Table 1.
Patient and tumor characteristics.
| Nordic Trial (2 mL) | Sentidose Trial (1.5 mL) | Sentidose Trial (1.0 mL) | p-Value | ||
|---|---|---|---|---|---|
| Patients, n = 534 | 206 | 163 | 165 | n.a. | |
| Age, years (mean) | 62 | 64 | 63 | 0.101 * | |
| BMI, kg/m2 (mean) | 27.9 | 27.2 | 26.5 | 0.568 * | |
| Tumor size, mm (mean) | 19 | 20 | 20 | 0.751 * | |
| Histology | DCIS | 12 | 9 | 4 | 0.694 # |
| IDC | 158 | 122 | 121 | ||
| ILC | 26 | 21 | 28 | ||
| Other | 10 | 11 | 12 | ||
| ER-status | Positive | 170 | 138 | 145 | 0.831 # |
| Negative | 20 | 13 | 16 | ||
| Missing | 16 | 12 | 4 | ||
| HER2-status | Positive | 20 | 9 | 16 | 0.217 # |
| Negative | 172 | 142 | 144 | ||
| Missing | 14 | 12 | 5 | ||
| Ki67 (%) (mean) | 26.6 | 23.5 | 25.2 | 0.349 * | |
| No. patients with metastasis | 54 | 33 | 29 | 0.120 # | |
| Previous ipsilateral breast surgery | Yes | 17 | 0 | 0 | <0.001 # |
| No | 189 | 163 | 165 | ||
| Previous ipsilateral axillary surgery | Yes | 3 | 0 | 0 | 0.114 # |
| No | 203 | 163 | 165 | ||
| Type of surgery | BCT | 154 | 130 | 141 | 0.038 # |
| Mastectomy | 52 | 33 | 24 | ||
| SPIO Injection site | Peri-/Sub-areolar | 198 | 157 | 68 | <0.001 # |
| Peritumoral | 3 | 6 | 97 | ||
| Missing | 5 | 0 | 0 | ||
BCT: breast conserving therapy, BMI: body mass index, DCIS: ductal cancer in situ, ER: estrogen receptor, HER2: Human epithelial growth factor receptor type 2, IDC: invasive ductal cancer, ILC: invasive lobular cancer, n.a.: not assessed, SPIO: superparamagnetic iron oxide. *: analysis of variance (ANOVA), #: Pearson’s χ2 test.