Table 1.
Baseline Patients Characteristics by Arm
| N (%) | ||||
|---|---|---|---|---|
| Arm A- ZA (n=70) | Arm B- Control (n=80) | Total CIOF (n=150) | Total at 3 years (177) | |
| Age (yr)* | 46 (40–57) | 48 (40–59) | 47 (40–59) | 47 (40–59) |
| Race | ||||
| White | 69 (99) | 73 (91) | 142 (95) | 165 (93) |
| Black | 0 (0) | 3 (4) | 3 (2) | 8 (5) |
| Asian | 0 (0) | 1 (1) | 1 (1) | 1 (2) |
| Other | 1 (1) | 3 (4) | 4 (3) | 2 (1) |
| ECOG PS | ||||
| 0 | 69 (93) | 71 (91) | 136 (92) | 165 (93) |
| 1 | 5 (7) | 7 (8) | 14 (8) | 12 (7) |
| Nodal Status | ||||
| negative | 29 (41) | 27 (34) | 56 (37) | 81 (46) |
| positive | 34 (49) | 45 (56) | 79 (53) | 89 (50) |
| unknown | 7 (10) | 8 (10) | 15 (10) | 7 (4) |
| Stage | ||||
| I/II | 55 (79) | 65 (82) | 120 (80) | 145 (82) |
| III | 13(18) | 10 (12) | 23 (15) | 26 (15) |
| unknown | 2 (3) | 5 (6) | 7 (5) | 6 (3) |
| E2 (pg/ml)* | 34 (7–324) | 31 (1–248) | 32 (1–324) | 35 (4–531) |
| FSH (miu/ml)* | 28 (1–103) | 34 (1–92) | 33 (1–109) | 21 (0.6–115) |
| LS BMD (g/cm2)* | 1.1 (0.8–1.6) | 1.1 (0.7–1.9) | 1.1 (0.7–1.9) | 1.1 (0.7–1.9) |
| Tamoxifen (%) | 51 (73) | 56 (70) | 107 (71) | 125 (71) |
Abbreviations: Eastern Cooperative Oncology Group (ECOG); performance status (PS);
estradiol (E2); follicle stimulating hormone (FSH); lumbar spine (LS); and bone mineral density (BMD).
*
median (range)