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Table 3 Prediction performance of tissue HER2 status and concordance with serum HER2 ECD level

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

Group analyzeda

Cross-table

P b

Concordance rate

Prediction performance

 

Sensitivity

Specificity

PPV

NPP

(1) Total patients (n = 2,860)

<0.001

78.7

15.0

99.0

82.5

78.5

 

Tissue(+)e

Tissue(-)f

      

  Elevatedc

104

22

      

  Normald

588

2,146

      

(2) Total patients (n = 2,860) HER2 ECD cutoff = 10.2 ng/ml

<0.001

70.4

54.9

75.3

41.5

84.0

 

Tissue(+)

Tissue(-)

      

  Elevated

380

535

      

  Normal

312

1,633

      

(3) Negative lymph node status (n = 1,747)

<0.001

80.3

11.2

99.1

76.4

80.4

 

Tissue(+)

Tissue(-)

      

  Elevated

42

13

      

  Normal

332

1,360

      

(4) Positive lymph node status (n = 1,113)

<0.001

76.2

19.5

98.9

87.3

75.4

 

Tissue(+)

Tissue(-)

      

  Elevated

62

9

      

  Normal

256

786

      

(5) Stage I (n = 1,243)

<0.001

80.4

9.6

99.2

75.8

80.5

 

Tissue(+)

Tissue(-)

      

  Elevated

25

8

      

  Normal

236

974

      

(6) Stage II (n = 1,212)

<0.001

78.7

13.3

98.9

79.2

78.7

 

Tissue(+)

Tissue(-)

      

  Elevated

38

10

      

  Normal

248

916

      

(7) Stage III (n = 405)

<0.001

73.3

28.3

98.5

91.1

71.1

 

Tissue(+)

Tissue(-)

      

  Elevated

41

4

      

  Normal

104

256

      
  1. aA diagnostic cutoff value of 15.2 ng/ml was used except where stated otherwise.
  2. bCalculated by chi-square test.
  3. cElevated serum HER2 ECD level.
  4. dNormal serum HER2 ECD level.
  5. eDefined as 3+ on IHC or amplification on fluorescence in situ hybridization in cases of IHC 2+.
  6. fTissue HER2 negative.
  7. PPV positive predictive value, NPV negative predictive value.