Long-term outcomes (estimated rates at 7 years with 95% CIs) by molecular response level at 6, 12, and 18 months (landmark analyses)
| Landmark, % (95% CI) . | BCR-ABL ratio (IS) categories . | Log-rank P . | |||||
|---|---|---|---|---|---|---|---|
| MMR . | No MMR . | Total no MMR . | |||||
| ≤ 0.1% . | > 0.1 to ≤ 1.0% . | > 1.0 to ≤ 10% . | > 10% . | > 0.1% . | Comparing MMR vs no MMR . | Comparing MMR vs > 0.1 to ≤ 1% . | |
| 6 mo | n = 86 | n = 89 | n = 44 | n = 39 | n = 172 | ||
| EFS rate, % | 85.1 (76; 94) | 92.8 (87; 98) | 85.2 (74; 96) | 56.3 (39; 74) | 83.5 (78; 89) | ns | ns |
| Without AP/BC | 96.2 (92; 100) | 98.4 (95; 100) | 95.2 (89; 100) | 75.8 (60; 92) | 93 (89; 97) | ns | ns |
| OS rate | 90.3 (83; 97) | 93.0 (88; 98) | 100 (100; 100) | 68.2 (53; 83) | 89 (85; 94) | ns | ns |
| 12 mo | n = 153 | n = 90 | n = 36 | n = 25 | n = 151 | ||
| EFS rate | 91 (85; 97) | 91.7 (86; 98) | 64.1 (48; 80) | 52.5 (31; 74) | 79.4 (73; 86) | .001† | ns‡ |
| Without AP/BC | 99 (97; 100)* | 95.5 (91; 100) | 83.4 (70; 97) | 76 (57; 95) | 89.9 (85; 95) | .0004† | .048‡ |
| OS rate | 92.5 (88; 97) | 96.7 (93; 100) | 85.7 (74; 97) | 65.5 (46; 85) | 89.2 (84; 94) | ns | ns |
| 18 mo | n = 164 | n = 48 | n = 25 | n = 16 | n = 89 | ||
| EFS rate | 94.9 (91; 99) | 86.4 (76; 97) | 62.3 (43; 82) | 58.0 (30; 87) | 75.3 (66; 85) | < .001† | .014‡ |
| Without AP/BC | 99.1 (98; 100)* | 95.7 (90; 100) | 82.6 (67; 98) | 81.5 (58; 100) | 90.1 (84; 97) | < .001† | .054 |
| OS rate | 94.9 (91; 99) | 95.7 (90; 100) | 84.0 (70; 98) | 80.8 (61; 100) | 89.8 (84; 96) | ns | ns |
| Landmark, % (95% CI) . | BCR-ABL ratio (IS) categories . | Log-rank P . | |||||
|---|---|---|---|---|---|---|---|
| MMR . | No MMR . | Total no MMR . | |||||
| ≤ 0.1% . | > 0.1 to ≤ 1.0% . | > 1.0 to ≤ 10% . | > 10% . | > 0.1% . | Comparing MMR vs no MMR . | Comparing MMR vs > 0.1 to ≤ 1% . | |
| 6 mo | n = 86 | n = 89 | n = 44 | n = 39 | n = 172 | ||
| EFS rate, % | 85.1 (76; 94) | 92.8 (87; 98) | 85.2 (74; 96) | 56.3 (39; 74) | 83.5 (78; 89) | ns | ns |
| Without AP/BC | 96.2 (92; 100) | 98.4 (95; 100) | 95.2 (89; 100) | 75.8 (60; 92) | 93 (89; 97) | ns | ns |
| OS rate | 90.3 (83; 97) | 93.0 (88; 98) | 100 (100; 100) | 68.2 (53; 83) | 89 (85; 94) | ns | ns |
| 12 mo | n = 153 | n = 90 | n = 36 | n = 25 | n = 151 | ||
| EFS rate | 91 (85; 97) | 91.7 (86; 98) | 64.1 (48; 80) | 52.5 (31; 74) | 79.4 (73; 86) | .001† | ns‡ |
| Without AP/BC | 99 (97; 100)* | 95.5 (91; 100) | 83.4 (70; 97) | 76 (57; 95) | 89.9 (85; 95) | .0004† | .048‡ |
| OS rate | 92.5 (88; 97) | 96.7 (93; 100) | 85.7 (74; 97) | 65.5 (46; 85) | 89.2 (84; 94) | ns | ns |
| 18 mo | n = 164 | n = 48 | n = 25 | n = 16 | n = 89 | ||
| EFS rate | 94.9 (91; 99) | 86.4 (76; 97) | 62.3 (43; 82) | 58.0 (30; 87) | 75.3 (66; 85) | < .001† | .014‡ |
| Without AP/BC | 99.1 (98; 100)* | 95.7 (90; 100) | 82.6 (67; 98) | 81.5 (58; 100) | 90.1 (84; 97) | < .001† | .054 |
| OS rate | 94.9 (91; 99) | 95.7 (90; 100) | 84.0 (70; 98) | 80.8 (61; 100) | 89.8 (84; 96) | ns | ns |
Patients with event (or censored) before the landmark are excluded from the landmark analyses (ie, 2, 3, and 4 patients in the “No MMR” category are excluded for analyses of EFS after the 6, 12, and 18 months' landmark, respectively; for AP/BC, 2, 1, 1 patients, respectively; for OS, 1 patient was censored before 12 months at the 12-month landmark).
AP/BC indicates accelerated phase or blast crisis; CI, confidence interval; EFS, event-free survival; MMR, major molecular response; ns, not significant; and OS, overall survival.
EFS = loss of CHR, loss of MCyR, progression to AP/BC, death due to any cause on treatment. Progression to AP/BC = progression to AP/BC, CML-related deaths on treatment.
This reflects an event that was recorded as progression between months 72 and 84. The records of this patient were subsequently reviewed and the event was a death not due to CML. This data correction could not be reflected in the database after cutoff and database lock. Therefore, the estimated rate without progression to AP/BC was 100% in patients who had achieved MMR at 12 or 18 months.
Log-rank test MMR versus no MMR. The log-rank test calculates a P value testing the null hypothesis that the 2 survival functions are the same (ie, that the long-term outcome is similar between the responder groups).
Log-rank test (MMR versus > 0.1 to ≤ 1.0%).