Table 2.
Protocol deviations and treatment
| Protocol deviation groups | Treatment after protocol deviations | |||||
|---|---|---|---|---|---|---|
| Re-excision Alone | Re-excision + WBRT | WBRT alone | Mastectomy | Refused additional treatment | Number patients | |
| Margin | 30 | 3 | 21 | 4 | 87 | 145 |
| Margin, node | 0 | 0 | 0 | 0 | 1 | 1 |
| Margin, node, size | 0 | 1 | 2 | 1 | 1 | 5 |
| Margin, size | 7 | 6 | 24 | 10 | 19 | 66 |
| Margin, LVI | 1 | 0 | 4 | 0 | 0 | 5 |
| Margin, LVI, size | 0 | 0 | 1 | 0 | 0 | 1 |
| Margin, multifocal, node | 0 | 1 | 0 | 0 | 0 | 1 |
| Margin, multifocal, size | 0 | 1 | 0 | 0 | 0 | 1 |
| Node | 0 | 0 | 25 | 0 | 4 | 29 |
| Node, size | 0 | 0 | 5 | 0 | 1 | 6 |
| Node, LVI | 0 | 0 | 5 | 0 | 0 | 5 |
| Node, LVI, size | 0 | 0 | 2 | 0 | 0 | 2 |
| Size | 0 | 0 | 54 | 2 | 48 | 104 |
| Size, multifocal | 0 | 0 | 2 | 0 | 1 | 3 |
| Multifocal | 0 | 1 | 0 | 0 | 1 | 2 |
| LVI | 0 | 0 | 4 | 1 | 28 | 33 |
| Total | 38 | 13 | 149 | 18 | 191 | 409 |
409 patients experienced 1 or more protocol violations. They redivided into 16 groups