Table 3 –
Baseline characteristics, clinical course, and QOL by disease progression type
| Clinical PD first | Current PSA and clinical PD PSA PD then clinical PD PSA PD only |
|||
|---|---|---|---|---|
| N = 140 % | % | N = 419 % | % | |
| Age at randomization | ||||
| Median | 62.5 | 62 | ||
| Range | 36–91 | 39–88 | ||
| Gleason score | ||||
| <7 | 10 | 7.8 | 20 | 5.4 |
| 7 | 20 | 15.6 | 83 | 22.6 |
| 8–10 | 98 | 76.6 | 265 | 72.0 |
| Missing | 12 | 51 | ||
| Prior local therapy | ||||
| No | 104 | 74.3 | 336 | 80.2 |
| Yes | 36 | 25.7 | 83 | 19.8 |
| Baseline PSA | ||||
| Median | 20.4 | 93.8 | ||
| Range | 0.1–2960 | 0.4–8540.1 | ||
| PSA <0.2 at 6 mo a, n (%) | ||||
| No | 67 (67.7) | 254 (82.5) | ||
| Yes | 32 (32.3) | 54 (17.5) | ||
| PSA <0.2 at 12 mo b, n (%) | ||||
| No | 40 (71.4) | 145 (79.7) | ||
| Yes | 16(28.6) | 37 (20.3) | ||
| QOL change from baseline c,d | ||||
| N | 70 | 212 | ||
| Mean (standard deviation) | −5.6(16.4) | −1.1 (17.5) | ||
| Median (range) e | −4.7 (−55.3, 35.0) | −2.0 (−69.4, 64.0) | ||
| Time to clinical progression (both arms) f | ||||
| N | 140 | 419 | ||
| Number of events | 140 | 295 | ||
| Median (mo) | 9.1 | 20.5 | ||
| 95% CI | (7.8, 11.4) | (18.2, 22.9) | ||
| Time to clinical progression (docetaxel arm) | ||||
| N | 64 | 193 | ||
| Number of events | 64 | 130 | ||
| Median (mo) | 11.1 | 24.1 | ||
| 95% CI | (8.0, 13.5) | (20.7, 29.1) | ||
| Time to clinical progression (ADT-alone arm) | ||||
| N | 76 | 226 | ||
| Number of events | 76 | 165 | ||
| Median (mo) | 8.5 | 17.8 | ||
| 95% CI | (5.7, 11.3) | (14.2, 20.1) | ||
ADT = androgen deprivation therapy; CI = confidence interval; PD = progressive disease; PSA = prostate-specific antigen; QOL = quality of life.
Only patients with first disease progression observed at least 6 mo after randomization were included in the analysis.
Only patients with first disease progression observed at least 12 mo after randomization were included in the analysis.
As QOL assessment was administered at baseline, and at 3, 6, 9, and 12 mo, only patients with baseline QOL assessment available and follow-up QOL assessment administered within 4 mo prior to first disease progression were included in this analysis. There are 70 and 212 patients meeting the criterion in the “clinical PD first” and “other” categories, respectively.
QOL change is defined as change in the FACT-P total score from baseline to the follow-up visit prior to disease progression. For example, a patient with disease progression at 8 mo has QOL change calculated as follows: FACT-P total score at 6 mo – FACT-P total score at baseline.
p = 0.14 by Wilcoxon rank-sum test.
Time to clinical progression is defined as the time from randomization to clinical progression. Patients without clinical progression were censored at the date of last disease assessment.