Participating centres and individuals are listed in Appendix 1.
Results of a randomized trial in children with Acute Myeloid Leukaemia: Medical Research Council AML12 trial
Article first published online: 9 SEP 2011
© 2011 Blackwell Publishing Ltd
British Journal of Haematology
Volume 155, Issue 3, pages 366–376, November 2011
How to Cite
Gibson, B. E. S., Webb, D. K. H., Howman, A. J., De Graaf, S. S. N., Harrison, C. J., Wheatley, K. and for the United Kingdom Childhood Leukaemia Working Group and the Dutch Childhood Oncology Group (2011), Results of a randomized trial in children with Acute Myeloid Leukaemia: Medical Research Council AML12 trial. British Journal of Haematology, 155: 366–376. doi: 10.1111/j.1365-2141.2011.08851.x
- Issue published online: 11 OCT 2011
- Article first published online: 9 SEP 2011
- Received 28 April 2011; accepted for publication 11 July 2011
- myeloid leukaemia;
- childhood leukaemia;
- clinical trial;
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.