Table 2.
Studies investigating the impact of genomic test risk score and outcomes in young breast cancer patients21,23,25,27,29,32,48–50.
| Trial | Genomic test (Oncotype DX recurrence risk categories, if applicable) | Definition of young used (n) | Outcome(s) measured | % risk of event for patients with low genomic risk (95% CI or ±SE) | % risk of event for patients with intermediate genomic risk (95% CI or ±SE) | % risk of event for patients with high genomic risk (95% CI or ±SE) |
|---|---|---|---|---|---|---|
| ECOG E2197: phase III trial48 | Oncotype DX (<18, 18–30, >30) | <50 years (170) | Local recurrence at 10 years | 1.9 (0.5–7.9) | 8.1 (3.4–19.6) | 8.3 (4.5–15.6) |
| Loco-regional recurrence at 10 years | 2.0 (0.5–7.9) | 8.1 (3.4–19.6) | 9.4 (5.3–16.5) | |||
| NSABP B-14 and B-28: phase III trials49 | Oncotype DX (<18, 18–30, >30) | <50 years (339a) | Risk of distant recurrence after 5 years |
NSABP B-28 5.3 (2.2–12.2) NSABP B-14 4.9 (1.6–14.4) |
NSABP B-28 20.4 (12.6–32.1) NSABP B-14 25.2 (10.9–51.6) |
NSABP B-28 23.3 (13.9–37.6) NSABP B-14 3.5 (0.5–23.1) |
| TAILORx: phase III trial50 | Oncotype DX (<11, 11–25, >25) | ≤50 years (3054) | Invasive disease-free survival at 9 years |
Endocrine therapy arm 87.4 (±2.0) |
Endocrine therapy arm Score 11–15: 85.7 (±2.2) Score 16–20: 80.6 (±2.5) Score 21–25: 79.2 (±3.3) Chemotherapy arm Score 11–15: 89.2 (±1.9) Score 16–20: 89.6 (±1.7) Score 21–25: 85.5 (±3.0) |
Chemotherapy arm 80.3 (±2.9) |
| Freedom from recurrence of breast cancer at a distant site at 9 years |
Endocrine therapy arm 98.5 (±0.8) |
Endocrine therapy arm Score 11–15: 97.2 (±1.0) Score 16–20: 93.6 (±1.4) Score 21–25: 86.9 (±2.9) Chemotherapy arm Score 11–15: 98.0 (±0.8) Score 16–20: 95.2 (±1.3) Score 21–25: 93.4 (±2.3) |
Chemotherapy arm 88.7 (±2.1) | |||
| Freedom from recurrence of breast cancer at a distant or local–regional site at 9 years | Endocrine therapy arm 95.4 (±1.3) |
Endocrine therapy arm Score 11–15: 93.3 (±1.6) Score 16–20: 89.6 (±1.9) Score 21–25: 82.0 (±3.2) Chemotherapy arm Score 11–15: 94.4 (±1.5) Score 16–20: 93.0 (±)1.5 Score 21–25: 90.7 (±2.5) |
Chemotherapy arm 86.1 (±2.2) | |||
| OS at 9 years |
Endocrine therapy arm 98.6 (0.9) |
Endocrine therapy arm Score 11–15: 96.8 (±1.0) Score 16–20: 95.8 (±1.2) Score 21–25: 92.7 (±2.0) Chemotherapy arm Score 11–15: 97.5 (±0.9) Score 16–20: 96.1 (±1.2) Score 21–25: 93.9 (±1.9) |
Chemotherapy arm 92.4 (±1.9) | |||
| TAILORx: phase III trial25 | Oncotype DX (<11, 11–25, >25) | ≤50 years (2958) | Recurrence, second primary cancer, or death at 9 years |
Endocrine therapy arm: Low clinical risk 13.3 (±2.3) High clinical risk 9.3 (±4.5) |
Endocrine therapy arm: Low clinical risk 17.4 (±1.8) High clinical risk 19.8 (±3.0) Chemotherapy arm: Low clinical risk 11.3 (±1.4) High clinical risk 13.5 (±3.0) |
Chemotherapy arm: Low clinical risk 14.8 (±4.2) High clinical risk 24.0 (±4.2) |
| Distant recurrence at 9 years |
Endocrine therapy arm: Low clinical risk 1.8 (±0.9) High clinical risk 0 (±0) |
Endocrine therapy arm: Low clinical risk 4.7 (±1.0) Clinical high-risk 12.3 (±2.4) Chemotherapy arm: Low clinical risk 3.9 (±1.0) High clinical risk 6.1 (±1.8) |
Chemotherapy arm: Low clinical risk 6.2% (±2.5) High clinical risk 15.2% (±3.3) |
|||
| HOHO: longitudinal cohort study21 | Oncotype DX (<18, 18–30, >30) | ≤40 years (577) | DRFS at 6 years |
Lymph node-negative 97.5 (90.1–99.4) Lymph node-positive 85.9 (72.6–93.0) |
Lymph node-negative 93.1 (86.0–96.7) Lymph node-positive 87.3 (76.0–93.5) |
Lymph node-negative 86.4 (72.0–93.7) Lymph node-positive 62.8 (45.1–76.2) |
| HOHO: longitudinal cohort study21 | Oncotype DX (<11, 11–25, >25) | ≤40 years (577) | DRFS at 6 years |
Lymph node-negative 94.4 (66.6–99.2) Lymph node-positive 92.3 (56.6–98.9) |
Lymph node-negative 96.9 (92.7–98.7) Lymph node-positive 85.2 (75.3–91.4) |
Lymph node-negative 85.1 (72.9–92.1) Lymph node-positive 71.3 (57.3–81.5) |
| Petkov et al.32 | Oncotype DX (<11, 11–25, >25) | ≤50 years (2588) | Breast cancer specific mortality at 5 years |
No/unknown chemotherapy arm (±0) |
No/unknown chemotherapy arm Score 11–15: 0.5 (±0.3) Score 16–20: 1.3 (±0.9) Score 21–25: 1.6 (±1.6) Chemotherapy arm Score 11–15: 2.3 (±1.4) Score 16–20: 1.6 (±0.9) Score 21–25: 1.2 (±1.2) |
No/unknown chemotherapy arm 4.4 (±4.3) Chemotherapy arm 6.1 (±2.0) |
| Sammons et al.23 | Oncotype DX (<11, 11–25, >25) | ≤40 years (5899) | OS at 5 years | Recurrence score 0–25: 99 (ND) |
Score: 26–30: 94 (ND) Score: 31–100: 92 (ND) |
|
| EORCT 10041/BIG 03-04 MINDACT: phase III trial27 | MammaPrint | <45 years (1100) | DMFS at 5 years |
Low clinical risk 98.3 (96–99.3) High clinical risk 97.4 (90–99.4) |
N/A |
Low clinical risk 95.5 (91.6–97.7) High clinical risk 89.2 (85.6–92.0) |
| GEICAM 9906: phase III trial29 | EndoPredict | Premenopausal (300) | DMFS at 10 years | 93 (ND) | N/A | 67 (ND) |
CI confidence interval, SE standard error, N/A not applicable, ND not disclosed, DMFS distant metastasis-free survival, DRFS distant recurrence-free survival, OS overall survival.
Only those with ahigh ESR1 expression were taken into account.