Table 1 Patient demographics and baseline disease characteristics
Characteristics | Placebo group (n = 195) |
|---|---|
Age, mean years ± SD | 56 ± 12 |
Patients < 50 years of age, n (%) | 67 (34) |
ECOG performance status, n (%) | |
0 – 1 | 128 (66) |
2 – 3 | 67 (34) |
Estrogen- and progesterone-receptor status, n (%) | |
Positive for at least 1 | 120 (62) |
Other | 75 (38) |
Sites of metastasis, patients, n (%) | |
Bone, any | 195 (100) |
Bone as only metastatic site | 117 (60) |
Lung | 30 (15) |
Liver | 29 (15) |
Brain | 1 (1) |
Other | 27 (14) |
Time from primary to bone metastases diagnosis, median years ± SD | 3.8 ± 4.5 |
Time from bone metastases to study entry, mean years ± SD | 1.6 ± 1.7 |
Patients with bone lesions ≥ 1 cm in diameter, n (%) | |
1 lesion | 82 (42) |
2 lesions | 71 (36) |
≥ 3 lesions | 42 (22) |
Lesion types and numbers | |
1 – 2 osteolytic | 104 (53) |
≥ 3 osteolytic | 91 (47) |
0 osteoblastic | 146 (75) |
1 – 2 osteoblastic | 37 (19) |
≥ 3 osteoblastic | 12 (6) |
0 mixed lesions | 28 (14) |
1 – 2 mixed lesions ≥ 3 mixed lesions | 61 (31) 106 (54) |
Patients with SREs during the 3 months before study entry, n (%) | |
Palliative radiotherapy | 57 (29) |
Fracture | 35 (18) |
Pain scores, n (%) | |
0 | 27 (14) |
1 – 3 | 76 (39) |
4 – 9 | 92 (47) |
Prior therapy regimens, n (%) | |
0 – 1 chemotherapy | 80 (41) |
2 – 3 chemotherapy | 104 (53) |
≥ 4 chemotherapy | 11 (6) |
0 – 1 hormonal therapy | 102 (52) |
2 – 3 hormonal therapy | 77 (39) |
≥ 4 hormonal therapy | 16 (8) |