CYTOSINE-ARABINOSIDE AND MITOXANTRONE INDUCTION CHEMOTHERAPY FOLLOWEDBY BONE-MARROW TRANSPLANTATION OR CHEMOTHERAPY FOR RELAPSED OR REFRACTORY PEDIATRIC ACUTE MYELOID-LEUKEMIA

The purpose of this study was to determine the induction rate, duratio n of response and toxicity of cytosine arabinoside (1.0 gm/m(2) i.v. o ver 2 h q 12 h x 8 doses days 1 through 4) and mitoxantrone (12 mg/m(2 ) over 1 h daily x 4 doses days 3 through 6) in pediatric patients wit h acute myeloid leukemia (AML). Patients achieving a complete remissio n received either bone marrow transplantation or further chemotherapy. Twenty-seven of 37 evaluable patients (73% (95% confidence interval 5 9-87%)) achieved a complete remission. For all responding patients, th e projected median time to relapse is 12 months. The projected 1 and 2 year disease-free survival is 47% (28-66) and 41% (21-61) with a rang e of follow-up of 0 to 48+ months. The major toxicity was bone marrow suppression and infection. This therapy is very active in pediatric AM L and has acceptable toxicity. Some patients treated achieve prolonged survival.