Table 1. Pre-therapeutic and therapeutic parameters in both groups.
| Parameter | Group 1 (Hx of Ra-223) | Group 2 | p-value | ||
|---|---|---|---|---|---|
| n of patients | 20 (40.8%) | 29 (59.2%) | |||
| Age (mean; +/-SD) | 71.2 (+/- 5.6) (range: 57–82) | 71.3 (+/- 9.6) (range: 48–87) | 0.94 | ||
| Gleason score1 | <=7 | >7 | <=7 | >7 | 0.48 |
| 5 (25%) | 15 (75%) | 8 (27.5%) | 19 (65.5%) | ||
| laboratory findings (mean; range) | |||||
| Hb (g/dl) (norm: 12.5–17,2) | 11.1 (8.2–12.9) | 11.2 (6–14.5) | 0.73 | ||
| WBC (G/l) (norm: 3.6-10,5) | 5.4 (3.3–10.8) | 6.6 (1.52–12.2) | 0.07 | ||
| Plt (G/l) (norm: 160–370) | 219 (62–562) | 271 ( 152–557) | 0.07 | ||
| PSA (ng/ml) | 818 (5.6–5910) | 377 (4.7–1180) | 0.09 | ||
| ALP (U/l) (norm: 34–117) | 189 (50–682) | 205 (36–997) | 0.77 | ||
| LDH (norm: < 248) | 264 (151–550) | 283 (146–908) | 0.61 | ||
| red blood cell transfusion2 | 5 patients (25%) 0–14 days prior to the RLT |
3 patients (10%) 0,14 and 180 days prior to the RLT |
0.24 | ||
| Therapy | Hx of n (%) | ongoing n (%) | Hx of n (%) | ongoing n (%) | |
| Abiraterone | 10 (50%) | 4 (20%) | 12 (41%) | 8 (27.5%) | 0.79 |
| Enzalutamide | 6 (30%) | 7 (35%) | 9 (31%) | 9 (31%) | 0.95 |
| Bisphosphonate or RANKL3 inhibitor | 3 (15%) | 15 (75%) | 3 (10%) | 18 (62%) | 0.31 |
| Chemotherapy4 | 11 (55%) | 17 (58%) | 0.50 | ||
| External radiation5 | 8 (40%) | 13 (44.8%) | 0.65 | ||
| Extent of bone met | n of patients (%) | n of patients (%) | 0.63 | ||
| < 6 met | 0 | 2 (7%) | |||
| 6–20 met | 4 (20%) | 7 (24%) | |||
| > 20 met | 11 (55%) | 13 (45%) | |||
| Diffus/SuperScan | 5 (25%) | 7 (24%) | |||
| Lymph node met | 14 (70%) | 23 (79%) | 0.43 | ||
| Liver met | 1 (5%) | 5 (17%) | 0.19 | ||
| Lung met | 1 (5%) | 4 (14%) | 0.32 | ||
| ECOG | n of patients (%) | n of patients (%) | 0.35 | ||
| 0 | 6 (30%) | 10 (35%) | |||
| 1 | 7 (35%) | 14 (48%) | |||
| 2 | 7 (35%) | 5 (17%) | |||
| Amount of activity (GBq) | |||||
| First cycle | 6.1 (+/- 0.6) | 5.9 (+/- 0.6) | 0.32 | ||
| Second cycle | 6.0 (+/- 0.5) | 6.0 (+/- 0.6) | 0.64 | ||
| Third cycle | 5.8 (+/- 0.6) | 5.8 (+/- 0.6) | 0.99 | ||
| Cumulative | 18.0 (+/- 1.2) | 17.8 (+/- 1.5) | 0.55 | ||
Abbreviations: Hx: history; ns: nonsignificant; n: number; met: metastases; SD: standard deviation; Hb: hemoglobin; WBC: white blood cells; Plt: platelets; ALP: alkaline phosphatase; ECOG: Eastern Cooperative Oncology Group performance status; RLT: radioligand therapy
1 Gleason score of two patients in group 2 was unclear
2 Red blood cell transfusion prior to the first cycle
3 Receptor activator of nuclear factor kappa-B ligand
4 in the group 1, eight patients received Docetaxel and three patients Docetaxel as well as cabazitaxel as the second line chemotherapy. In the group 2, eleven patients received docetaxel and 6 patients docetaxel as well as cabazitaxel as the second line chemotherapy
5 the extent of radiation to the bone metastases was in all patients in this study under 25 % of skeleton.