Characteristic | Primary study populationa (n = 1166) | HaBCSb (n = 338) | GeparSeptob paclitaxel (n = 392) | GeparSeptob nab-pacitaxel (n = 389) | GeparOctob ETC (n = 269) | |||||
---|---|---|---|---|---|---|---|---|---|---|
No pCR (n = 893) | pCR (n = 273) | No pCR (n = 247) | pCR (n = 91) | No pCR (n = 325) | pCR (n = 67) | No pCR (n = 280) | pCR (n = 109) | No pCR (n = 181) | pCR (n = 88) | |
Age (years) | 52.9 (11.5) | 50.3 (12.4) | 54.9 (12.4) | 50.5 (11.2) | 49.2 (11.0) | 48.5 (11.2) | 49.7 (10.2) | 50.3 (9.5) | 49.2 (10.8) | 47.0 (10.2) |
BMI (kg/m2) | 26.4 (5.2) | 25.1 (4.9) | 25.1 (2.3) | 25.4 (2.6) | 26.5 (5.5) | 25.9 (5.6) | 26.6 (5.5) | 26.0 (5.2) | 26.2 (5.1) | 26.6 (5.5) |
Tumor stage | ||||||||||
cT1 | 185 (20.7) | 110 (40.3) | 36 (14.6) | 23 (25.3) | 96 (29.2) | 31 (46.3) | 79 (28.2) | 52 (47.7) | 64 (35.4) | 36 (40.9) |
cT2 | 567 (63.5) | 148 (54.2) | 179 (72.5) | 62 (68.1) | 177 (54.5) | 34 (50.7) | 158 (56.4) | 50 (54.9) | 90 (49.7) | 48 (43.5) |
cT3 | 48 (5.4) | 5 (1.8) | 15 (6.1) | 4 (4.4) | 32 (9.8) | 1 (1.5) | 24 (8.6) | 2 (1.8) | 20 (11.0) | 3 (3.4) |
cT4 | 93 (10.4) | 10 (3.7) | 17 (6.9) | 2 (2.2) | 20 (6.2) | 1 (1.5) | 19 (6.8) | 5 (4.6) | 7 (3.9) | 1 (1.1) |
Grade | ||||||||||
Grade 1 | 36 (4.0) | 2 (0.7) | 3 (1.2) | 0 (0.0) | 7 (2.2) | 1 (1.5) | 8 (2.9) | 4 (3.7) | 2 (1.1) | 1 (1.1) |
Grade 2 | 401 (44.9) | 34 (12.5) | 71 (28.7) | 6 (6.6) | 141 (43.4) | 15 (22.4) | 138 (49.3) | 27 (24.8) | 62 (34.3) | 4 (4.5) |
Grade 3 | 456 (51.1) | 237 (86.8) | 173 (70.0) | 85 (93.4) | 177 (54.5) | 51 (76.1) | 134 (47.9) | 78 (71.6) | 117 (64.6) | 83 (94.3) |
Lymph node status | ||||||||||
cN0 | 389 (43.6) | 159 (58.2) | 137 (55.5) | 60 (65.9) | 209 (64.3) | 49 (73.1) | 173 (61.8) | 80 (73.4) | 105 (58.0) | 66 (75.0) |
cN + | 504 (56.4) | 114 (41.8) | 110 (44.5) | 31 (34.1) | 116 (35.7) | 18 (26.9) | 107 (38.2) | 29 (26.6) | 76 (32.0) | 22 (25.0) |
Tumor type | ||||||||||
Ductal | 634 (71.0) | 193 (70.7) | 221 (89.5) | 87 (95.6) | 275 (84.6) | 53 (79.1) | 233 (83.2) | 92 (84.4) | 155 (85.6) | 63 (71.6) |
Lobular | 94 (10.5) | 5 (1.8) | 17 (6.9) | 1 (1.1) | 18 (6.6) | 2 (3.0) | 22 (7.9) | 1 (0.9) | 0 (0.0) | 0 (0.0) |
Other | 165 (18.5) | 75 (27.5) | 9 (3.6) | 3 (3.3) | 32 (9.4) | 12 (17.9) | 25 (8.9) | 16 (14.7) | 26 (14.4) | 25 (28.4) |
