Table 1.
Bosutinib | Imatinib | ||
---|---|---|---|
Duration of treatment, mo | n = 268 | n = 265 | |
Median (range) | 55.1 (0.3–60.1) | 55.0 (0.7–56.8) | |
Cumulative response rates, % (95% CI) | n = 268 | n = 268 | ORa (95% CI) |
MMR | 73.9 (68.6–79.1) | 64.6 (58.8–70.3) | 1.57 (1.08–2.28) |
MR4 | 58.2 (52.3–64.1) | 48.1 (42.2–54.1) | 1.50 (1.07–2.12) |
MR4.5 | 47.4 (41.4–53.4) | 36.6 (30.8–42.3) | 1.57 (1.11–2.22) |
Cumulative molecular response rates by Sokal risk group at screening, % (95% CI) | |||
Low risk | n = 95 | n = 106 | ORa (95% CI) |
MMR | 75.8 (67.2–84.4) | 72.6 (64.2–81.1) | 1.18 (0.63–2.22) |
MR4 | 60.0 (50.1–69.9) | 55.7 (46.2–65.1) | 1.20 (0.68–2.10) |
MR4.5 | 53.7 (43.7–63.7) | 42.5 (33.0–51.9) | 1.57 (0.90–2.74) |
Intermediate risk | n = 117 | n = 105 | |
MMR | 74.4 (66.4–82.3) | 63.8 (54.6–73.0) | 1.65 (0.93–2.92) |
MR4 | 56.4 (47.4–65.4) | 46.7 (37.1–56.2) | 1.48 (0.87–2.51) |
MR4.5 | 42.7 (33.8–51.7) | 37.1 (27.9–46.4) | 1.26 (0.74–2.17) |
High risk | n = 56 | n = 57 | |
MMR | 69.6 (57.6–81.7) | 50.9 (37.9–63.9) | 2.22 (1.03–4.79) |
MR4 | 58.9 (46.0–71.8) | 36.8 (24.3–49.4) | 2.46 (1.15–5.24) |
MR4.5 | 46.4 (33.4–59.5) | 24.6 (13.4–35.7) | 2.66 (1.20–5.92) |
All ratios are bosutinib vs. imatinib. OR > 1 favor bosutinib.
CI confidence interval, MMR major molecular response, MR molecular response, OR odds ratio.
aOverall adjusted for Sokal risk group and region as determined at the time of randomization and unadjusted for subgroups.