Department of Breast Disease, Henan Breast Cancer Center, The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou, China
Copyright © 2023 by the Korean Cancer Association
This is an Open-Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Ethical Statement
This study was conducted in accordance with the standards set out in the Declaration of Helsinki. This study was approved by the Medical Ethics Committee of Henan Cancer Hospital (Research Approval Number: 2022-299). The Medical Ethics Committee of Henan Cancer Hospital granted exemption from informed consent for the study given its retrospective nature.
Author Contributions
Conceived and designed the analysis: Ma Y, Chen X, Liu Z.
Collected the data: Ma Y, Zhu M, Zhang J, Lv M.
Contributed data or analysis tools: Ma Y, Zhu M, Zhang J, Chen X.
Performed the analysis: Ma Y, Zhu M, Zhang J, Lv M, Liu Z.
Wrote the paper: Ma Y, Zhu M, Chen X, Liu Z.
Funding acquisition: Ma Y, Liu Z.
Conflicts of Interest
Conflict of interest relevant to this article was not reported.
Clinicopathological characteristics associated with change in HER2 status
Characteristic | Total | HER2-0, n (%) | HER2-low, n (%) | Univariate analysis |
Multivariate analysis | |||
---|---|---|---|---|---|---|---|---|
χ2 | p-value | OR | 95% CI | p-value | ||||
Age at diagnosis (yr) | ||||||||
< 50 | 396 | 131 (33.1) | 265 (66.9) | 9.988 | 0.002 | 1.196 | 0.728–1.966 | 0.480 |
≥ 50 | 294 | 65 (22.1) | 229 (77.9) | |||||
Menopausal status | ||||||||
Premenopausal | 438 | 145 (33.1) | 293 (66.9) | 13.022 | < 0.001 | 2.111 | 1.245–3.579 | 0.006 |
Postmenopausal | 252 | 51 (20.2) | 201 (79.8) | |||||
cT | ||||||||
T1 | 49 | 17 (34.7) | 32 (65.3) | 1.615 | 0.656 | - | - | - |
T2 | 499 | 138 (27.7) | 361 (72.3) | |||||
T3 | 105 | 32 (30.5) | 73 (69.5) | |||||
T4 | 37 | 9 (24.3) | 28 (75.7) | |||||
cN | ||||||||
N0 | 128 | 34 (26.6) | 94 (73.4) | 1.447 | 0.695 | - | - | - |
N1 | 345 | 95 (27.5) | 250 (72.5) | |||||
N2 | 49 | 17 (34.7) | 32 (65.3) | |||||
N3 | 168 | 50 (29.8) | 118 (70.2) | |||||
HR (%) | ||||||||
< 10 | 244 | 107 (43.9) | 137 (56.1) | 44.288 | < 0.001 | 3.389 | 2.359–4.870 | < 0.001 |
≥ 10 | 446 | 89 (20.0) | 357 (80.0) | |||||
Ki-67 (%) | ||||||||
< 20 | 54 | 7 (13.0) | 47 (87.0) | 6.902 | 0.009 | 0.521 | 0.226–1.201 | 0.126 |
≥ 20 | 635 | 189 (29.8) | 446 (70.2) |
CI, confidence interval; HER2, human epidermal growth factor receptor 2; HR, hormone receptor; OR, odds ratio.
