Table 1.
Baseline characteristics neoadjuvant vs. adjuvant cohort (patients included after third amendment)
| Parameter | Neoadjuvant N = 593 N (%) | Adjuvant N = 291 N (%) | Overall N = 884 N (%) | p-value | |
|---|---|---|---|---|---|
| Age, years | <30 | 24 (4.0) | 1 (0.3) | 25 (2.8) | <0.001 |
| 30–<40 | 86 (14.5) | 28 (9.6) | 114 (12.9) | ||
| 40–<50 | 195 (32.9) | 77 (26.5) | 272 (30.8) | ||
| 50–<60 | 208 (35.1) | 124 (42.6) | 332 (37.6) | ||
| 60–65 | 60 (10.1) | 48 (16.5) | 108 (12.2) | ||
| >65, biologically younger | 20 (3.4) | 13 (4.5) | 33 (3.7) | ||
| Menopausal status | Premenopausal | 338 (57.0) | 144 (49.5) | 482 (54.5) | 0.037 |
| Postmenopausal | 255 (43.0) | 147 (50.5) | 402 (45.5) | ||
| Karnofsky index | 80% | 3 (0.5) | 5 (1.7) | 8 (0.9) | 0.046 |
| 85% | 0 (0.0) | 0 (0.0) | 0 (0.0) | ||
| 90% | 54 (9.1) | 37 (12.7) | 91 (10.3) | ||
| 95% | 0 (0.0) | 0 (0.0) | 0 (0.0) | ||
| 100% | 536 (90.4) | 249 (85.6) | 785 (88.8) | ||
| Bilateral tumor | No | 579 (97.6) | 281 (96.6) | 860 (97.3) | 0.381 |
| Yes | 14 (2.4) | 10 (3.4) | 24 (2.7) | ||
| Tumor focality | Unifocal | 474 (79.9) | 183 (62.9) | 657 (74.3) | <0.001 |
| Multifocal | 77 (13.0) | 66 (22.7) | 143 (16.2) | ||
| Multicentric | 42 (7.1) | 42 (14.4) | 84 (9.5) | ||
| Tumor stage (all)a | c/pT1 | 224 (37.8) | 103 (35.4) | 327 (37.0) | <0.001 |
| c/pT2 | 312 (52.7) | 129 (44.3) | 441 (49.9) | ||
| c/pT3 | 25 (4.2) | 53 (18.2) | 78 (8.8) | ||
| c/pT4 | 31 (5.2) | 6 (2.1) | 37 (4.2) | ||
| Nodal status (all)a | c/pN0-1 | 514 (86.8) | 81 (27.8) | 595 (67.4) | <0.001 |
| c/pN2 | 60 (10.1) | 120 (41.2) | 180 (20.4) | ||
| c/pN3 | 18 (3.0) | 90 (30.9) | 108 (12.2) | ||
| ER/PgR | Both ER and PgR negative | 253 (42.7) | 43 (14.8) | 296 (33.5) | <0.001 |
| ER and/or PgR positive | 340 (57.3) | 248 (85.2) | 588 (66.5) | ||
| sTILsb | Low (0–10%) | 314 (53.1) | 217 (74.6) | 531 (60.2) | <0.001 |
| Intermediate (11–59%) | 225 (38.1) | 60 (20.6) | 285 (32.3) | ||
| High (60–100%) | 52 (8.8) | 14 (4.8) | 66 (7.5) | ||
| Biological subtype | Luminal A high risk | 11 (1.9) | 109 (37.5) | 120 (13.6) | <0.001 |
| Luminal B/HER2- | 138 (23.3) | 108 (37.1) | 246 (27.8) | ||
| Triple negative | 172 (29.0) | 33 (11.3) | 205 (23.2) | ||
| HER2+ER+ and/or PgR+ | 191 (32.2) | 31 (10.7) | 222 (25.1) | ||
| HER2+ non-luminal | 81 (13.7) | 10 (3.4) | 91 (10.3) | ||
| HER2, central | negative | 321 (54.1) | 250 (85.9) | 571 (64.6) | <0.001 |
| positive | 272 (45.9) | 41 (14.1) | 313 (35.4) | ||
| Tumor grading | G1 | 6 (1.0) | 5 (1.7) | 11 (1.2) | <0.001 |
| G2 | 215 (36.3) | 167 (57.4) | 382 (43.2) | ||
| G3 | 372 (62.7) | 119 (40.9) | 491 (55.5) | ||
| Histological tumor type | lobular invasive | 22 (3.7) | 49 (16.8) | 71 (8.0) | <0.001 |
| other | 571 (96.3) | 242 (83.2) | 813 (92.0) | ||
| Ki67, central | ≤20% | 72 (12.1) | 123 (42.3) | 195 (22.1) | <0.001 |
| >20% | 521 (87.9) | 168 (57.7) | 689 (77.9) | ||
aInformation missing from one patient. For patients receiving neoadjuvant treatment, cT and cN were used. For patients receiving adjuvant treatment, pT and pN were used.
bInformation missing from two patients.