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Results of a randomized trial in children with Acute Myeloid Leukaemia: Medical Research Council AML12 trial

Lookup NU author(s): Professor Christine Harrison FRCPath FMedSci


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The Medical Research Council Acute Myeloid Leukaemia 12 (MRC AML12) trial (children) addressed the optimal anthracenedione/anthracycline in induction and the optimal number of courses of consolidation chemotherapy. 504 children (<16 years) with AML were randomized between mitoxantrone/cytarabine/etoposide or daunorubicin/cytarabine/etoposide as induction chemotherapy and 270 entered a second randomization between a total of four or five courses of treatment. Ten-year event-free (EFS) and overall survival (OS) was 54% and 63% respectively; the relapse rate was 35%. There was no difference in complete remission rate between the induction regimens, but there was a benefit for mitoxantrone with regard to relapse rate [32% vs. 39%; Hazard ratio (HR) 0.73; 95% confidence interval (CI) 0.54, 1.00] and disease-free survival (DFS; 63% vs. 55%; HR 0.72; 95% CI 0.54, 0.96). However, this did not translate into a better EFS or OS (HR 0.84; 95% CI 0.63, 1.12). Results of the second randomization did not show a survival benefit for a fifth course of treatment (HR 1.01; 95% CI 0.63, 1.62), suggesting a ceiling of benefit for conventional chemotherapy and demonstrating the need for new agents. EFS was superior compared to the preceding trial AML10, partly due to fewer deaths in remission, highlighting the importance of supportive care.

Publication metadata

Author(s): Gibson BES, Webb DKH, Howman AJ, De Graaf SSN, Harrison CJ, Wheatley K, United Kingdom Childhood Leukaemia, Dutch Childhood Oncology Grp

Publication type: Article

Publication status: Published

Journal: British Journal of Haematology

Year: 2011

Volume: 155

Issue: 3

Pages: 366-376

Print publication date: 01/11/2011

ISSN (print): 0007-1048

ISSN (electronic): 1365-2141

Publisher: Wiley-Blackwell Publishing Ltd.


DOI: 10.1111/j.1365-2141.2011.08851.x


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