Table 1. Patients’ characteristics.
n | Imatinib 400 | Imatinib+IFN | Imatinib+AraC | Imatinib after IFN | Imatinib 800 | Total | |
---|---|---|---|---|---|---|---|
Age (years), median (range) | 1538 | 53 (16–88) | 53 (16–83) | 52 (18–79) | 53 (18–87) | 51 (18–85) | 53 (16–88) |
% Male | 1538 | 61% | 59% | 63% | 63% | 59% | 60% |
% Smoker | 1326 | 21% | 16% | 21% | 20% | 20% | 19% |
Karnofsky index (%), median (range) | 1394 | 100 (70–100) | 100 (50–100) | 100 (70–100) | 100 (70–100) | 100 (50–100) | 100 (50–100) |
Hemoglobin (g/dl), median (range) | 1524 | 12.4 (4.9–17.5) | 12.2 (6.2–17.7) | 12.5 (6.7–15.9) | 12.9 (8.1–17.6) | 12.2 (4.7–19.1) | 12.3 (4.7–19.1) |
WBC (× 109/l), median (range) | 1531 | 77 (5.7–582) | 89 (2.8–630) | 58 (2.9–529) | 56 (3.2–456) | 79 (2.6–570) | 76 (2.6–630) |
Platelets (× 109/l), median (range) | 1533 | 382 (58–2419) | 343 (49–3020) | 403 (34–2799) | 390 (44–2205) | 386 (39–2716) | 374 (34–3020) |
Eosinophils (%), median (range) | 1530 | 2 (0–20) | 2 (0–12) | 2 (0–14) | 2 (0–14) | 2 (0–16) | 2 (0–20) |
Basophils (%), median (range) | 1526 | 3 (0–22)a | 3 (0–20) | 4 (0–21) | 3 (0–17) | 4 (0–26) | 3 (0–26) |
Blasts in blood (%), median (range) | 1525 | 1 (0–17)b | 1 (0–16) | 1 (0–19) | 0 (0–16) | 1 (0–17) | 1 (0–19) |
Spleen size (cm below costal margin), median (range) | 1529 | 2 (0–28) | 2 (0–38) | 0 (0–20) | 0 (0–19) | 2 (0–30) | 2 (0–38) |
Euro score, n (%) | 1527 | ||||||
Low | — | 142 (36) | 150 (35) | 55 (35) | 48 (38) | 159 (38) | 554 (36) |
Intermediate | — | 205 (51) | 226 (53) | 81 (51) | 79 (62) | 202(48) | 793 (52) |
High | — | 51 (13) | 49 (12) | 22 (14) | 1 (1) | 57 (14) | 180 (12) |
Sokal score, n (%) | 1513 | ||||||
Low | 140 (36) | 164 (39) | 62 (39) | 51 (40) | 153 (37) | 570 (38) | |
Intermediate | 155 (40) | 164 (39) | 53 (34) | 58 (45) | 152 (37) | 582 (38) | |
High | 97 (25) | 92 (22) | 42 (27) | 19 (15) | 111 (27) | 361 (24) | |
EUTOS score, n (%) | 1523 | ||||||
Low | 348 (88) | 384 (90) | 139 (88) | 118 (92) | 352 (85) | 1341 (88) | |
High | 49 (12) | 44 (10) | 19 (12) | 10 (8) | 60 (15) | 182 (12) | |
ELTS score, n (%) | 1521 | ||||||
Low | 212 (54) | 236 (55) | 106 (67) | 80 (62) | 235 (57) | 869 (57) | |
Intermediate | 123 (31) | 136 (32) | 35 (22) | 40 (31) | 116 (28) | 450 (30) | |
High | 60 (15) | 55 (13) | 17 (11) | 9 (7) | 61 (15) | 202 (13) | |
BCR-ABL1 transcript type, n (%) | 1506 | ||||||
b2a2 | 147 (38) | 192 (46) | 54 (35) | 43 (34) | 160 (39) | 596 (40) | |
b3a2 | 178 (46) | 167 (40) | 69 (45) | 57 (46) | 187 (45) | 658 (44) | |
b2a2 and b3a2 | 54 (14) | 55 (13) | 29 (19) | 24 (19) | 61 (15) | 223 (15) | |
Atypical transcripts | 10 (2) | 8 (1) | 3 (1) | 1 (1) | 7 (1) | 29 (1) |
Abbreviations: ELTS, European treatment and outcome study (EUTOS)-long-term-survival; IFN, interferon-α WBC, white blood cells.
There were no significant differences between the treatment groups.
One patient with 66% basophils (basophil leukemia).
One patient with ambivalent findings: 30% blasts in blood, 7% blasts in the marrow.