Patient characteristics (intention-to-treat population)
| . | Nilotinib 400 mg twice daily (n = 104) . | Imatinib 400-600 mg once daily (n = 103) . |
|---|---|---|
| Median age (range), y | 46 (23-82) | 52 (19-76) |
| Sex, n (%) | ||
| Male | 71 (68.3) | 65 (63.1) |
| Female | 33 (31.7) | 38 (36.9) |
| Race or ethnic group, n (%) | ||
| White | 88 (84.6) | 80 (77.7) |
| Black | 5 (4.8) | 3 (2.9) |
| Asian | 4 (3.8) | 0 |
| Hispanic | 3 (2.9%) | 8 (7.8) |
| Other | 4 (3.8%) | 12 (11.7) |
| Prior duration of imatinib, n (%) | ||
| ≤36 mo | 18 (17.3) | 21 (20.4) |
| >36 mo | 86 (82.7) | 82 (79.6) |
| Prior interferon use, n (%) | ||
| None | 59 (56.7) | 57 (55.3) |
| ≤12 mo | 21 (20.2) | 22 (21.3) |
| >12 mo | 24 (23.1) | 24 (23.3) |
| Responses at study start, n (%) | ||
| Missing | 1 (1.0) | 1 (1.0) |
| CCyR but no MMR (BCR-ABL1IS ≤1% and >0.1) | 24 (23.1) | 28 (27.2) |
| MMR but no MR4 (BCR-ABL1IS ≤0.1% and >0.01) | 50 (48.1) | 50 (48.5) |
| MR4 but no MR4.5 (BCR-ABL1IS ≤0.01% and >0.0032%) | 24 (23.1) | 18 (17.5) |
| MR4.5 but not undetectable BCR-ABL1 (BCR-ABL1IS ≤0.0032% and >0.00001%) | 3 (2.9) | 4 (3.9) |
| Undetectable BCR-ABL1* | 2 (1.9) | 2 (1.9) |
| . | Nilotinib 400 mg twice daily (n = 104) . | Imatinib 400-600 mg once daily (n = 103) . |
|---|---|---|
| Median age (range), y | 46 (23-82) | 52 (19-76) |
| Sex, n (%) | ||
| Male | 71 (68.3) | 65 (63.1) |
| Female | 33 (31.7) | 38 (36.9) |
| Race or ethnic group, n (%) | ||
| White | 88 (84.6) | 80 (77.7) |
| Black | 5 (4.8) | 3 (2.9) |
| Asian | 4 (3.8) | 0 |
| Hispanic | 3 (2.9%) | 8 (7.8) |
| Other | 4 (3.8%) | 12 (11.7) |
| Prior duration of imatinib, n (%) | ||
| ≤36 mo | 18 (17.3) | 21 (20.4) |
| >36 mo | 86 (82.7) | 82 (79.6) |
| Prior interferon use, n (%) | ||
| None | 59 (56.7) | 57 (55.3) |
| ≤12 mo | 21 (20.2) | 22 (21.3) |
| >12 mo | 24 (23.1) | 24 (23.3) |
| Responses at study start, n (%) | ||
| Missing | 1 (1.0) | 1 (1.0) |
| CCyR but no MMR (BCR-ABL1IS ≤1% and >0.1) | 24 (23.1) | 28 (27.2) |
| MMR but no MR4 (BCR-ABL1IS ≤0.1% and >0.01) | 50 (48.1) | 50 (48.5) |
| MR4 but no MR4.5 (BCR-ABL1IS ≤0.01% and >0.0032%) | 24 (23.1) | 18 (17.5) |
| MR4.5 but not undetectable BCR-ABL1 (BCR-ABL1IS ≤0.0032% and >0.00001%) | 3 (2.9) | 4 (3.9) |
| Undetectable BCR-ABL1* | 2 (1.9) | 2 (1.9) |
MR4 molecular response 4-log reduction from a standardized baseline.
With a sample sensitivity of ≥4.5 logs.