Event-free survival (estimated rates at 7 years with 95% CIs), including loss of CCyR as an event by molecular response level at 6, 12, and 18 months (landmark analyses)
| Landmark . | 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 = 43 | n = 38 | n = 170 | ||
| EFS rate, % (95% CI) | 84.4 (75; 94) | 81.1 (72; 90) | 78.0 (65; 91) | 36.5 (19; 54) | 71.6 (64; 79) | .0114* | ns† |
| 12 mo | n = 151 | n = 89 | n = 33 | n = 20 | n = 142 | ||
| EFS rate, % (95% CI) | 86.6 (80; 94) | 84.0 (76; 92) | 57.2 (39; 75) | 48.5 (26; 71) | 73.1 (65; 81) | .0006* | ns† |
| 18 mo | n = 160 | n = 43 | n = 22 | n = 13 | n = 78 | ||
| EFS rate, % (95% CI) | 92.3 (87; 98) | 78.5 (66; 91) | 47.7 (26; 70) | 48.0 (18; 78) | 65.4 (54; 77) | < .001* | .0019† |
| Landmark . | 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 = 43 | n = 38 | n = 170 | ||
| EFS rate, % (95% CI) | 84.4 (75; 94) | 81.1 (72; 90) | 78.0 (65; 91) | 36.5 (19; 54) | 71.6 (64; 79) | .0114* | ns† |
| 12 mo | n = 151 | n = 89 | n = 33 | n = 20 | n = 142 | ||
| EFS rate, % (95% CI) | 86.6 (80; 94) | 84.0 (76; 92) | 57.2 (39; 75) | 48.5 (26; 71) | 73.1 (65; 81) | .0006* | ns† |
| 18 mo | n = 160 | n = 43 | n = 22 | n = 13 | n = 78 | ||
| EFS rate, % (95% CI) | 92.3 (87; 98) | 78.5 (66; 91) | 47.7 (26; 70) | 48.0 (18; 78) | 65.4 (54; 77) | < .001* | .0019† |
AP/BC indicates accelerated phase or blast crisis; CHR, complete hematologic response; CI, confidence interval; CCyR, complete cytogenetic response; EFS, event-free survival; IS, international scale; MCyR, major cytogenetic response; MMR, major molecular response; and ns, not significant.
Patients with event (including loss of CCyR) before the landmark are excluded from the landmark analyses. EFS (loss of CHR, loss of MCyR, progression to AP/BC, death due to any cause on treatment) or loss of CCyR.
Log-rank test MMR versus no MMR.
Log-rank test (MMR versus > 0.1 to ≤ 1.0%). 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).