Table 1.
Overview of HER2+.
| Study | Study design | N | HER2+ | HER2+ criteria and assay | ||
|---|---|---|---|---|---|---|
| LA/mUC | ||||||
| Fleischmann 2011 | Observational | 150 | 6.7% | IHC 3+ or 2+ and FISH+; Dako HercepTest (IHC), Abbott/Vysis PathVysion HER2 DNA Probe Kit (FISH) | ||
| Oudard 2015 | Clinical trial, phase II | 563 | 13.3% | IHC 3+ or 2+ and FISH+; Dako HercepTest (IHC), Dako HER2 FISH pharmDx Kit (FISH) | ||
| Sheng 2021 | Clinical trial, phase II | 133 | 15.8% | IHC 3+ or 2+ and FISH+; Ventana PATHWAY anti-HER-2/neu (4B5) (IHC) | ||
| Banerji 2019 | Clinical trial, phase I | 16 | 37.5% | ASCO/CAP guidelines for breast and gastric cancer; IHC 3+ or 2+ and ISH+; N/A | ||
| Weighted average of HER2+ defined as IHC 3+ or IHC 2+ and ISH/FISH+: 13.0% | ||||||
| Earlier stage UC | ||||||
| Latif 2003 | Observational | 25 | 76.0% | IHC 3+ or 2+ and FISH+; Ventana monoclonal anti-human HER-2 protein CB11 (IHC), Vysis (FISH) | ||
| Weighted average of HER2+ defined as IHC 3+ or IHC 2+ and ISH/FISH+: 76.0% | ||||||
ASCO/CAP, American Society of Clinical Oncology/College of American Pathologists; FISH, fluorescence in situ hybridization; FISH+, FISH positive; HER2, human epidermal growth factor receptor; HER2+, HER2 positive; IHC, immunohistochemistry; N/A, not available.