Table 5.
Cox regression univariable models for BCFi and OS by ROR score categories for different time intervals for patients with ER-positive/HER2-negative tumours in all patients, node-negative, and node-positive (1–3 positive nodes) subgroups of patients.
| All patients (ER+/HER2−) | Node-negative (ER+/HER2−) | Node-positive (ER+/HER2−)a | ||||
|---|---|---|---|---|---|---|
| BCFi | OS | BCFi | OS | BCFi | OS | |
| HR (95% CI); P-value | ||||||
| 0–10 years | ||||||
| ROR score | (n = 236, n = 102 events) overall P-value < 0.001d | (n = 236, n = 74 events) overall P-value = 0.002d | (n = 60, n = 21 events) overall P-value = 0.01d | (n = 60, n = 14 events) overall P-value = 0.04d | (n = 121, n = 49 events) | (n = 121, n = 36 events) |
| Low (Ref.) | 1.00 | 1.00 | 1.00 | 1.00 | – | – |
| Intermediate | 0.83 (0.37–1.88); 0.66 | 1.19 (0.42–3.37); 0.75 | 0.20 (0.03–1.59); 0.13 | 0.40 (0.05–3.43); 0.40 | 1.00 | 1.00 |
| High | 2.36 (1.18–4.72); 0.02 | 2.99 (1.19–7.46); 0.02 | 2.53 (1.04–6.12); 0.04 | 3.17 (1.03–9.75); 0.04 | 1.99 (1.08–3.66); 0.03 | 1.84 (0.91–3.74); 0.09 |
| >10 yearsb | ||||||
| ROR score | (n = 130, n = 43 events) overall P-value = 0.93d | (n = 162, n = 77 events) overall P-value = 0.19d | (n = 39, n = 13 events) overall P-value = 0.56d | (n = 46, n = 16 events) overall P-value = 0.40d | (n = 69, n = 21 events) | (n = 84, n = 38 events) |
| Low (Ref.) | 1.00 | 1.00 | 1.00 | 1.00 | – | – |
| Intermediate | 0.85 (0.36–2.01); 0.71 | 0.76 (0.37–1.56); 0.45 | 1.22 (0.38–3.92); 0.74 | 0.38 (0.08–1.75); 0.21 | 1.00 | 1.00 |
| High | 0.88 (0.39–2.01); 0.77 | 1.24 (0.65–2.35); 0.51 | 0.37 (0.05–3.03); 0.36 | 1.18 (0.36–3.79); 0.79 | 1.19 (0.50–2.80); 0.70 | 1.02 (0.54–1.93); 0.96 |
| Maximum follow-upc | ||||||
| ROR score | (n = 236, n = 145 events) overall P-value = 0.001d | (n = 236, n = 151 events) overall P-value = 0.001d | (n = 60, n = 34 events) overall P-value = 0.15d | (n = 60, n = 30 events) overall P-value = 0.03d | (n = 121, n = 70 events) | (n = 121, n = 74 events) |
| Low (Ref.) | 1.00 | 1.00 | 1.00 | 1.00 | – | – |
| Intermediate | 0.84 (0.47–1.53); 0.58 | 0.89 (0.49–1.61); 0.70 | 0.66 (0.26–1.69); 0.39 | 0.39 (0.11–1.35); 0.14 | 1.00 | 1.00 |
| High | 1.70 (1.01–2.85); 0.04 | 1.77 (1.06–2.97); 0.03 | 1.69 (0.79–3.58); 0.17 | 1.96 (0.91–4.22); 0.09 | 1.68 (1.03–2.75); 0.04 | 1.34 (0.84–2.14); 0.22 |
All analyses are stratified by study region. The ROR score categories are defined by the following cut-offs based on N-status; N0; low: 0–40, intermediate: 41–60, high: 61–100, N1; low: 0–15, intermediate: 16–40, high: 41–100, N2: high: 0–100.
BCFi breast cancer-free interval, CI confidence interval, ER oestrogen receptor, HER2 human epidermal growth factor receptor 2, HR hazard ratio, OS overall survival, ROR risk of recurrence.
aOnly N1 (1–3 positive nodes) are included in the node-positive definition. Since only n = 2 patients are defined as ROR low in the N1 category, these are omitted from the analyses.
bFrom year 10 to maximum follow-up time.
c32 and 36 years regarding BCFi and OS, respectively.
dTwo-degree of freedom Wald test.