Table 1.
Patient Demographic and Clinical Characteristics
| Characteristic | Patients (N = 87) |
|---|---|
| Age, years | |
| At diagnosis | |
| Median | 45.4 |
| Range | 20.9-86.4 |
| At enrollment | |
| Median | 50.7 |
| Range | 25.5-89.0 |
| Sex, % | |
| Male | 56.3 |
| Weight, kg | |
| Median | 74.0 |
| Range | 40.0-119.7 |
| Sokal risk group, % | |
| Low | 37.9 |
| Intermediate | 36.8 |
| High | 25.3 |
| Hemoglobin at diagnosis, g/L | |
| Median | 116 |
| Range | 69-160 |
| Leukocyte count at diagnosis, × 109/L | |
| Median | 139.5 |
| Range | 5.1-410.9 |
| BCR-ABL1 transcript type, % | |
| e13a2 | 37.9 |
| e14a2 | 46.0 |
| e13a2 and e14a2 | 16.1 |
| BCR-ABL1/ABL1 ratio at diagnosis, % | |
| Median | 73.2 |
| Range | 10.1-334.3 |
| Tyrosine kinase domain mutations at enrollment* | 1.2 |
| Imatinib plasma level at end of trial, μg/mL | |
| On 400 mg daily | |
| Median | 0.9 |
| Range | 0.4-1.6 |
| On 600 mg daily | |
| Median | 1.3 |
| Range | 0.6-3.5 |
| MDR1 polymorphism, % | |
| C/C | 86.2 |
| T/C | 13.8 |
| hOCT1/GUSB transcript ratio at diagnosis | |
| Median | 0.16 |
| Range | 0.013-3.5 |
| Time from diagnosis to imatinib therapy, months | |
| Median | 2.2 |
| Range | 0-5.1 |
| Time from imatinib therapy to enrollment, months | |
| Median | 59.7 |
| Range | 25-104 |
| Patients with MMR | |
| % | 65.5 |
| Probability at 6 years | 69.7 |
| Time to MMR, months | |
| Median | 20.4 |
| Range | 9-63 |
| Patients with a 4-log reduction | |
| % | 42.5 |
| Probability at 6 years | 55.0 |
| Time to 4-log reduction, months | |
| Median | 33 |
| Range | 9-63 |
| Patients with CMR | |
| % | 25.3 |
| Probability at 6 years | 32.1 |
| Time to CMR, months | |
| Median | 45.6 |
| Range | 9-69 |
Abbreviations: MMR, major molecular response; CMR, complete molecular response; MDR1, multidrug resistance gene-1; hOTC1, human organic cation transporter-1; GUS, glucuronidase.
*
One patient had the kinase domain mutation Q252H at the beginning of the monitoring period. In a second patient, the mutation T315I was found at the end of the monitoring period. Both patients had a low adherence rate (87 and 79%, respectively).