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. 2009 Jul 22;114(13):2598–2605. doi: 10.1182/blood-2008-08-173674

Table 1.

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 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.