Phase II evaluation of a high-dose mitoxantrone based induction regimen inuntreated adults with acute myeloid leukemia

To evaluate a regimen including high-dose mitoxantrone in previously untrea ted adults with AML, 45 patients aged 21-59 (median 41) were given cytarabi ne, 3 g/m(2) days 1-5, mitoxantrone, 80 mg/m(2) day 2 and etoposide, 150 mg /m(2) days 1,3,5. Post-remission therapy consisted of 5 cycles combining th e same agents at reduced doses. Complete remission was seen in 36 patients. The observed 3-year survival is 28%. Cytogenetic pattern and CD34 expressi on correlated with response and survival. Significant toxicity included mye losuppression, mucositis, diarrhea and hyperbilirubinemia. Ventricular ejec tion fraction was generally reduced, with clinical cardiac dysfunction in o nly 2 patients. This high-dose mitoxantrone combination can be administered to young adults with AML with tolerable toxicity and results comparable to those of other dose-intensive regimens.