FS-HAI for Relapsed AML

Treatment results in patients with refractory and relapsed acute myeloid leukemia (AML) need to be improved. The current study aimed at enhancing the anti-leukemic efficacy of the sequential high-dose AraC and idarubicin (S-HAI) regimen by the addition of fludarabine as a chemo-modulator. High-dose AraC was applied q 12 hours on days on days 1, 2, 8, and 9 and idarubicin on days 3, 4, 10, and 11. Patients were randomized to receive fludarabine q 12 hours on days 1, 2, 8, and 9 in addition to S-HAI or S-HAI alone. Of 179 patients having entered the study 120 are fully evaluable at the present time (median age 55 years, range 20–77). Thirty-eight percent of the patients had refractory disease…