Table 1 Baseline demographics and clinical characteristics (PRO-evaluable population).
Characteristic | Ponatinib (n = 159) | Imatinib (n = 79) |
---|---|---|
Agea (years), mean (SD) | 51.4 (16.0) | 50.6 (14.8) |
Age category, n (%) | ||
18 to <45 years | 54 (34.0) | 29 (36.7) |
45 to <60 years | 45 (28.3) | 20 (25.3) |
≥60 years | 60 (37.7) | 30 (38.0) |
Sex, n (%) | ||
Female | 87 (54.7) | 42 (53.2) |
Male | 72 (45.3) | 37 (46.8) |
Race, n (%) | ||
American Indian or Alaska Native | 2 (1.3) | 2 (2.5) |
Asian | 20 (12.6) | 11 (13.9) |
Black or African American | 8 (5.0) | 4 (5.1) |
White | 101 (63.5) | 60 (75.9) |
Multiple | 1 (0.6) | 0 |
Not reported | 27 (17.0) | 2 (2.5) |
Ethnicity, n (%) | ||
Hispanic or Latino | 38 (23.9) | 19 (24.1) |
Not Hispanic or Latino | 102 (64.2) | 55 (69.6) |
Unknownb | 19 (11.9) | 4 (6.3) |
ECOG performance status, n (%) | ||
0 | 69 (43.4) | 33 (41.8) |
1 | 83 (52.2) | 41 (51.9) |
2 | 7 (4.4) | 5 (6.3) |
Time from initial diagnosis to first dose date of prior anticancer regimen (days), mean (SD) | 15.2 (10.0) | 15.9 (13.1) |
Framingham score, mean (SD) | 7.7 (10.6) | 7.4 (8.5) |
BCR::ABL1 transcript type | ||
e1a2 | 110 (69.2) | 51 (64.6) |
e13/14a2 | 40 (25.2) | 25 (31.6) |
Undetermined/not tested/other | 9 (5.7) | 3 (3.8) |
White blood cell count (109/L), mean (SD) | 12.9 (25.1) | 8.1 (14.6) |
Hemoglobin (g/L), mean (SD) | 90.0 (16.7) | 89.5 (16.6) |
Platelets (109/L), mean (SD) | 80.3 (87.8) | 85.4 (97.8) |
Blast count (%), mean (SD) | 68.1 (28.6) | 64.0 (31.2) |
Extramedullary disease, n (%) | ||
Yes | 10 (6.3) | 3 (3.8) |
No | 149 (93.7) | 76 (96.2) |