Table 1.
Baseline demographics and disease characteristics in the ASCT-intent subgroup
| Denosumab (n = 465) | Zoledronic acid (n = 465) | All patients (N = 930) | |
|---|---|---|---|
| Male | 269 (57.8) | 278 (59.8) | 547 (58.8) |
| Age, median (IQR), y | 59.0 (54.0-64.0) | 59.0 (54.0-64.0) | 59.0 (54.0-64.0) |
| Race | |||
| White | 380 (81.7) | 378 (81.3) | 758 (81.5) |
| Asian | 66 (14.2) | 59 (12.7) | 125 (13.4) |
| Black | 14 (3.0) | 17 (3.7) | 31 (3.3) |
| Other | 5 (1.1) | 11 (2.4) | 16 (1.7) |
| Geographic region | |||
| Europe | 251 (54.0) | 267 (57.4) | 518 (55.7) |
| North America | 133 (28.6) | 134 (28.8) | 267 (28.7) |
| Rest of the world | 81 (17.4) | 64 (13.8) | 145 (15.6) |
| Bone marrow plasma cell percentage at initial diagnosis, median (IQR) | 40.0 (20.0-70.0) | 39.0 (20.0-65.0) | 40.0 (20.0-68.0) |
| ECOG performance status at study entry | |||
| 0 | 181 (38.9) | 171 (36.8) | 352 (37.8) |
| 1 | 194 (41.7) | 207 (44.5) | 401 (43.1) |
| 2 | 90 (19.4) | 87 (18.7) | 177 (19.0) |
| Previous SRE | |||
| Any | 314 (67.5) | 314 (67.5) | 628 (67.5) |
| Pathological fracture | 264 (56.8) | 245 (52.7) | 509 (54.7) |
| Spinal cord compression | 52 (11.2) | 68 (14.6) | 120 (12.9) |
| Radiation therapy to bone | 67 (14.4) | 79 (17.0) | 146 (15.7) |
| Surgery to bone | 69 (14.8) | 88 (18.9) | 157 (16.9) |
| ISS stage at diagnosis | |||
| I | 167 (35.9) | 164 (35.3) | 331 (35.6) |
| II | 166 (35.7) | 174 (37.4) | 340 (36.6) |
| III | 122 (26.2) | 115 (24.7) | 237 (25.5) |
| Not available | 10 (2.2) | 12 (2.6) | 22 (2.4) |
| Prior oral bisphosphonate exposure, median (IQR), months | 5.4 (0.5-6.5) | 2.5 (0.6-4.2) | 3.8 (0.6-5.4) |
Data are n (%) unless indicated otherwise.
ECOG, Eastern Cooperative Oncology Group; IQR, interquartile range.