Hazard ratio and 1- to 3-year DFS analysis at 3 PML-RARα NQ cutoff levels of samples after consolidation therapy in 53 INT0129 cases
| NQ cutoff . | Relapses/patients . | HR4-150,4-151 . | P4-151 . | DFS, % . | ||
|---|---|---|---|---|---|---|
| 1 y . | 2 y . | 3 y . | ||||
| Greater than 10−5 | 6/9 | 4.1 | .008 | 56 | 44 | 33 |
| Less than 10−5 | 16/44 | 86 | 72 | 65 | ||
| Greater than 10−7/10−8 | 8/13 | 2.4 | .074 | 62 | 54 | 46 |
| Less than 10−7/10−8 | 14/40 | 88 | 72 | 63 | ||
| Greater than 10−10 | 11/21 | 1.7 | .244 | 67 | 62 | 52 |
| Negative | 11/32‡ | 91 | 70 | 64 | ||
| NQ cutoff . | Relapses/patients . | HR4-150,4-151 . | P4-151 . | DFS, % . | ||
|---|---|---|---|---|---|---|
| 1 y . | 2 y . | 3 y . | ||||
| Greater than 10−5 | 6/9 | 4.1 | .008 | 56 | 44 | 33 |
| Less than 10−5 | 16/44 | 86 | 72 | 65 | ||
| Greater than 10−7/10−8 | 8/13 | 2.4 | .074 | 62 | 54 | 46 |
| Less than 10−7/10−8 | 14/40 | 88 | 72 | 63 | ||
| Greater than 10−10 | 11/21 | 1.7 | .244 | 67 | 62 | 52 |
| Negative | 11/32‡ | 91 | 70 | 64 | ||
Cases with NQs higher than the cutoff level are defined as poor-risk cases as compared with good-risk cases, those with NQs below the cutoff level. Percentages indicate DFS of the good-risk versus bad-risk categories at each level estimated for up to 3 years of follow-up. (Figure 3 shows plot of < 10−5versus > 10−5 cutoff level.) HR indicates hazard ratio.
The hazard ratio indicates the relative risk of relapse in poor-risk versus good-risk cases calculated at 3 selected cutoff levels.
The HRs and P's are adjusted for induction treatment, PML-RARα type, and pretreatment WBC count at 2000/μL cutoff.
The median GAPDH copy number for PML-RARα− relapse cases was 4.3 × 106, higher than the median of 3.9 × 106 for all cases after consolidation therapy.