Table 2.
<65 yrs | 65–74 yrs | ≥75 yrs | p | |
---|---|---|---|---|
Efficacy end point | ||||
Pain | ||||
No. evaluated (n) | 59 | 69 | 25 | |
Response rate (n/%) | 20 (34) | 26 (38) | 7 (28) | 0.69 |
Median duration (months) | 4.9 | 2.7 | 2.8 | 0.90 |
≥50% reduction in PSA | ||||
No. evaluated (n) | 103 | 125 | 63 | |
Response rate (n/%) | 45 (44) | 60 (48) | 27 (43) | 0.74 |
Median duration (months) | 8.8 | 7.2 | 10.3 | 0.22 |
Tumor response | ||||
No. evaluated | 54 | 56 | 31 | |
Response rate (n/%) | 9 (17) | 4 (7) | 4 (13) | 0.30 |
Overall survival | ||||
Median (months) | 20.4 | 18.6 | 18.9 | 0.53 |
1 year (%) | 76 | 74 | 68 | |
Treatment intensity | ||||
Drug exposure | ||||
Median no. of cycles | 10 | 10 | 7 | 0.22 |
Median duration of | 27 | 26.7 | 18.7 | 0.19 |
Rx (wks) | ||||
No. (%) with dose reductions | 9 (7) | 17 (12) | 15 (22) | 0.010 |
>1 reductions | 0 | 2 (1) | 1 (2) | |
No. (%) with cycle delays | 27 (21) | 36 (26) | 17 (25) | 0.72 |
>1 cycles delayed | 3 (2) | 8 (6) | 4 (6) | |
Dose discontinuation | ||||
Completed Rx | 62 (49) | 67 (48) | 25 (37) | 0.23 |
Disease progression | 58 (46) | 46 (33) | 23 (34) | |
Adverse event | 4 (3) | 19 (14) | 13 (19) | |
Death | 0 | 3 (2) | 1 (2) | |
Other | 2 (2) | 6 (4) | 6 (9) |
P value of ≤ 0.05 was considered statistically significant.
Abbreviations: yrs: years; wks: weeks; PSA = Prostate Specific Antigen; Rx = treatment.