Troxacitabine administered by continuous infusion (CI) is well tolerated and effective in adults with relapsed or refractory acute myeloid leukemia (AML)

6597 Background: Troxacitabine, the first β-L-deoxycytidine nucleoside analog to demonstrate potent anti-tumor activity has unique mechanistic and pharmacokinetic properties that overcome resistance observed with the β-D-analogs, cytarabine and gemcitabine. Recent studies show that troxacitabine has a slower rate of entry into cells because it is not recognized by nucleoside transporters. Therefore, prolonged, continuous exposure greatly increases cytotoxicity and results in potent in vivo anti-tumor activity. Initial studies with bolus administration demonstrated encouraging but modest clinical efficacy in AML patients. To potentially increase clinical efficacy a new evaluation of troxacitabine by CI was done. Methods: Adults (20 M, 12 F) of median age of 67 and ECOG performance status of 1 (range 0–2) with previously treated AML were entered. Troxacitabine was administered at a dose of 10.1 mg/m2 by CI for 2,3,4,5 and 6 days in successive cohorts such that cumulative doses ranged from 20.2 to 60.6 mg/m2...