Table 1.
Baseline patient demographic and disease characteristics
| Characteristic | Imatinib resistant (n = 200) |
Imatinib intolerant (n = 88) |
Total (N = 288) |
|||
|---|---|---|---|---|---|---|
| No. | % | No. | % | No. | % | |
| Age, y | ||||||
| Median | 51.0 | 54.5 | 53.0 | |||
| Range | 18-86 | 23-91 | 18-91 | |||
| Sex, male | 116 | 58 | 38 | 43 | 154 | 53 |
| Hematologic analysis, 109/L | ||||||
| White blood cell count | ||||||
| Median | 6.7 | 5.9 | 6.5 | |||
| Range | 2.1-151 | 2.1-160.7 | 2.1-151 | |||
| Platelet count | ||||||
| Median | 261.5 | 202.5 | 237.5 | |||
| Range | 47-2436 | 48-2251 | 47-2436 | |||
| Duration of disease, y | ||||||
| Median | 4.0 | 2.8 | 3.6 | |||
| Range | 0.1-15.1 | 0.1-13.6 | 0.1-15.1 | |||
| Treatment history | ||||||
| No. of previous therapies* | ||||||
| 1 | 131 | 66 | 65 | 74 | 196 | 68 |
| 2 | 69 | 35 | 23 | 26 | 92 | 32 |
| Previous IFN | 69 | 35 | 23 | 26 | 92 | 32 |
| Previous stem cell transplantation | 6 | 3 | 2 | 2 | 8 | 3 |
| Features of imatinib treatment | ||||||
| Duration of previous imatinib treatment, y | ||||||
| Median | 2.6 | 1.5 | 2.2 | |||
| Range | 0.4-8.8 | < 0.1-8.3 | < 0.1-8.8 | |||
| Previous complete hematologic response with imatinib | 164 | 82 | 55 | 63 | 219 | 76 |
| Reason for stopping imatinib | ||||||
| Adverse event (intolerance)† | 1 | 1 | 86 | 98 | 87 | 33 |
| Disease progression | 163 | 92 | 1 | 1 | 164 | 62 |
| Regimen completed | 7 | 4 | 0 | 0 | 8 | 3 |
| Other | 7 | 4 | 1 | 1 | 7 | 3 |
| Missing‡ | 22 | 0 | 22 | |||
| 1 or more Bcr-Abl mutations detected§ | 57/83 | 69 | 8/32 | 25 | 65/115 | 57 |
*
Includes previous tyrosine kinase inhibitor therapies. Percentages may not total 100% because of rounding.
†
Patients simultaneously meeting the protocol definitions for imatinib resistance and imatinib intolerance are categorized as having imatinib resistance.
‡
The reason for stopping imatinib was not reported.
§
Total of 83 imatinib-resistant and 32 imatinib-intolerant patients assessed for mutation status at baseline.