Clinicopathological characteristics associated with pCR
Characteristic | Total | Non-pCR, n (%) | pCR, n (%) | Univariate analysis |
Multivariate analysis | |||
---|---|---|---|---|---|---|---|---|
χ2 | p-value | OR | 95% CI | p-value | ||||
Age at diagnosis (yr) | ||||||||
< 50 | 396 | 328 (82.8) | 68 (17.2) | 0.171 | 0.680 | - | - | |
≥ 50 | 294 | 247 (84.0) | 47 (16.0) | |||||
Menopausal status | ||||||||
Premenopausal | 438 | 367 (83.8) | 71 (16.2) | 0.180 | 0.671 | - | - | |
Postmenopausal | 252 | 208 (82.5) | 44 (17.5) | |||||
cT | ||||||||
T1 | 49 | 37 (75.5) | 12 (24.5) | 10.124 | 0.018 | Reference | 0.036 | |
T2 | 498 | 408 (81.9) | 90 (18.1) | 0.594 | 0.281–1.255 | 0.172 | ||
T3 | 105 | 93 (88.6) | 12 (11.4) | 0.319 | 0.123–0.827 | 0.019 | ||
T4 | 37 | 36 (97.3) | 1 (2.7) | 0.103 | 0.012–0.872 | 0.037 | ||
cN | ||||||||
N0 | 127 | 95 (74.8) | 32 (25.2) | 14.014 | 0.003 | Reference | 0.014 | |
N1 | 345 | 285 (82.6) | 60 (17.4) | 0.801 | 0.473–1.354 | 0.407 | ||
N2 | 49 | 41 (83.7) | 8 (16.3) | 0.599 | 0.238–1.510 | 0.277 | ||
N3 | 168 | 153 (91.1) | 15 (8.9) | 0.329 | 0.163–0.664 | 0.002 | ||
HR (%) | ||||||||
< 10 | 244 | 168 (68.9) | 76 (31.1) | 56.994 | < 0.001 | Reference | < 0.001 | |
≥ 10 | 446 | 407 (91.3) | 39 (8.7) | 0.228 | 0.144–0.361 | < 0.001 | ||
Ki-67 (%) | ||||||||
< 20 | 54 | 50 (92.6) | 4 (7.4) | 3.632 | 0.057 | - | - | |
≥ 20 | 635 | 524 (82.5) | 111 (17.5) | |||||
HER2 | ||||||||
0 | 196 | 151 (77.0) | 45 (23.0) | 7.805 | 0.005 | Reference | - | |
IHC 1+/2+(FISH−) | 494 | 424 (85.8) | 70 (14.2) | 0.800 | 0.505–1.265 | 0.340 |
CI, confidence interval; FISH, fluorescence in situ hybridization; HER2, human epidermal growth factor receptor 2; HR, hormone receptor; IHC, immunohistochemistry; OR, odds ratio; pCR, pathological complete response.
Cox proportional hazards model for clinicopathological characteristics associated with DFS
Characteristic | Total | No-DFS events, n (%) | DFS events, n (%) | Univariate analysis |
Multivariate analysis | |||
---|---|---|---|---|---|---|---|---|
χ2 | p-value | OR | 95% CI | p-value | ||||
Age at diagnosis (yr) | ||||||||
< 50 | 396 | 329 (83.1) | 67 (16.9) | 0.007 | 0.792 | - | - | |
≥ 50 | 294 | 242 (82.3) | 52 (17.7) | |||||
Menopausal status | ||||||||
Premenopausal | 438 | 365 (83.3) | 73 (16.7) | 0.282 | 0.595 | - | - | |
Postmenopausal | 252 | 206 (81.7) | 46 (18.3) | |||||
cT | ||||||||
T0 | 17 | 15 (88.2) | 2 (11.8) | 13.731 | 0.030 | - | 0.085 | |
T1 | 214 | 178 (83.2) | 36 (16.8) | |||||
T2 | 114 | 79 (69.3) | 35 (30.7) | |||||
T3 | 5 | 2 (40.0) | 3 (60.0) | |||||
cN | ||||||||
N0 | 116 | 104 (89.7) | 12 (10.3) | 30.932 | < 0.001 | Reference | < 0.001 | |
N1 | 110 | 88 (80.0) | 22 (20.0) | 1.335 | 0.569–3.131 | 0.506 | ||
N2 | 61 | 48 (78.7) | 13 (21.3) | 4.340 | 1.689–11.155 | 0.020 | ||
N3 | 63 | 34 (54.0) | 29 (46.0) | 10.634 | 4.868–23.233 | < 0.001 | ||
HR (%) | ||||||||
< 10 | 244 | 188 (77.0) | 56 (23.0) | 8.607 | 0.003 | Reference | ||
≥ 10 | 446 | 383 (85.9) | 63 (14.1) | 0.387 | 0.267–0.560 | < 0.001 | ||
HER2 | ||||||||
0 | 196 | 157 (80.1) | 39 (19.9) | 1.349 | 0.246 | - | - | |
IHC 1+/2+ (FISH−) | 494 | 414 (83.8) | 80 (16.2) | |||||
Ki-67 (%) | ||||||||
< 20 | 54 | 48 (88.9) | 6 (11.1) | 1.556 | 0.212 | - | - | |
≥ 20 | 635 | 522 (82.2) | 113 (17.8) | |||||
Radiotherapy | ||||||||
No | 85 | 68 (80.0) | 17 (20.0) | 0.515 | 0.473 | - | - | |
Yes | 605 | 503 (83.1) | 102 (16.9) | |||||
pCR | ||||||||
No | 575 | 461 (80.2) | 114 (19.8) | 16.087 | < 0.001 | Reference | ||
Yes | 115 | 110 (95.7) | 5 (4.3) | 0.203 | 0.081–0.506 | 0.001 |
CI, confidence interval; DFS, disease-free survival; FISH, fluorescence in situ hybridization; HER2, human epidermal growth factor receptor 2; HR, hormone receptor; IHC, immunohistochemistry; OR, odds ratio; pCR, pathological complete response.
