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Blood, 15 January 2005, Vol. 105, No. 2, pp. 481-488. Prepublished online as a Blood First Edition Paper on June 22, 2004; DOI 10.1182/blood-2004-01-0326. This Article Full Text (PDF) All Versions of this Article: 2004-01-0326v1 105/2/481    most recent Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Rights and Permissions Citing Articles Citing Articles via HighWire Citing Articles via CrossRef Citing Articles via Google Scholar Google Scholar Articles by Bradstock, K. F Articles by Young, G. A Search for Related Content PubMed PubMed Citation Articles by Bradstock, K. F Articles by Young, G. A Social Bookmarking                   What's this?  Previous Article  |  Next Article  Submitted January 29, 2004 Accepted May 5, 2004 A randomized trial of high versus conventional dose cytarabine in consolidation chemotherapy for adult de novo acute myeloid leukemia in first remission after induction therapy containing high dose cytarabine Kenneth F Bradstock*, Jane P Matthews, Raymond M Lowenthal, Heather Baxter, John Catalano, Timothy Brighton, Devinder Gill, Paul Eliadis, Douglas Joshua, Paul Cannell, Anthony P Schwarer, Simon Durrant, Anne Gillett, Jerry Koutts, Kerry Taylor, John Bashford, Chris Arthur, Arno Enno, Lindsay Dunlop, Jeff Szer, Michael Leahy, Surender Juneja, and Graham A Young Department of Haematology, Westmead Hospital, Sydney, NSW, Australia Peter McCallum Cancer Centre, Melbourne, Victoria, Australia Royal Hobart Hospital, Hobart, Tasmania, Australia Monash Medical Centre, Clayton, Victoria, Australia St George Hospital, Kogarah, NSW, Australia Princess Alexandra Hospital, Woolloongabba, Queensland, Australia Wesley Medical Centre, Brisbane, Queensland, Australia Royal Prince Alfred Hospital, Camperdown, NSW, Australia Royal Perth Hospital, Perth, Western Australia, Australia Alfred Hospital, Prahran, Victoria, Australia Royal Brisbane Hospital, Herston, Queensland, Australia Mater Hospital, South Brisbane, Queensland, Australia Royal North Shore Hospital, St Leonards, NSW, Australia Mater Hospital, Newcastle, NSW, Australia Liverpool Hospital, Liverpool, NSW, Australia Royal Melbourne Hospital, Melbourne, Victoria, Australia Fremantle Hospital, Fremantle, Western Australia,, Australia * Corresponding author; email: bradstok{at}icpmr.wsahs.nsw.gov.au. High-dose cytarabine used either in induction or consolidation phases of initial treatment has been shown to prolong relapse-free survival in younger patients with newly diagnosed de novo acute myeloid leukemia (AML). However, the value of administering sequential courses of chemotherapy containing high-dose cytarabine in both induction and consolidation therapy has not been assessed in a prospective randomized trial. Between November 1995 and May 2000, the Australasian Leukaemia and Lymphoma Group (ALLG) entered 292 eligible patients onto the ALLG M7 AML protocol to evaluate the role of high-dose cytarabine in both the induction and consolidation phases of treatment for AML. All AML subtypes, excluding FAB M3 and cases of secondary leukemia, were eligible. Patients were aged between 15 and 60 years (median 43 years). Patients received high-dose cytarabine induction therapy with the ICE protocol (idarubicin 9 mg/m2 x 3 days IV, cytarabine 3 g/m2 q 12 hrs by 2 hour IV infusion on days 1,3, 5, 7, and etoposide 75 mg/m2 IV on days 1 to 7). Complete remission was achieved in 234 (80%) patients, with one course of ICE in 225, and two cycles in an additional 9 cases; 5% had resistant leukemia, 3% had prolonged aplasia/thrombocytopenia and 11% were not evaluable, primarily due to early death. 202 of 235 eligible patients entering remission were randomized to consolidation therapy with either a further identical cycle of high-dose cytarabine therapy (ICE), or 2 attenuated courses of cytarabine 100 mg/m2 daily by continuous infusion for 5 days, together with idarubicin (2 doses) and etoposide (5 doses) (IcE). ICE consolidation therapy was more toxic than IcE, with more prolonged neutropenia, and an increase in non-hematological toxicities, however the treatment-related death rate was not significantly different between the 2 arms, 5% for patients receiving ICE, and 2% for IcE (p=0.26). With a median follow-up of 45 months, there was no significant difference between the 2 consolidation arms with regard to relapse-free survival at 3 years (49% for ICE, versus 46% for IcE; p=0.66), overall survival (61% versus 62%; p=0.91) or the cumulative incidence of relapse (43% versus 51%, p=0.31). No difference was detected between the 2 arms within favorable, intermediate, or adverse cytogenetic risk groups. Intensive induction chemotherapy incorporating high-dose cytarabine results in high complete remission rates in younger AML patients, but further intensive consolidation treatment does not appear to confer additional benefit in this context. 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