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Leukemia Drug in High Dose Helps Survival
Date:9/23/2009

ngly argue for incorporating high-dose daunorubicin into the initial treatment of younger patients with AML, at least for those with favorable- and intermediate-risk cytogenetic profiles, unless an increased rate of toxic effects is feared when high-dose daunorubicin is used in association with new agents, such as FLT3 inhibitors, currently in ongoing trials."

According to the Leukemia & Lymphoma Society, 13,290 Americans were "expected to be diagnosed" with AML last year. Half of all AML patients are older than 65.

Treatment usually includes a so-called "7+3" induction regimen, in which patients are given cytarabine for seven days and daunorubicin (or a related drug, such as idarubicin) for three. The daunorubicin is typically administered at 45 mg per square meter of body surface area, yet anecdotal evidence suggested higher doses might be more effective, Fernandez said.

The two research teams set out to determine whether that was actually the case -- in patients younger than age 60 in the ECOG trial, or older than age 60 in the European trial.

Rates of complete remission and overall survival improved in both studies. Yet the effects were most pronounced when the researchers focused on specific subgroups, rather than the entire study population.

For instance, in the ECOG study overall, complete remission rates jumped from 57.3 percent for the standard treatment group, to 70.6 percent for the high-dose group, while median survival improved from 15.7 months to 23.7. For those patients younger than 50, survival improved from a median of 19 months, to 34.3 months. But no benefit was seen for patients 50 or older.

Similarly, survival improved from 20.7 to 34.3 months for patients with "favorable" or "intermediate" genetic profiles, but no benefit at all was observed in patients with an "unfavorable" profile.

In the European trial, overall complete remission rates rose in the high-dose grou
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