CYTOSINE-ARABINOSIDE, ETOPOSIDE AND ACLARUBICIN (AVA) FOR THE TREATMENT OF ACUTE MYELOID-LEUKEMIA (AML) IN ELDERLY PATIENTS

Background. Elderly patients (age greater than or equal to 60 years) w ith acute myeloid leukemia (AML) have unfavourable prognoses when poly chemotherapy regimens are used, because therapy response is characteri zed by low remission rates, short remission duration and high toxicity . Patients and methods. A phase II trial in elderly AML patients was c onducted to determine the efficacy of two induction courses of a moder ately-dosed combination of aclarubicin (25 mg/m(2), 30 min i.v., days 1-4), etoposide (100 mg/m(2), 30 min i.v., days 1-3) and conventional- dose cytosine arabinoside (ara-C, 100 mg/m(2), c.i.v., days 1-3 and 30 min i.v., q 12 hours, days 4-7) (AVA-7), followed by one consolidatio n treatment using a reduced-dose schedule over five days (AVA-5) after three months in CR. Results. Thirty-two AML patients with a median ag e of 66.2 years (range 60-76) were included in the study: three of the m had histories of preexisting myelodysplasia and one of polycythemia vera. Following 1-2 courses of AVA-7 17 patients (53%) achieved CR, tw o PR (6%), and nine had resistant disease (28%); the overall response rate was thus 59%. Toxicity was significant but acceptable, with an ov erall treatment-related death rate of five of 32 patients (16%) after 63 courses of AVA. The median disease-free survival (DFS) was 12 month s, and the median survival of all patients was 16.6 months. Conclusion s: These results indicate that the combination of aclarubicin, etoposi de and conventional-dose ara-C is effective in elderly AML patients. T he relatively brief remission duration requires new consolidation and maintenance therapy approaches.