ER (continuous, 0%–100%) | 55.7 (39.8) | 12.9 (28.4) | 55.5 (42.5) | 9.7 (24.7) | 52.4 (45.3) | 18.5 (34.8) | 60.8 (44.4) | 15.6 (31.8) | 28.8 (43.1) | 3.0 (14.7) |
ER (categorical) | ||||||||||
Negative (< 1%) | 246 (27.5) | 199 (72.9) | 74 (30.0) | 73 (80.2) | 113 (34.8) | 44 (65.7) | 111 (39.6) | 82 (75.2) | 118 (65.2) | 82 (93.2) |
Positive (≥ 1%) | 647 (72.5) | 74 (27.1) | 173 (70.0) | 18 (19.8) | 212 (65.2) | 23 (34.3) | 169 (60.4) | 27 (24.8) | 63 (34.8) | 6 (6.8) |
PgR (continuous, 0%–100%) | 34.1 (36.4) | 4.4 (14.8) | 34.8 (36.4) | 6.2 (19.4) | 28.7 (36.5) | 8.3 (21.5) | 33.1 (37.8) | 7.9 (19.9) | 14.0 (27.9) | 1.3 (8.8) |
PgR (categorical) | ||||||||||
Negative (< 1%) | 332 (37.2) | 225 (82.4) | 102 (41.3) | 77 (84.6) | 142 (43.7) | 48 (71.6) | 111 (39.6) | 82 (75.2) | 125 (69.1) | 84 (95.5) |
Positive (≥ 1%) | 561 (62.8) | 48 (17.6) | 145 (58.7) | 14 (15.4) | 183 (56.3) | 19 (28.4) | 169 (60.4) | 27 (24.8) | 56 (30.9) | 4 (4.5) |
Ki-67 (continuous, 0%–100%) | 37.9 (25.0) | 62.9 (21.0) | 38.4 (22.4) | 58.5 (23.5) | 38.6 (25.4) | 62.0 (23.1) | 37.5 (25.2) | 58.1 (25.0) | 52.0 (21.3) | 66.4 (18.5) |
Ki-67 (categorical) | ||||||||||
Negative (< 14%) | 164 (18.4) | 4 (1.5) | 14 (5.7) | 1 (1.1) | 53 (16.3) | 2 (3.0) | 53 (18.9) | 5 (4.6) | 5 (2.8) | 0 (0.0) |
Positive (≥ 14%) | 729 (81.6) | 269 (98.5) | 233 (94.3) | 90 (98.9) | 272 (83.7) | 65 (97.0) | 227 (81.1) | 104 (95.4) | 176 (97.2) | 88 (100) |
Molecular subtypec | ||||||||||
Luminal A–like | 388 (43.4) | 17 (6.2) | 68 (27.5) | 4 (4.4) | 122 (37.5) | 10 (14.9) | 129 (46.1) | 14 (12.8) | 33 (18.2) | 0 (0.0) |
Luminal B–like | 279 (31.2) | 64 (23.4) | 109 (44.1) | 21 (23.1) | 104 (32.0) | 21 (31.3) | 82 (29.3) | 28 (25.7) | 35 (19.3) | 7 (8.0) |
Triple-negative | 226 (25.3) | 192 (70.3) | 70 (28.3) | 66 (72.5) | 99 (30.5) | 36 (53.7) | 69 (24.6) | 67 (61.5) | 113 (62.4) | 81 (92.0) |
Chemotherapyd | ||||||||||
Anthracycline | 673 (75.4) | 131 (48.0) | 208 (86.7) | 71 (81.6) | 325 (100.0) | 67 (100.0) | 280 (100.0) | 109 (100.0) | 181 (100.0) | 88 (100.0) |
Platinum | 132 (14.8) | 130 (47.6) | 17 (7.1) | 15 (17.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Taxane | 721 (80.7) | 248 (90.8) | 228 (94.2) | 86 (98.9) | 325 (100.0) | 67 (100.0) | 280 (100.0) | 109 (100.0) | 181 (100.0) | 88 (100.0) |