Introduction
Materials and methods
Patient selection
Pathology
Imaging data
Gene expression assay and tumor percentage
Validation cohort
Data analyses and statistics
Results
Patient selection in cohort
Association with clinical characteristics
No GE data available (n = 347) | GE data available (n = 391) |
p value | ||
---|---|---|---|---|
Age | < 50 | 189 (55%) | 237 (61%) | 0.13 |
> = 50 | 153 (45%) | 153 (39%) | ||
Unknown | 5 | 1 | ||
Histology | IDC | 244 (87%) | 291 (90%) | 0.25 |
ILC | 38 (13%) | 34 (10%) | ||
Unknown | 65 | 66 | ||
Subtype | ER+, Her2− | 182 (53%) | 182 (47%) | 0.25 |
Her2+ | 73 (21%) | 96 (25%) | ||
Tripleneg | 91 (26%) | 113 (29%) | ||
Unknown | 1 | 0 | ||
ER | ER neg | 122 (35%) | 149 (38%) | 0.44 |
ER pos | 223 (65%) | 242 (62%) | ||
Unknown | 2 | 0 | ||
HER2 | Her2 neg | 272 (79%) | 293 (75%) | 0.26 |
Her2 pos | 73 (21%) | 96 (25%) | ||
Unknown | 2 | 2 | ||
Grade | Grade 1 & 2 | 184 (70%) | 158 (48%) |
< 0.01
|
Grade 3 | 80 (30%) | 170 (52%) | ||
Unknown | 83 | 63 | ||
T-stage | T1/T2 | 232 (68%) | 270(70%) | 0.65 |
T3/T4 | 109 (32%) | 118 (30%) | ||
Unknown | 6 | 3 | ||
N-stage | Neg | 104 (30%) | 94 (24%) | 0.06 |
Pos | 239 (70%) | 294 (76%) | ||
Unknown | 4 | 3 | ||
Response (breast and lymph node) | No pCR | 270 (79%) | 293 (75%) | 0.22 |
pCR | 72 (21%) | 97 (25%) | ||
Unknown | 5 | 1 | ||
Ki-67 | > 15% | 103 (49%) | 98 (49%) | 0.95 |
≤ 15% | 107 (51%) | 103 (51%) | ||
Unknown | 137 | 190 | ||
Mass (MRI) | Non-mass | 47 (55%) | 53 (55%) | 0.94 |
Mass | 39 (45%) | 43 (45%) | ||
Unknown | 261 | 295 | ||
Maximal SUV-uptake mean (sd) | 7.19 (4.55) | 10.03 (6.79) |
0.03
| |
Unknown | 259 | 294 |
Variable | Frequency | Odds ratio | 95% CI |
p value | |
---|---|---|---|---|---|
Age | < 50 | 339 | 1.00 | ||
> = 50 | 245 | 0.91 | 0.64–1.28 | 0.58 | |
ER | ER neg | 218 | 1.00 | ||
ER pos | 366 | 1.19 | 0.81–1.74 | 0.38 | |
HER2 | Her2 neg | 440 | 1.00 | ||
Her2 pos | 144 | 1.20 | 0.81–1.80 | 0.36 | |
Grade | Grade 1 & 2 | 336 | 1.00 | ||
Grade 3 | 248 | 2.56 | 1.77–3.71 |
< 0.01
| |
T-stage | T1/T2 | 408 | 1.00 | ||
T3/T4 | 176 | 0.94 | 0.65–1.35 | 0.73 | |
N-stage | Neg | 163 | 1.00 | ||
Pos | 421 | 1.53 | 1.05–2.23 |
0.03
|
Association with treatment response and survival
Frozen tissue available | Quality of frozen biopsy | Tumor % | RNA quality and quantity | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
No | Yes |
p value | Insufficient | Sufficient |
p value | < 50% | > = 50% |
p value | Insufficient | Sufficient |
p value | ||
(n = 73) | (n = 665) | (n = 78) | (n = 587) | (n = 126) | (n = 461) | (n = 70) | (n = 391) | ||||||
Age | <50 | 44 (62%) | 382 (58%) | 0.50 | 34 (45%) | 348 (59%) |
0.02
| 77 (61%) | 271 (59%) | 0.66 | 34 (49%) | 237 (61%) | 0.06 |
> = 50 | 27 (38%) | 279 (42%) | 41 (55%) | 238 (41%) | 49 (39%) | 189 (41%) | 36 (51%) | 153 (39%) | |||||
Unknown | 2 | 4 | 3 | 1 | 0 | 1 | 0 | 1 | |||||
Histology | IDC | 58 (92%) | 477 (88%) | 0.31 | 49 (85%) | 428 (88%) | 0.43 | 88 (87%) | 340 (88%) | 0.74 | 49 (82%) | 291 (90%) | 0.08 |
ILC | 5 (8%) | 67 (12%) | 9 (16%) | 58 (12%) | 13 (13%) | 45 (12%) | 11 (18%) | 34 (11%) | |||||
