Table 3 Estimated 10-year PFS rates.
Nilotinib 300 mg twice daily | Nilotinib 400 mg twice daily | Imatinib 400 mg once daily | |
|---|---|---|---|
PFS on study | |||
All patients, n | 282 | 281 | 283 |
PFS events, n | 36 | 25 | 32 |
Estimated rate of PFS, % (95% CI) | |||
At 5 years | 92.3 (89.1–95.4) | 95.9 (93.5–98.3) | 91.2 (87.8–94.5) |
At 10 years | 86.2 (81.9–90.5) | 89.9 (86.1–93.8) | 87.2 (83.0–91.4) |
HR vs imatinib (95% CI) | 1.08 (0.67–1.74) | 0.74 (0.44–1.25) | NA |
P vs imatinib | 0.75 | 0.27 | NA |
PFS on study by age at baseline | |||
Patients <60 years, na | 223 | 228 | 224 |
PFS events in patients <60 years, n | 17 | 12 | 24 |
Estimated rate of PFS at 10 years, % (95% CI) | 91.8 (88.0–95.5) | 94.1 (90.8–97.3) | 88.3 (83.9–92.8) |
Patients ≥60 years, na | 59 | 53 | 59 |
PFS events in patients ≥60 years, n | 19 | 13 | 8 |
Estimated rate of PFS at 10 years, % (95% CI) | 63.7 (50.2–77.3) | 69.4 (54.5–84.2) | 83.6 (73.0–94.2) |
PFS on study by Sokal risk score at baseline | |||
Patients in low Sokal risk group, na | 103 | 103 | 104 |
PFS events, n | 6 | 5 | 2 |
Estimated rate of PFS at 10 years, % (95% CI) | 93.7 (88.9–98.6) | 94.1 (89.1–99.1) | 97.5 (94.2–100) |
Patients in intermediate Sokal risk group, na | 101 | 100 | 101 |
PFS events, n | 13 | 9 | 15 |
Estimated rate of PFS at 10 years, % (95% CI) | 87.1 (80.2–93.9) | 89.6 (83.2–96.1) | 83.6 (75.8–91.4) |
Patients in high Sokal risk group, na | 78 | 78 | 78 |
PFS events, n | 17 | 11 | 15 |
Estimated rate of PFS at 10 years, % (95% CI) | 74.0 (63.2–84.8) | 84.6 (75.7–93.6) | 77.7 (67.6–87.9) |
