RESUMEN
BACKGROUND: The therapeutic outcome for refractory or relapsed acute myeloid leukemia (AML) is very poor; 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- dose cytarabine and idarubicin. METHODS: From December 1995 to September 2000, 20 patients (12 patients with primary refractory AML and 8 patients with first relapsed AML) were treated with the regimen that included cytarabine 3.0g/m2 (1.5g/m2 for patients >or=50 years of age) over 3 hours every 12 hours for 12 doses (D1-6, total 36g/m2) plus 12mg/m2 idarubicin for 3 days (D2-4) by intravenous infusion. RESULTS: The complete remission (CR) rate was 55.0% (95% confidence interval, 31.2 ~ 78.8%): 58.3% (7 of 12) for refractory AML and 50.0% (4 of 8) for relapsed AML. The causes of remission induction failure were resistant disease (15.0%, 3 of 20) and early death from infection (30.0%, 6 of 20). The median duration of disease free survival of the CR patients was 15 months (range, 1~59 months) and the median duration of overall survival of all patients was 6 months (range, 0~61 months). The median time of neutrophil recovery over 500/nL from the initiation of chemotherapy was 31 days and the median time of platelet recovery over 20X10(3)/nL was 32 days. For a total of 20 patients, grade 3 and 4 toxicity were observed in 20.0% for nausea/vomiting, 20.0% for diarrhea and 5.0% for stomatitis. CONCLUSIONS : We found that a combination chemotherapy of high-dose cytarabine and idarubicin was an effective salvage regimen for patients with refractory or relapsed acute myeloid leukemia. However aggressive supportive care is necessary to minimize the treatment related morbidity and mortality resulting from prolonged myelosuppression.