Background: The therapeutic outcome for relapsed or refractory adults with acute leukemia is so poor, and it is difficult to expect the long-term disease-free survival in these patients. We evaluated the therapeutic outcome of a salvage chemotherapy consisting of high- or intermediate-dose(HD or ID) cytarabine and a new daunorubicin analogue, idarubicin. Material and method: Twenty one patients with refractory or relapsed acute lymphocytic leukemia(ALL) and 13 patients with acute myeloid leukemia(AML) were treated with a regimen that included idarubicin 12 mg/§³ intravenously daily for 3 days plus HD cytara- bine(3,000 mg/§³ by infusion over 2 hours daily for 3 days) or ID cytarabine(1,000 mg/§³ every 12 hours for six doses). Results: 1) Complete remission(CR) was achieved in thirteen of 34 patients (38%; 10 of relapsed and 3 of refractory): 16 patients(47%) did not respond to the treatment and 5 patients(15%) died during chemotherapy. 2) The median days to the neutrophils over 500/ul was 23 from the initiation of chemotherapy (range 12-39). The significant non-hematologic taxicities were not observed. 3) Two of 13 patients who achieved CR relapsed within 2 months, four relapsed 2 months after CR. Remaining seven patients have been in continuous CR(CCR). 4) For all complete responders, the median CR duration was 6 months, and the projected actuarial disease-free survival rate was 32% at 9 months. For the all patients, the projected overall survival was 15% at 18 months. Conclusion: We found that HD or ID cytarabine and idarubicin can be one of the effective salvage regimens for patients with relapsed acute leukemia. To improve remission rate of refractory cases, the modification of administration and combination therapy with other non-cross resistant drug will be designed.
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