SALVAGE TREATMENT FOR PRIMARY RESISTANT ACUTE MYELOGENOUS LEUKEMIA CONSISTING OF INTERMEDIATE-DOSE CYTOSINE-ARABINOSIDE AND INTERSPACED CONTINUOUS INFUSIONS OF IDARUBICIN - A PHASE-II STUDY (NO-06901) OF THE EORTC LEUKEMIA COOPERATIVE GROUP

Twenty-one patients with acute myeloid leukemia (AML) who failed to en ter complete remission (CR) after first-line standard-dose remission-i nduction therapy with 7 days of cytarabine and 3 days of daunorubicin were treated with a salvage regimen containing intermediate-dose cytos ine arabinoside (Ara-C) 2x500 mg/m(2)/day during 7 days in combination with continuous infusions of idarubicin 12 mg/m(2)/day on days 1, 3, and 5. Twenty patients were considered primary resistant, and one pati ent had a partial remission after two remission-induction courses. Ove rall, 11 patients (52%, 95% confidence interval: 30-74%) entered CR. T hree patients died during hypoplasia and seven patients had resistant disease or a partial remission. The remission rate in this study compa res favorably with the results obtained in similar patient categories. The toxicity of this salvage regimen was remarkably mild. No extramed ullary toxicity was observed except for hepatic dysfunction in seven p atients. The median duration of remission was 8.5 months, and ultimate ly, all complete remitters have relapsed except the patient who died f rom infectious complications after allogeneic bone marrow transplantat ion (BMT), This study shows that new intensive chemotherapy regimens m ay be effective after failure of primary treatment. Salvage regimens c ontaining intermediate/high-dose Ara-C and/or alternative anthracyclin es or anthracenes should be induced in the treatment of young patients with de novo AML.