CP-CML n = 270 | Total N = 449 | |
---|---|---|
Characteristic at baseline | ||
Median age (range), y | 60 (18–94) | 59 (18–94) |
Female, n (%) | 126 (47) | 211 (47) |
Previous use of approved TKIs, n (%)a | ||
≥ 2 drugs | 251 (93) | 417 (93) |
≥ 3 drugs | 154 (57) | 250 (56) |
Median duration of previous treatment with approved TKIs (range), ya | 5.4 (0.4–13.3) | 4.6 (0.1–13.3) |
Resistant or intolerant to dasatinib or nilotinib, n (%) | ||
Resistant | 215 (80) | 375 (84) |
Intolerant only | 39 (14) | 49 (11) |
Both resistant and intolerant | 52 (19) | 81 (18) |
Mutation status, n (%)b | ||
No mutation detected | 138 (51) | 198 (44) |
BCR::ABL1T315I | 64 (24) | 128 (29) |
Best response of MMR or better to most recent regimen containing dasatinib or nilotinib, n (%)c | 8 (3) | 16 (4) |
Baseline cardiovascular risk factorsd | ||
Arterial hypertension | NA | 240 (53) |
Hypercholesterolemia | NA | 219 (49) |
Obesity | NA | 109 (24) |
Diabetes mellitus | NA | 72 (16) |
Baseline history of cardiovascular disease | ||
Non-ischemic cardiac disease | NA | 193 (43) |
Ischemic disease | NA | 102 (23) |
Patient disposition at end of study | ||
Median duration of treatment, mo (range) | 32.1 (0.1–73.0) | 16.7 (0.03–73.0) |
Median follow-up, mo (range) | 56.8 (0.1–73.1) | 37.3 (0.1–73.1) |
Median dose intensity, mg/d (range) | 27.2 (5–45) | ND |
Primary reason for discontinuation, n (%) | ||
Disease progression | 29 (11) | 105 (23) |
Adverse event | 57 (21) | 79 (18) |
Patient request | 31 (11) | 42 (9) |
Lack of efficacy | 15 (6) | 26 (6) |
Deathe | 9 (3) | 26 (6) |
Investigator decision | 11 (4) | 17 (4) |
Lost to follow-up | 0 | 3 (< 1) |
Non-compliance | 3 (1) | 4 (< 1) |
Protocol violation | 2 (< 1) | 2 (< 1) |
Study closuref | 90 (33) | 107 (24) |
Otherf,g | 14 (5) | 28 (6) |