ORAL INDUCTION AND CONSOLIDATION OF ACUTE MYELOID-LEUKEMIA WITH ETOPOSIDE, 6-THIOGUANINE, AND IDARUBICIN (ETI) IN ELDERLY PATIENTS - A RANDOMIZED COMPARISON WITH 5-DAY TAD

In order to study the efficacy of an oral induction and consolidation regimen in the treatment of acute myeloid leukemia (AML) in elderly pa tients assessed not to tolerate full-scale intensive chemotherapy, 51 patients over 65 years of age with newly diagnosed AML were randomized to receive two cycles of either totally oral ETI (25 patients) or con ventional 5-day TAD (26 patients). The median age of the patients was 73 years, range 65-87 years. Thirty-eight patients had de nova AML and the remaining patients AML subsequent to myelodysplastic syndrome ((n = 11) or treatment related AML (n = 2)). ETI consisted of etoposide 8 0 mg/m(2) and thioguanine 100 mg/m(2) twice a day on days 1-5, and ida rubicin 15 mg/m(2) on days 1-3, all given orally. TAD consisted of ora l thioguanine and i.v. cytarabine, bath in the dose of 100 mg/m(2) twi ce a day on days 1-5, and daunorubicin 60 mg/m(2) on day 5. The mainte nance treatment was daily oral mercaptopurine 70 mg/m(2) and weekly or al methotrexate 12 mg/m(2). In the ETI group complete remission (CR) w as achieved in six patients after the first cycle and in nine more pat ients after the second cycle. The CR rate was 15/25 = 60%. The corresp onding figures for the TAD group were four and two remissions, CR rate 6/26 = 23% (p = 0.007). The survival was significantly longer in the ETI arm (p = 0.042). The median survival was 9.9 months in the ETI gro up and 3.7 months in the TAD group. There were no significant differen ces in the side effects between the two arms. In conclusion, the total ly oral ETI regimen resulted in a significantly higher remission rate and longer survival than the 5-day TAD regimen in elderly patients wit h AML, with no more toxicity.