Combination chemotherapy with risk factor-adjusted dose attenuation for high-risk myelodysplastic syndrome and resulting leukemia in the multicenter study of the Japan Adult Leukemia Study Group (JALSG): results of an interim analysis.

Forty-nine adult patients with high-risk myelodysplastic syndrome (MDS) or acute myeloid leukemia that progressed from MDS were registered for the multicenter study of the Japan Adult Leukemia Study Group. Forty-three patients were evaluable for the analysis. Idarubicin 12 mg/m2 per day for 3 days and continuous cytosine arabinoside 100 mg/m2 per day for 7 days were given as induction therapy, followed by postremission chemotherapy after complete remission (CR). Because elderly patients and those with hypoplastic marrow usually have complications after intensive chemotherapy, often causing early death, the treatment dose was reduced to 60% or 80% according to the presence of 3 risk factors: age 60 years or older, performance status 2 or more, or presence of hypoplastic bone marrow. Of the 43 evaluable patients (median age, 58 years), 26 (60%) achieved CR. Two patients (5%) died within 2 months of completion of induction therapy. The CR rates for patients treated with 100%, 80%, and 60% of the chemotherapy dose were 55% (12 of 22), 63% (10 of 16), and 80% (4 of 5), respectively, indicating that the risk factor-adjusted dose attenuation was appropriately applied to those who might have had problems with the original dose, thus reducing regimen-related mortality rate. The median overall survival of the 43 patients was 8 months.