Table 2.
Characteristics of the patients whose tissue was assessed on TMAs in this study (as at baseline on the AZURE study) and first disease-free survival events
| Characteristic | Training set | Validation set | Combined sets | Full AZURE trial population | ||||
|---|---|---|---|---|---|---|---|---|
| Zoledronate (n = 216) |
Control (n = 211) |
Zoledronate (n = 147) |
Control (n = 150) |
Zoledronate (n = 363) |
Control (n = 361) |
Zoledronate (N = 1681) |
Control (n = 1678) |
|
| Age, median (range), y | 51 (26–75) | 51 (33–79) | 50 (26–77) | 52 (33–79) | 50 (26–77) | 52 (33–79) | 51 (20–87) | 51 (21–89) |
| Axillary lymph nodes, No. (%) | ||||||||
| 0 | 1 (0.5) | 4 (1.9) | 1 (0.7) | 1 (0.7) | 2 (0.6) | 5 (1.4) | 30 (1.8) | 32 (1.9) |
| 1–3 | 140 (64.8) | 147 (69.7) | 107 (72.8) | 96 (64.0) | 247 (68.0) | 243 (67.3) | 1042 (62.0) | 1033 (61.6) |
| ≥4 | 75 (34.7) | 60 (28.4) | 39 (26.5) | 53 (35.3) | 114 (31.4) | 113 (31.3) | 604 (35.9) | 607 (36.2) |
| Tumor stage, No. (%) | ||||||||
| T1 | 73 (33.8) | 80 (37.9) | 55 (37.4) | 58 (38.7) | 128 (35.3) | 138 (38.2) | 542 (32.2) | 523 (31.2) |
| T2 | 117 (54.2) | 98 (46.4) | 76 (51.7) | 77 (51.3) | 193 (53.2) | 175 (48.5) | 850 (50.6) | 867 (51.7) |
| T3 | 20 (9.3) | 29 (13.7) | 12 (8.2) | 14 (9.3) | 32 (8.8) | 43 (11.9) | 228 (13.6) | 228 (13.6) |
| T4 | 6 (2.8) | 4 (1.9) | 4 (2.7) | 1 (0.7) | 10 (2.8) | 5 (1.4) | 58 (3.5) | 59 (3.5) |
| Histological grade, No. (%) | ||||||||
| 1 | 14 (6.5) | 16 (7.6) | 14 (9.5) | 22 (14.7) | 28 (7.7) | 38 (10.5) | 145 (8.6) | 140 (8.3) |
| 2 | 85 (39.4) | 85 (40.3) | 53 (36.1) | 61 (40.7) | 138 (38.0) | 146 (40.4) | 731 (43.5) | 708 (42.2) |
| 3 | 115 (53.2) | 108 (51.2) | 79 (53.7) | 66 (44.0) | 194 (53.4) | 174 (48.2) | 765 (45.5) | 787 (46.9) |
| ER status, No. (%) | ||||||||
| ER positive | 160 (74.1) | 170 (80.6) | 118 (80.3) | 119 (79.3) | 278 (76.6) | 289 (80.1) | 1319 (78.5) | 1316 (78.4) |
| ER negative | 55 (25.5) | 38 (18.0) | 29 (19.7) | 31 (20.7) | 84 (23.1) | 69 (19.1) | 349 (20.8) | 355 (21.2) |
| ER unknown | 1 (0.50) | 3 (1.4) | 0 (0.0) | 0 (0.0) | 1 (0.3) | 3 (0.8) | 13 (0.8) | 7 (0.4) |
| PR status, No. (%) | ||||||||
| PR positive | 71 (32.9) | 62 (29.4) | 60 (40.8) | 56 (37.3) | 131 (36.1) | 118 (32.7) | 725 (43.1) | 698 (41.6) |
| PR negative | 37 (17.1) | 40 (1908) | 26 (17.7) | 36 (24.0) | 63 (17.4) | 76 (21.1) | 382 (22.7) | 424 (25.3) |
| PR unknown | 107 (49.5) | 108 (51.2) | 61 (41.5) | 58 (38.7) | 168 (46.3) | 166 (46.0) | 571 (34.0) | 548 (32.7) |
| HER2 status, No. (%) | ||||||||
| HER2 positive | 27 (12.5) | 33 (15.6) | 14 (9.5) | 13 (8.7) | 41 (11.3) | 46 (12.7) | 192 (11.4) | 223 (13.3) |
| HER2 negative | 60 (27.8) | 54 (25.6) | 52 (35.4) | 40 (26.7) | 112 (30.9) | 94 (26.0) | 648 (38.5) | 603 (35.9) |
