TABLE 3.
Secondary endpoint: treatment response at selected study visits based on MIDs for the EQ‐5D‐5L, FACT‐P and BPI‐SF scales a
| Enzalutamide Cohort 1: chemotherapy naïve + abiraterone naïve (n = 1171) | Enzalutamide Cohort 2: postchemotherapy + abiraterone naïve (n = 418) | |||||
|---|---|---|---|---|---|---|
| Improve | No change | Worsen | Improve | No change | Worsen | |
| EQ index (MID, 0.12) b | ||||||
| 3 months | 184 (20.9) | 506 (57.5) | 190 (21.6) | 71 (20.7) | 192 (56.0) | 80 (23.3) |
| 6 months | 146 (21.8) | 357 (53.3) | 167 (24.9) | 56 (25.2) | 119 (53.6) | 47 (21.2) |
| 9 months | 117 (21.7) | 290 (53.7) | 133 (24.6) | 37 (23.0) | 83 (51.6) | 41 (25.5) |
| EQ‐VAS (MID, 7) c | ||||||
| 3 months | 238 (27.2) | 410 (46.9) | 227 (25.9) | 117 (34.3) | 116 (34.0) | 108 (31.7) |
| 6 months | 184 (27.6) | 292 (43.9) | 189 (28.3) | 87 (39.0) | 83 (37.2) | 53 (23.7) |
| 9 months | 160 (30.0) | 213 (40.1) | 158 (29.7) | 53 (32.9) | 65 (40.4) | 43 (26.7) |
| FACT‐P (MID, 6) d | ||||||
| 3 months | 267 (31.3) | 319 (37.4) | 266 (31.2) | 112 (33.1) | 91 (26.9) | 135 (39.9) |
| 6 months | 206 (31.5) | 207 (31.7) | 241 (36.9) | 73 (33.8) | 70 (32.4) | 73 (33.8) |
| 9 months | 178 (34.4) | 163 (31.5) | 176 (34.0) | 47 (29.9) | 48 (30.6) | 62 (39.5) |
| BPI‐SF severity (MID, 2) e | ||||||
| 3 months | 82 (10.0) | 640 (77.8) | 101 (12.3) | 53 (16.3) | 237 (72.2) | 36 (11.0) |
| 6 months | 71 (11.4) | 466 (74.6) | 88 (14.1) | 33 (15.2) | 160 (73.7) | 24 (11.1) |
| 9 months | 55 (10.9) | 378 (75.2) | 70 (13.9) | 19 (13.4) | 108 (76.1) | 15 (10.6) |
| BPI‐SF interference (MID, 1.25) e | ||||||
| 3 months | 166 (20.5) | 475 (58.6) | 169 (20.9) | 76 (23.9) | 171 (53.8) | 71 (22.3) |
| 6 months | 135 (22.3) | 364 (60.2) | 106 (17.5) | 50 (23.6) | 110 (51.9) | 52 (24.5) |
| 9 months | 102 (21.1) | 284 (58.7) | 98 (20.3) | 32 (22.9) | 78 (55.7) | 30 (21.4) |
Note: Data are presented as n (%) unless stated otherwise.
a
Due to patient dropout at months 12, 15 and 18, data are only shown from months 3‐9.
b
On EQ index, 0 = equivalent to dead and 1 = perfect health.
c
EQ‐VAS is measured on a scale from 0 to 100, with higher values indicating better QoL.
d
FACT‐P total score (range, 0‐156) is the combination of FACT‐G (range, 0‐108) and FACT‐PCS (range, 0‐48) subscale scores, with higher scores indicating better QoL.
e
BPI‐SF severity and interference are measured on a scale from 0 to 10, with higher scores indicating less pain severity or interference.