Table 1.
Baseline demographics and disease characteristics of Asian subgroups
| Denosumab 120 mg SC Q4W (N = 103)a | Zoledronic acid 4 mg IV Q4W (N = 93)b | |
|---|---|---|
| Sex, n (%) | ||
| Men | 65 (63.1) | 43 (46.2) |
| Women | 38 (36.9) | 50 (53.8) |
| Age, median (Q1, Q3) | 61.0 (54.0, 69.0) | 61.0 (54.0, 68.0) |
| ECOG performance status at study entry, n (%) | ||
| 0 | 33 (32.0) | 24 (25.8) |
| 1 | 45 (43.7) | 52 (55.9) |
| 2 | 25 (24.3) | 17 (18.3) |
| Multiple myeloma ISS stage at diagnosis, n (%) | ||
| I | 25 (24.3) | 31 (33.3) |
| II | 35 (34.0) | 36 (38.7) |
| III | 42 (40.8) | 26 (28.0) |
| Not available | 1 (1.0) | 0 |
| History of SREs, n (%) | ||
| Any SRE | 64 (62.1) | 70 (75.3) |
| Pathological fracture | 57 (55.3) | 60 (64.5) |
| Spinal cord compression | 14 (13.6) | 16 (17.2) |
| Radiation therapy to bone | 6 (5.8) | 8 (8.6) |
| Surgery to bone | 9 (8.7) | 22 (23.7) |
| Prior radiotherapy to soft tissue/mass for multiple myeloma, n (%) | 2 (1.9) | 6 (6.5) |
| Prior oral bisphosphonate use, n (%) | 1 (1.0) | 4 (4.3) |
| Class of the first-line therapy, n (%) | ||
| PI only | 37 (35.9) | 42 (45.2) |
| IMiD only | 26 (25.2) | 31 (33.3) |
| PI + IMiD | 32 (31.1) | 17 (18.3) |
| Other | 7 (6.8) | 3 (3.2) |
| Cytogenetics risk group, n (%) | ||
| Standard risk | 77 (74.8) | 71 (76.3) |
| High risk | 10 (9.7) | 9 (9.7) |
| Unknown | 16 (15.5) | 13 (14.0) |
ECOG Eastern Cooperative Oncology Group, IMiD immunomodulatory drug, ISS International Staging System, IV intravenously, PI proteasome inhibitor, Q4W every 4 weeks, SC subcutaneously, SRE skeletal-related event
aOf the 103 patients randomized to denosumab, 36 (35%) were from Korea, 24 (23%) were from Japan, 15 (15%) were from Taiwan, 15 (15%) were from Singapore, 8 (8%) were from Malaysia, and 5 (5%) were from Hong Kong
bOf the 93 patients randomized to zoledronic acid, 48 (52%) were from Korea, 18 (19%) were from Japan, 11 (12%) were from Taiwan, 6 (6%) were from Singapore, 6 (6%) were from Malaysia, and 4 (4%) were from Hong Kong