High-dose mitoxantrone-based induction therapy in newly diagnosed AML. Results of 171 patients treated at NYMC between 1991–2003

6610 Background: We developed a high dose mitoxantrone(M)-based induction regimen based on the steep dose-response curve for M. Methods: 171 newly dx'd AML pts were rx'd on 4 trials between 1991–2003. Study 1: Phase II study, age <60. Induction: M 80 mg/m2 x 1, ara-C (A) 3 gm/m2/d x 5, VP-16 (V) 150 mg/m2/d qod x 3. Consolidation: 5 mos A x 4d with M 20 mg/m2 mos 3 + 5, V 150 mg/m2 x 2 mos 4 + 6. Study 2: randomized study of high vs standard dose M with A in pts ≥ 60 yrs. Pts did not receive consolidation. Only pts with high dose M are included here. Study 3: Same as study 1 except pts received ATRA 45 mg/m2 x 3 doses. Pts < 60 received consolidation as in study 1. Pts ≥ 60 did not receive consolidation. Study 4: Pts ≥60 yrs, same as study 2 + temozolomide postremission therapy. In each study, pts with prior antecedent hematologic disorder (AHD) or secondary AML were included. Results: Median age: 59 (21–88); M/F: 91/80; cytogenetics(SWOG): good:13%, intermediate:50%, poor:26%, indeterminate:5%, IM:6%; Pr...