TABLE 4.
Outcomes in the post‐ and pre‐chemotherapy enzalutamide populations
| Post chemotherapy enzalutamide | Pre chemotherapy enzalutamide | |||||||
|---|---|---|---|---|---|---|---|---|
| Outcome Patient group | All patients | Trial eligible patients | Trial ineligible patients | Pivotal study 6 | All patients | Trial eligible patients | Trial ineligible patients | Pivotal study 10 |
| Number of patients | 74 | 41 | 33 | 800 | 42 | 16 | 26 | 872 |
| Potential follow‐up, KM estimate (months) | ||||||||
| Median (95% CI) | 31.8 (26.5‐36.1) | 27.3 (25.5‐NR) | 34.2 (33.1‐NR) | 14.4 | 20.7 (20.7‐30.3) | 20.7 (19.7‐ NR) | 26.9 (20.7‐NR) | 31.0 |
| Observed follow‐up (months) | ||||||||
| Median (IQR) | 12.6 (5.3‐22.6) | 16.5 (10.5‐25.1) | 7.8 (2.7‐14.5) | 15.6 (4.7‐20.4) | 19.4 (16.5‐21.7) | 9 (3.5‐17.0) | ||
| Mean (SD) | 14.6 (10.6) | 14.1 (9.4) | ||||||
| Range | 0.4‐31.4 | 0.4‐31.4 | ||||||
| Total | 1079.2 | 590.3 | ||||||
| Patients alive at censor date | 18/74 (24%) | 13/41 (32%) | 5/33 (15%) | 492/800 (62%) | 17/42 (40%) | 11/16 (69%) | 6/26 (23%) | 504/872 (58%) |
| Overall survival (95% CI) (months) | 12.6 (10.5‐18.2) | 18.2 (12.1‐30.0) | 7.8 (5.2‐13.7) | 18.4 (17.3‐NR) | 16 (9.8‐NR) | 19 (NR‐NR) | 9 (4.2‐19.2) | 35.3 (32.2‐NR) |
Abbreviations: CI, Confidence Interval; IQR, Inter Quartile Range; KM, Kaplan–Meier; NR, Not reached.