Table 2. Clinicopathological variables and serum HER2 levels at baseline and after 2 cycles of treatment in the study cohort.
Baseline sHER2 levels (N=309) | sHER2 level after 2 cycles of treatment (N=208) | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Low | High | P value | Low | High | P value | ||||||||
N | % | N | % | N | % | N | % | ||||||
Total | 145 | 46.93 | 164 | 53.07 | 177 | 85.10 | 31 | 14.90 | |||||
Age group | 0.252 | 0.321 | |||||||||||
<50 years | 74 | 23.95 | 73 | 23.62 | 80 | 38.46 | 17 | 8.17 | |||||
≥50 years | 71 | 22.98 | 91 | 29.45 | 97 | 46.63 | 14 | 6.73 | |||||
Menstrual status | 0.23 | 0.102 | |||||||||||
Premenopausal | 78 | 25.24 | 77 | 24.92 | 86 | 41.35 | 20 | 9.62 | |||||
Postmenopausal | 67 | 21.68 | 87 | 28.16 | 91 | 43.75 | 11 | 5.29 | |||||
cT | 0.006 | 0.209 | |||||||||||
T1 | 6 | 1.94 | 6 | 1.94 | 5 | 2.40 | 0 | 0.00 | |||||
T2 | 63 | 20.39 | 45 | 14.56 | 64 | 30.77 | 7 | 3.37 | |||||
T3 | 55 | 17.80 | 67 | 21.68 | 70 | 33.65 | 13 | 6.25 | |||||
T4 | 21 | 6.80 | 46 | 14.89 | 38 | 18.27 | 11 | 5.29 | |||||
cN | 0.053 | 0.172 | |||||||||||
N0 | 13 | 4.21 | 8 | 2.59 | 6 | 2.88 | 2 | 0.96 | |||||
N1 | 81 | 26.21 | 74 | 23.95 | 95 | 45.67 | 11 | 5.29 | |||||
N2 | 33 | 10.68 | 55 | 17.80 | 52 | 25.00 | 10 | 4.81 | |||||
N3 | 18 | 5.83 | 27 | 8.74 | 24 | 11.54 | 8 | 3.85 | |||||
Clinical stage | 0.002 | 0.943 | |||||||||||
II | 50 | 16.18 | 31 | 10.03 | 41 | 19.71 | 7 | 3.37 | |||||
III | 95 | 30.74 | 133 | 43.04 | 136 | 65.38 | 24 | 11.54 | |||||
ER status | 0.029 | 0.424 | |||||||||||
Negative | 66 | 21.36 | 95 | 30.74 | 89 | 42.79 | 18 | 8.65 | |||||
Positive | 79 | 25.57 | 69 | 22.33 | 88 | 42.31 | 13 | 6.25 | |||||
PgR status | 0.282 | 0.969 | |||||||||||
Negative | 98 | 31.72 | 120 | 38.83 | 125 | 60.10 | 22 | 10.58 | |||||
Positive | 47 | 15.21 | 44 | 14.24 | 52 | 25.00 | 9 | 4.33 | |||||
Subtype | 0.029 | 0.424 | |||||||||||
Luminal B | 79 | 25.57 | 69 | 22.33 | 88 | 42.31 | 13 | 6.25 | |||||
HER2-enriched | 66 | 21.36 | 95 | 30.74 | 89 | 42.79 | 18 | 8.65 | |||||
Overall tumor response | 0.784 | 0.626 | |||||||||||
CR | 12 | 3.88 | 12 | 3.88 | 15 | 7.21 | 2 | 0.96 | |||||
PR | 131 | 42.39 | 148 | 47.90 | 160 | 76.92 | 28 | 13.46 | |||||
SD | 2 | 0.65 | 3 | 0.97 | 2 | 0.96 | 1 | 0.48 | |||||
PD | 0 | 0.00 | 1 | 0.32 | 0 | 0.00 | 0 | 0.00 | |||||
pCR | 0.159 | 0.038 | |||||||||||
No | 76 | 24.60 | 99 | 32.04 | 96 | 46.15 | 23 | 11.06 | |||||
Yes | 69 | 22.33 | 65 | 21.04 | 81 | 38.94 | 8 | 3.85 | |||||
Miller-Payne grade | 0.024 | 0.013 | |||||||||||
1 | 8 | 2.59 | 5 | 1.62 | 6 | 2.88 | 0 | 0.00 | |||||
2 | 0 | 0.00 | 12 | 3.88 | 5 | 2.40 | 4 | 1.92 | |||||
3 | 23 | 7.44 | 30 | 9.71 | 29 | 13.94 | 10 | 4.81 | |||||
4 | 28 | 9.06 | 32 | 10.36 | 36 | 17.31 | 7 | 3.37 | |||||
5 | 71 | 22.98 | 68 | 22.01 | 83 | 39.90 | 7 | 3.37 | |||||
NA | 15 | 4.85 | 17 | 5.50 | 18 | 8.65 | 3 | 1.44 | |||||
iDFS events | 0.015 | 0.003 | |||||||||||
No | 138 | 44.66 | 143 | 46.28 | 166 | 79.81 | 24 | 11.54 | |||||
Yes | 7 | 2.27 | 21 | 6.80 | 11 | 5.29 | 7 | 3.37 | |||||
Surgery | 0.003 | 0.080 | |||||||||||
Mastectomy | 117 | 37.86 | 151 | 48.87 | 151 | 72.60 | 30 | 14.42 | |||||
Breast conserving | 28 | 9.06 | 13 | 4.21 | 26 | 12.50 | 1 | 0.48 |
According to AJCC Cancer Staging Manual, Eighth Edition (2017): cT, clinical primary tumor size; cN, clinical regional lymph nodes. sHER2, serum human epidermal growth factor receptor 2; ER, estrogen receptor; PgR, progesterone receptor; HER2, human epidermal growth factor receptor 2; CR, complete response; PR, partial response; SD, stable disease; PD, progressive disease; pCR, pathological complete response; NA, not available; iDFS, invasive disease-free survival.