Table 1.
Patients’ characteristics.
| Characteristics | All Patients | Before EMA Restricted Use | After EMA Restricted Use | p Value |
|---|---|---|---|---|
| n = 494 | n = 405 | n = 89 | ||
| n (%) | ||||
| Age, years Median (range) |
74 (50–90) | 74 (50–90) | 75 (52–89) | 0.465 |
| <75 | 257 (52.0) | 212 (52.4) | 45 (50.6) | 0.760 |
| ≥75 | 237 (48.0) | 193 (47.7) | 44 (49.4) | |
| ECOG PS | ||||
| Median (range) | 1 (0–3) | 1 (0–3) | 1 (0–3) | 0.409 |
| 0–1 | 379 (76.7) | 313 (77.3) | 66 (74.2) | 0.527 |
| 2–3 | 115 (23.3) | 92 (22.7) | 23 (25.8) | |
| Gleason score | ||||
| Median (range) | 8 (5–10) | 8 (5–10) | 8 (6–10) | 0.892 |
| ≤7 | 166 (33.6) | 135 (33.3) | 31 (34.8) | 0.959 |
| ≥8 | 249 (50.4) | 203 (50.1) | 46 (51.7) | |
| Missing | 79 (16.0) | 67 (16.5) | 12 (13.5) | |
| Lymphadenopathies | ||||
| Yes | 156 (31.6) | 119 (29.4) | 37 (41.6) | 0.063 |
| No | 297 (60.1) | 248 (61.2) | 49 (55.1) | |
| Missing | 41 (8.3) | 38 (9.4) | 3 (3.4) | |
| Number of bone metastases | ||||
| <6 | 60 (12.2) | 56 (13.8) | 4 (4.5) | <0.001 |
| 6–20 | 286 (57.9) | 243 (60.0) | 43 (48.3) | |
| >20 | 148 (30.0) | 106 (26.2) | 42 (47.2) | |
| Ra-223 treatment line | ||||
| Median (range) | 3 (1–9) | 2 (1–9) | 3 (1–9) | 0.001 |
| First and second line | 235 (47.6) | 208 (51.4) | 27 (30.3) | <0.001 |
| ≥Third line | 259 (52.4) | 197 (48.6) | 62 (69.7) | |
| Prior chemotherapy | ||||
| Yes | 304 (61.5) | 239 (59.0) | 65 (73.0) | 0.014 |
| No | 190 (38.5) | 166 (41.0) | 24 (27.0) | |
| Bisphosphonates/Denosumab use | ||||
| Yes | 224 (45.3) | 178 (44.0) | 46 (51.7) | 0.107 |
| No | 267 (54.1) | 227 (56.1) | 40(44.9) | |
| Missing | 3 (0.6) | 0(0.0) | 3 (3.4) | |
| Baseline ALP, U/L | ||||
| Median (range) | 145 (0–2474) | 142 (0–1798) | 149 (36–2474) | 0.744 |
| <220 | 330 (66.8) | 273 (67.4) | 57 (64.0) | 0.542 |
| ≥220 | 164 (33.2) | 132 (32.6) | 32 (36.0) | |
| Baseline median LDH, U/L (range) | 295 (129–2146) | 309.5 (129–2146) | 266 (152–988) | 0.038 |
| Baseline median PSA, ng/mL (range) | 58.6 (0.03–6089) | 53.3 (0.03–3000) | 85.3 (0.39–6089) | 0.024 |
| Baseline median Hb, g/dL (range) | 12.2 (7.8–15.9) | 12.3 (8.1–15.9) | 11.5 (7.8–15) | 0.007 |
n, number; ECOG, Eastern Cooperative Oncology Group; PS, performance status; EMA, European Medicines Agency; ALP, alkaline phosphatase; LDH, lactate dehydrogenase; PSA, prostate-specific antigen; Hb, haemoglobin.