| HER2 unknown/not measured | 129 (59.7) | 124 (58.8) | 81 (55.1) | 97 (64.7) | 210 (57.9) | 221 (61.2) | 831 (49.5) | 841 (50.1) |
| Menopausal status, No. (%) | ||||||||
| Pre-menopausal | 94 (43.5) | 94 (44.5) | 69 (46.9) | 60 (40.0) | 163 (44.9) | 154 (42.7) | 751 (44.7) | 753 (44.9) |
| ≤ 5 years since menopause | 32 (14.8) | 38 (18.0) | 19 (12.9) | 22 (14.7) | 51 (14.0) | 60 (16.6) | 247 (14.7) | 243 (14.5) |
| > 5 years since menopause | 74 (34.3) | 57 (27.0) | 45 (30.6) | 56 (37.3) | 119 (32.8) | 113 (31.3) | 519 (30.9) | 522 (31.1) |
| Menopausal status unknown | 16 (7.4) | 22 (10.4) | 14 (9.5) | 12 (8.0) | 30 (8.3) | 34 (9.4) | 164 (9.8) | 160 (9.5) |
| Planned systemic therapy, No. (%) | ||||||||
| Endocrine therapy alone | 18 (8.3) | 13 (6.2) | 6 (4.1) | 7 (4.7) | 24 (6.6) | 20 (5.5) | 76 (4.5) | 76 (4.5) |
| Chemotherapy alone | 56 (25.9) | 42 (19.9) | 25 (17.0) | 30 (20.0) | 81 (22.3) | 72 (19.9) | 361 (21.3) | 358 (21.3) |
| Endocrine therapy plus chemotherapy | 142 (65.7) | 156 (73.9) | 116 (78.9) | 113 (75.3) | 258 (71.1) | 269 (74.5) | 1244 (74.0) | 1244 (74.1) |
| Type of chemotherapy, No. (%) | ||||||||
| Anthracyclins | 194 (89.8) | 193 (91.5) | 134 (91.2) | 139 (92.7) | 328 (90.4) | 332 (92.0) | 1568 (97.7) | 1564 (97.6) |
| Taxanes | 35 (16.2) | 29 (13.7) | 14 (9.5) | 15 (10.0) | 49 (13.5) | 44 (12.2) | 390 (24.3) | 385 (24.0) |
| Timing of chemotherapy | ||||||||
| Neo-adjuvant | 7 (3.2) | 5 (2.4) | 2 (1.4) | 3 (2.0) | 9 (2.5) | 8 (2.2) | 103 (6.5) | 104 (6.5) |
| Postoperative | 209 (96.8) | 206 (97.6) | 145 (98.6) | 147 (98.0) | 354 (97.5) | 353 (97.8) | 1502 (93.6) | 1498 (93.5) |
| Statin use, No. (%) | 9 (4.2) | 9 (4.3) | 7 (4.8) | 8 (5.3) | 16 (4.4) | 17 (4.7) | 97 (5.8) | 100 (6.0) |
| Type of first disease-free survival event, No. (%) | ||||||||
| Loco-regional recurrence | 16 (7.4) | 10 (4.7) | 12 (8.2) | 5 (3.3) | 28 (7.7) | 15 (4.2) | 79 (4.7) | 78 (4.7) |
| Distant recurrence | 41 (19) | 44 (20.9) | 21 (14.3) | 32 (21.3) | 62 (17.1) | 76 (21.1) | 332 (19.8) | 341 (20.3) |
| Distant and loco-regional recurrence | 5 (2.3) | 2 (0.9) | 0 (0) | 1 (0.7) | 5 (1.4) | 3 (0.8) | 18 (1.1) | 21 (1.3) |
| Death without prior recurrence | 6 (2.8) | 9 (4.3) | 1 (0.7) | 3 (2) | 7 (1.9) | 12 (3.3) | 44 (2.6) | 53 (3.2) |
| First distant recurrence is nonskeletal, No. (%) | 31 (14.4) | 18 (8.5) | 10 (6.8) | 17 (11.3) | 41 (11.3) | 35 (9.7) | 194 (11.5) | 165 (9.8) |
| First distant recurrence is skeletal and other, No. (%) | 15 (6.9) | 28 (13.3) | 11 (7.5) | 16 (10.7) | 26 (7.2) | 44 (12.2) | 156 (9.3) | 197 (11.7) |
| First distant recurrence is skeletal only, No. (%)* | 7 (3.2) | 22 (10.4) | 11 (7.5) | 9 (6) | 18 (5) | 31 (8.6) | 97 (5.8) | 140 (8.3) |
* This group is a subset of those classified as skeletal and other, where skeletal recurrences were the only first distant recurrences.