Table 1.
Patient Status at 5 Years
Status | No. of Patients (%) | |
---|---|---|
Dasatinib 100 mg Once Daily (n = 258) | Imatinib 400 mg Once Daily (n = 258) | |
On initial therapy at study end | 158 (61) | 162 (63) |
Discontinued | ||
Progression or treatment failure | 28 (11) | 36 (14) |
Intolerance* | 42 (16) | 17 (7) |
AE unrelated to study treatment | 12 (5) | 4 (2) |
Poor compliance/nonadherence | 1 (< 1) | 7 (3) |
Patient request | 4 (2) | 10 (4) |
Withdrawal of consent | 4 (2) | 3 (1) |
Lost to follow-up | 1 (< 1) | 2 (1) |
Other | 8 (3)† | 16 (6)‡ |
Abbreviation: AE, adverse event.
As decided by investigator. Intolerance is defined as recurrent grade ≥ 3 hematologic toxicity or grade ≥ 2 nonhematologic toxicity requiring discontinuation despite dose reduction.
Includes insufficient molecular response (n = 3), pregnancy (n = 2), loss of complete cytogenetic response (n = 1), increased BCR-ABL1 (n = 1), and relocation to the United States (n = 1).
Includes no molecular response/loss of molecular response (n = 4), suboptimal response (n = 3), insufficient cytogenetic response (n = 2), investigator request (n = 2), pregnancy (n = 1), recurrence of blasts in bone marrow (n = 1), no complete molecular response (n = 1), no major molecular response (n = 1), and appearance of mutation (n = 1).