Table 4.
Summary of iDFS events in the per-protocol set
| Parameter | Category | cALND N (%) N = 169 |
SLNB alone N (%) N = 217 |
Overall N (%) N = 386 |
|---|---|---|---|---|
| iDFS event | No | 150 (88.8) | 179 (82.5) | 329 (85.2) |
| Yes | 19 (11.2) | 38 (17.5) | 57 (14.8) | |
| First iDFS event | Invasive locoregional relapse | 2 (1.2) | 4 (1.8) | 6 (1.6) |
| Invasive contralateral BC | 0 (0.0) | 1 (0.5) | 1 (0.3) | |
| Distant relapse | 7 (4.1) | 15 (6.9) | 22 (5.7) | |
| Secondary malignancy (not related to breast cancer) | 4 (2.4) | 9 (4.1) | 13 (3.4) | |
| Death | 6 (3.6) | 9 (4.1) | 15 (3.9) | |
| Locoregional relapse | Axillary recurrence | 0 (0.0) | 1 (0.5) | 1 (0.3) |
| Invasive ipsilateral breast recurrence | 2 (1.2) | 3 (1.4) | 5 (1.3) |
BC breast cancer, cALND completion axillary lymph node dissection, SLNB sentinel lymph node biopsy, iDFS invasive disease-free survival.