Table 1.
Cox regression univariable analysis of clinical baseline and on-treatment factors.
| Variable | No. (%) | OS HR (95% CI) |
p-Value | rPFS HR (95% CI) |
p-Value |
|---|---|---|---|---|---|
| Age a, median, years | |||||
| <78 | 121 (52) | 1.00 (ref) | 1.00 (ref) | ||
| ≥78 | 113 (48) | 2.51 (1.35–4.6) | 0.004 | 1.42 (0.96–2.10) | 0.077 |
| <75 | 84 (36) | 1.00 (ref) | 1.00 (ref) | ||
| ≥75 | 150 (64) | 2.27 (1.77–4.39) | 0.014 | 1.41 (0.95–2.11) | 0.090 |
| Gleason score, median | |||||
| <8 | 78 (36) | 1.00 (ref) | 1.00 (ref) | ||
| ≥8 | 136 (64) | 1.27 (0.68–2.36) | 0.449 | 1.60 (1.04–2.46) | 0.032 |
| Surgery at diagnosis | |||||
| No | 146 (62) | 1.00 (ref) | 1.00 (ref) | ||
| Yes | 88 (38) | 0.55 (0.30–1.01) | 0.055 | 0.64 (0.43–0.95) | 0.025 |
| Time to CR, mo, median | |||||
| ≥31 | 118 (50) | 1.00 (ref) | 1.00 (ref) | ||
| <31 | 116 (50) | 1.60 (0.90–2.85) | 0.111 | 1.84 (1.25–2.70) | 0.002 |
| ≥12 | 183 (78) | 1.00 (ref) | 1.00 (ref) | ||
| <12 | 51 (22) | 1.57 (0.83–3.00) | 0.168 | 1.76 (1.16–2.66) | 0.007 |
| Sites of metastases a | |||||
| Bone (non-visceral) | 163 (70) | 1.00 (ref) | 1.00 (ref) | ||
| Lymph nodes (only) | 49 (21) | 0.00 (NA) | 0.997 | 0.31 (0.16–0.62) | <0.001 |
| Visceral | 22 (9) | 20.7 (NA) | 0.428 | 0.80 (0.43–1.49) | 0.488 |
| Setting of therapy | |||||
| Post-chemotherapy | 57 (24) | 1.00 (ref) | 1.00 (ref) | ||
| Pre-chemotherapy | 162 (69) | 0.78 (0.41–1.50) | 0.350 | 0.79 (0.51–1.23) | 0.300 |
| Post-Abi/Enza | 15 (6) | 2.06 (0.45–9.41) | 0.451 | 3.68 (1.57–8.66) | 0.003 |
| Steroid use b | |||||
| No | 134 (57) | 1.00 (ref) | 1.00 (ref) | ||
| Yes | 100 (43) | 1.02 (0.57–1.84) | 0.935 | 0.84 (0.57–1.24) | 0.378 |
| Charlson score, median | |||||
| ≥10 | 175 (75) | 1.00 (ref) | 1.00 (ref) | ||
| <10 | 59 (25) | 0.99 (0.52–1.89) | 0.977 | 0.96 (0.62–1.47) | 0.846 |
| ≥9 | 190 (81) | 1.00 (ref) | 1.00 (ref) | ||
| <9 | 44 (19) | 0.70 (0.32–1.51) | 0.361 | 0.55 (0.32–0.96) | 0.034 |
| Geriatric G8, median | |||||
| >14 | 145 (62) | 1.00 (ref) | 1.00 (ref) | ||
| ≤14 | 89 (38) | 3.58 (1.72–7.49) | <0.001 | 1.55 (1.04–2.31) | 0.032 |
| IADL, median | |||||
| >6 | 121 (52) | 1.00 (ref) | 1.00 (ref) | ||
| ≤6 | 113 (48) | 1.60 (0.88–2.91) | 0.123 | 1.11 (0.76–1.63) | 0.576 |
| Concomitant therapies, no. | |||||
| ≥3 | 132 (56) | 1.00 (ref) | 1.00 (ref) | ||
| <3 | 102 (44) | 1.07 (0.60–1.93) | 0.815 | 0.89 (0.61–1.31) | 0.550 |
| Caregiver | |||||
| Yes | 190 (81) | 1.00 (ref) | 1.00 (ref) | ||
| No | 44 (19) | 0.46 (0.18–1.16) | 0.098 | 0.57 (0.32–0.99) | 0.047 |
| Treatment | |||||
| Enza | 148 (63) | 1.00 (ref) | 1.00 (ref) | ||
| Abi | 86 (37) | 0.74 (0.40–1.36) | 0.329 | 0.65 (0.43–0.99) | 0.042 |
| PSA50 | |||||
| No | 65 (28) | 1.00 (ref) | 1.00 (ref) | ||
| Yes | 164 (71) | 0.18 (0.10–0.32) | <0.001 | 0.25 (0.17–0.37) | <0.001 |
| Toxicity, G1/G2 | |||||
| No | 100 (43) | 1.00 (ref) | 1.00 (ref) | ||
| Yes | 134 (57) | 1.58 (0.83–2.99) | 0.164 | 1.07 (0.72–1.59) | 0.732 |
| Toxicity, G3/G4 | |||||
| No | 222 (95) | 1.00 (ref) | 1.00 (ref) | ||
| Yes | 12 (5) | 2.53 (0.90–7.08) | 0.077 | 1.88 (0.87–4.07) | 0.107 |
a At the time of initiation of treatment. b During the whole treatment. Abi, abiraterone; CI, confidence intervals; CR, castration resistance; Enza, enzalutamide; FU, follow-up; mo., months; G, grade; NA, not assessable; No., number; OS, overall survival; PSA50, decline in the PSA ≥ 50%; ref, reference; rPFS, radiographic progression-free survival; Tx, treatment. Statistically significant values in bold (p < 0.005).