Cytarabine, Daunorubicin and Etoposide (ADE) Chemotherapy in Acute Myeloid Leukemia (AML) Patients ≥60 Years (CALGB 9720).

CALGB 9720 was a phase 3 trial evaluating the multidrug resistance modulator PSC-833 (Valspodar) in induction and consolidation, and subcutaneous interleukin-2 (IL-2) maintenance therapy (rx) in older AML patients (pts). The PSC-833-containing arm was closed after randomization of 120 pts due to excessive toxicity (Blood2002;100:1224). All subsequent pts received ADE induction (A 100 mg/m2/d by 7-day continuous intravenous infusion, with D 60 mg/m2 and E 100 mg/m2 each daily for 3 days), a second induction if needed (same drugs and doses for 5, 2 and 2 days) based on day 14 marrow (BM) cellularity ≥20% and >5% blasts, and one consolidation course (same drugs and doses for 5, 2 and 2 days), and were then randomized to IL-2 or no further rx. We report outcome of ADE rx on this study in 610 pts ≥60 years (yrs; median=70.5 yrs) with de novo AML (n=396; 65%) or secondary AML (S-AML) defined by prior myelodysplastic syndromes or cytotoxic rx (n=168; 28%). Complete remissions (CR) were achieved in 283 (46%) of the 610 pts, 5 (