%) | 64 (37%) |  | 26 (46%) | 40 (29%) |  | 54 (70%) | 55 (41%) |  | 17 (45%) | 45 (40%) |  |
Triple-negative | 7 (9.9%) | 19 (11%) | Â | 6 (11%) | 17 (12%) | Â | 16 (21%) | 17 (13%) | Â | 12 (32%) | 13 (12%) | Â |
  Her2(−)&HR( +) | 27 (38%) | 88 (51%) |  | 25 (44%) | 83 (59%) |  | 7 (9.1%) | 63 (47%) |  | 9 (24%) | 54 (48%) |  |
Diameter (mean ± sd) | 3.438 ± 1.345 | 3.604 ± 1.285 | 0.378 | 3.182 ± 1.364 | 3.795 ± 1.272 | 0.064 | 2.121 ± 1.387 | 2.974 ± 2.232 |  < 0.0001 | 1.926 ± 0.955 | 2.291 ± 0.963 | 0.056 |
P0-signature | − 0.16 (1.75) | − 1.37 (1.44) |  < 0.001 | − 0.14 (2.60) | − 1.69 (1.89) |  < 0.001 | 0.59 (5.02) | − 2.73 (3.20) |  < 0.001 | − 0.4 (3.4) | − 4.0 (10.3) |  < 0.001 |
P1-signature | − 0.09 (1.49) | − 2.95 (5.43) |  < 0.001 | 0.12 (2.77) | − 2.42 (4.78) |  < 0.001 | 0.7 (3.0) | − 3.0 (6.2) |  < 0.001 | 0.4 (1.3) | − 3.1 (6.5) |  < 0.001 |
P2-signature | 0.13 (1.33) | − 2.77 (3.17) |  < 0.001 | 1.0 (1.6) | − 2.3 (3.9) |  < 0.001 | 1.8 (2.0) | − 2.8 (4.3) |  < 0.001 | 0.6 (1.6) | − 2.4 (3.5) |  < 0.001 |
Radiologist interpretation |  |  | 0.030 |  |  |  < 0.001 |  |  |  < 0.001 |  |  |  < 0.001 |
  NpCR | 59 (83%) | 158 (92%) |  | 48 (84%) | 128 (91%) |  | 47 (61%) | 118 (87%) |  | 21 (55%) | 112 (100%) |  |
  pCR | 12 (17%) | 13 (7.6%) |  | 9 (16%) | 12 (8.6%) |  | 30 (39%) | 17 (13%) |  | 17 (45%) | 0 (0%) |  |