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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.