Patient characteristics and 24-month probabilities of cytogenetic relapse and EFS
| Variables . | n . | 24-month probability of losing the CCyR, % . | 24-month probability of EFS, % . |
|---|---|---|---|
| Variables at diagnosis | |||
| Sex | P = .41 | P = .12 | |
| Male | 49 | 10.3 | 79.0 |
| Female | 38 | 5.8 | 90.9 |
| Age | P = .55 | P = .20 | |
| ≤ 45 y | 42 | 9.6 | 76.6 |
| > 45 y | 45 | 6.9 | 89.7 |
| Sokal risk group | P = .13 | P = .79 | |
| Low | 33 | 6.6 | 85.8 |
| Intermediate | 32 | 3.4 | 85.3 |
| High | 22 | 17.9 | 79.7 |
| Hemoglobin | P = .82 | P = .77 | |
| ≤ 115 g/L | 40 | 8.1 | 81.9 |
| > 115 g/L | 47 | 7.3 | 83.7 |
| Leukocytes | P = .95 | P = .99 | |
| ≤ 140 × 109/L | 44 | 7.2 | 85.1 |
| > 140 × 109/L | 43 | 7.1 | 82.3 |
| BCR-ABL1 transcript type | P = .72 | P = .43 | |
| e14a2 | 40 | 10.9 | 89.0 |
| e13a2 | 33 | 9.4 | 74.6 |
| e13a2 and e14a2 | 14 | 4.6 | 75.0 |
| hOCT1 transcript level* | P = .30 | P = .51 | |
| ≤ 0.16 | 30 | 11.2 | 81.1 |
| > 0.16 | 30 | 3.4 | 86.7 |
| MDR-1 polymorphism | P = .82 | P = .79 | |
| C/C | 75 | 10.1 | 82.3 |
| T/C | 12 | 7.9 | 80.2 |
| Early molecular response† | 55 | P = .08 | P = .13 |
| Yes | 32 | 4.1 | 92.9 |
| No | 15.0 | 78.0 | |
| Baseline response | P = .0006 | P = .0007 | |
| CCyR and no MMR | 34 | 21.1 | 67.5 |
| MMR | 53 | 0 | 94.4 |
| On study variables | n | ||
| Age | P = .18 | P = .03 | |
| ≤ 50 y | 42 | 12.5 | 74.7 |
| > 50 y | 45 | 4.6 | 91.7 |
| Weight | P = .57 | P = .14 | |
| ≤ 74 kg | 47 | 6.5 | 90.9 |
| > 74 kg | 40 | 10.4 | 75.5 |
| Imatinib plasma level‡ | P = .98 | P = .80 | |
| ≤ 1 μg/mL | 43 | 6.8 | 86.7 |
| > 1 μg/mL | 41 | 7.0 | 83.9 |
| Adherence rate§ | P < .0001 | P = .0002 | |
| > 85% | 69 | 1.4 | 91.4 |
| ≤ 85% | 18 | 36.3 | 54.2 |
| Dose of imatinib | P = .73 | P = .79 | |
| 400 mg/day | 55 | 7.7 | 81.6 |
| > 400 mg/day | 32 | 9.2 | 87.1 |
| Variables . | n . | 24-month probability of losing the CCyR, % . | 24-month probability of EFS, % . |
|---|---|---|---|
| Variables at diagnosis | |||
| Sex | P = .41 | P = .12 | |
| Male | 49 | 10.3 | 79.0 |
| Female | 38 | 5.8 | 90.9 |
| Age | P = .55 | P = .20 | |
| ≤ 45 y | 42 | 9.6 | 76.6 |
| > 45 y | 45 | 6.9 | 89.7 |
| Sokal risk group | P = .13 | P = .79 | |
| Low | 33 | 6.6 | 85.8 |
| Intermediate | 32 | 3.4 | 85.3 |
| High | 22 | 17.9 | 79.7 |
| Hemoglobin | P = .82 | P = .77 | |
| ≤ 115 g/L | 40 | 8.1 | 81.9 |
| > 115 g/L | 47 | 7.3 | 83.7 |
| Leukocytes | P = .95 | P = .99 | |
| ≤ 140 × 109/L | 44 | 7.2 | 85.1 |
| > 140 × 109/L | 43 | 7.1 | 82.3 |
| BCR-ABL1 transcript type | P = .72 | P = .43 | |
| e14a2 | 40 | 10.9 | 89.0 |
| e13a2 | 33 | 9.4 | 74.6 |
| e13a2 and e14a2 | 14 | 4.6 | 75.0 |
| hOCT1 transcript level* | P = .30 | P = .51 | |
| ≤ 0.16 | 30 | 11.2 | 81.1 |
| > 0.16 | 30 | 3.4 | 86.7 |
| MDR-1 polymorphism | P = .82 | P = .79 | |
| C/C | 75 | 10.1 | 82.3 |
| T/C | 12 | 7.9 | 80.2 |
| Early molecular response† | 55 | P = .08 | P = .13 |
| Yes | 32 | 4.1 | 92.9 |
| No | 15.0 | 78.0 | |
| Baseline response | P = .0006 | P = .0007 | |
| CCyR and no MMR | 34 | 21.1 | 67.5 |
| MMR | 53 | 0 | 94.4 |
| On study variables | n | ||
| Age | P = .18 | P = .03 | |
| ≤ 50 y | 42 | 12.5 | 74.7 |
| > 50 y | 45 | 4.6 | 91.7 |
| Weight | P = .57 | P = .14 | |
| ≤ 74 kg | 47 | 6.5 | 90.9 |
| > 74 kg | 40 | 10.4 | 75.5 |
| Imatinib plasma level‡ | P = .98 | P = .80 | |
| ≤ 1 μg/mL | 43 | 6.8 | 86.7 |
| > 1 μg/mL | 41 | 7.0 | 83.9 |
| Adherence rate§ | P < .0001 | P = .0002 | |
| > 85% | 69 | 1.4 | 91.4 |
| ≤ 85% | 18 | 36.3 | 54.2 |
| Dose of imatinib | P = .73 | P = .79 | |
| 400 mg/day | 55 | 7.7 | 81.6 |
| > 400 mg/day | 32 | 9.2 | 87.1 |
Samples were not available in 27 patients.
Early molecular response is defined as having achieved a 1-log reduction (BCR-ABL1/ABL1 ratio ≤ 10%) by 3 months.6-8
In 3 patients, the trough plasma level was not available.
We explored different cutoff levels for the adherence rate. In all cases, the patients in the group with the lower adherence rate were more likely to lose their CCyR during the follow-up, namely, ≤ 80 vs > 80 (54.5 vs 2, P < .0001), ≤ 85 vs > 85 (36.3 vs 1.4, P < .0001), ≤ 90 vs > 90 (26.9 vs 1.6, P = .0002), and ≤ 95 vs > 95 (24.5 vs 0, P = .0001). We use a multivariate Cox model to choose the better cutoff, which was 85. The adherence rate also predicted for loss of CCyR when considered as a continuous variable (RR = 1.05; P = .0001).