Nine patients 鈮?0 years with newly diagnosed, untreated CD33+ AML with adequate renal and hepatic function, and ECOG PS 0-2 were eligible. HiDAC was administered at two dose levels: 3000 mg/m2 every 12 h for 6 doses (cohort 1), or 9 doses (cohort 2). GO was administered at 6 mg/m2 on days 1 and 8.
The MTD was HiDAC 3000 mg/m2 for six doses along with GO 6 mg/m2. All patients had grades 3-4 pancytopenia, and two patients developed reversible grade 2 neurotoxicity. There were no cases of veno-occlusive disease. Seven of nine patients had a complete response (CR or CRp).
There was no difference in relapse-free survival in our patients when compared to historical data. However, despite high toxicity, two of nine patients treated in this dose-dense fashion remained in CR for > 60 months.