Table 3.
Baseline factors influencing OS and PFS: univariate and multivariate analysis.
| Univariate analysis HR (95% CI) |
p value | Multivariate analysis HR (95% CI) |
p value | |
|---|---|---|---|---|
| Overall survival | ||||
| ECOG > 1 | 2.71 (1.37–5.34) | 0.004 | ||
| Group (1–3) | 2.27 (1.41–3.65) | 0.001 | ||
| Prior ART overall | 3.09 (1.69–5.67) | < 0.001 | 2.56 (1.28–5.11) | 0.008 |
| Response to ART | 0.39 (0.15–0.99) | 0.047 | ||
| Previous prednisone | 2.8 (1.45–5.41) | 0.002 | ||
| FT < detection level at baseline | 2.05 (1.01–4.19) | 0.048 | ||
| CRP > median | 1.93 (1.01–3.68) | 0.047 | ||
| NLR > 3 | 3.46 (1.35–8.88) | 0.01 | ||
| Number of organs | 1.73 (1.29–2.31) | < 0.001 | ||
| Soft tissue metastases | 3.17 (1.67–6) | < 0.001 | 3.46 (1.81–6.6) | < 0.001 |
| Lymphatic metastasis | 2.38 (1.33–4.43) | 0.003 | ||
| Hepatic metastasis | 3.05 (1.43–6.48) | 0.004 | ||
| PD soft tissue and bone at baseline | 2.57 (1.39–4.74) | 0.002 | ||
| Narcotics required | 2.1 (1.16–3.8) | 0.015 | ||
| Treatment-dependent parameters** | ||||
| FT reduction = 100% | 0.31 (0.16–0.62) | 0.001 | 0.28 (0.14–0.57) | < 0.001 |
| FT median < 0.3 pg/mL | 0.49 (0.24–1.0) | 0.049 | ||
| Progression-free survival | ||||
| Group (1–3) | 1.87 (1.24–2.8) | 0.003 | ||
| Prior ART overall | 2.14 (1.25–3.66) | 0.006 | ||
| Response to ART | 0.39 (0.17–0.92) | 0.031 | ||
| Prior enzalutamide | 2.11 (1.18–3.76) | 0.012 | ||
| Prior abiraterone | 1.75 (1.02–2.99) | 0.043 | ||
| PD soft tissue and bone at baseline | 1.85 (1.06–3.2) | 0.029 | ||
| NLR > 3 | 4.87 (1.85–12.81) | 0.001 | ||
| Soft tissue metastases | 2.35 (1.28–4.32) | 0.006 | ||
| Lymphatic metastasis | 2.04 (1.16–3.6) | 0.013 | ||
| Number of organs | 1.47 (1.12–1.93) | 0.006 | ||
| Non-narcotics required | 1.93 (1.11–3.39) | 0.021 | 2.72 (1.1–6.72) | 0.03 |
| Narcotics required | 2.36 (1.3–4.3) | 0.005 | ||
| Treatment-dependent parameters ♦ | ||||
| PSA response | 0.33 (0.19–0.58) | < 0.001 | 0.32 (0.15–0.66) | 0.002 |
| FT reduction = 100% | 0.38 (0.2–0.71) | 0.002 | 0.43 (0.22–0.84) | 0.014 |
| FT median < 0.2 pg/mL | 0.47 (0.25–0.91) | 0.024 | ||
| FT nadir < 0.18 pg/mL | 0.46 (0.25–0.86) | 0.014 | 0.39 (0.18–0.81) | 0.011 |
HR hazard ratio, CI confidence interval, ECOG Eastern Cooperative Oncology Group, ART androgen receptor targeted therapy, FT free testosterone, CRP C-reactive protein, NLR neutrophile to lymphocyte ratio, PD progressive disease, PSA prostate-specific antigen, FT free testosterone.
** = time-dependent covariate analysis revealed for FT reduction = 100% and FT median < 0.3 pg/mL p > 0.05 for overall survival applying T_, ln(T_) and T ≥ 365 days.
♦ = ln(T) revealed for PSA response p = 0.015, for the remaining time dependent parameters using T_,ln(T) and T ≥ 365 days there was no significant time-dependence.