Efficacy and outcome rates
. | Treated patients . | |||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
100 mg once daily . | 50 mg twice daily . | 140 mg once daily . | 70 mg twice daily . | |||||||||||||||||||||
All (n = 167) . | Res (n = 124) . | Int (n = 43) . | All (n = 168) . | Res (n = 124) . | Int (n = 44) . | All (n = 167) . | Res (n = 123) . | Int (n = 44) . | All (n = 168) . | Res (n = 126) . | Int (n = 42) . | |||||||||||||
No. . | % . | No. . | % . | No. . | % . | No. . | % . | No. . | % . | No. . | % . | No. . | % . | No. . | % . | No. . | % . | No. . | % . | No. . | % . | No. . | % . | |
MMR by 6 y | 71 | 43 | 50 | 40 | 21 | 49 | 67 | 40 | 43 | 35 | 24 | 55 | 67 | 40 | 37 | 30 | 30 | 68 | 68 | 40 | 47 | 37 | 21 | 50 |
Patients with protocol-defined PFS status at 5 y (ie, not censored at ≤5 y) | 123 | 74 | — | — | 114 | 68 | — | — | 118 | 71 | — | — | 122 | 73 | — | — | ||||||||
Protocol-defined PFS at 5 y | 52 | 50 | 58 | 58 | 56 | 61 | 44 | 35 | 71 | 52 | 50 | 59 | ||||||||||||
95% CI | 43-60 | 40-59 | 41-75 | 49-66 | 46-66 | 45-77 | 35-52 | 26-45 | 55-87 | 44-61 | 40-60 | 41-77 | ||||||||||||
Patients with protocol-defined PFS status at 6 y (ie, not censored at ≤6 y) | 80 | 48 | — | — | 80 | 48 | — | — | 93 | 56 | — | — | 83 | 49 | — | — | ||||||||
Protocol-defined PFS at 6 y | 49 | 46 | 58 | 51 | 50 | 53 | 40 | 33 | 67 | 47 | 45 | 55 | ||||||||||||
95% CI | 41-58 | 36-56 | 41-75 | 42-61 | 40-61 | 33-73 | 31-49 | 23-42 | 49-84 | 38-56 | 35-55 | 37-73 | ||||||||||||
Patients with OS status at 5 y (ie, not censored at ≤5 y) | 143 | 86 | — | — | 135 | 80 | — | — | 132 | 79 | — | — | 139 | 83 | — | — | ||||||||
OS at 5 y | 77 | 75 | 82 | 76 | 74 | 82 | 80 | 78 | 87 | 72 | 69 | 81 | ||||||||||||
95% CI | 70-84 | 67-83 | 70-94 | 69-83 | 65-82 | 71-94 | 74-87 | 70-86 | 77-98 | 65-79 | 61-78 | 68-94 | ||||||||||||
Patients with OS status at 6 y (ie, not censored at ≤6 y) | 77 | 46 | — | — | 75 | 45 | — | — | 67 | 40 | — | — | 72 | 43 | — | — | ||||||||
OS at 6 y | 71 | 69 | 78 | 74 | 73 | 79 | 77 | 73 | 87 | 70 | 67 | 81 | ||||||||||||
95% CI | 64-79 | 60-77 | 64-92 | 67-81 | 64-81 | 66-92 | 70-84 | 65-82 | 77-98 | 63-78 | 58-76 | 68-94 |
. | Treated patients . | |||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
100 mg once daily . | 50 mg twice daily . | 140 mg once daily . | 70 mg twice daily . | |||||||||||||||||||||
All (n = 167) . | Res (n = 124) . | Int (n = 43) . | All (n = 168) . | Res (n = 124) . | Int (n = 44) . | All (n = 167) . | Res (n = 123) . | Int (n = 44) . | All (n = 168) . | Res (n = 126) . | Int (n = 42) . | |||||||||||||
No. . | % . | No. . | % . | No. . | % . | No. . | % . | No. . | % . | No. . | % . | No. . | % . | No. . | % . | No. . | % . | No. . | % . | No. . | % . | No. . | % . | |
MMR by 6 y | 71 | 43 | 50 | 40 | 21 | 49 | 67 | 40 | 43 | 35 | 24 | 55 | 67 | 40 | 37 | 30 | 30 | 68 | 68 | 40 | 47 | 37 | 21 | 50 |
Patients with protocol-defined PFS status at 5 y (ie, not censored at ≤5 y) | 123 | 74 | — | — | 114 | 68 | — | — | 118 | 71 | — | — | 122 | 73 | — | — | ||||||||
Protocol-defined PFS at 5 y | 52 | 50 | 58 | 58 | 56 | 61 | 44 | 35 | 71 | 52 | 50 | 59 | ||||||||||||
95% CI | 43-60 | 40-59 | 41-75 | 49-66 | 46-66 | 45-77 | 35-52 | 26-45 | 55-87 | 44-61 | 40-60 | 41-77 | ||||||||||||
Patients with protocol-defined PFS status at 6 y (ie, not censored at ≤6 y) | 80 | 48 | — | — | 80 | 48 | — | — | 93 | 56 | — | — | 83 | 49 | — | — | ||||||||
Protocol-defined PFS at 6 y | 49 | 46 | 58 | 51 | 50 | 53 | 40 | 33 | 67 | 47 | 45 | 55 | ||||||||||||
95% CI | 41-58 | 36-56 | 41-75 | 42-61 | 40-61 | 33-73 | 31-49 | 23-42 | 49-84 | 38-56 | 35-55 | 37-73 | ||||||||||||
Patients with OS status at 5 y (ie, not censored at ≤5 y) | 143 | 86 | — | — | 135 | 80 | — | — | 132 | 79 | — | — | 139 | 83 | — | — | ||||||||
OS at 5 y | 77 | 75 | 82 | 76 | 74 | 82 | 80 | 78 | 87 | 72 | 69 | 81 | ||||||||||||
95% CI | 70-84 | 67-83 | 70-94 | 69-83 | 65-82 | 71-94 | 74-87 | 70-86 | 77-98 | 65-79 | 61-78 | 68-94 | ||||||||||||
Patients with OS status at 6 y (ie, not censored at ≤6 y) | 77 | 46 | — | — | 75 | 45 | — | — | 67 | 40 | — | — | 72 | 43 | — | — | ||||||||
OS at 6 y | 71 | 69 | 78 | 74 | 73 | 79 | 77 | 73 | 87 | 70 | 67 | 81 | ||||||||||||
95% CI | 64-79 | 60-77 | 64-92 | 67-81 | 64-81 | 66-92 | 70-84 | 65-82 | 77-98 | 63-78 | 58-76 | 68-94 |
MMR was recorded on study treatment and is presented as a percentage (number of responders divided by the intent-to-treat population). Protocol-defined PFS and OS rates at 5 and 6 years were estimated by using Kaplan-Meier product-limit methodology. After discontinuation of study treatment, events of protocol-defined progression (assessed by the investigator) and death were included in the analysis to the extent these were reported.
Int, imatinib-intolerant patients; Res, imatinib-resistant patients.