Double induction strategy for acute myeloid leukemia: the effect of high-dose cytarabine with mitoxantrone instead of standard-dose cytarabine with daunorubicin and 6-thioguanine: a randomized trial by the German AML Cooperative Group.

摘要: Early intensification of chemotherapy with high-dose cytarabine either in the postremission or remission induction phase has recently been shown to improve long-term relapse-free survival (RFS) patients acute myeloid leukemia (AML). Comparable results have produced double strategy. The present trial evaluated contribution versus standard-dose this Between March 1985 and November 1992, 725 eligible 16 60 years age newly diagnosed primary AML entered trial. Before treatment started, were randomized between two versions induction: 2 courses (ara-C) daunorubicin 6-thioguanine (TAD) compared 1 course TAD followed by (3 g/m2 every 12 hours for 6 times) mitoxantrone (HAM). Second started on day 21 before criteria reached, regardless presence absence blast cells bone marrow. Patients received consolidation monthly maintenance reduced 3 years. complete (CR) rate TAD-TAD TAD-HAM arm was 65% 71% (not significant [NS]), early hypoplastic death 18% 14% (NS). corresponding RFS after 5 29% 35% An explorative analysis identified a subgroup 286 poor prognosis representing 39% entire population; they included more than 40% residual blasts day-16 marrow, unfavorable karyotype, those high levels serum lactate dehydrogenase. Their CR 49% (p =.004) favor associated superior event-free (median, 7 v months; years, 17% 12%; P =.012) overall 13 8 24% 18%; =.009). This suggests that incorporation may contribute specific benefit poor-risk that, however, requires further substantiation. Double induction, maintenance, proved safe effective strategy new way delivering AML.