Reasons for removal from protocol treatment and dose reduction or discontinuation within 12 months, by treatment arm
. | Imatinib 400 mg/d, N = 123, n (%) . | Dasatinib 100 mg/d, N = 123, n (%) . |
---|---|---|
Reason for removal from treatment | Patients removed from treatment within 12 mo | |
Toxicity | 12 (10) | 16 (13) |
Refusal | 6 (5) | 3 (2) |
Failure to achieve CHR | 4 (3) | 1 (1) |
Relapse or progression | 4 (3) | 1 (1) |
Other* | 8 (7) | 4 (3) |
Total | 34 (28) | 25 (20) |
Dose reduction or discontinuation within 12 mo | Patients not removed from treatment within 12 mo | |
None | 57 (46) | 53 (43) |
Temporary discontinuation | 9 (7) | 20 (16) |
Permanent reduction† | 4 (3) | 9 (7) |
Temporary reduction | 3 (2) | 7 (6) |
Indeterminate | 16 (13) | 8 (7) |
Received wrong treatment | 0 (0) | 1 (1) |
. | Imatinib 400 mg/d, N = 123, n (%) . | Dasatinib 100 mg/d, N = 123, n (%) . |
---|---|---|
Reason for removal from treatment | Patients removed from treatment within 12 mo | |
Toxicity | 12 (10) | 16 (13) |
Refusal | 6 (5) | 3 (2) |
Failure to achieve CHR | 4 (3) | 1 (1) |
Relapse or progression | 4 (3) | 1 (1) |
Other* | 8 (7) | 4 (3) |
Total | 34 (28) | 25 (20) |
Dose reduction or discontinuation within 12 mo | Patients not removed from treatment within 12 mo | |
None | 57 (46) | 53 (43) |
Temporary discontinuation | 9 (7) | 20 (16) |
Permanent reduction† | 4 (3) | 9 (7) |
Temporary reduction | 3 (2) | 7 (6) |
Indeterminate | 16 (13) | 8 (7) |
Received wrong treatment | 0 (0) | 1 (1) |
CHR indicates complete hematologic response; DAS, dasatinib; and IM, imatinib mesylate.
Other reasons include patient/physician dissatisfaction with response and/or decision to change treatment (7 IM patients, 1 DAS patient), loss of insurance (1 IM patient), and other medical reasons (3 DAS patients: myocardial infarction, circulatory complications, and pregnancy).
Includes 8 patients (2 IM, 6 DAS) who were last known to be on treatment at reduced doses.