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dc.contributor.authorBurnett, A
dc.contributor.authorRussell, N
dc.contributor.authorHills, R
dc.contributor.authorKell, J
dc.contributor.authorCavenagh, J
dc.contributor.authorKjeldsen, L
dc.contributor.authorMcMullin, M
dc.contributor.authorCahalin, P
dc.contributor.authorDennis, Michael
dc.contributor.authorFriis, L
dc.contributor.authorThomas, I
dc.contributor.authorMilligan, D
dc.contributor.authorClark, R
dc.date.accessioned2015-04-16T15:14:46Zen
dc.date.available2015-04-16T15:14:46Zen
dc.date.issued2015-04-01en
dc.identifier.citationA randomised comparison of daunorubicin 90mg/m2 vs 60mg/m2 in AML induction: results from the UK NCRI AML17 trial in 1206 patients. 2015: Blooden
dc.identifier.issn1528-0020en
dc.identifier.pmid25833957en
dc.identifier.doi10.1182/blood-2015-01-623447en
dc.identifier.urihttp://hdl.handle.net/10541/550240en
dc.description.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.
dc.languageENGen
dc.language.isoenen
dc.rightsArchived with thanks to Blooden
dc.titleA randomised comparison of daunorubicin 90mg/m2 vs 60mg/m2 in AML induction: results from the UK NCRI AML17 trial in 1206 patients.en
dc.typeArticleen
dc.contributor.departmentDepartment of Haematology, Cardiff University School of Medicine, Cardiff, United Kingdom; akburnett719@gmail.comDepartment 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 Kingdomen
dc.identifier.journalBlooden
html.description.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.


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