6-Year PFS and OS rates according to molecular and cytogenetic responses at 3 and 6 months
| . | At 3 months . | At 6 months . | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No. . | 6-y PFS (%) . | 95% CI . | P* . | 6-y OS (%) . | 95% CI . | P* . | No. . | 6-y PFS (%) . | 95% CI . | P* . | 6-y OS (%) . | 95% CI . | P* . | |
| Molecular response (BCR-ABL) | 565 | 477 | ||||||||||||
| ≤1% | 189 | 68 | 59-76 | .003 | 86 | 80-91 | .285 | 217 | 73 | 65-80 | .001 | 86 | 81-91 | .554 |
| >1%-10% | 139 | 58 | 49-67 | <.0001 | 84 | 78-91 | <.0001 | 94 | 52 | 41-63 | .017 | 84 | 76-91 | .001 |
| >10% | 237 | 26 | 19-33 | 60 | 53-66 | 166 | 19 | 11-27 | 61 | 53-69 | ||||
| Cytogenetic response (Ph+ metaphases) | 450 | 437 | ||||||||||||
| 0% (CCyR) | 164 | 68 | 59-77 | .172 | 87 | 81-93 | .244 | 208 | 72 | 64-80 | .063 | 86 | 81-91 | .974 |
| 1%-35% (PCyR) | 83 | 62 | 51-74 | .006 | 81 | 73-90 | .033 | 62 | 61 | 48-74 | .015 | 88 | 79-96 | .005 |
| >35% (no CCyR or PCyR) | 203 | 30 | 23-37 | 65 | 58-72 | 167 | 24 | 16-31 | 60 | 52-68 | ||||
| . | At 3 months . | At 6 months . | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No. . | 6-y PFS (%) . | 95% CI . | P* . | 6-y OS (%) . | 95% CI . | P* . | No. . | 6-y PFS (%) . | 95% CI . | P* . | 6-y OS (%) . | 95% CI . | P* . | |
| Molecular response (BCR-ABL) | 565 | 477 | ||||||||||||
| ≤1% | 189 | 68 | 59-76 | .003 | 86 | 80-91 | .285 | 217 | 73 | 65-80 | .001 | 86 | 81-91 | .554 |
| >1%-10% | 139 | 58 | 49-67 | <.0001 | 84 | 78-91 | <.0001 | 94 | 52 | 41-63 | .017 | 84 | 76-91 | .001 |
| >10% | 237 | 26 | 19-33 | 60 | 53-66 | 166 | 19 | 11-27 | 61 | 53-69 | ||||
| Cytogenetic response (Ph+ metaphases) | 450 | 437 | ||||||||||||
| 0% (CCyR) | 164 | 68 | 59-77 | .172 | 87 | 81-93 | .244 | 208 | 72 | 64-80 | .063 | 86 | 81-91 | .974 |
| 1%-35% (PCyR) | 83 | 62 | 51-74 | .006 | 81 | 73-90 | .033 | 62 | 61 | 48-74 | .015 | 88 | 79-96 | .005 |
| >35% (no CCyR or PCyR) | 203 | 30 | 23-37 | 65 | 58-72 | 167 | 24 | 16-31 | 60 | 52-68 | ||||
Patients without a molecular or cytogenetic assessment at 3 or 6 months were not included in the corresponding analyses. Also, patients who progressed (for PFS) or died (for OS) before the landmark time point were excluded from those analyses. Two of the 237 patients shown as having BCR-ABL >10% at 3 months, 1 of the 164 patients shown as having CCyR at 3 months, and 1 of the 203 patients shown as having no CCyR or PCyR at 3 months had assays between 2 and 3 months and died before 3 months.
P values compare BCR-ABL ≤1% vs >1% to 10%, BCR-ABL >1% to 10% vs >10%, CCyR vs PCyR, and PCyR vs no CCyR or PCyR by the log-rank test based on full Kaplan-Meier curves, rather than 6-year rates. P values for BCR-ABL ≤1% vs >10% at both 3 and 6 months were <.0001 for both PFS and OS. P values for CCyR vs no CCyR or PCyR at both 3 and 6 months were <.0001 for both PFS and OS.