Table 6.
Quality of Life assessment at pre-specified time points.
| QLQ30 | Pretreatment (n = 53) | 12 th week (n = 50) | 25th week (n = 47) | 1 month after enzalutamide (n = 45) | P-value |
|---|---|---|---|---|---|
| Global Health | |||||
| Mean ± SD | 82.55 ± 16.69 | 74.50 ± 19.30 | 80.50 ± 15.57 | 81.48 ± 18.02 | Pre vs 12th w: p = 0.011 |
| (range) | (33.33–100.00) | (16.67–100.00) | (50.00–100.00) | (33.33–100.00) | Pre vs 25th w: p = 0.155 |
| 95% CI | 78.05–87.04 | 69.15–79.85 | 76.05–84.95 | 76.22–86.75 | Pre vs 1 month: p = 0.682 |
| Functioning area | |||||
| Mean ± SD | 94.12 ± 7.19 | 88.53 ± 14.00 | 92.17 ± 8.53 | 92.05 ± 10.66 | Pre vs 12th w: p = 0.011 |
| (range) | (62.22–100.00) | (31.11–100.00) | (71.11–100.00) | (57.78–100.00) | Pre vs 25th w: p = 0.075 |
| 95% CI | 92.18–96.05 | 84.65–92.41 | 89.73–94.61 | 88.97–95.13 | Pre vs 1 month: p = 0.260 |
| Symptoms Area | |||||
| Mean ± SD | 2.95 ± 3.17 | 6.49 ± 6.45 | 4.71 ± 4.37 | 4.37 ± 4.75 | Pre vs 12th w: p <0.001 |
| (range) | (0.00–11.54) | (0.00–26.92) | (0.00–20.51) | (0.00–16.67) | Pre vs 25th w: p = 0.005 |
| 95% CI | 2.10–3.80 | 4.70–8.28 | 3.46–5.96 | 3.00–5.75 | Pre vs 1 month: p = 0.088 |
| QLQ-PR25 | Pretreatment (n = 53) | 12th week (n = 50) | 25th week (n = 47) | 1 month after enzalutamide (n = 47) | P-value |
| Urinary Symptoms | |||||
| Mean ± SD | 84.04 ± 12.60 | 69.51 ± 21.86 | 79.61 ± 17.64 | 81.84 ± 19.57 | Pre vs 12th w: p <0.0001 |
| (range) | (37.50–100.00) | (0.00–100.00) | (25.00–100.00) | (16.67–100.00) | Pre vs 25th w: p = 0.031 |
| 95% CI | 80.65–87.43 | 63.45–75.57 | 75.57–84.65 | 76.39–87.29 | Pre vs 1 month: p = 0.470 |
| Gastrointestinal Symptoms | |||||
| Mean ± SD | 97.01 ± 5.91 | 94.33 ± 9.44 | 96.45 ± 6.89 | 96.92 ± 5.92 | Pre vs 12th w: p = 0.059 |
| (range) | (75.00–100.00) | (50.00–100.00) | (75.00–100.00) | (75.00–100.00) | Pre vs 25th w: p = 0.569 |
| 95% CI | 95.42–98.60 | 91.72–96.95 | 94.48–98.43 | 95.21–98.63 | Pre vs 1 month: p = 0.844 |
| Hormonal related symptoms | |||||
| Mean ± SD | 96.54 ± 5.99 | 87.22 ± 10.86 | 84.75 ± 12.40 | 85.93 ± 10.42 | Pre vs 12th w: p <0.0001 |
| (range) | (72.22–100.00) | (50.00–100.00) | (55.56–100.00) | (55.56–100.00) | Pre vs 25th w: p <0.0001 |
| 95% CI | 94.93–98.15 | 84.21–90.23 | 81.18–88.33 | 82.96–88.91 | Pre vs 1 month: p <0.0001 |
| Sexual activity | |||||
| Mean ± SD | 77.04 ± 19.97 | 80.79 ± 25.00 | 72.86 ± 25.84 | 78.70 ± 25.84 | Pre vs 12th w: p = 0.550 |
| (range) | (33.33–100.00) | (5.56–100.00) | (11.11–100.00) | (16.67–100.00) | Pre vs 25th w: p = 0.232 |
| 95% CI | 71.67–82.42 | 73.71–87.86 | 65.47–80.25 | 71.86–85.54 | Pre vs 1 month: p = 0.822 |