Unknown | 10 | 121 | 20 | 101 | 25 | 76 | 10 | 66 | |||||
Subtype | ER+,Her2− | 33 (45%) | 331 (50%) | 0.62 | 46 (60%) | 285 (49%) | 0.18 | 62 (49%) | 223 (48%) | 0.79 | 41 (59%) | 182 (47%) |
0.04
|
Her2+ | 20 (28%) | 150 (23%) | 14 (18%) | 136 (23%) | 31 (24%) | 104 (23%) | 8 (11%) | 96 (25%) | |||||
Triple negative | 20 (28%) | 183 (27%) | 17 (22%) | 167 (28%) | 33 (26%) | 134 (29%) | 21 (30%) | 113 (29%) | |||||
Unknown | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | |||||
ER | ER neg | 26 (36%) | 245 (37%) | 0.82 | 24 (32%) | 221 (38%) | 0.30 | 48 (38%) | 173 (38%) | 0.91 | 24 (34%) | 149 (38%) | 0.54 |
ER pos | 47 (64%) | 418 (63%) | 52 (68%) | 366 (62%) | 78 (62%) | 288 (63%) | 46 (66%) | 242 (62%) | |||||
Unknown | 2 | 2 | 2 | 0 | 0 | 0 | 0 | 0 | |||||
Her2 | Her2 Neg | 52 (72%) | 513 (78%) | 0.31 | 63 (82%) | 450 (77%) | 0.33 | 95 (75%) | 355 (77%) | 0.65 | 62 (89%) | 293 (75%) |
0.02
|
Her2 pos | 20 (28%) | 149 (22%) | 14 (18%) | 135 (23%) | 31 (25%) | 104 (23%) | 8 (11%) | 96 (25%) | |||||
Unknown | 1 | 3 | 1 | 2 | 0 | 2 | 0 | 2 | |||||
Grade | Grade 1 & 2 | 36 (72%) | 306 (57%) |
0.03
| 43 (72%) | 263 (55%) |
0.01
| 61 (66%) | 202 (52%) |
0.02
| 44 (72%) | 158 (48%) |
< 0.01
|
Grade 3 | 14 (28%) | 236 (43%) | 17 (28%) | 219 (45%) | 32 (34%) | 187 (48%) | 17 (28%) | 170 (52%) | |||||
Unknown | 23 | 123 | 18 | 105 | 33 | 72 | 9 | 63 | |||||
T-stage | T1/T2 | 43 (61%) | 459 (70%) | 0.11 | 58 (78%) | 401 (69%) | 0.09 | 84 (67%) | 317 (69%) | 0.59 | 47 (67%) | 270 (70%) | 0.68 |
T3/T4 | 28 (39%) | 199 (30%) | 16 (22%) | 183 (31%) | 42 (33%) | 141 (31%) | 23 (33%) | 118 (30%) | |||||
Unknown | 2 | 7 | 4 | 3 | 0 | 3 | 0 | 3 | |||||
N-stage | Neg | 21 (29%) | 177 (27%) | 0.68 | 21 (28%) | 156 (27%) | 0.81 | 35 (28%) | 121 (26%) | 0.76 | 27 (39%) | 94 (24%) |
0.01
|
Pos | 51 (71%) | 482 (83%) | 54 (72%) | 428 (73%) | 91 (72%) | 337 (74%) | 43 (61%) | 294 (76%) | |||||
Unknown | 1 | 6 | 3 | 3 | 0 | 3 | 0 | 3 | |||||
Response | No pCR | 55 (76%) | 508 (77%) | 0.91 | 65 (88%) | 443 (76%) |
0.02
| 98 (78%) | 345 (75%) | 0.52 | 52 (74%) | 293 (75%) | 0.88 |
pCR | 17 (24%) | 152 (23%) | 9 (12%) | 143 (24%) | 28 (22%) | 115 (25%) | 18 (26%) | 97 (25%) | |||||
Unknown | 1 | 5 | 4 | 1 | 0 | 1 | 0 | 1 |
Results in the validation dataset
n = 585 | ||||
---|---|---|---|---|
No GE data available (n = 158) | GE data available (n = 427) |
p value | ||
Age | < 50 yr | 86 (54%) | 251 (59%) | 0.34 |
≥ 50 yr | 72 (46%) | 176 (41%) | ||
Unknown | 0 | 0 | ||
Histology | IDC | 125 (79%) | 345 (81%) | 0.11 |
ILC | 12 (7%) | 47 (11%) | ||
Rest | 21 (13%) | 35 (8%) | ||
Unknown | 0 | 0 | ||
Subtype | Luminal | 121 (77%) | 312 (73%) | 0.49 |
Her2 | 19 (12%) | 48 (11%) | ||
Triple negative | 18 (11%) | 65 (15%) | ||
Unknown | 0 | 2 | ||
ER | ER Neg | 23 (15%) | 85 (20%) | 0.14 |
ER Pos | 135 (85%) | 342 (80%) | ||
Unknown | 0 | 0 | ||
Her2 | Her2 Neg | 119 (75%) | 358 (88%) | 0.55 |
Her2 Pos | 19 (14%) | 48 (1%) | ||
unknown | 20 | 21 | ||
Grade | Grade 1 & 2 | 120 (76%) | 291 (68%) |
0.05
|
Grade 3 | 37 (24%) | 136 (32%) | ||
Unknown | 1 | 0 | ||
T-stage | T1/T2 | 158 (100%) | 426 (99%) | 0.54 |
T3/T4 | 0 | 1 (1%) | ||
Unknown | 0 | 0 |