Table 1.
Characteristics of the patients included in the OPTIM-imatinib trial.
| Initial [C]min <1000 ng/mL |
Initial [C]min ≥1000 ng/mL |
p Value | |||
|---|---|---|---|---|---|
| Evaluable Patients |
TDM Arm | Control Arm | Observational Arm | ||
| Patients (n) | 133 | 43 | 43 | 47 | |
| Median age at diagnosis, years (min–max) | 64 (27–87) |
61 (27–85) |
67 (36–87) |
0.007 | |
| Sex ratio [M/F] | 2.09 [90/43] |
1.96 [65/33] |
1.13 [25/22] |
0.17 | |
| Median body surface area, m2 (min–max) | 1.94 (1.09–2.52) |
1.96 (1.09–2.44) |
1.91 (1.25–2.52) |
0.15 | |
| Median body weight, kg (min–max) | 80 (41–124) |
80 (52–124) |
78 (41–118) |
0.087 | |
| Sokal score, n (%) Low/Intermediate/High/NA |
37/73/20/3 (28/55/15/2) |
24/46/13/3 (28/53/15/4) |
13/27/7/0 (28/57/15/0) |
0.97 | |
| Additional chromosomal abnormalities, n (major route) | 5 (1) |
3 (1) |
2 (none) |
0.79 | |
| Median time between diagnosis and inclusion, weeks (range) | 5 (0–16) |
6 (0–16) |
3 (0–16) |
0.025 | |
| Median [C]min at inclusion ng/mL (range) |
808 (236–2292) |
619 (236–998) |
1286 (1002–2292) |
<0.0001 | |
| Patients with imatinib before inclusion: n, (%) | 68 (51) |
44 (51) |
24 (51) |
1.0 | |