Oralldarubicin in Maintenance Therapy ofAcute Myeloid Leukemia

More than half of all acute myeloid leukaemia (AML) patients are over 60 years. The disease free survival (DFS) and overall survival (OS) rate of these patients is poor. These unsatis­ factory results are associated with adverse cytogenetic characteristics, prior myelods­ plasia , adverse phenotypic features, MDR and BCL2 overexpression. Furthermore a large fraction of patients achieving CR early relap­ ses. This is due to two factors: acquired tumor cell drug resistance and tumor re-growth. Maintenance therapy could provide a means to keep leukemic growth under control. We enrolled 31 elderly previous responder patients to standard induction therapy to receive maintenance oral IDA 3mg/m 2 daily d 1-14 at a 2 weeks interval for a total of 12 cycles or until disease progression. We also evaluated the cell cycle and apoptosis in leu­ kemic cells from PR patients after IDA admi­ nistration, and as a control from HL60 cell line exposed to IDA and idarubicinol in vitro. DNA anal ysis showed an increase of G2/M cell frequencies and evidence of apoptosis (sub G1 peak). In CR patients the median DFS and OS was 8 months and 12.5 months res­ pectively. In PR patient the median OS was 9 months. In contrast comparing these results with an historical control group we observe a lower median cumulative OS (3 vs 11 months) and in CR patients a DFS and OS of 4 and 7 months. The treatment was well tolerated. Low haematological and extrahaematological toxicit y were observed. In conclu sion, long­ term low dose s of oral IDA would appear valuable as a maintenance regimen for elderly AML patients.