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A randomized trial of high-dose versus conventional-dose cytarabine in consolidation chemotherapy for adult de nova acute myeloid leukemia in first remission after induction therapy containing high-dose cytarabine

journal contribution
posted on 2023-05-16, 17:05 authored by Bradstock, KF, Mathews, JP, Raymond Lowenthal, Baxter, H, Catalano, J, Brighton, T, Gill, D, Elliadis, P, Joshua, D, Cannell, P, Schwarer, AP, Durrant, S, Gillett, A, Koutts, J, Taylor, K, Bashford, J, Arthur, C, Enno, A, Dunlop, L, Szer, J, Leahy, M, Juneja, S, Young, GAR
The value of administering sequential courses of chemotherapy containing high-dose cytarabine in both induction and consolidation therapy for acute myeloid leukemia (AML) has not been assessed in a prospective randomized trial. Two hundred ninety-two AML patients aged 15 to 60 years were enrolled in the Australasian Leukaemia and Lymphoma Group (ALLG) AML trial number 7 (M7) protocol to evaluate this question. All received induction therapy with the ICE protocol (idarubicin 9 mg/m 2 × 3; cytarabine 3 g/m 2 twice a day on days 1, 3, 5, 7; etoposide 75 mg/m 2 × 7). Complete remission was achieved in 234 (80%) patients. Two hundred two patients in remission were then randomized to either a further identical cycle of ICE or 2 attenuated courses (cytarabine 100 mg/m 2 daily × 5, idarubicin × 2, etoposide × 5 [IcE]). ICE consolidation therapy was more toxic than IcE, however, the treatment-related death rate was not significantly different. There was no difference between the 2 consolidation arms for relapse-free survival at 3 years (49% for ICE vs 46% for IcE; P = .66), survival following randomization (61% vs 62%; P = .91), or the cumulative incidence of relapse (43% vs 51%; P = .31), and there was no difference within cytogenetic risk groups. Intensive induction chemotherapy incorporating high-dose cytarabine results in high complete remission rates, but further intensive consolidation treatment does not appear to confer additional benefit. © 2005 by The American Society of Hematology.

History

Publication title

Blood

Volume

105

Pagination

481-488

ISSN

0006-4971

Department/School

Tasmanian School of Medicine

Publisher

American Society Hematology

Place of publication

Washington, USA

Repository Status

  • Restricted

Socio-economic Objectives

Clinical health not elsewhere classified

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