6533b7dcfe1ef96bd12731fc

RESEARCH PRODUCT

Induction Therapy with Idarubicin, Ara-C, and VP-16, Followed by G-CSF and Maintenance Immunotherapy with Interleukin-2 for High-Risk AML

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description

Aggressive chemotherapy followed by administration of G-CSF and maintenance therapy with interleukin-2 was evaluated in 16 patients with advanced myelodxysplastic syndrome, 47 patients with AML evolving from myelodysplastic syndromes, 3 patients with subacute myeloid leukemia and 5 patients with secondary AML. Median age was 59 years (range: 23 to 76 years). All patients achieving a complete remission (CR) after two induction courses went on to receive two consolidation courses, to be followed by randomization to either high-dose or low-dose IL-2 to evaluate the potential of IL-2 to eliminate residual leukemic cells and to prolong the duration of CR. Patients ≤ age 55 with an HLA identical sibling donor subsequently proceeded to allogeneic bone marrow transplantation. Sixty-eight of 71 patients are evaluluable on the chemotherapy arm. Thirty-one patients (46%) achieved a complete remission, 7 patients (10%) a partial remission, while 24 patients (35%) were treatment failures. Early death occurred in 6 pts (9%). Three patients with CR and 3 with PR underwent allogeneic bone marrow transplantation. Until now, 12 patients were randomized to receive four cycles of IL-2 treatment, either 9 × 106 or 0.9 × 106 IU/m2/day IV, days 1–5 and 8–12. Eight patients relapsed, 6 prior to IL-2 maintenance therapy, and 2 after IL-2. Median relapse-free survival was 11 months. We conclude that aggressive chemotherapy with idarubicin/ara-C/VP-16 followed by G-GSF is both effective and well tolerated with a low rate of early death when compared to published trials without growth factor support, while the assessment of IL-2 treatment warrants additional patient accrual and longer follow-up.