Overall survival with LD ara-C was better than with HU (OR, 0.60; 95% CI, 0.44–0.81; P = .0009). There was no clear evidence that the beneficial effect of LD ara-C, compared was HU, was restricted to any particular type of patient, although no remissions were observed in patients with adverse cytogenetics, which had an impact on the OS of the adverse-risk and intermediate-risk groups. Similar treatment effects were observed for all ages, levels of white blood cells, and disease types. Older patients (aged greater than 75 years) derived benefit from LD ara-C similar to that of younger patients.r
When compared to older AML patients receiving HU, treatment with LD ara-C had an improved rate of CR (18% vs. 1% hydroxyurea; P=0.0006), which accounted for improved OS (estimated 1-year survival rate, 25% vs 5%; P = 0.0009) in this trial. In the LD ara-C arm, the achievement of CR was related strongly to survival, with a median survival of 66 days (~10 weeks) in non-remitters compared with 575 days (~80 weeks) in remitters.r
In those who achieved CR in the LD ara-C arm, 6% of patients achieved CR at the end of Course 1, for 33% of patients after Course 2, for 44% of patients after Course 3, and for 17% of patients after Course 4, with a median overall time to CR being 114 days. The median disease-free survival for patients who achieved CR in the LD ara-C arm was 8 months.
© CANCER 2007