Intermediate and high dose Ara-C and m-AMSA for remission induction and consolidation treatment of patients with acute myeloid leukemia: an EORTC Leukemia Cooperative Group phase II study.

Seventy-nine patients (aged 17-76 years) with acute myelogenous leukemia in first (56) or second (3) relapse, primary refractory leukemia (15) or leukemia occurring as secondary malignancy that developed after a preleukemic phase (3) or after another tumor (2) were given remission induction therapy consisting of cytosine arabinoside (Ara-C, 1 g/m2 as a 2-h infusion every 12 h for 6 days) and m-AMSA (120 mg/m2, i.v. on days 5, 6, 7). In total 45 patients (57%) achieved complete remission. Younger patients and those with a relatively low initial white blood cell count, a good performance status or in first relapse had a higher response rate. Thirty-five patients were given one or two courses of consolidation chemotherapy consisting of Ara-C (3 g/m2 as a 2-h infusion every 12 h for 4 days) and m-AMSA (120 mg/m2 i.v. on day 5). Three patients received an allogeneic bone marrow graft after the induction courses and four patients received an autologous bone marrow transplantation after consolidation therapy. The median of the disease-free survival curve was 21 weeks. The median duration of survival was 25 weeks. The response rate for this intermediate dose Ara-C regimen is satisfactory and does not differ from that reported for high dose Ara-C. The impact of consolidation chemotherapy in bad risk acute myelogenous leukemia is questionable.