Clinicopathological characteristics associated with HER2-negative and HER2-positive status after NACT
Characteristic | Total | HER2-negative after NACT, n (%) | HER2-positive after NACT, n (%) | Univariate analysis |
Multivariate analysis | |||
---|---|---|---|---|---|---|---|---|
χ2 | p-value | OR | 95% CI | p-value | ||||
Age at diagnosis (yr) | ||||||||
< 50 | 325 | 292 (89.8) | 33 (10.2) | 0.002 | 0.965 | - | - | - |
≥ 50 | 239 | 215 (90.0) | 24 (10.0) | |||||
Menopausal status | ||||||||
Premenopausal | 364 | 328 (90.1) | 36 (9.9) | 0.053 | 0.818 | - | - | - |
Postmenopausal | 200 | 179 (89.5) | 21 (10.5) | |||||
cT | ||||||||
T1 | 37 | 35 (94.6) | 2 (5.4) | 1.503 | 0.682 | - | - | - |
T2 | 401 | 357 (89.0) | 44 (11.0) | |||||
T3 | 90 | 82 (91.1) | 8 (8.9) | |||||
T4 | 36 | 33 (91.7) | 3 (8.3) | |||||
cN | ||||||||
N0 | 94 | 89 (94.7) | 5 (5.3) | 6.603 | 0.086 | - | - | 0.227 |
N1 | 277 | 241 (87.0) | 36 (13.0) | |||||
N2 | 40 | 35 (87.5) | 5 (12.5) | |||||
N3 | 153 | 142 (92.8) | 11 (7.2) | |||||
HR (%) | ||||||||
< 10 | 160 | 156 (97.5) | 4 (2.5) | 14.225 | < 0.001 | 3.995 | 1.391–11.469 | 0.010 |
≥ 10 | 404 | 351 (86.9) | 53 (13.1) | |||||
Ki-67 (%) | ||||||||
< 20 | 50 | 42 (84.0) | 8 (16.0) | 2.082 | 0.149 | - | - | - |
≥ 20 | 513 | 464 (90.4) | 49 (9.6) | |||||
HER2 | ||||||||
0 | 150 | 147 (98.0) | 3 (2.0) | 14.781 | < 0.001 | 5.798 | 1.763–19.072 | 0.004 |
IHC 1+/2+ (FISH−) | 414 | 360 (87.0) | 54 (13.0) |
CI, confidence interval; FISH, fluorescence in situ hybridization; HER2, human epidermal growth factor receptor 2; HR, hormone receptor; IHC, immunohistochemistry; NACT, neoadjuvant chemotherapy; OR, odds ratio.
CI, confidence interval; HER2, human epidermal growth factor receptor 2; HR, hormone receptor; OR, odds ratio.
CI, confidence interval; FISH, fluorescence
CI, confidence interval; DFS, disease-free survival; FISH, fluorescence
CI, confidence interval; FISH, fluorescence