JPN-201 | JPN-202 | |||
---|---|---|---|---|
Chemotherapy-naive | Chemotherapy-treated | |||
HR | 95 % CI | HR | 95 % CI | |
Maximum % PSA decline | 0.975 | 0.964–0.986 | 0.981 | 0.975–0.987 |
Time to PSA nadir (months) | 0.818 | 0.741–0.903 | 0.153 | 0.081–0.291 |
Nadir PSA value (ng/mL) | 1.012 | 1.002–1.022 | 1.001 | 0.999–1.002 |
% PSA decline at week 4 | 0.989 | 0.981–0.998 | 0.980 | 0.973–0.986 |
% PSA decline at week 12 | 0.981 | 0.974–0.989 | 0.998 | 0.984–0.992 |
PSA decline (≥30 %) at week 4 | ||||
Non-decline (reference) | – | – | – | – |
Decline | 0.753 | 0.341–1.664 | 0.342 | 0.180–0.648 |
PSA response (≥30 %) at week 12 | ||||
Non-responder (reference) | – | – | – | – |
Responder | 0.331 | 0.158–0.692 | 0.335 | 0.167–0.674 |
PSA response (≥50 %) at week 12 | ||||
Non-responder (reference) | – | – | – | – |
Responder | 0.394 | 0.119–0.781 | 0.298 | 0.141–0.627 |
PSA response (≥90 %) at week 12 | ||||
Non-responder (reference) | – | – | – | – |
Responder | 0.357 | 0.137–0.930 | 0.807 | 0.193–3.369 |