Patient characteristics
| . | All patients (n = 268) . | Arm A (n = 135) . | Arm B (n = 133) . | P . |
|---|---|---|---|---|
| Males/females, n | 145/123 | 63/72 | 82/51 | .015 |
| Median age, y (range) | 47 (18-59) | 48.6 (18-59) | 45 (21-59) | .31 |
| Age ≥30 y, n | 229 | 115 | 114 | .99 |
| BMI, kg/m2 (range) | 24.3 (15.4-46.6) | 24.3 (17.5-40.0) | 24.2 (15.4-46.6) | .99 |
| ECOG PS 0/1/2/3, n | 93/132/36/4 | 41/72/19/3 | 52/60/17/1 | .35 |
| CNS disease, n | 9 | 6 | 3 | .50 |
| Median WBC, 109/L (range) | 22.4 (0.8-768) | 26.8 (0.8-382) | 21.7 (1.0-768) | .74 |
| WBC ≥30 × 109/L, n | 118 | 63 | 55 | .46 |
| Karyotype* | ||||
| Failure (yes/no) | 15/253 | 6/129 | 9/124 | .44 |
| t(9;22) (yes/no) | 247/21 | 125/10 | 122/11 | .82 |
| ACAs (yes/no/unknown) | 176/77/15 | 86/43/6 | 90/34/9 | .44 |
| bcr subtype (m/M/both/unknown)† | 195/69/3/1 | 99/36/0/0 | 96/33/3/1 | .27 |
| . | All patients (n = 268) . | Arm A (n = 135) . | Arm B (n = 133) . | P . |
|---|---|---|---|---|
| Males/females, n | 145/123 | 63/72 | 82/51 | .015 |
| Median age, y (range) | 47 (18-59) | 48.6 (18-59) | 45 (21-59) | .31 |
| Age ≥30 y, n | 229 | 115 | 114 | .99 |
| BMI, kg/m2 (range) | 24.3 (15.4-46.6) | 24.3 (17.5-40.0) | 24.2 (15.4-46.6) | .99 |
| ECOG PS 0/1/2/3, n | 93/132/36/4 | 41/72/19/3 | 52/60/17/1 | .35 |
| CNS disease, n | 9 | 6 | 3 | .50 |
| Median WBC, 109/L (range) | 22.4 (0.8-768) | 26.8 (0.8-382) | 21.7 (1.0-768) | .74 |
| WBC ≥30 × 109/L, n | 118 | 63 | 55 | .46 |
| Karyotype* | ||||
| Failure (yes/no) | 15/253 | 6/129 | 9/124 | .44 |
| t(9;22) (yes/no) | 247/21 | 125/10 | 122/11 | .82 |
| ACAs (yes/no/unknown) | 176/77/15 | 86/43/6 | 90/34/9 | .44 |
| bcr subtype (m/M/both/unknown)† | 195/69/3/1 | 99/36/0/0 | 96/33/3/1 | .27 |
ACAs, additional chromosomal abnormalities; BMI, body mass index; ECOG PS, Eastern Cooperative Oncology Group performance status; WBC, white blood cell count.
All 268 patients had a bone marrow cytogenetic examination, but 15 karyotypes failed; among the 253 patients with an evaluable karyotype, 5 had a normal karyotype, 1 had an isolated trisomy 11, and the remaining 247 patients had the t(9;22) chromosomal translocation; among these 247 patients, 176 had ACAs and 77 did not.
The single patient with unknown bcr subtype had t(9;22) translocation on karyotype/fluorescence in situ hybridization analysis.