DaunoXome + Ara-C vs Daunorubicin + Ara-C in Elderly AML
Status:
Completed
Trial end date:
2005-11-01
Target enrollment:
Participant gender:
Summary
Overall results in the treatment of middle aged adults acute myelogenous leukemia (AML) are
substantially improved in the last decade, with complete remission (CR) rates established to
values of 70 to 80per cent and also encouraging long-term outcome, especially in patients who
can tolerate intensified post remissional treatment strategies. On the contrary, there has
been little progress in the treatment of older patients. In these patients the response rate
generally range between 40 and 60per cent, and overall survival at 2 years is often less than
10 per cent.
Usually, a combination of anthracyclines daunomycin DNR or doxorubicin and cytarabyne Ara-C
has been utilized for the remission-induction treatment, with schedules similar to those
utilized in younger cases, for patients eligible to intensive treatments. Variation of the
dose of DNR has not brought any significant benefit. The EORTC HOVON randomized trial AML9
compared two drugs in induction for previously untreated patients. DNR versus Mithoxantrone
(MTZ). MTZ induction therapy produces a slightly better CR rate than DNR-containing regimen
(47per cent vs 38per cent, P equals 0.069), without any significant effect on remission
duration and survival. The DFS probability between the two treatment arms was not different.
The median DFS estimates were 39 weeks in both groups. The DFS rate at 5 years was 8per cent.
Also the duration of survival was similar (p equals 0.23) in the two treatment groups. Median
survival estimates were 36 weeks (DNR) and 39 weeks (MTZ). The percentage of patients still
alive at 5 years were 6per cent and 9per cent respectively.