Table 3 —
Kaplan-Meier estimated free-of-clinical failure rates by PSA category at 3.5–4.5 years for combined cohort and for validation cohorts.
| PSA category | % in category (no.) | Combined Cohort PSA @ 4 years | Validation Cohort 1 (Australia) 75% low-risk/25% intermediate-risk | Validation Cohort 2 (MD Anderson) intermediate-risk | Validation Cohort 3 (Ascende-RT) 70% high-risk/30% upper-tier intermediate-risk | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % NED 10 years | % NED 15 years | % pts in category (no.) | % NED 10 years | % NED 15 years | % in category (no.) | % NED 10 years | % NED 15 years | % pts in category (no.) | % NED 10 years | % NED 15 years | ||
| ≤0.2 | 77.1% (6746) | 98.7 (98. 3–99.0) | 96.1 (94. 8–97.2) | 54.6% (200) | 99.0 (96. 1–99.8) | 99.0 (96.1–99.8) | 73.5% (164) | 99.4 (95. 8–99.9) | ------ | 85.7% (137) | 96.7 (89. 9–99.0) | 96.7 (89.9–99.0) |
| >0.2 to ≤0.5 | 12.6% (1100) | 93.5 (91. 0–95.3) | 86.8 (81. 4–90.7) | 25.7% (94) | 98.9 (92. 7–99.9) | 96.2 (88. 4–98.8) | 14.8% (33) | 92.7 (53. 9–98.8) | ------ | 8.1% (13) | 88.9 (43.3–98.4) | ------ |
| >0.5 to ≤1.0 | 4.1% (444) | 85.9 (80. 6–89.8) | 78.2 (68. 6–85.2) | 9.6 (35) | 94.3 (79. 0–98.5) | 91.0 (74. 6–97.0) | 6.3% (14) | 90.9 (50. 8–98.7) | ------ | 0.6% (1) | ------ | ------ |
| > 1.0 | 5.1% (456) | 48.0 (41. 8–53.8) | 33.2 (24. 9–41.6) | 10.1 (37) | 73.0 (55. 6–84.4) | 54.6 (32. 9–71.9) | 5.4% (12) | ------ | ------ | 5.6% (9) | 33.3 (7.8–62.3) | ------ |
%: percentage of patients with readings in that category
NED 10 years / 15 years: % of patients with no evidence of recurrence at 10 years or 15 years (followed by 95% confidence intervals)