Table 1.
Results of Her-2 D-FISH assay per the 2013 and 2007 ASCO/CAP guidelines in 1676 cases of BCa with Her-2 IHC analysis
| IHC | ASCO 2013 | Negative versus Others | Equivocal versus Others | Positive versus Others | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
| ||||||||||||
| Negative | Equivocal | Positive | Total | Mcnemar | Kappa | Mcnemar | Kappa | Mcnemar | Kappa | |||
| 1+ | ASCO 2007 | Negative | 101(85.6) | 12(10.2) | 2(1.7) | 115(97.5) | P<0.001 | P<0.001 | P=0.003 | P=0.735 | ||
| Equivocal | 0(0.0) | 0(0.0) | 1(0.8) | 1(0.8) | ||||||||
| Positive | 0(0.0) | 0(0.0) | 2(1.7) | 2(1.7) | ||||||||
| Total | 101(85.6) | 12(10.2) | 5(4.2) | 118(100.0) | ||||||||
| 2+ | ASCO 2007 | Negative | 711(56.2) | 116(9.2) | 5(0.4) | 832(65.7) | P<0.001 | P=0.063 | ||||
| Equivocal | 10(0.8) | 4(0.3) | 4(0.3) | 18(1.4) | ||||||||
| Positive | 0(0.0) | 0(0.0) | 416(32.9) | 416(32.9) | ||||||||
| Total | 721(57.0) | 120(9.5) | 425(33.6) | 1266(100.0) | ||||||||
| 3+ | ASCO 2007 | Negative | 5(1.7) | 4(1.4) | 18(6.2) | 27(9.2) | P=0.077 | P=0.089 | P<0.001 | P<0.001 | ||
| Equivocal | 2(0.7) | 1(0.3) | 10(3.4) | 13(4.5) | ||||||||
| Positive | 0(0.0) | 0(0.0) | 252(86.3) | 252(86.3) | ||||||||
| Total | 7(2.4) | 5(1.7) | 280(95.9) | 292(100.0) | ||||||||
Her-2 D-FISH: Her-2 dual-probe fluorescent in situ hybridization
BCa: Breast Cancer
IHC: Immunohistochemistry