Table 1.
Characteristics of the most common and commercially available genomic signatures
| Oncotype DX® | MammaPrint® | EndoPredict® (EP) | Prosigna® (PAM50, ROR) | Breast Cancer Index® | |
|---|---|---|---|---|---|
| Manufacturer | Genomic Health | Agendia NV | Myriad Genetics | NanoString Technologies | Biotheranostics |
| Genes | 21 genes (16 cancer-related + 5 reference genes) |
70 genes | 12 genes (EP) (8 cancer-related + 4 reference genes) |
50 genes (+5 reference genes) |
7 genes (HOXB13:IL17BR ratio + 5 genes) |
| Test method | RT-PCR | RT-PCR or RNA microarray | RT-PCR | RT-PCR (nCounter®) | RT-PCR |
| Central lab | Yes | Yes | No | No | Yes |
| Type of tissue | FFPE | FFPE or fresh tissue | FFPE | FFPE | FFPE |
| Classification | RS 0–100: Low risk (0–10) Intermediate risk (11–25) High risk (>25 in women aged <50 years, > 15 and high clinical risk or >21, independently of the clinical risk) [38, 42] |
MammaPrint Index: Low risk High risk |
EP molecular score 0–15: Low risk (<5) High risk (>5) EPclin score (with tumor size and nodal status): Low risk (<3.3) High risk (≥ 3.3) |
ROR 0–100: Low risk (<40) Intermediate risk (41–60) High risk (61–100) |
Molecular grade index 0–10: Low risk (<5) Intermediate risk (5–6.3) High risk (>6.3) |
| Clinical applicability | Prognostic, endocrine treated, HR+, HER2–, N–/+ | Prognostic, age <70 years, HR+, HER2–, N–/+ | Prognostic, endocrine treated, (pre-) postmenopausal, HR+, HER2–, N–/+ | Prognostic, endocrine treated, postmenopausal, HR+, HER2–, N–/+ | Prognostic, endocrine treated, HR+, HER2–, N–/+ |
| Prognosis after 5 years (late recurrence) | Yes | Not separately shown | Yes | Yes | Yes |
| Predictive value (chemotherapy) | Yes | Yes | No | No | No |
| Predictive value (endocrine therapy) | Yes | No | No | Yes | Yes (extended endocrine therapy) |
| Molecular subtyping | No | Yes (BluePrint®) | No | Yes | No |
| Clinical studies | NSABP Β14 NSABP B20 SWOG 8814 TransATAC (retrospective) TAILORx WSG-PlaB (prospective) RxPonder WSG-ADAPT (prospective, ongoing) |
TRANSBIG (retrospective) RASTER MINDACT (prospective) |
GEICAM 9906 ABCSG6 ABCSG8 (retrospective) | ABCG8 ATAC (retrospective) | TransATAC, Stockholm trials (retrospective) |
| Guideline recommendations (chemotherapy) | NCCN (1 for N0, 2A for N+) ASCO (N0, strong) NICE St. Gallen/ESMO IQWiG AGO + (adj.) |
NCCN (1 for N0 and 1–3 N+) ASCO (N0 strong, 1–3 N+ moderate) St. Gallen ESMO AGO + (adj.) |
NCCN (2A for N0 and 1–3 N+) ASCO (N0, moderate) NICE St. Gallen ESMO AGO + (adj.) |
NCCN (2A for N0 and 1–3 N+) ASCO (N0, strong) NICE St. Gallen ESMO AGO + (adj.) |
NCCN (2A) ASCO (N0, moderate) AGO +/− (NACT) |