A randomised comparison of daunorubicin 90mg/m2 vs 60mg/m2 in AML induction: results from the UK NCRI AML17 trial in 1206 patients.
AffiliationDepartment of Haematology, Cardiff University School of Medicine, Cardiff, United Kingdom; firstname.lastname@example.orgDepartment of Haematology, Nottingham University Hospital NHS Trust, Nottingham, United Kingdom;Department of Haematology, Cardiff University School of Medicine, Cardiff, United Kingdom;Department of Haematology, University Hospital of Wales, Cardiff, United Kingdom;Department of Haematology, St Bartholomew's Hospital, London, United Kingdom;Department of Haematology, Rigshospitalet, Copenhagen, Denmark;Department of Haematology, Belfast City Hospital, Belfast, United Kingdom;Blackpool Victoria Hospital, Blackpool, United Kingdom;Department of Haematology, Christie Hospital, Manchester, United Kingdom;Department of Haematology, University of Odense, Odense, Denmark;Department of Haematology, Cardiff University School of Medicine, Cardiff, United Kingdom;Department of Haematology, Heartlands Hospital, Birmingham, United Kingdom;Department of Haematology, Royal Liverpool University Hospital, Liverpool, United Kingdom
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AbstractModifying induction therapy in AML may improve the remission rate and reduce the risk of relapse thereby improving survival. Escalation of the daunorubicin dose to 90mg/m(2) has shown benefit for some patient subgroups when compared with a dose of 45mg/m(2) and has been recommended as a standard of care. However 60mg/m(2) is widely used and has never been directly compared to 90mg/m(2). As part of the UK NCRI AML17 trial 1206 adults with untreated AML or high risk MDS, mostly under 60 years of age, were randomised to a first induction course of chemotherapy which delivered either 90mg/m(2) or 60mg/m(2) on days 1,3 and 5 combined with cytosine arabinoside. All patients then received a second course which included daunorubicin 50mg/m(2) on days 1,3 and 5. There was no overall difference in complete remission rate (CR) (73% vs 75%, OR1.07 (0.83-1.39), p=0.6) or in any recognised subgroup. The 60 day mortality was increased in the 90mg/m2 arm (10% vs 5% (HR 1.98(1.30-3.02) p=0.001)), which resulted in no difference in overall 2 year survival (59% vs 60%, HR 1.16(0.95-1.43), p=0.15). In exploratory subgroup analysis there was no subgroup which showed significant benefit, although there was a significant interaction by FLT3 ITD mutation. The trial is registered to www.isrctn.com as ISRCTN55675535.
CitationA randomised comparison of daunorubicin 90mg/m2 vs 60mg/m2 in AML induction: results from the UK NCRI AML17 trial in 1206 patients. 2015: Blood
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