Effect of induction cytarabine dose intensity on long-term survival in acute myelogenous leukemia: Results of a randomized, controlled study

The optimal dose and schedule of cytarabine in induction chemotherapy of newly diagnosed acute myelogenous leukemia is not established. We compared the use of cytarabine 200 mg/ m*day by continuous infusion for seven days to an intermediate-dose of cytarabine, 500 mg/m- every 12 hours for 12 doses. Thirty-seven of 52 patients assigned to conventional-dose cytarabine achieved complete remission (71% and the actuarial disease-free and overall survival after achieving remission were 22 ± 16% and 31 t 19% respectively. Thirty-seven of 50 patients assigned to intermediate-dose cytarabine achieved remission (74% and the actuarial disease-free and overall survival after achieving remission were 26 ± 16% and 39 ± 18% respectively. There were no statistically significant differences in complete remission rate, actuarial leukemia-free survival or overall survival between the groups. The most significant predictor for survival was age. Actuarial two year leukemia-free survival and overall survival for patients age >60 were 8 ± 15% and 20 ± 19% respectively compared to 36 2 14% and 54 ± 15% for patients age ≤60 (P =.058 and. 01, respectively). Induction regimen did not significantly affect disease free or overall survival for patients under or over age 60. We conclude that intermediate-dose cytarabine did not substantially improve results of induction for newly diagnosed acute myeloid leukemia.