Table 2.
Summary of phase 3 trials comparing second generation tyrosine kinase inhibitors to imatinib as first line therapy for chronic phase CML.
Trial Name Reference | Second Generation TKI/Dose | Progression Free Survival | Overall Survival | CCyR (12 months) | MMR (12 months) |
---|---|---|---|---|---|
ENESTnd Hochhaus A et al (79) | Nilotinib 300 mg twice daily | 5 years: 96.5% | 5 years: 93.7% | 93%* | 44%* |
Nilotinib 400 mg twice daily | 5 years: 98.3%* | 5 years: 96.2%* | 93%* | 43%* | |
Imatinib 400 mg once daily | 5 years: 94.7% | 5 years: 91.7% | 76% | 22% | |
BELA Brummendorf TH et al (83) | Bosutinib 500 mg once daily | 24 months: 92% | 24 months: 97% | 70% | 41%* |
Imatinib 400 mg once daily | 24 months: 88% | 24 months: 95% | 68% | 27% | |
BFORE Cortes et al (85) | Bosutinib 500 mg once daily | 12 months: 96.3 | 12 months: 99.6% | 77.2%* | 47.2%* |
Imatinib 400 mg once daily | 12 months: 93.6 | 12 months: 97.9% | 66.4% | 36.9% | |
DASISION Cortes et al (163) | Dasatinib 100 mg once daily | 5 year: 85% | 5 year: 91% | 77%* | 46%* |
Imatinib 400 mg once daily | 5 year: 86% | 5 year: 910% | 66% | 28% |
CCyR - complete cytogenetic response; MMR - major molecular response.
p<0.05 compared to imatinib.