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Region Hovedstaden - en del af Københavns Universitetshospital
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A randomized comparison of daunorubicin 90 mg/m2 vs 60 mg/m2 in AML induction: results from the UK NCRI AML17 trial in 1206 patients

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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  • Alan K Burnett
  • Nigel H Russell
  • Robert K Hills
  • Jonathan Kell
  • Jamie Cavenagh
  • Lars Kjeldsen
  • Mary-Frances McMullin
  • Paul Cahalin
  • Mike Dennis
  • Lone Friis
  • Ian F Thomas
  • Don Milligan
  • Richard E Clark
  • UK NCRI AML Study Group
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Modifying induction therapy in acute myeloid leukemia (AML) may improve the remission rate and reduce the risk of relapse, thereby improving survival. Escalation of the daunorubicin dose to 90 mg/m(2) has shown benefit for some patient subgroups when compared with a dose of 45 mg/m(2), and has been recommended as a standard of care. However, 60 mg/m(2) is widely used and has never been directly compared with 90 mg/m(2). As part of the UK National Cancer Research Institute (NCRI) AML17 trial, 1206 adults with untreated AML or high-risk myelodysplastic syndrome, mostly younger than 60 years of age, were randomized to a first-induction course of chemotherapy, which delivered either 90 mg/m(2) or 60 mg/m(2) on days 1, 3, and 5 combined with cytosine arabinoside. All patients then received a second course that included daunorubicin 50 mg/m(2) on days 1, 3, and 5. There was no overall difference in complete remission rate (73% vs 75%; odds ratio, 1.07 [0.83-1.39]; P = .6) or in any recognized subgroup. The 60-day mortality was increased in the 90 mg/m(2) arm (10% vs 5% (hazard ratio [HR] 1.98 [1.30-3.02]; P = .001), which resulted in no difference in overall 2-year survival (59% vs 60%; HR, 1.16 [0.95-1.43]; P = .15). In an exploratory subgroup analysis, there was no subgroup that showed significant benefit, although there was a significant interaction by FLT3 ITD mutation. This trial is registered at http://www.isrctn.com as #ISRCTN55675535.

OriginalsprogEngelsk
TidsskriftBlood
Vol/bind125
Udgave nummer25
Sider (fra-til)3878-85
Antal sider8
ISSN0006-4971
DOI
StatusUdgivet - 18 jun. 2015

ID: 46004327