Cytogenetic response (CgR), failure, dropouts and treatment discontinuation for adverse events (AE) and severe AE (SAE) at 3, 6, and 12 months
| . | At 3 mo . | At 6 mo . | At 12 mo . | |||
|---|---|---|---|---|---|---|
| 800-mg arm . | 400-mg arm . | 800-mg arm . | 400-mg arm . | 800-mg arm . | 400-mg arm . | |
| CgR, complete | 27 (25) | 21 (19) | 56 (52) | 54 (50) | 69 (64) | 63 (58) |
| CgR, partial | 25 (23) | 23 (21) | 10 (9) | 12 (11) | 5 (5) | 17 (16) |
| CgR, major (C+P) | 52 (48) | 44 (41) | 66 (61) | 66 (61) | 74 (68) | 80 (74) |
| CgR, minor | 9 (8) | 13 (12) | 3 (3) | 4 (4) | 0* | 0* |
| CgR, minimal/none | 15 (14) | 26 (24) | 2 (2) | 6 (6) | 0* | 0* |
| CgR, nonevaluable | 24 (22) | 21 (19) | 14 (13) | 12 (11) | 0 | 0 |
| Failure | 1 (1) | 0 | 11 (10) | 10 (9) | 16 (15) | 18 (17) |
| Off for AE/SAE | 2 (2) | 1 (1) | 4 (4) | 5 (5) | 9 (8) | 5 (5) |
| Dropouts | 5 (5) | 3 (3) | 8 (7) | 5 (5) | 9 (8) | 5 (5) |
| . | At 3 mo . | At 6 mo . | At 12 mo . | |||
|---|---|---|---|---|---|---|
| 800-mg arm . | 400-mg arm . | 800-mg arm . | 400-mg arm . | 800-mg arm . | 400-mg arm . | |
| CgR, complete | 27 (25) | 21 (19) | 56 (52) | 54 (50) | 69 (64) | 63 (58) |
| CgR, partial | 25 (23) | 23 (21) | 10 (9) | 12 (11) | 5 (5) | 17 (16) |
| CgR, major (C+P) | 52 (48) | 44 (41) | 66 (61) | 66 (61) | 74 (68) | 80 (74) |
| CgR, minor | 9 (8) | 13 (12) | 3 (3) | 4 (4) | 0* | 0* |
| CgR, minimal/none | 15 (14) | 26 (24) | 2 (2) | 6 (6) | 0* | 0* |
| CgR, nonevaluable | 24 (22) | 21 (19) | 14 (13) | 12 (11) | 0 | 0 |
| Failure | 1 (1) | 0 | 11 (10) | 10 (9) | 16 (15) | 18 (17) |
| Off for AE/SAE | 2 (2) | 1 (1) | 4 (4) | 5 (5) | 9 (8) | 5 (5) |
| Dropouts | 5 (5) | 3 (3) | 8 (7) | 5 (5) | 9 (8) | 5 (5) |
At each time point, the rates are calculated on all randomly assigned patients (intention-to-treat principle). No difference is significant. The CCgR rate at 12 months was based on FISH test in 10 patients in the high-dose arm and in 6 patients in the standard-dose arm. If these cases were considered nonevaluable, the respective CCgR rates would become 55% (59 of 108) in the high-dose arm and 53% (57 of 108) in the standard-dose arm. Dropouts include major protocol violations, refusal to continue treatment, and loss to follow-up. In the high-dose arm, 7 patients went off treatment for AE (skin rash, 2 patients; interstitial pneumonitis, pulmonary hypertension, AST/ALT increase, chronic diarrhea, and persistent thrombocytopenia, 1 patient each), and 2 patients for SAE (including 1 case of death by Staphylococcus aureus septicemia, without neutropenia, and 1 case of myocardial infarction). In the standard-dose arm, 5 patients went off treatment for AE (AST/ALT increase, 3 cases; skin rash and persistent neutropenia, 1 case each). Total number of patients in each treatment arm was 108. Data are number of patients; percentage in parentheses.
At 12 months, the patients with a minor or a minimal CgR or with no CgR were classified as failures.