Table 1.
Patient and tumor characteristics: comparison or included versus not included clinically eligible patients
| Characteristic | Clinically eligible and included (n = 901) | Clinically eligible but not included (n = 1029) | p value* |
|---|---|---|---|
| Arm assignment | |||
| A | 475 (53 %) | 548 (53 %) | 0.81 |
| C | 426 (47 %) | 481 (47 %) | |
| Age at randomization (years) | |||
| 18–39 | 150 (17 %) | 162 (16 %) | 0.94 |
| 40–49 | 299 (33 %) | 352 (34 %) | |
| 50–59 | 292 (32 %) | 344 (33 %) | |
| ≥60 | 160 (18 %) | 171 (17 %) | |
| Menopausal status | |||
| Premenopausal | 480 (53 %) | 551 (54 %) | 0.90 |
| Postmenopausal | 421 (47 %) | 478 (46 %) | |
| Extent of surgery | |||
| Breast sparing | 354 (39 %) | 396 (38 %) | 0.72 |
| Mastectomy | 547 (61 %) | 633 (62 %) | |
| Extent of nodal examination | |||
| Axillary node dissection | 816 (91 %) | 925 (90 %) | 0.62 |
| Sentinel biopsy | 85 (9 %) | 104 (10 %) | |
| Histologically positive nodes | |||
| 0 | 125 (14 %) | 132 (13 %) | 0.82 |
| 1–3 | 424 (47 %) | 497 (48 %) | |
| 4–9 | 233 (26 %) | 262 (25 %) | |
| ≥10 | 119 (13 %) | 138 (13 %) | |
| Tumor size (cm) | |||
| ≤2.0 | 340 (38 %) | 429 (42 %) | 0.03 |
| 2.1–4.9 | 481 (53 %) | 532 (52 %) | |
| ≥5 | 80 (9 %) | 68 (7 %) | |
| Tumor grade | |||
| 1 | 16 (2 %) | 12 (1 %) | 1.00 |
| 2 | 233 (26 %) | 274 (27 %) | |
| 3 | 641 (71 %) | 730 (71 %) | |
| Unknown | 11 (1 %) | 13 (1 %) | |
| Hormone receptor status | |||
| ER or PR positive | 481 (53 %) | 552 (54 %) | 0.89 |
| ER and PR negative | 420 (47 %) | 476 (46 %) | |
| Unknown | - | 1 (<1 %) |
ER estrogen receptor, PR progesterone receptor
*p value from chi-square test for nominal categories or Cochran-Mantel-Haenszel test for ordered categories