Table 3.
Summary of discussed validation studies with assigned Simon Hayes level of evidence
| Assay | Focus | Study | Setting | Pre‐menopausal | Post‐menopausal | ER+ | ER− | LN+ | LN− | Simon category |
|---|---|---|---|---|---|---|---|---|---|---|
| Blue print | ||||||||||
| Prognostic | ||||||||||
| Krijgsman Breast Cancer Res Treat 2011 | Various | ✓ | ✓ | ✓ | ✓ | ✓ | D | |||
| Breast Cancer Index | ||||||||||
| Prognostic | ||||||||||
| Goetz Clin Cancer Res 2006 | AET | ✓ | ✓ | ✓ | ✓ | B | ||||
| Jerevall Br J Cancer 2011 | AET | ✓ | ✓ | ✓ | B | |||||
| Sgroi Breast Cancer Res 2016 | AET | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | B | ||
| Prognostic and predictive | ||||||||||
| Sgroi Lancet Oncol 2013 | AET | ✓ | ✓ | ✓ | B | |||||
| Zhang Clin Cancer Res 2013 | AET | ✓ | ✓ | ✓ | B | |||||
| Endopredict | ||||||||||
| Prognostic | ||||||||||
| Filipits Clin Cancer Res 2011 | AET | ✓ | ✓ | ✓ | ✓ | B | ||||
| Dubsky Ann Oncol 2013 | AET | ✓ | ✓ | ✓ | ✓ | B | ||||
| Martin Breast Cancer Res 2014 | AET/ACT | ✓ | ✓ | ✓ | ✓ | B | ||||
| Buus J Natl Cancer Inst 2016 | AET | ✓ | ✓ | ✓ | ✓ | ✓ | B | |||
| IHC4 | ||||||||||
| Prognostic | ||||||||||
| Cuzick J Clin Oncol 2011 | AET | ✓ | ✓ | ✓ | B | |||||
| Park Oncology 2014 | AET/ACT | ✓ | ✓ | ✓ | ✓ | ✓ | C | |||
| Sgroi Lancet Oncol 2013 | AET | ✓ | ✓ | ✓ | B | |||||
| Stephen Br J Cancer 2014 | AET | ✓ | ✓ | ✓ | ✓ | B | ||||
| MammaPrint | ||||||||||
| Prognostic | ||||||||||
| Bueno‐de‐Mesquita Lancet Oncol 2007 | AET/ACT | ✓ | ✓ | ✓ | ✓ | ✓ | D | |||
| Buyse J Natl Cancer Inst 2006 | No Rx | ✓ | ✓ | ✓ | ✓ | C | ||||
| Cardoso N Engl J Med 2016 | AET/ACT | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | A | ||
| Mook Ann Oncol 2010 | AET | ✓ | ✓ | ✓ | ✓ | ✓ | D | |||
| Mook Breast Cancer Res Treat 2009 | AET/ACT | ✓ | ✓ | ✓ | D | |||||
| van de Vijver N Engl J Med 2002 | AET/ACT | ✓ | ✓ | ✓ | ✓ | ✓ | D | |||
| Wittner Clin Cancer Res 2008 | AET/ACT | ✓ | ✓ | ✓ | ✓ | ✓ | D | |||
| Predictive | ||||||||||
| Knauer Breast Cancer Res Treat 2010 | ACT | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | D | ||
| Oncotype | ||||||||||
| Prognostic | ||||||||||
| Dowsett J Clin Oncol 2010 | AET | ✓ | ✓ | ✓ | ✓ | B | ||||
| Paik N Engl J Med 2004 | AET | ✓ | ✓ | ✓ | ✓ | ✓ | B | |||
| Sparano N Engl J Med 2015 | AET | ✓ | ✓ | ✓ | ✓ | A | ||||
| Gluz J Clin Oncol 2016 | AET | ✓ | ✓ | ✓ | ✓ | ✓ | A | |||
| Prognostic and predictive | ||||||||||
| Albain Lancet Oncol 2010 | AET/ACT | ✓ | ✓ | ✓ | B | |||||
| Predictive | ||||||||||
| Paik J Clin Oncol 2006 | AET/ACT | ✓ | ✓ | ✓ | ✓ | B | ||||
| PAM50 | ||||||||||
| Prognostic | ||||||||||
| Chia Clin Cancer Res 2012 | AET | ✓ | ✓ | ✓ | ✓ | ✓ | B | |||
| Dowsett J Clin Oncol 2013 | AET | ✓ | ✓ | ✓ | ✓ | B | ||||
| Gnant Ann Oncol 2014 | AET | ✓ | ✓ | ✓ | ✓ | B | ||||
| Gnant Ann Oncol 2015 | AET | ✓ | ✓ | ✓ | ✓ | B | ||||
| Predictive | ||||||||||
| Cheang Clin Cancer Res 2012 | ACT | ✓ | ✓ | ✓ | ✓ | B | ||||
| Liu Breast Cancer Res Treat 2015 | ACT | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | B |
AET, adjuvant ETx; ACT, adjuvant CTx; ER+, estrogen receptor positive; ER−, estrogen receptor negative; LN+, lymph node positive; LN−, lymph node negative; LOE, level of evidence (Simon J Natl Cancer Inst 2009).