Table 3.
Overview of HER2-.
| Study | Study design | N | IHC 0 | ISH | HER2– | Assay |
|---|---|---|---|---|---|---|
| LA/mUC | ||||||
| Banerji 2019 | Clinical trial, phase I | 16 | 0% | Performed only for 2+ (n=16)ISH+: 11.1%/ISH-: 43.8%ISH unevaluable: 6.3% | 0% | N/A |
| Goodman 2016 | Observational | 11 | 0% | 0% | Dako HER2 monoclonal mouse anti-human (IHC) | |
| Carlsson 2015 | Observational | 72 | 11.1% | 11.1% | Dako anti-HER2 rabbit polyclonal antibody A0485 (IHC) | |
| Gårdmark 2005 | Observational | 86 (H)86 (T)90 (M) | H 33.7%T 52.3%M 15.6% | H 33.7%T 52.3%M 15.6% | Dako HercepTest (IHC) | |
| Wülfing 2009 | Clinical trial, phase II | 57 | 22.8% | 22.8% | Dako HercepTest (IHC) | |
| Moktefi 2018 | Observational | 178 | ‘07: 32%‘13: 32% | n=51FISH+: 29.4%/FISH-: 39.2% | 32% | Dako anti-HER2 rabbit polyclonal antibody A0485 (IHC)Dako HER2 FISH pharmDx Kit (FISH) |
| Cimpean 2017 | Observational | 34 | 47.1% | 47.1% | Bond Oracle Human Epidermal Growth Factor Receptor 2 (IHC) | |
| Choudhury 2016 | Clinical trial, phase II | 23 | 65.2% | 65.2% | Dako HercepTest (IHC) | |
| Fleischmann 2011 | Observational | 150 | 79.9% | n=147FISH+: 8.8%Borderline +: 4.8%FISH-: 86.4% | 79.9% | Dako HercepTest (IHC)Vysis PathVysion HER2 DNA Probe Kit (FISH) |
| Weighted average of HER2- defined as IHC 0: 39.5% | ||||||
| Earlier stage UC | ||||||
| Latif 2003 | Observational | 25 | 20.0% | 20.0% | Ventana monoclonal anti-human HER-2 protein CB11 (IHC), Vysis (FISH) | |
| Tabriz 2021 | Observational | 84 | 23.8% | 23.8% | Dako anti-HER2 rabbit polyclonal antibody A0485 (IHC) | |
| Chakravarti 2005 | Pooled analysis of clinical trials | 55 | 40.0% | 40.0% | Zymed (IHC) | |
| Coogan 2004 | Observational | 54 | 40.7% | 40.7% | Ventana monoclonal anti-human HER-2 protein CB11 (IHC) | |
| Jimenez 2001 | Observational | 80 | 51.3% | 51.3% | Dako c-erbB-2 primary antibody (IHC) | |
| Bolenz 2010 | Observational | 198 | 73.9% | 72.2% | Dako anti-HER2 rabbit polyclonal antibody A0485 (IHC) | |
| Weighted average of HER2- defined as IHC 0: 48.4% | ||||||
FISH, fluorescence in situ hybridization; FISH+, FISH positive; FISH-, FISH negative; H, HercepTest; HER2, human epidermal growth factor receptor; HER2-, HER2 negative; IHC, immunohistochemistry; ISH, in situ hybridization; ISH+, ISH positive; ISH-, ISH negative; M, modified HercepTest; N/A, not available; T, target score.