Table 4.
Outcomes according to various BCR‐ABL1 values between baseline and 3 mo
| Parameters | Value | MMR by 12 mo | P‐value | MMR by 5 y | P‐value | DMR by 5 y | P‐value | OS by 5 y | P‐value | PFS by 5 y | P‐value |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline BCR‐ABL1 | Continuous variable (n = 183) | 1.00 (0.99‐1.00) | 0.326 | 1.00 (1.00‐1.00) | 0.555 | 1.00 (0.99‐1.00) | 0.394 | 1.00 (0.99‐1.01) | 0.922 | 1.00 (0.99‐1.01) | 0.923 |
| 4‐wk BCR‐ABL1 | Continuous variable (n = 258) | 0.98 (0.97‐0.99) | <0.001 | 0.98 (0.97‐0.99) | <0.001 | 0.97 (0.95‐0.98) | <0.001 | 0.99 (0.95‐1.03) | 0.596 | 0.99 (0.97‐1.03) | 0.901 |
| 4‐wk BCR‐ABL1, median | ≤41.57% (n = 129) | 65.7% ± 4.5 | <0.001 | 88.6% ± 3.9 | <0.001 | 54.7% ± 8.0 | 0.002 | 97.5% ± 1.4 | 0.679 | 97.6% ± 1.4 | 0.996 |
| >41.57% (n = 129) | 29.1% ± 4.8 | 71.4% ± 9.3 | 28.7% ± 8.1 | 97.1% ± 2.2 | 96.3% ± 2.3 | ||||||
| VEMR | ≤40% (n = 121) | 67.9% ± 4.6 | <0.001 | 89.1% ± 3.9 | <0.001 | 56.5% ± 8.4 | 0.001 | 97.3% ± 1.5 | 0.581 | 97.4% ± 1.5 | 0.873 |
| >40% (n = 137) | 29.0% ± 4.6 | 72.3% ± 9.0 | 29.4% ± 7.8 | 97.2% ± 2.1 | 96.5% ± 2.2 | ||||||
| 3‐mo EMR | ≤10% (n = 176) | 52.5% ± 4.2 | <0.001 | 85.2% ± 5.1 | <0.001 | 50.6% ± 7.5 | 0.041 | 98.8% ± 0.9 | 0.478 | 98.2% ± 1.0 | 0.692 |
| >10% (n = 37) | 8.5% ± 5.9 | 47.6% ± 18.8 | 16.7% ± 15.2 | 96.8% ± 3.2 | 97.1% ± 2.8 | ||||||
| 4‐wk FC | FC≤1 (n = 156) | 47.3% ± 4.3 | 0.899 | 82.7% ± 5.1 | 0.485 | 43.9% ± 7.3 | 0.433 | 97.9% ± 1.2 | 0.464 | 98.0% ± 1.1 | 0.466 |
| FC>1 (n = 27) | 44.5% ± 10.1 | 63.0% ± 13.4 | 33.4% ± 15.7 | 100% | 100% | ||||||
| 4‐wk HTa | ≤22 d (n = 53) | 39.8% ± 7.4 | 0.209 | 79.5% ± 8.8 | 0.292 | 38.6% ± 13.4 | 0.450 | 95.8% ± 2.9 | 0.231 | 96.1% ± 2.7 | 0.214 |
| >22 d (n = 103) | 50.8% ± 5.3 | 83.7% ± 6.1 | 46.1% ± 8.7 | 99.0% ± 1.0 | 99.0% ± 1.0 | ||||||
| 3‐mo HTb | ≤21 d (n = 101) | 52.4% ± 5.4 | 0.015 | 82.1% ± 6.9 | 0.039 | 46.2% ± 8.2 | 0.097 | 100% | 0.031 | 100% | 0.035 |
| >21 d (n = 45) | 35.4% ± 7.7 | 62.1% ± 9.5 | 37.7% ± 18.2 | 94.9% ± 3.5 | 95.4% ± 3.2 |
DMR, deep molecular response; FC, fold change; HT, halving time; MMR, molecular response; OS, overall survival; PFS, progression‐free survival; VEMR, very early molecular response.
a
Twenty‐seven patients with increasing transcript level were excluded in this analysis.
b
Additional 10 patients with increasing transcript level during this period were excluded in this analysis.