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Table 1 Distributions of serum human epidermal growth factor receptor-2 (HER2) extracellular domain (ECD) levels and proportions of patients with elevated serum HER2 ECD levels (i.e., >15.2 ng/ml) according to subgroups stratified according to various clinicopathologic variables ( n = 2,862)

From: Preoperative serum HER2 extracellular domain levels in primary invasive breast cancer

Subgroup classified by variables

n(%)

Serum HER2 ECD level (ng/ml)

P a

Patients with HER2 ECD >15.2 ng/ml

 

Mean ± SD

Median (range)

 

n

%b

Total patients

2,862 (100%)

10.1 ± 9.4

9.2 (3.3–427.8)

 

126

4.4%

Age, years

   

0.149

  

  ≤ 34

172 (6%)

10.1 ± 5.6

8.8 (4.8–56.0)

 

10

5.8%

 35–49

1,510 (53%)

9.8 ± 12.1

8.8 (3.3–427.8)

 

55

3.6%

  ≥ 50

1,180 (41%)

10.5 ± 9.4

9.8 (4.4–90.1)

 

61

5.2%

Stage

   

<0.001

  

 I/II

2,457 (86%)

9.6 ± 4.6

9.1 (3.3–184.3)

 

81

3.3%

 III

405 (14%)

12.8 ± 22.1

10.1 (5.5–427.8)

 

45

11.1%

Tumor size, cm

   

0.001

  

  ≤ 2

1,676 (59%)

9.6 ± 5.1

9.0 (3.3–184.3)

 

51

3.0%

  > 2

1,186 (41%)

10.8 ± 13.2

9.5 (3.8–427.8)

 

75

6.3%

Lymph node

   

<0.001

  

 Negative

1,749 (61%)

9.6 ± 3.0

9.0 (3.3–48.2)

 

55

3.1%

 Positive

1,113 (39%)

11.0 ± 14.6

9.4 (4.3–427.8)

 

71

6.4%

Histologic grade

      

 1/2

1,787 (64%)

9.7 ± 5.5

9.0 (3.8–184.3)

0.002

53

3.0%

 3

1,025 (36%)

10.8 ± 13.8

9.5 (4.6–427.8)

 

71

6.9%

 Unknown

50

   

2

 

Nuclear grade

   

0.006

  

 1/2

1,775 (63%)

9.6 ± 5.4

9.0 (3.3–184.3)

 

45

2.5%

 3

1,049 (37%)

10.6 ± 13.6

9.4 (4.6–427.8)

 

65

6.2%

 Unknown

38

   

16

 

LVI

   

0.018

  

 Negative

2,095 (76%)

9.8 ± 3.7

9.1 (3.3–67.5)

 

88

4.2%

 Positive

660 (24%)

10.3 ± 8.5

9.3 (3.8–184.3)

 

29

4.4%

 Unknown

107

   

9

 

Hormone-receptor status

   

<0.001

  

 Negative

916 (32%)

11.5 ± 15.0

9.8 (4.6–427.8)

 

85

9.3%

 Positivec

1,940 (68%)

9.5 ± 4.7

9.0 (3.3–184.3)

 

41

2.1%

 Unknown

6

   

0

 

Tissue HER2 status

   

<0.001

  

 Negative

2,168 (76%)

9.3 ± 4.3

8.9 (3.8–184.3)

 

22

1.0%

 Positived

692 (24%)

12.8 ± 17.3

10.6 (3.3–427.8)

 

104

15.0%

 Unknown

2

   

0

 

Definitive surgery

   

<0.001

  

 Conservation

1,781 (62%)

9.3 ± 2.5

8.9 (3.3–44.8)

 

38

2.1%

 Mastectomy

1,081 (38%)

11.4 ± 14.9

9.7 (4.3–427.8)

 

88

8.1%

Radiotherapy

   

0.135

  

 Yes

2,047 (72%)

9.9 ± 10.2

9.1 (3.3–427.8)

 

74

3.6%

 No

813 (28%)

10.5 ± 7.1

9.6 (4.3–184.3)

 

52

6.4%

 Unknown

2

   

0

 

Chemotherapy

   

<0.001

  

 Yes

1,852 (65%)

10.6 ± 11.5

9.4 (4.3–427.8)

 

106

5.7%

 No

1,007 (35%)

9.2 ± 2.6

8.9 (3.3–35.6)

 

20

2.0%

 Unknown

3

   

0

 

Anti-HER2 therapy

   

<0.001

  

 Yes

264 (9%)

15.0 ± 27.2

11.0 (4.3–427.8)

 

53

20.1%

 No

2,598 (91%)

9.6 ± 4.4

9.1 (3.3–184.3)

 

73

2.8%

  1. aCalculated by ANOVA.
  2. bPercentage calculated by dividing the number of patients with elevated serum HER2 ECD level (>15.2 ng/ml) by the total number of patients in each subgroup.
  3. cEstrogen- and/or progesterone-receptor positive.
  4. dGraded as 3+ on immunohistochemistry (IHC) or 2+ on fluorescence in situ hybridization in cases of IHC 2+.
  5. LVI lymphovascular invasion.
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