Demographic characteristics of study subjects
| . | RQ-PCR rise greater than 3-fold, n = 101 . | No RQ-PCR rise greater than 3-fold, n = 49 . | P . | All patients, N = 150 . |
|---|---|---|---|---|
| Median age, y (range) | 51.1 (16-79) | 47.8 (23-74) | .45 | 50.6 (16-79) |
| Sex, % male | 56 | 47 | .15 | 53 |
| Median months from leukemia diagnosis to imatinib start (range) | 21 (0-161) | 6 (0-155) | .03 | 17 (0-161) |
| Patients with “early” CML diagnosis, fewer than 6 mo before imatinib, % | 26 | 53 | .002 | 35 |
| Baseline diagnosis of chronic-phase CML/ accelerated-phase/blast crisis, % | 79/20/1 | 90/10/0 | .31 | 82/17/1 |
| Median months of follow-up, after imatinib (range) | 48 (11-80) | 40 (7-75) | 46 (7-80) | |
| Median no. of laboratory monitoring visits (range) | 9 (2-21) | 7 (2-18) | .76 | 8 (2-21) |
| Median months between monitoring visits (range) | 3.9 (1.6-8.3) | 4.0 (2.3-7.8) | .66 | 3.9 (1.6-8.3) |
| CCR ever achieved, % | 58 | 82 | .003 | 66 |
| MCR (< 35% Ph) never achieved, % | 24 | 10 | .051 | 19 |
| Imatinib treatment failure, % (primary resistance)* | 60 | 37 | .11 | 53 |
| MMR ever achieved, % | 39 | 57 | .019 | 45 |
| Median RQ-PCR log-drop at time of DNA sequencing (range) | 0.77 (−1.0 to 2.6) | 1.8 (−0.4 to 5.2) | < .001 | 1.0 (−1.0 to 5.2) |
| CCR (MCR) at time of sequencing, % | 28 (49) | 58 (75) | .007 | 37 (57) |
| Complete hematologic response at time of sequencing, % | 80 | 90 | .17 | 83 |
| Kinase domain mutation, no. (%) | 43 (43) | 10 (20) | .010 | 53 (35) |
| . | RQ-PCR rise greater than 3-fold, n = 101 . | No RQ-PCR rise greater than 3-fold, n = 49 . | P . | All patients, N = 150 . |
|---|---|---|---|---|
| Median age, y (range) | 51.1 (16-79) | 47.8 (23-74) | .45 | 50.6 (16-79) |
| Sex, % male | 56 | 47 | .15 | 53 |
| Median months from leukemia diagnosis to imatinib start (range) | 21 (0-161) | 6 (0-155) | .03 | 17 (0-161) |
| Patients with “early” CML diagnosis, fewer than 6 mo before imatinib, % | 26 | 53 | .002 | 35 |
| Baseline diagnosis of chronic-phase CML/ accelerated-phase/blast crisis, % | 79/20/1 | 90/10/0 | .31 | 82/17/1 |
| Median months of follow-up, after imatinib (range) | 48 (11-80) | 40 (7-75) | 46 (7-80) | |
| Median no. of laboratory monitoring visits (range) | 9 (2-21) | 7 (2-18) | .76 | 8 (2-21) |
| Median months between monitoring visits (range) | 3.9 (1.6-8.3) | 4.0 (2.3-7.8) | .66 | 3.9 (1.6-8.3) |
| CCR ever achieved, % | 58 | 82 | .003 | 66 |
| MCR (< 35% Ph) never achieved, % | 24 | 10 | .051 | 19 |
| Imatinib treatment failure, % (primary resistance)* | 60 | 37 | .11 | 53 |
| MMR ever achieved, % | 39 | 57 | .019 | 45 |
| Median RQ-PCR log-drop at time of DNA sequencing (range) | 0.77 (−1.0 to 2.6) | 1.8 (−0.4 to 5.2) | < .001 | 1.0 (−1.0 to 5.2) |
| CCR (MCR) at time of sequencing, % | 28 (49) | 58 (75) | .007 | 37 (57) |
| Complete hematologic response at time of sequencing, % | 80 | 90 | .17 | 83 |
| Kinase domain mutation, no. (%) | 43 (43) | 10 (20) | .010 | 53 (35) |
RQ-PCR indicates real-time quantitative reverse-transcription polymerase chain reaction; CML, chronic myeloid leukemia; CCR, complete cytogenetic response; MCR, major cytogenetic response; and MMR, major molecular response.
Defined, per European LeukemiaNet (ELN) criteria,3 as failure to reach MCR (< 35% Ph-positivity) by 12 months or CCR by 18 months.