DECITABINE (5-AZA-2'-DEOXYCYTIDINE, DAC) PLUS DAUNORUBICIN AS A FIRSTLINE TREATMENT IN PATIENTS WITH ACUTE MYELOID-LEUKEMIA - PRELIMINARY-OBSERVATIONS

The authors report on the preliminary results of an ongoing phase II t rial whereby the combination of the new DNA hypomethylating agent, 5-A za-deoxycytidine (DAC), plus daunorubicin was given as first-line indu ction therapy to non pretreated patients with acute myeloid leukemia ( except FAB M3). DAC was given as a 4-h intravenous infusion at the dos e of 90 mg/m(2) daily from days 1-5, while daunorubicin was administer ed at the dose of 50 mg/m(2) on days 1-3. A maximum of two courses wer e given to the patients with an interval of 4-6 weeks. Up to now, eigh t patients were accrued, of those six were evaluable for toxicity and response. The main toxic effects were bone marrow suppression, mucosit is, nausea and vomiting, and alopecia. All six patients achieved a com plete remission after one (five cases) or two (one case) courses. The trial is open for patient accrual.