Intensive chemotherapy with idarubicin, ara-C, etoposide, and m-AMSA followed by immunotherapy with interleukin-2 for myelodysplastic syndromes and high-risk Acute Myeloid Leukemia (AML)

Intensive chemotherapy followed by treatment with interleukin-2 (IL-2) was evaluated in a prospective. randomized, multicenter trial including 18 pati ents with refractory anemia with excess of blasts in transformation (RAEB-T ), 86 patients with acute myeloid leukemia (AML) evolving from myelodysplas tic syndromes, and six patients with secondary AML after previous chemother apy, Median age was 58 years (range: 18-76 years). Forty-nine patients (45% ) achieved a complete remission (CR) after two induction cycles with idarub icin, ara-C, and etoposide, 52% of them aged less than or equal to 60 years and 35% aged >60 years (p = 0.06), After two consolidation courses, patien ts were randomized to four cycles of either high- or low-dose IL-2, Patient s aged up to 55 years with an HLA-identical sibling donor were eligible for allogeneic bone marrow transplantation. The median relapse-free survival w as 12.5 months, with a probability of ongoing CR at 6.5 years of 19%. Overa ll survival of all patients was 8 months, and 21 months for the CR patients . Median survival was significantly longer among patients aged less than or equal to 60 years than among the older patients (16 vs 6 months, p < 0.001 ), Median duration of survival and relapse-free survival were not statistic ally different in the two IL-2 treatment arms.