Table 1.
The distribution of patient, treatment and disease characteristics for the POSITIVE participants (N = 272), the eligible SOFT/TEXT cohort (N = 1499), and the means of the 5000 random sample sets drawn from the eligible SOFT/TEXT cohort using Method II.
| POSITIVE enrolled (N = 272) |
SOFT/TEXT eligible (N = 1499) |
SOFT/TEXT group matched random samplesa |
|||
|---|---|---|---|---|---|
| N | % | N | % | % | |
| Age (years) | |||||
| <35 | 92 | 33.8 | 286 | 19.1 | 33.9 |
| 35-39 | 110 | 40.4 | 573 | 38.2 | 40.3 |
| 40-42 | 70 | 25.7 | 640 | 42.7 | 25.8 |
| Body mass index (BMI; kg/m2) | |||||
| Normal (<25) | 199 | 73.2 | 871 | 58.1 | 72.9 |
| Overweight (25-<30) | 43 | 15.8 | 337 | 22.5 | 13.2 |
| Obese (≥30) | 21 | 7.7 | 257 | 17.1 | 10.5 |
| Unknown | 9 | 3.3 | 34 | 2.3 | 3.4 |
| Previous pregnancy | |||||
| No | 160 | 58.8 | 387 | 25.8 | 33.0 |
| Yes | 112 | 41.2 | 1112 | 74.2 | 67.0 |
| Previous delivery of a baby | |||||
| No | 200 | 73.5 | 431 | 28.8 | 35.7 |
| Yes | 72 | 26.5 | 1068 | 71.2 | 64.3 |
| No. nodes positive | |||||
| pN0 | 182 | 66.9 | 794 | 53.0 | 66.6 |
| pN+ 1–3 | 75 | 27.6 | 523 | 34.9 | 28.1 |
| pN+ 4–9 | 14 | 5.1 | 175 | 11.7 | 5.3 |
| Unknown | 1 | 0.4 | 7 | 0.5 | |
| Tumor size (path.; cm) | |||||
| ≤2 cm | 169 | 62.1 | 847 | 56.5 | 63.5 |
| >2 cm | 97 | 35.7 | 605 | 40.4 | 33.6 |
| Unknown | 6 | 2.2 | 47 | 3.1 | 3.0 |
| Tumor grade | |||||
| 1 | 47 | 17.3 | 223 | 14.9 | 17.3 |
| 2 | 127 | 46.7 | 770 | 51.4 | 52.5 |
| 3 | 91 | 33.5 | 478 | 31.9 | 28.9 |
| Unknown | 7 | 2.6 | 28 | 1.9 | 1.3 |
| HER2 status | |||||
| Negative | 208 | 76.5 | 1191 | 79.5 | 77.7 |
| Positive | 61 | 22.4 | 256 | 17.1 | 17.6 |
| Unknown | 3 | 1.1 | 52 | 3.5 | 4.7 |
| Estrogen receptor (ER ≥ 10%) | |||||
| Negative | 3 | 1.1 | 42 | 2.8 | 2.1 |
| Positive | 269 | 98.9 | 1457 | 97.2 | 97.9 |
| Progesterone receptor (PgR≥10%) | |||||
| Negative | 30 | 11.0 | 181 | 12.1 | 11.1 |
| Positive | 239 | 87.9 | 1300 | 86.7 | 87.8 |
| Missing | 3 | 1.1 | 18 | 1.2 | 1.1 |
| Prior chemotherapy | |||||
| No | 105 | 38.6 | 359 | 23.9 | 37.5 |
| Yes | 167 | 61.4 | 1140 | 76.1 | 62.5 |
| Prior AI received | |||||
| No | 214 | 78.7 | 893 | 59.6 | 78.5 |
| Yes | 58 | 21.3 | 606 | 40.4 | 21.5 |
| Prior OFS received | |||||
| No | 121 | 44.5 | 315 | 21.0 | 23.4 |
| Yes | 151 | 55.5 | 1184 | 79.0 | 76.6 |
a
In Method II, 5000 random sample sets of eligible SOFT/TEXT patients were drawn with replacement matching characteristics of the POSITIVE participants. The matched characteristics used are age (<35, 35–39, 40–42), BMI (unknown/normal, overweight/obese), nodal status (pN0, pN+1–3, pN+4–9), prior AI received (yes, no), and prior chemotherapy received (yes, no).