Modification or Dose or Treatment Duration Has No Impact on Outcome of AML in Older Patients: Preliminary Results of the UK NCRI AML14 Trial.

The NCRI AML14 Trial was devised for patients aged over 60 years with de novo or secondary AML or high risk MDS (defined as >10% blasts). There was a non-intensive option which compared Low Dose Ara-C vs Hydroxyurea each with or without All-Trans Retinoic Acid which has been reported previously (Burnett et al Blood 2004: 249a), and an intensive approach which we now report. This compared two dose levels of Daunorubicin (50mg/m2 vs 35mg/m2) and Ara-C (200mg/m2 vs 400mg/m2) within a Daunorubicin/Ara-C (3+10) followed by (3+8) schedule. After a 3rd course (MidAC: Mitoxantrone/Ara-C), patients were randomised to receive or not a 4th course (ICE: Idarubicin/Ara-C/Etoposide). In addition some patients (n=200) were randomised to receive PSC-833 in addition to Dauno 35. The results of this randomisation have been reported previously (Burnett et al Blood 2003614a).