Table 3.
Postoperative systemic therapy and regional nodal irradiation (RNI) in the per-protocol set (N = 386)
| Parameter | Category | cALND N/N (%) N = 169 |
SLNB only N/N (%) N = 217 |
Overall N/N (%) N = 386 |
P value |
|---|---|---|---|---|---|
| Adjuvant chemotherapy | Yes | 66/166 (39.8%) | 73/217 (33.6%) | 139/386 (36.3%) | 0.239 |
| Missing | 3 | 0 | 3 | ||
| Chemotherapy regimen | Anthracycline-based | 2 (1.2) | 5 (2.3) | 7 (1.8) | |
| Taxane-based | 6 (3.6) | 5 (2.3) | 11 (2.9) | ||
| Anthracycline- and taxane-based | 58 (34.9) | 63 (29.0) | 121 (31.6) | ||
| Missing | 3 | 0 | 3 | ||
| Adjuvant endocrine therapy | Yes | 156/165 (94.5%) | 208/217 (95.9%) | 364/382 (95.3%) | 0.629 |
| Missing | 4 | 0 | 4 | ||
| Other adjuvant therapy regimen | Anti-HER2 treatment | 3 (1.8) | 7 (3.3) | 10 (2.6) | 0.524 |
| Bisphosphonate | 23 (13.9) | 25 (11.6) | 48 (12.6) | 0.536 | |
| Denosumab | 1 (0.6) | 2 (0.9) | 3 (0.8) | 1.0 | |
| RNI performed | Yes | 32/89 (36.0%) | 26/126 (20.6%) | 58/215 (27.0%) | 0.019 |
| Pts. before AM4 | 80 | 91 | 171 | ||
| RNI supraclavicular nodes | Yes | 31/89 (34.8%) | 25/125 (20.0%) | 56/214 (26.2%) | 0.018 |
| RNI infraclavicular nodes | Yes | 23/89 (25.8%) | 18/126 (14.3%) | 41/215 (19.1%) | 0.036 |
| RNI internal mammary nodes | Yes | 5/88 (5.7%) | 1/126 (0.8%) | 6/214 (2.8%) | 0.084 |
RNI documentation started in March 2017 after implementing protocol amendment #4 (AM4).
Pts. patients.