SEQUENTIAL MITOXANTRONE, DAUNORUBICIN, AND CYTOSINE-ARABINOSIDE FOR PATIENTS WITH NEWLY-DIAGNOSED ACUTE MYELOCYTIC-LEUKEMIA

Mitoxantrone (M) is a synthetic aminoanthraquinone with anti-leukemic activity in patients with daunorubicin (D) resistant acute leukemia. T he Cancer and Leukemia Group B (CALGB) has undertaken a limited access pilot study in which M, 12 mg/m(2), over 30 min, daily for 3 days, an d cytosine arabinoside (Ara-C), 100 mg/m(2)/day by constant infusion f or 7 days were used for the induction of newly diagnosed patients with AML. Responding patients were consolidated with daunorubicin, 45 mg/m (2)/day for 3 days, and 7 days of Ara-C. After a second consolidation identical to induction, no further therapy was given. Twenty-nine pati ents with a median age of 50 years (range 18-72) were entered in the s tudy; 18 were males and 11 females. Twenty-four (83%) patients achieve d CR, 1 patient achieved a PR, and 4 died in induction from leukemia-r elated causes. Two patients died in CR from consolidation-related neut ropenic sepsis and two additional patients died in CR, Of 24 patients, 7 remain disease-free at a median follow-up interval of 8 years. The regimen is active and well tolerated. The duration of disease-free sur vival in responding patients is consistent with that seen in similar r egimens using intensification chemotherapy without prolonged maintenan ce. (C) 1997 Wiley-Liss, Inc.