Table 1 Patient and tumor characteristics (per-protocol set, N = 386)
Parameter | Category | cALND N (%) N = 169 | SLNB alone N (%) N = 217 | Overall N (%) N = 386 |
|---|---|---|---|---|
Age | <35 years | 1 (0.6) | 0 (0.0) | 1 (0.3) |
35 to <50 years | 29 (17.2) | 34 (15.7) | 63 (16.3) | |
50 to <60 years | 60 (35.5) | 75 (34.6) | 135 (35.0) | |
60 to <70 years | 47 (27.8) | 57 (26.3) | 104 (26.9) | |
≥70 years | 32 (18.9) | 51 (23.5) | 83 (21.5) | |
BMI | <30 kg/m2 | 117 (69.2) | 164 (75.6) | 281 (72.8) |
≥30 kg/m2 | 52 (30.8) | 53 (24.4) | 105 (27.2) | |
Preoperative tumor sizea | ≤2 cm | 139 (82.2) | 174 (80.2) | 313 (81.1) |
>2 cm | 30 (17.8) | 43 (19.8) | 73 (18.9) | |
Pathological tumor size | pTis | 0 (0.0) | 1 (0.5) | 1 (0.3) |
pT1 | 99 (58.6) | 129 (59.4) | 228 (59.1) | |
pT2 | 68 (40.2) | 84 (38.7) | 152 (39.4) | |
pT3 | 2 (1.2) | 3 (1.4) | 5 (1.3) | |
Number of involved SLNs (only macrometastases) | 1 | 127 (75.2) | 171 (78.8) | 298 (77.2) |
2 | 34 (20.1) | 41 (18.9) | 75 (19.4) | |
3 | 8 (4.7) | 5 (2.3) | 13 (3.4) | |
Number of all involved LNs (SLNB + cALND) | 1–3 | 150 (88.8) | ||
4–9 | 19 (11.2) | |||
ER/PgR status | Negative | 2 (1.2) | 5 (2.3) | 7 (1.8) |
Positive | 167 (98.8) | 212 (97.7) | 379 (98.2) | |
HER2 status | Negative | 162 (95.9) | 205 (94.9) | 367 (95.3) |
Positive | 7 (4.1) | 11 (5.1) | 18 (4.7) | |
Missing | 0 | 1 | 1 | |
Intrinsic subtype | HR+/HER2− | 160 (94.7) | 201 (93.1) | 361 (93.8) |
TNBC | 2 (1.2) | 4 (1.9) | 6 (1.6) | |
HER2+ | 7 (4.1) | 11 (5.1) | 18 (4.7) | |
Missing | 0 | 1 | 1 | |
Tumor grading | G1 | 45 (26.6) | 63 (29.0) | 108 (28.0) |
G2 | 115 (68.0) | 143 (65.9) | 258 (66.8) | |
G3 | 9 (5.3) | 11 (5.1) | 20 (5.2) | |
Ki-67 | ≤20% | 128 (76.6) | 176 (84.6) | 304 (81.1) |
>20% | 39 (23.4) | 32 (15.4) | 71 (18.9) | |
Missing | 2 | 9 | 11 | |
Histological subtype | Invasive carcinoma (NST) | 125 (74.0) | 155 (71.4) | 280 (72.5) |
Invasive or mixed lobular carcinoma | 22 (13.0) | 25 (11.5) | 47 (12.2) | |
Other | 22 (13.0) | 37 (17.1) | 59 (15.3) |