Table 2.
Baseline characteristics.
| Characteristic | Patients with FFPE profiles from Swiss participants used in the study (N = 342) | Provided material of Swiss participants (N = 437) |
Patients of the BIG 1-98 population not used in the study (N = 7573) |
Overall BIG 1-98 population (N = 8010) |
|---|---|---|---|---|
| Menopausal category - N (%) | ||||
| Postmen. before chemo | 321 (93.9) | 413 (94.5) | 7279 (96.1) | 7692 (96.0) |
| Postmen. after chemo | 10 (2.9) | 11 (2.5) | 181 (2.4) | 192 (2.4) |
| Premenopausal (ineligible) | 0 (0.0) | 2 (0.5) | 21 (0.3) | 23 (0.3) |
| Uncertain status | 10 (2.9) | 10 (2.3) | 92 (1.2) | 102 (1.3) |
| Unknown/missing | 1 (0.3) | 1 (0.2) | 0 | 1 (<0.1) |
| Age at randomization - years | ||||
| Median | 62 | 62 | 61 | 61 |
| Range | 41-86 | 41-86 | 38-90 | 38-90 |
| Tumor size - N (%) | ||||
| ≤ 2 cm | 195 (57.0) | 251 (57.4) | 4706 (62.1) | 4957 (61.9) |
| > 2 cm | 144 (42.1) | 179 (41.0) | 2794 (36.9) | 2973 (37.1) |
| Unknown/missing | 3 (0.9) | 7 (1.6) | 73 (1.0) | 80 (1.0) |
| Tumor grade - N (%) | ||||
| Grade 1 | 94 (27.5) | 124 (28.4) | 2007 (26.5) | 2131 (26.6) |
| Grade 2 | 196 (57.3) | 251 (57.4) | 3649 (48.2) | 3900 (38.7) |
| Grade 3 | 49 (14.3) | 59 (13.5) | 1166 (15.4) | 1225 (15.3) |
| Unknown/missing | 3 (0.9) | 3 (0.7) | 751 (9.9) | 754 (9.4) |
| Nodal status - N (%) | ||||
| Negative (including Nx) | 186 (54.4) | 245 (56.1) | 4342 (57.3) | 4587 (57.3) |
| Positive | 152 (44.4) | 188 (43.0) | 3123 (41.2) | 3311 (41.3) |
| Unknown/missing | 4 (1.2) | 4 (1.0) | 108 (1.4) | 112 (1.4) |
| ER and PgR status - N (%) | ||||
| ER pos and PgR pos. | 268 (78.4) | 340 (77.8) | 4715 (62.3) | 5055 (63.1) |
| ER pos and PgR neg. | 66 (19.3) | 87 (19.9) | 1544 (20.4) | 1631 (20.4) |
| ER pos and PgR unknown | 1 (0.3) | 1 (0.2) | 1153 (15.2) | 1154 (14.4) |
| ER neg and PgR pos. | 5 (1.5) | 7 (1.6) | 136 (1.8) | 143 (1.8) |
| ER unknown, PGR pos. | 0 | 0 | 7 (0.1) | 7 (0.1) |
| Other | 2 (0.6) | 2 (0.5) | 18 (0.3) | 20 (0.2) |
| Local therapy - N (%) | ||||
| BCS and RT | 236 (69.0) | 310 (70.9) | 3987 (52.7) | 4297 (53.7) |
| BCS and no RT | 13 (3.8) | 16 (3.7) | 228 (3.0) | 244 (3.0) |
| Mastectomy and RT | 24 (7.0) | 25 (5.7) | 1415 (18.7) | 1440 (18.0) |
| Mastectomy and no RT. | 68 (19.9) | 85 (19.5) | 1926 (25.4) | 2011 (25.1) |
| Other | 1 (0.3) | 1 (0.2) | 17 (0.2) | 18 (0.2) |
| Adjuvant or neoadjuvant | ||||
| chemo (or both) - N (%) | ||||
| Yes | 133 (38.9) | 159 (36.4) | 1865 (24.6) | 2024 (25.3) |
| No | 209 (61.1) | 278 (63.6) | 5708 (75.4) | 5986 (74.7) |
Abbreviations: BCS, breast conserving surgery; Nx, nodal status unknown; postmen., postmenopausal; RT, radiotherapy; PgR, progesterone receptor; pos., positive; neg., negative