Table 1.
Concordance between local and central HER2 status/combined IHC and FISH methodsa (as of December 2009)
| Central Laboratory |
||
|---|---|---|
| Local HER2 status | Mayo | IEO |
| Local HER2 positive | ||
| Total cases | 412 | 8037 |
| Centrally eligible | 388 | 6871 |
| Centrally not eligible | 24 (5.8%) | 1166 (14.5%) |
| Local HER2 equivocal | ||
| Total cases | 13 | 1041 |
| Centrally eligible | 6 | 647 |
| Centrally not eligible | 7 (53.8%) | 394 (37.8%) |
HER2 human epidermal growth factor receptor 2, IHC immunohistocytochemical, FISH fluorescent in situ hydridization, Mayo Mayo Clinic central laboratory, IEO European Institute of Oncology central laboratory
a
A case was centrally eligible (HER+ positive) if either central IHC or FISH were positive; positivity of one test was sufficient. Both IHC and FISH were performed on all carcinomas eligible for enrollment in the trial.